U.S. FOOD AND DRUG ADMINISTRATION

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

MEDICAL DEVICES ADVISORY COMMITTEE

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GENERAL AND PLASTIC SURGERY DEVICES PANEL

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66TH MEETING

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MONDAY,

APRIL 11, 2005

The Panel met at 8:00 a.m. in Salons A, B,

and C of the Hilton Washington, D.C.

North/Gaithersburg, 620 Perry Parkway, Gaithersburg,

Maryland, MICHAEL A. CHOTI, M.D., Chairman, presiding.

PRESENT:

MICHAEL A. CHOTI, M.D., Chairman

GRACE T. BARTOO, Ph.D., RAC, Industry Representative

BRENT A. BLUMENSTEIN, Ph.D., Voting Member

LEIGH F. CALLAHAN, Ph.D., Temporary Voting Member

LEELEE DOYLE, Ph.D., Consumer Representative

CHERYL A. EWING, M.D., Voting Member

A. MARILYN LEITCH, M.D., Voting Member

STEPHEN LI, Ph.D., Temporary Voting Member

JOSEPH LoCICERO III, M.D., Voting Member

BARBARA R. MANNO, Ph.D., Temporary Voting Member

MICHAEL J. MILLER, M.D., Voting Member

AMY E. NEWBURGER, M.D., Voting Member

DAVID KRAUSE, Ph.D., Executive Secretary

I‑N‑D‑E‑X

AGENDA ITEM: PAGE

Call to Order 3

Conflict of Interest and Opening Remarks 4

David Krause, Ph.D. Executive Secretary

Panel Introductions 6

Michael Choti, M.D., Chairman

Panel Update 13

CDR Stephen R. Rhoades, USPHS, Acting Deputy

Director, Division of General, Restorative,

and Neurological Devices, Office of Device

Evaluation

Welcoming Remarks 16

Miriam Provost, Ph.D., Acting Director,

DGRND, ODE

Open Public Comment 26

P‑R‑O‑C‑E‑E‑D‑I‑N‑G‑S

(8:05 a.m.)

CALL TO ORDER

EXECUTIVE SECRETARY KRAUSE: Good morning everybody. If we could have
everybody find a chair? We\'re trying to get the speakers. There are
still some speakers outside. And it\'s the staff trying to get them in.
So we may have to wait a little bit later, but I think we\'ll go ahead
and get started now. And then if everybody\'s not quite ready, we\'ll
just hold up a few minutes. But I think we\'ll get the meeting started
so that we can at least try to keep close to schedule.

Good morning, everyone. We\'re ready to begin the 66th meeting of the
General and Plastic Surgery Devices Panel. My name is David Krause. I\'m
the Executive Secretary of this panel. And I\'m also a biologist and a
reviewer in the Plastic and Reconstructive Surgery Devices Branch in the
Division of General, Restorative, and Neurological Devices.

I\'d like to remind everyone that you are requested to sign in on the
attendants\' sheets, which are available at the tables by the doors just
outside. You may also pick up an agenda, a panel member roster, and
information about today\'s meeting out there on the tables.

The information includes how to find out about future meeting dates
through the advisory panel phone line and how to obtain meeting minutes
or transcripts.

Before I turn the meeting over to Dr. Choti, I\'m required to read a
statement into the record regarding conflict of interest.

CONFLICT OF INTEREST AND OPENING REMARKS

EXECUTIVE SECRETARY KRAUSE: \"The following announcement addresses
conflict of interest issues associated with this meeting and is made a
part of the record to preclude the appearance of an impropriety.

\"To determine if any conflict existed, the agency reviewed the
submitted agenda for this meeting and all financial interests reported
by the committee participants.

\"Conflict of interest statutes prohibit special government employees
from participating in matters that could affect their or their
employers\' financial interests. However, the agency has determined that
participation of certain members and consultants, the need for whose
services outweigh the potential conflict of interest involved, is in the
best interest of the government.

\"We would like to note for the record that the agency took into
consideration certain matters regarding Dr. Miller. Dr. Miller reported
his institution\'s past and current involvement with firms at issue.

\"In the absence of personal financial interest, the agency has
determined that he may participate fully in the panel\'s deliberations.
In the event that the discussions involve any other products or firms
not already on the agenda for which an FDA participant has a financial
interest, a participant should excuse him or her self from such
involvement. And the exclusion will be noted for the record.

\"With respect to all other participants, we ask in the interest of
fairness that all persons making statements or presentations disclose
any current or previous financial involvement with any firm whose
products they may wish to comment upon.\"

At this point I\'d like to turn the meeting over to Dr. Choti, the
chairman.

CHAIRMAN CHOTI: Thank you, Dr. Krause, and good morning.

My name is Dr. Michael Choti. I\'m in the Division of Surgical Oncology
at Johns Hopkins University. And I am the standing chair of this panel.

During this three‑day meeting, we, our panel, would like to make
recommendations to the Food and Drug Administration on two pre‑market
approval applications.

PANEL INTRODUCTIONS

CHAIRMAN CHOTI: The next item of business is to introduce the panel
members, who are giving their time to help the FDA in these matters and
the FDA staff here at the table. I\'m going to ask each person to
introduce him or herself, starting with both the area of expertise,
position title, institution, and his or her status on the panel, either
voting member or industry. Let me start on the left side of the panel
here with Dr. Bartoo.

MEMBER BARTOO: My name is Grace Bartoo. I\'m the General Manager of
Decus Biomedical. I have experience in biomedical engineering. That\'s
what my training is in. But I also have a lot of experience in clinical
trials and medical advice research.

I am the industry representative for the panel.

MEMBER DOYLE: My name is LeeLee Doyle. I have a Ph.D. in reproductive
physiology. I am a Professor Emeritus of Obstetrics and Gynecology and
currently the Assistant Dean for Faculty Development at the University
of Arkansas for Medical Sciences College of Medicine.

I am the consumer representative, a nonvoting member.

MEMBER BLUMENSTEIN: My name is Brent Blumenstein. I am a
biostatistician. I work independently from Seattle, Washington.

MEMBER EWING: My name is Cheryl Ewing. I am a faculty member at the
University of California at San Francisco in the Department of Surgery
in surgical oncology with a specialty in breast oncology.

MEMBER NEWBURGER: I\'m Dr. Amy Newburger. I\'m a dermatologist in
private practice, Director of Dermatology Consultants of Westchester. I
teach at St. Luke\'s‑Roosevelt Hospital Medical Consortium.

MEMBER LoCICERO: I\'m Joseph LoCicero. I\'m a thoracic surgeon
specializing in foregut surgery. I\'m Professor and Chair of Surgery at
the University of South Alabama.

And I am a voting member.

MEMBER MANNO: I\'m Dr. Barbara Manno. I am a toxicologist. I\'m a
professor with the Department of Psychiatry at the Louisiana State
University Health Sciences Center in Shreveport, Louisiana and voting
today.

MEMBER LI: My name is Steve Li. I am the President of Medical Device
Testing and Innovations in Sarasota, Florida. My areas of expertise are
biomechanics and biomaterials.

And I am a voting member today.

EXECUTIVE SECRETARY KRAUSE: My name is David Krause. I am the Executive
Secretary.

MEMBER CALLAHAN: I\'m Leigh Callahan. I\'m a health outcomes researcher,
an epidemiologist at the University of North Carolina in Chapel Hill.
I\'m in the Departments of Medicine and Orthopedics.

And I am a temporary voting member for this panel.

DR. MILLER: I\'m Michael Miller. I am Professor and Deputy Chairman of
Plastic Surgery at University of Texas, M. D. Anderson Cancer Center.

My clinical work involves cancer‑related reconstructive surgery. I also
have appointments in biomedical engineering with the University of Texas
Center for Biomedical Engineering and at Rice University.

MEMBER LEITCH: I\'m Marilyn Leitch. I\'m a surgical oncologist at the
University of Texas Southwestern Medical Center in Dallas. I also am
involved primarily in the treatment of breast cancer patients but do see
patients with benign diseases as well. And I am a professor of surgery.

DR. PROVOST: I\'m Miriam Provost. I am Acting Director for the Division
of General, Restorative, and Neurological Devices in the Office of
Device Evaluation at FDA.

EXECUTIVE SECRETARY KRAUSE: Let me just clarify for the record that Drs.
Leitch, Miller, LoCicero, Newburger, Ewing, and Blumenstein are all
voting members on this panel. Drs. Manno, Li, and Callahan are deputized
voting members. And we will read the deputization memo tomorrow.

CHAIRMAN CHOTI: I would like to note for the record that the voting
members present constitute a quorum, as required by 21 CFR Part 14.

Let me read a letter from Dr. Michael Olding, who was to be a member, a
nonvoting member, on this panel. He elected not to be present and
requested that the following letter be read, \"Dear Dr. Choti, I would
like to request the following statement to be read into the record at
the time of the General and Plastic Surgery Panel meeting.

\"On December 2004, I agreed to serve on this panel with great
enthusiasm for its mission and with a full understanding of the
commitment and the need for impartiality. Accordingly, I completed the
required conflict of interest statement in January 2005, indicated that
there are no conflicts.

\"Subsequently, on March 21st, 2005, Medicus Pharmaceutical Corporation
announced plans to merge with Inamed Corporation, a firm at issue. That
merger is subject to approval by stockholders, regulatory approvals, and
customary closing conditions according to the companies.

\"Upon learning of the planned merger, I immediately notified the
Executive Secretary of the proposed merger and that I owned a quantity
of stock in Medicus.

\"Initially, on April 1st, 2005, the Executive Secretary indicated that
my service on the panel would not be affected by my stock holdings and
the planned merger, but one business day before this meeting, on Friday,
April 8th, I received a fax from Integrity Committee and Conference
Management Branch informing me that due to the stock‑holding value,
between 50,000 and 100,000, in a firm that is slated to merge with a
firm at issue, I would be excluded from voting on the panel. It does
appear that I would be allowed to \'review and discuss matters before
the panel,\' even though I am denied the right to vote.

\"As the chronology demonstrates, the incipient conflict was created by
the decision of the two companies to merge and not by any action on my
part. Indeed, I made the FDA aware of the situation.

\"I was fully prepared and committed to continuing my service on the
panel impartially and a relatively small stock‑holding I have in the
company, which until March 2005 had no interest in the outcome of our
work, would have no bearing on my decision‑making process.

\"I do not feel it is appropriate for me to continue my service on the
panel as a partial member; that is, one without voting rights. Since the
FDA has concluded that my voting may create an appearance of a conflict
due to my stock holdings, I do not want my continued service as a
nonvoting panel member to be suspect in any way.

\"I regret having to make this decision as I possess important
experience as a plastic surgeon for the panel to consider. And my
departure will leave only one other professional with similar
experience. But the handicap that the FDA has placed upon me because of
the incipient conflict, not of my making, that arose since my
appointment to the panel makes my decision necessary.

\"Thank you for your consideration and understanding. And good luck to
you and the panel in your important work. Sincerely, Michael Olding.\"

Now I would like to introduce Commander Stephen Rhoades, the Acting
Deputy Director of the Division of General, Restorative, and
Neurological Devices, who will update the panel since the last meeting.

Dr. Rhoades?

CDR RHOADES: Thank you, Dr. Choti.

PANEL UPDATE

CDR RHOADES: I am Stephen Rhoades. I am the Acting Deputy Director in
the Division of General, Restorative, and Neurological Devices. Welcome,
members of the panel, members of the public, and manufacturers, to this
important three‑day meeting of the General and Plastic Surgery Devices
Panel on two silicone gel‑filled breast implants.

Tomorrow you will make recommendations and vote on Inamed Corporation\'s
pre‑market approval application. On Wednesday, you will make
recommendations and vote on Mentor Corporation\'s pre‑market approval
application.

Because of the high public interest in silicone gel‑filled breast
implants, in addition to the regular public comment periods for any PMA
discussion, we have scheduled a full day for a public comment on issues
related to silicone gel‑filled breast implants.

This panel last met on March 25th of 2004, at which time you recommended
approval of Dermik Laboratories pre‑market approval application for
their Sculptra dermal filler for lipoatrophy in HIV‑positive patients.
This device application was approved on August 3rd with a conditional
post‑approval study to evaluate long‑term safety.

On April 22nd of 2004, FDA approved Genzyme Corporation\'s Hylaform
dermal filler for moderate to severe facial wrinkles and folds.

This panel recommended approval of this device at the November 21st,
2003 panel meeting. The approval included a condition for a
post‑approval study in patients with Fitzpatrick IV to VI skin types.

On August 9th, 2004, FDA issued a final rule classifying silicone
sheeting for the management of closed hyperproliferative scars as Class
I devices exempt from pre‑market notification. This panel recommended
that these be Class I‑exempt at the July 24th, 2003 panel meeting.

The agency appreciates the commitment of the panel members. And we also
appreciate the comments of the representatives of the 30 professional
organizations and 145 members of the public who have requested time to
address the panel today.

Thank you for your attention. I would now like to introduce Dr. Miriam
Provost for a few words.

WELCOMING REMARKS

DR. PROVOST: Good morning. As Commander Rhoades said, I am Miriam
Provost. I am the Acting Director for the Division of General,
Restorative, and Neurological Devices.

I would like to just take a few minutes and give everyone a brief
regulatory background followed by a discussion of why we have convened
this meeting and what are we asking you, our distinguished advisory
panel, to do.

First, some background on the regulatory status of silicone gel‑filled
breast implants. Prior to 1991, silicone gel‑filled breast implants were
sold on the market either as pre‑amendments devices, which means they
were on the market prior to May 1976, or as a 510(k)‑cleared device.

In April 1991, FDA issued a regulation that required all manufacturers
of silicone gel‑filled breast implants to submit safety and
effectiveness data in PMAs in order for their products to remain on the
market.

Several PMAs were submitted and presented to an advisory panel in
November 1991 and then again in February 1992. In April 1992, FDA
determined that the PMAs did not include adequate safety data to support
approval. However, at the same time, FDA believed there was a public
health need to have breast implants available for reconstruction in
revision patients.

In 1992, because FDA believed it was important to provide continued
availability of silicone gel‑filled breast implants for women seeking
breast reconstruction or revision, we developed a new type of study
design referred to by industry and the FDA as an adjunct study.

Inamed in 1998 and Mentor in 1992 are the only two companies that have
received FDA approval for an adjunct study. Inamed\'s and Mentor\'s
adjunct studies currently remain active. Both adjunct studies require
five‑year follow‑up for each patient enrolled. And there is no limit on
the enrollment of reconstruction or revision patients or on the number
of investigational sties.

Adjunct studies are focused on the collection of safety data and do not
include MRIs screening for silent rupture. The 1992 agreements between
FDA and industry also described information to be collected in the study
design to evaluate safety and effectiveness to support a PMA, the
so‑called \"core study.\"

The investigational device exemption, or IDE, studies are the mechanism
by which the core study data, which you will hear referenced during this
panel meeting, are collected.

Inamed submitted and received approval for their core study in 1998.
Mentor submitted and received approval for their core study in 2000.

At the current time, FDA has not approved any PMAs for silicone
gel‑filled breast implants. They remain investigational devices, which
means that a patient must be enrolled in an adjunct study or an IDE
study in order to receive one of these implants in the U.S.

I\'d also like to note that in January 2004, FDA issued a draft update
of our guidance document for manufacturers of breast implants. This
document is a framework for breast implant manufacturers. And it
includes recommendations on the kind of information that FDA recommends
be provided in a PMA.

We have received numerous comments on the draft guidance. And at the
present time, we are continuing to review the comments that we received.
Once we have reviewed the comments and made revisions, as appropriate,
the guidance document will be released in final.

It should be emphasized that our review of the information in a PMA is
not affected by whether a guidance document for the product in question
is in draft or final form. As is the case for all medical device
applications, FDA will base our decisions on the scientific and clinical
data in the PMAs as well as the panel\'s deliberations and
recommendations regarding those data.

Now for the task at hand. Inamed\'s PMA, P020056, was presented
previously at the October 2003 meeting of the General and Plastic
Surgery Devices Advisory Panel. The panel recommended in a nine to six
vote that the PMA was approvable with conditions.

In January of 2004, after considering the data in the PMA and the
panel\'s deliberations of the data, we determined that the PMA was not
approvable because the data did not provide a reasonable assurance of
safety for the device.

Therefore, FDA\'s presentation at this panel meeting for the Inamed PMA
will focus on the additional information submitted by Inamed to address
the outstanding safety issues. The Inamed PMA will be the panel\'s focus
on Tuesday.

Mentor\'s PMA, P030053, is being presented for the first time at a panel
meeting. Therefore, FDA\'s presentation for this PMA will involve a
summary of all relevant preclinical and clinical data. The Mentor PMA
will be the panel\'s focus on Wednesday.

It should be noted that, although the core study is the primary source
of clinical data for both PMAs, both sponsors use data and information
from multiple sources to address the key safety issues.

Based on your own scientific and clinical knowledge, we are asking you,
the panel, to discuss the data in each individual PMA and advise us as
to whether there is sufficient information to provide a reasonable
assurance of safety and effectiveness for each device.

After the panel meeting, FDA will continue to review the information
contained in this PMA. We will carefully consider the deliberations and
recommendations that you make during this meeting. Ultimately FDA will
make a decision on the approvability of these two PMAs.

We will also hear a number of comments from the public today as well as
on Tuesday and Wednesday. And I want to thank the members of the public
for making the effort to come here today to present their views on these
applications.

I want to assure everyone that the FDA will carefully listen to these
comments. And, as previously stated, we will make our decision based on
the scientific data in the PMAs and the panel\'s deliberations on the
data.

I do want to remind everyone, however, that this meeting is not intended
as a general referendum on silicone gel‑filled breast implants. This
panel meeting focuses specifically on the safety and effectiveness of
two individual breast implant PMAs. And the object of this meeting is to
obtain input from you, the panel, on the data in these applications. The
FDA is very appreciative of your giving of your time and expertise to
accomplish this important task.

Thank you very much. And now I\'m going to turn it back over to you, Dr.
Choti.

CHAIRMAN CHOTI: Thank you, Dr. Provost.

We will now proceed with the open public hearing session of this
meeting. All persons addressing the panel are asked to speak clearly
into the microphone as the transcriptionist is depending on this as a
means to accurate recording of the meeting.

I would like to have the attention of all of the individuals who are
registered to speak to the panel today. You have been given a number of
correspondence regarding the order of your appearance.

Please come to the podium area in advance so that we are not spending a
great deal of time in transitions from speaker to speaker. And we have
two podiums set up in order to alternate and for time sake. The FDA
panel will direct you to the appropriate podium.

Please remain within your time constraints as a timer will be present to
help you with this. We have many public speakers today. And so it is
extremely important that we stay on time.

There is a yellow light that will flash 30 seconds before your time is
up. And the red light flashes as soon as your time is up. If you\'re
still speaking at that time, then I will promptly instruct you to
summarize and cut off. If after ten seconds that is not done, then I
have been told that the microphone will be cut off. So please try to
stay to your allotted times.

Also, regarding your written comments, please only bring to the panel
your written comments that have been submitted or your presentation
slides. No additional material, please.

We would also like to address the issue of financial disclosure. Before
the Food and Drug Administration and the public believe in transparent
process for the information gathering and decision‑making, to ensure
such transparency at the open public hearing session of the Advisory
Committee meeting, the FDA believes it is important to understand the
context of an individual\'s presentation.

For this reason, the FDA encourages you, the open public hearing
speaker, at the beginning of your written or oral statement to advise
the Committee of any financial relationship you may have with the
sponsor; its product; and, if known, its direct competitors. For
example, this financial information may include the sponsor\'s payment
for your travel, lodging, or other expenses in connection with your
attendance at the meeting. Likewise, the FDA encourages that you at the
beginning of your statement advise the Committee if you do not have such
financial relationships.

If you do not choose to address this issue of financial relationships at
the beginning of your presentation, it will not preclude you from
speaking.

Let\'s begin with the first speaker. These individuals are the ones who
have notified the FDA of their intent to testify during the open public
session.

The first speaker, please? Thank you. Good morning.

MS. JOHNSTON: Thank you.

OPEN PUBLIC COMMENT

MS. JOHNSTON: Good morning. My name is Kathy Keithley Johnston. I\'m the
Executive Director and founder of Toxic Discovery, a national
not‑for‑profit consumer advocacy organization. I am also a registered
nurse. And I myself used to have silicone gel breast implants. I have no
conflicts of interest.

I am here today carrying the voices of thousands who have been directly
affected by the failure of the FDA to require long‑term safety studies
concerning breast implants.

We believe the FDA made the right decision in 2004 when they decided not
to approve Inamed\'s silicone breast implants. The new guidance that the
FDA issued at the same time was an important step forward, demonstrating
the FDA\'s commitment to assure that breast implants are safe for
long‑term health studies before they allow them to be widely sold.

I am here today counting on you to help the FDA to adhere to the
guidance document. Silicone breast implants should not be approved until
a company can prove the safety of devices for long‑term use. Since
safety cannot be proven, we ask you to deny the manufacturer\'s
application.

Implant lobbyists claim that there are over 100 studies of women with
implants that show no evidence of harm. That is clearly and absolutely
false. These groups conveniently ignore the following studies: a study
by the FDA of women with silicone breast implants that at least found
for six years that women had at least one failed breast implant, even
though they did not know it. This is referred to as a \"silent
rupture.\"

That same study found that 21 percent had silicone leakage outside the
scar capsule surrounding their implant. From there, silicone could harm
breast tissue, could migrate into lymph nodes and, thereby, travel to
lungs, liver, or other vital organs.

The FDA also found that women with leaking silicone breast implants were
more likely to report fibromyalgia and other connective tissue diseases.
Scientists at the National Cancer Institute found that women having
breast implants for at least seven years were twice as likely to die of
brain cancer, three times as likely to die of lung cancer, and four
times as likely to commit suicide compared to other plastic surgery
patients.

A Canadian study found that women with breast implants for augmentation
were more likely to be hospitalized and had more physician visits than
women of the same age living in the same communities.

These are just a few of the studies that were a serious concern about
risk of silicone leakage. Research has not yet been done to determine
exactly what chemicals leak into a woman\'s body and what long‑term
health consequences then results from that leakage and migration of
silicone. How can informed consent be obtained when information is not
even known by the very physician implanting these risky devices?

Neither Inamed nor Mentor has conducted studies of the health impact of
leaking silicone in a woman\'s body. Dow‑Corning has funded one such
study. In a Danish study, Holmich claimed that leakage was not
significantly related to connective tissue disease. However, there were
only 23 women in this study with extracapsular leakage, a sample that is
much too small to provide meaningful safety data. In fact, the study
showed that women were four times as likely in that study to report a
connective tissue disease compared to women whose implants were not
ruptured. But these impressive differences were not statistically
significant because the sample was too small.

You would certainly think after 40 years that implant manufacturers
should find more than 23 women with extracapsular rupture. Without a
doubt, there are more than 40 in this very room today. There are
hundreds of thousands of women in this nation whose body would show you
that leakage is present if testing was provided.

Our organization has serious concerns about the integrity of the studies
conducted by Inamed and Mentor. Patients in these studies have informed
us of their fears that they believed that their problems with implants
were never reported by their physician or the manufacturer.

In closing, let me remind you of the duties of the FDA. First and
foremost, the FDA is a public health agency charged with protecting
American consumers. The FDA should be the consumer watchdog and not the
advocate of the breast implant manufacturer.

It is your job to make sure that the FDA protects patient safety
concerning breast implants. This can only be done by requiring long‑term
health studies before approval and not after approval.

It is certainly not your job to protect the livelihood of plastic
surgeons or implant makers. Both have failed in their promises to
protect women, which will not make the situation better. It will only
allow it to continue. And we ask you, please protect the women of this
nation.

CHAIRMAN CHOTI: Thank you.

Next speaker?

MS. GROSS: Good morning, panel. I am Marcy Gross. I am a consultant who
specializes in women\'s health issues. I am a member of the State of
Maryland Women\'s Health Promotion Council and serve on the boards of
various private health organizations.

Prior to becoming a consultant, I worked for the Department of Health,
U.S. Department of Health and Human Services, where I was a Senior
Policy Analyst for a number of years in the Office of the Assistant
Secretary for Health. And in my last position, I was the Senior Adviser
for Women\'s Health at the Agency for Healthcare Research and Quality,
where I served while there on the secretarial ad hoc task force on
silicone breast implants.

I give you this resume to establish my familiarity with the issues at
hand. However, I am speaking as a private citizen. I have no financial
links to any of the applicants.

A legacy from my six‑year tenure at AHRQ is an appreciation of the need
for a strong evidence base to support medical decisions. One of my
concerns today is that an adequate evidence base for the approval of
silicone gel breast prosthesis still does not exist. Worse, a truly
long‑term gold standard study that will produce independent, objective
research findings seems not to be on the horizon.

We do have 40 years of experience with breast implants, including 25
years when the silicone implants were available to women, all women.
They were pulled from the market for good reason. They were associated
with major medical problems.

The basic facts on this issue have not changed in the 14 years
subsequent. First, available studies on the health aspects of silicone
gel implants are still short‑term and are often produced by companies
that manufacture the devices or materials.

Second, the work that is available, some from FDA itself, indicates that
the rate of complications of implantation, reinfections, reoperations,
and other adverse events are sufficiently high to remain a major
concern, despite advances in materials.

Third ‑‑ and this is a change from the past ‑‑ the Mentor applicant
agrees that the devices will not last indefinitely and warned women that
they should expect to have them replaced. So the issue becomes one of
sequencing in looking at the data. Do we get the data first and approval
after or the reverse?

Letting women be living testers I find highly objectionable since these
are elective procedures and there are alternatives, especially since the
data on improvements in the quality of life for patients undergoing
implantation are weak by accepted research standards and most especially
since it is expected the devices will fail and will have to be removed.

On this last point, the overall failure rate, it should be noted that
Mentor acknowledges that their devices will have a finite in vivo life,
which means, really, that all will fail and need to be surgically
removed. We just don\'t know when.

I would assert that if this were an NIH‑funded research study, it\'s
unlikely it would go forward.

CHAIRMAN CHOTI: Please sum up for us.

MS. GROSS: Yes, please. I just ask that you have the data in hand before
you reintroduce the silicone breast implants. Thank you for your time.

CHAIRMAN CHOTI: Thank you.

Let me remind the audience that speakers have three minutes unless it\'s
a national organization. And then it\'s five minutes.

Yes, next speaker?

MR. SCHULTZ: Good morning. My name is William Schultz. I am representing
a group of women\'s organizations led by Command Trust. I appreciate
being given five minutes. Thank you.

Thank you for the opportunity to address this Committee on the very
important question of whether FDA should approve the applications for
silicone gel breast implants. For the record, I have no financial ties
to either of the applicants.

Congress enacted the medical device amendments in 1976 in the wake of
several tragedies, including the Dalkon shield IUD, which killed 16
women and injured countless others. Congress sought to remedy the defect
by a new law, the defect being that medical devices were being marketed
without any demonstration of their safety or any adequate testing.

Congress was particularly concerned about the safety of implantable
devices. The basic showing that it required manufacturers of these
devices to make was that there was a reasonable assurance that the
device was safe and effective. In the case of breast implants, efficacy
is obviously not the issue. Instead, the issue is safety.

If you think about it, for a therapeutic product, such as a heart valve,
the safety standard entails a weighing of risk versus benefits to
health. And so FDA may approve a product with substantial risks if it
finds the benefits are even greater.

But for a cosmetic product, which is what we have before us today, there
are no therapeutic benefits. For these products, the law does not allow
approval if the product is associated with significant risk or even if
there is significant uncertainty about safety. And I think that is a
very important principle to keep in mind as we go through the next three
days.

It is also relevant that the manufacturer has the burden of proof. Where
there are doubts or uncertainties, then the product may not be approved
because the manufacturer has not carried its burden. The law does not
contemplate that the patients or consumers should bear the risk of
unanswered questions.

At the October 2003 Advisory Committee meeting, there was discussion of
various approval conditions and post‑market studies. First, the
Committee should understand that any approval conditions are not
enforceable by FDA. Once the agency approves a product, then physicians
are allowed to deviate from restrictions on the use of the product. And
FDA has no authority to enforce those restrictions.

Second, while post‑market studies may be useful, they cannot substitute
for the basic safety standard in the statute. The statute does not
provide that the agency may approve a product now and allow the
demonstration of safety at a later date.

At the last Advisor Committee meeting, there was also discussion about
whether women should have the option or the choice of using breast
implants as long as they were fully informed.

Although Congress has adopted the buyer beware approach for dietary
supplements and in other areas, this was not the approach that it
adopted for medical devices. Instead, for these products, it has
declared in law that medical devices are not to be available until the
manufacturer has demonstrated safety. It is this Committee\'s charge to
do its best to apply that law.

Congress\' approach has two important benefits. First, it means that
patients and consumers can be confident of the safety of device products
that they use. It also creates an important incentive to the
manufacturers to design their products to meet the high standard that
Congress established.

Significant questions have been raised about the safety of breast
implants. I\'m not going to address those. But it\'s important, of
course. These products are going to be in the body for many years. Even
though the manufacturers have known about the standards of the statute
for more than 25 years, we don\'t really have long‑term data. And given
the extremely high breakage rate of these products, lack of long‑term
data raises serious problems.

In January 2004, FDA determined that the evidence was not adequate. And
the question that this Committee must look at is whether the companies
have produced additional data that is sufficient to justify approval.

In conclusion, approval of silicone gel breast implants without an
adequate demonstration of safety would have two very unfortunate
consequences. First, we would have lost the opportunity to require that
these products be adequately tested.

And, perhaps even more important, such a decision would send a message
to other product manufacturers that the door has been open for approval
of medical devices that do not meet the safety requirements established
by law and that patients will suffer.

Thank you very much. And good luck.

CHAIRMAN CHOTI: Thank you.

Next speaker?

DR. HELMAN: Hi. Good morning. I\'m Susan Helman from Florida. I have
paid my own way here because I feel that this panel needs to hear from
women like me.

I had breast implants for 15 years and suffered greatly. My implants
ruptured. And after numerous surgeries to remove silicone from my body,
the last surgeon stated, \"There is no way to remove it all, Susan.
It\'s migrated to all your tissues, your organs. It\'s everywhere.\"
Silicone as well as platinum was found in my cheek cells, bone marrow,
and lymph nodes, also in my urine and in my blood.

My urine platinum levels when measured eight years after explantation
were 25 parts per billion, which is within the range of patients
receiving chemotherapy agent cisplatin. The urine platinum level in the
general population is .04 parts per billion. So mine was more than 500
times greater.

The platinum ion in my urine and in my tissues I found was the exact
match to my implants that they studied as well. My body is full of
ionized platinum with no known way to remove it.

As you know, the CDC has identified platinum as a suspected toxin.
Because of my ruptured implants and the resulting exposure to silicone
and platinum, I have been diagnosed with MS and lupus and fibromyalgia
and scleroderma among many other things.

And I\'m sick. And I can\'t get health insurance. When I need it the
most, I can\'t get it. I don\'t want anybody else to suffer this way. I
get severe disabling headaches and nausea when I am exposed to exhaust
fumes or unusual odors of any kind, and I never had this problem before
ever.

I\'m also concerned about young women of childbearing age and their
children. I\'ve heard that platinum can be transmitted in milk. And I
have platinum in my urine. So, you know, I see no reason why it
couldn\'t be in breast milk.

Any mother would be heartbroken to find out that during a cosmetic
surgery, unbeknownst to her, it caused her breast milk to be adulterated
and cause injury to her newborn child.

I just ask that before implants are considered safe, platinum testing be
done on a random sample of women with silicone gel breast implants and
on women with implants, the breast milk of women with implants.

And, in closing, please, please, please vote against the gel‑filled
breast implants until you\'re sure that the benefits far outweigh the
risks. The first oath a doctor learns is do no harm.

Thank you.

CHAIRMAN CHOTI: Thank you.

Next speaker?

DR. GLICKSMAN: Mr. Chairman and members of the panel, my name is Dr.
Caroline Glicksman. And I am reading the testimony from my patient
Valerie Hartwell, a 45‑year‑old mother of 3 who is unable to attend
today because of work requirements.

\"I would like to advise the Committee that I have no financial
relationships with anyone connected at this meeting. I had silicone
breast implants for two years. I had them put in because of a chest wall
deformity I was born with that caused a considerable and noticeable
depression along the sternum on my right side.

\"The size of one of my breasts was considerably smaller than the other,
causing me to be extremely self‑conscious my whole life. I would not
wear bathing suits or shirts with a neckline lower than my collarbone
because my deformity was so obvious.

\"I am so thrilled that I had the silicone implant option available to
me. It has made a dramatic difference in my self‑esteem. My
self‑confidence has improved drastically.

\"I have one anatomical implant on the defective side, which has helped
with the depression along my sternum. The other implant is round, to
create uniformity. I have had absolutely no side effects.

\"My breasts remain soft and natural‑looking, which is very important to
me. They feel natural as well. I am able to sleep comfortably in any
position. I have had no problem with hardness and no dimpling.

\"My husband and I were concerned that I would lose nipple sensitivity.
That has not been the case at all. I am so pleased with the results. I
am a grateful recipient of a wonderful product that has made a huge
difference in my life.

\"Thank you, Valerie Hartwell.\"

CHAIRMAN CHOTI: Thank you.

Next speaker, please? Good morning.

MR. BRENT: Good morning. My name is Ed Brent. And I am representing my
wife, P. J. Brent, and our children.

My wife had silicone breast implants for ten years. She had no problems
at first but became increasingly ill. On May 29th, 2000, my wife
committed suicide. She left behind seven children. On behalf of my wife
and my seven children, I urge this panel and the FDA not to approve
silicone breast implants unless there is clear evidence that the
implants being sold now are safe for long‑term use, meaning ten years or
more.

Several studies have shown higher rates of suicide among breast implant
patients. And a National Cancer Institute study found that women with
implants were four times as likely to kill themselves as other plastic
surgery patients.

The implant makers think the explanation is that women with breast
implants had lower self‑esteem before they got their implants, but there
is no reason to think that women who decide to get implants have lower
self‑esteem than women who decide to get liposuction, nose jobs, or any
other plastic surgery.

My wife was not a woman with low self‑esteem. She was a vibrant, loving
wife and mother. P. J. loved the way she looked the first few years
after her implants. Then she began to get sick, and her joints hurt, her
fingers would swell. She had lupus‑like symptoms and was diagnosed with
fibromyalgia.

P. J. breast‑fed two of our daughters after getting implants. Both are
seriously ill. My daughter Catherine, who is with me now, was diagnosed
with chronic inflammatory demyelinating polyneuropathy as well as
esophageal motility disorder. She spent years in leg braces, and now the
leg braces have been replaced with a wheelchair.

Our daughter Christine also has esophageal motility disorder and leg
weakness as well. In contrast, our five children born before my wife got
breast implants are perfectly healthy.

After P. J. committed suicide, an autopsy was performed. Large amounts
of platinum were found in her body. And a doctor at the CDC after seeing
the amount of platinum in P. J.\'s body said she could not have been in
her right mind.

Tissue samples from our daughters who had breast‑fed found that they,
too, had elevated platinum levels. These findings were presented at a
meeting of the American Chemical Society last year.

P. J. felt terrible guilt that her two daughters had been so seriously
harmed by her decision to get breast implants. It was not her fault. She
had no way of knowing what would happen. Most doctors did not know that
there had not been any long‑term studies on the breast implants.

Just two months before my wife\'s death, she testified at a previously
FDA meeting on breast implants. She felt the panel ignored testimony
given by women with implants.

And I am here today to ask you to listen to these patients and their
loved ones and do not endorse a product not proven safe for long‑term
use. Women and their yet unborn children may be forever affected. This
is a scientific issue and a moral issue.

Thank you.

CHAIRMAN CHOTI: Thank you.

Next? Good morning.

MS. HICKEY: Good morning. I am Lisa Hickey, and I am from Phoenix. I
have no conflicts of interest.

I am here to tell you I experienced four surgeries in four years due to
complications with implants. My experience involved three manufacturers
and new and improved products. Two of the surgeries were back to back
after a rupture occurred.

Concurrent with the implant exposures, I experienced serious systemic
illness and visual and motor impairment, which improved considerably
after the implants and capsules were removed.

After the rupture diagnosis, I was required to sign a Mentor informed
consent document in order to receive replacements. That occurred after a
moratorium had been placed on the implants that I knew nothing about.

During prep for the rupture removal, I was sedated and negotiated with
for my rupture evidence. My baseline mammogram and evidence were taken
away from me around the same time as that surgery.

If implants are so safe, why are there gag orders and sealed documents
regarding silicone implants from an historical perspective? Now I
understand that the Justice Department has entered a settlement
agreement with manufacturers for recovery of enormous expenses paid out
to Health and Human Services claims for breast implant complications.

Aren\'t Social Security and Medicare in enough trouble already? How is
it that the Justice Department can recover its losses with the Daubert
rule in place, not allowing important evidence from expensive medical
testing, while at the same time there is a law in place requiring
insurance to cover breast cancer reconstruction with implants?

And I have been told the Navy Department is conducting a large breast
cancer study. I am a furloughed flight attendant for a struggling
airline that is required to pay for products with high complication
rates for reconstructions when the Justice Department is trying to
recover U.S. losses incurred by enormous claims from complication.

Now, I do not have a fancy degree or knowledge about rocket science, but
my grandparents were educators. And they taught me to read the road
signs on the highway of life. I can read that things just don\'t add up
to safety when it comes to silicone gel.

Many of my fellow flight attendant friends and acquaintances with
implant exposures have been ill. And some have passed on in the prime of
their lives.

Is silicone research taking place in the morgue? In your approval
process, please consider what this research does not tell you. Breast
implant exposures altered my health forever. Believe me, experiencing
illness serious enough to have my implants cut out in hopes of feeling
better did not improve my self‑esteem.

I implore you to help ensure that what happened to me and my friends
with silicone exposures never happens to anyone else, especially young
women in childbearing years, single mothers with limited financial
resources, and vulnerable cancer patients.

Thank you.

CHAIRMAN CHOTI: Thank you.

Next? Good morning.

MS. P. DOWD: Good morning. Mr. Chairman, ladies and gentlemen of the
panel, I thank you for this opportunity to come before my government and
speak on the dangers of silicone gel breast implants. I come as a little
David to approach the giants of the silicone industry.

My name is Pam Dowd of Boise, Idaho. I represent Implant Veterans of
Toxic Exposure. I have driven almost 2,500 miles in a 1984 Southwind
motor home at my own expense to be here. I felt it was that critical.

On May 21st, I will reach my 30th year of being free of breast cancer.
In 2003, I told the panel about my experience as a breast cancer
survivor and about the failed reconstruction that included three
ruptured silicone breast implants. I told the panel about the
excruciating pain of a spontaneous rupture that literally had me pulling
at my hair, about the experience of having my chest scraped and
cauterized following the explant, and that the Mentor implants of 1988
that caused me to cough constantly and choke on my own saliva for seven
years, and about the pain in the long bones that at times has me
screaming in pain.

Today I come to address the issue of the denial of health care insurance
for women who have had breast implants. On page 5 of the Mentor
Corporation 48‑page informed consent is this warning. Inamed does not
provide this information online. \"For patients who have undergone
breast implantation, either as a cosmetic or a reconstructive procedure,
health insurance premiums may increase, coverage may be dropped, and/or
future coverage may be denied. Treatment of complications may not be
covered as well. You should check with your insurance company regarding
these coverage issues.\"

Ladies and gentlemen, there is no \"may\" about this critical health
crisis with implanted women. The denial of health insurance to women who
have had implants is increasing across the land. Until last year, I had
no personal knowledge of being denied health insurance.

Last October, my late husband went on Medicare. And we lost his COBRA
insurance. For 30 years, I had been covered under group policies. Blue
Cross had paid for this devastation that\'s called breast
reconstruction. Yet, in the end, I am denied health insurance based on
the diagnosis of Sjogren\'s, Raynaud\'s, peripheral neuropathy,
fibromyalgia, and a long list of other diagnoses I have received since
getting breast implants.

Insurance companies such as Blue Cross/Blue Shield, Equitable Life
Insurance, Aetna, AARP supplemental insurance, Prudential, Republic
Bankers Life Insurance, Times Insurance Company are denying health care
coverage to women who have had breast implants.

I found evidence on the evidentiary CDs from the MDL that this concern
was first reported by doctors in 1989. Insurance application forms are
now asking for implant history.

If, as the manufacturers and members of the ASPRS repeatedly claim,
there is no connection between implants and health problems, then why
the insurance denials? If there are no health risks, then why does Blue
Cross/Blue Shield of Texas have declined if implants are explanted as
their underwriting guidelines as far back as 1996? What is the toxic
secret the insurance companies know but aren\'t sharing?

In 1998, I presented the results of a survey of implanted women to the
Institute of Medicine. Of the respondents, 30 percent of the women were
on disability and are drawing assistance for living needs from
government and charity offices. Many of those who were disabled were
disabled before the age of 50 and within 15 years of getting breast
implants.

With Inamed\'s latest figures of 325,000 newly augmented women per year,
this has the probability of creating another 100,000 women on disability
a year within the next 15 years. This has the potential of being in
excess of \$100 million burden on the American taxpayer.

On pages 40 and 41 of Mentor\'s 48‑page informed consent are Mentor\'s
support of the diabolical and barbaric flat surgeries that are
disabling, creating permanent and sometimes total disability for the
recipients.

The insurance companies are already saying they are not going to pay for
the health care needs of even the reconstruction patients they have
already covered.

Ladies and gentlemen, it will be seven and a half years ‑‑

CHAIRMAN CHOTI: Would you please sum up?

MS. P. DOWD: ‑‑ before I am eligible for Medicare. I am 57, uninsured,
and uninsurable.

CHAIRMAN CHOTI: If you could please sum up for us?

MS. P. DOWD: Yes.

CHAIRMAN CHOTI: Your time is up.

MS. P. DOWD: Putting the burden of health care of thousands of women on
my child\'s shoulder is a task I could not in good conscience do. Can
you?

Again, thank you for this opportunity.

CHAIRMAN CHOTI: Thank you.

Next? Good morning.

MS. B. DOWD: Good morning. Mr. Chairman and members of the panel, I
appreciate the opportunity to speak to you about the dangers of silicone
breast implants.

My name is Brenna Dowd. I am from Boise, Idaho. I came with my mother in
our old motor home. We used my father\'s life insurance money to get
here.

Ever since I have been old enough to pay attention to my mother\'s
health, she has been sick. My dad died in December. And now we are
alone, and I have to take care of her.

I have never known a healthy mother. Mom will never tell people about
all the times she has been unable to walk right, sometimes crawling,
many times falling. She would never tell you about the times when she
gets confused or when her legs hurt her so much she has to sit in a hot
bath maybe three times a day or more just to ease the pain because of
the silicone breast implants.

Mom will never tell you how she fell out of the motor home on the way
here and I was afraid she wouldn\'t be able to finish the trip or when
we got to Hagerstown Saturday night, she was too exhausted to even eat.

My mother liked to go camping in the mountains in Idaho with my father.
She hasn\'t been able to do that for a long time. She gets too tired to
do anything physical.

Mom has never been able to do many things other moms should be able to
do with their children, such as shop all day in the mall or play real
hard with me. Even simple walks exhaust her. She tries, but she is too
sick.

In closing, I leave a message from my father. One of his greatest
regrets in life was that he had not protected my mom from the implants
and that she could not get health insurance. He blamed himself, but Dad
was not to blame. These companies that sell implants to innocent women
and make them sick are the ones who should be held accountable. They
poisoned my mother and robbed me of a healthy mom and my father of a
healthy wife.

I beg you to please ban silicone breast implants. Thank you.

CHAIRMAN CHOTI: Thank you.

Next?

DR. BERMAN: Good morning. I\'m Dr. Alan Berman, Executive Director of
the American Association of Suicidology located here in Washington, D.C.
For 37 years, the AAS has had as its primary mission that of
understanding suicide as a means of promoting human welfare.

I come here today at my own expense with no financial ties to either
sponsor or any of their competitors. The majority of Americans report
having thought about suicide at some time in their lives. Most everyone
decides to live because they come to realize that their pain is
temporary but death is not.

On the other hand, some people in the midst of a crisis perceive their
problems as inescapable and feel utterly hopeless. Tragically, some
31,000 Americans take their lives annually.

The AAS believes it is essential to have sound empirical study of
suicide. I am here to briefly discuss five studies that have shown an
increased risk of suicide among women who have undergone breast
augmentation.

Scientists from the NCI reported that breast augmentation patients were
four times as likely to kill themselves as were other female plastic
surgery patients matched for age, socioeconomic status, health status,
and habits. It is important to note that all the women in this study had
implants for at least seven years, much longer than in other implant
studies. A weakness of the study was the confounding variables, such as
depression or marital discord, were not controlled.

Three European studies, one each from Sweden, Finland, and Denmark,
consistently found that women who had had breast implants for
augmentation were three times more likely to complete suicide than women
in the general population of those countries.

In the U.S., a recent study of mastectomy reconstruction patients also
found a higher rate of suicide among implant patients compared with
women who underwent mastectomies without reconstruction.

The American Society of Aesthetic Plastic Surgeons and Dow‑Corning
funded articles concluding that the increased risk of suicide likely
existed before surgery. They argue that women who get breast implants
may be more likely to suffer from low self‑esteem and/or depression. In
addition, based on their demographics, they may be at higher risk for
suicide.

But the research data does not back this up. One study noted that eight
percent of Danish augmentation patients had a psychiatric admission
before surgery compared to six percent of women who had other cosmetic
procedures. Danish women, however, had to get psychiatric referrals
before they could get free augmentation from the public health system.
Clearly, this could be the reason behind this insignificant difference.

Implant patients, like most plastic surgery patients, tend to be unhappy
with the specific body part they want changed. But they are not less
satisfied with the overall appearance or with themselves.

A Danish study found that women who had breast implants for augmentation
were five to seven times more likely to be taking antidepressants than
women who had breast reduction surgery or women in the general
population. Women who had their implants removed and replaced at least
one time were also more likely to be taking antidepressants than women
who still had their original implants.

The relationship between multiple implant surgeries and the use of
antidepressants may be, in part, because complications from implants
contribute to depression, but it is not possible to know if these women
had a prior history of depression.

Women with breast implants who testified before the FDA in October 2003
provide anecdotal evidence for the connection between pain following
augmentation surgery and suicidal thoughts. Several women described
feeling depressed and suicidal as a result of debilitating pain,
fatigue, and mental confusion, years after getting silicone breast
implants. They said when the implants were removed, their health
improved. And they experienced less depression and less suicidal
thinking.

Anecdotal case reports such as these are for qualitative data that
informs hypothesis testing that simply has not occurred to date. We have
here an ad hoc challenge/dechallenge test that has never been studied or
rechallenged empirically.

It is possible that women who undergo augmentation have lower
self‑esteem than other women, but studies have not supported this.
Again, studies show that women who plan to undergo augmentation tend to
feel less attractive regarding their breasts but do not have overall
lower self‑esteem or self‑confidence.

There is no a priori reason to believe that women who decide to undergo
breast augmentation have lower self‑esteem or are more depressed than
women who undergo liposuction or other plastic surgery procedures.

Interestingly, while breast implant manufacturers attribute suicide
excess to pre‑implant psychiatric disorders, they also maintain that
implants improve a woman\'s self‑worth. There are no studies to support
this assertion either.

The bottom line is that every published study on suicide and breast
implants shows that there is an increased risk of suicide. The question
is why.

No prospective study of depression before versus after augmentation has
yet been reported. No study has yet examined post‑surgical outcomes
among patients who later completed suicide. Well‑designed,
case‑controlled psychological autopsy studies are needed to make
differentiations and/or links between preoperative and postoperative
risk variables.

Thank you.

CHAIRMAN CHOTI: Thank you.

Good morning. Next?

MS. HOUSER: Good morning. My name is Christie Houser. I have no
conflicts of interest. I\'m a 47‑year‑old mother of 2 boys and a
full‑time first grade teacher\'s assistant. I got silicone implants for
augmentation at age 25. I researched my particular implants and was told
by every doctor that everything would be fine and that the implants
would outlive me.

Everything was great for a while, but after five years, I started
experiencing joint problems, flu‑like symptoms, rashes, and a cough that
wouldn\'t go away. The doctors told me that the symptoms could not be
related to the implants. And I believed them and trusted them.

The implant makers will present four years of studies tomorrow. If I had
been included in these studies, most of my problems would not have been
seen. We must have real long‑term studies to truly evaluate the safety
of the product.

Silicone implants have been on the market for 40 years. Yet, the
industry has never presented more than four years\' worth of data. Why
is that? What are they afraid of? I believe we need to ask the long,
hard‑term questions.

Eventually my health got so bad that I had an MRI and an ultrasound.
They found that there was something behind my left breast, but they
couldn\'t really see exactly what it was. The implant was covering it.
So they couldn\'t really tell.

When they removed my implants ten years after augmentation, the outer
coverings of both of my implants were gone. There was a golf ball‑sized
cyst behind my left breast, which they could not see with an MRI or
ultrasound. And both implants were ruptured.

They removed the implants and as much silicone as they possibly could
and sewed me up. After two months of the surgery, I noticed that my
scars were not healing and they were tender. I went to the doctor, and
he told me that it would take time to heal.

I went to another doctor. And he saw something that was trying to come
out of the scar. In fact, it was silicone that was leaking out of my
scars in places that were not healing.

I have two sons. They both have diseases that are unusual. My
16‑year‑old son has Hashimoto\'s thyroid disease, which is typically
found in adult women over 30. My eight‑year‑old has something called
urticaria pigmentosa, which is a cafe au lait spot that can blister and
previously has put him in anaphylactic shock.

There is no evidence showing that my son\'s illnesses are through
breast‑feeding, but it does beg the question. How did they end up with
these strange diagnoses?

There are too many unanswered questions to approve this product. The
American people look to you to guide their health and their children\'s
health. I am not against implants, but if we do not demand the research
to determine that silicone implants are safe for long‑term use, we have
to answer a new generation of women and their children with serious,
serious health problem.

Thank you so much for listening.

CHAIRMAN CHOTI: Thank you.

MS. VAN FOSSEN‑NYE: Good morning. My name is Kathleen Van Fossen‑Nye. I
drove here from Sinking Spring, Pennsylvania to speak before the panel.
And I have no conflict of interest. I spoke before the panel in October
of 2003.

My history with silicone breast implants is almost as long as the
products have been on the market. In 1968, when I was 22 years old, I
was implanted with the original Cronin implant following a bilateral
mastectomy for a precancerous condition.

A military doctor performed my first breast implant surgery because my
husband was in the U.S. Navy. In the government lawsuit, manufacturers
agreed to pay five government agencies, including the Department of
Defense, the Department of Veterans Affairs, Medicaid, and Medicare,
millions of dollars to reimburse them for the costs they incurred
treating women made ill by silicone breast implants. This settlement
demonstrates that the federal government is aware and has acknowledged
that silicone breast implants cause health problems and disabilities.

However, how can the FDA even consider approving these PMAs when the
Department of Health and Human Services has already made it clear that
silicone breast implants pose a serious health risk to women, costing
millions of dollars?

In the past, I have heard the panel members ask why so many women get
breast implants and why they keep getting them, even after they fail? I
have heard plastic surgeons on the panel say that the women don\'t mind
the complications because they really like their implants. This was not
true for me.

I started to suffer from fatigue and joint pain, and the implants were
hard and painful. I went to a number of plastic surgeons, asking to have
my implants removed. I found a plastic surgeon who was willing to remove
the implants. He removed and replaced my implants with a new and
improved implant. This started my journey through a silicone nightmare.

I have experienced the gamut of problems, including outright rejection.
Eventually necrosis developed, and the implant actually came out through
my skin and popped out on its own. Here is the photo of what happened.

Despite my mastectomy, I developed breast cancer in \'86. I have had a
total of 15 implants and expanders over the years. Why did I have 15
implants? I had so many because I believed my doctors when they told me
they were new and improved. I wanted to believe my doctors when they
told me they were new and improved.

For over 35 years, I have experienced new and improved implants. I have
come to the conclusion there is no such thing as a new and improved
silicone breast implant.

CHAIRMAN CHOTI: Thank you. Good morning.

DR. GLICKSMAN: Mr. Chairman and members of the panel, I am a plastic
surgeon practicing in New Jersey for 15 years. I have not received any
financial support from any implant manufacturer. And I traveled here at
my own expense.

Before I get to my statement, I have a quick comment regarding Dr.
Olding\'s letter to the panel. This development clearly demonstrates
that the FDA\'s review process is flawed. They have no backup plan and
no provisions for an alternate panelist. I now have serious questions
about the FDA\'s ability to conduct fair hearing.

I am testifying again, as I did in 2003. And the question today should
be what has changed since 1992. Now, clearly we have the evidence‑based
science to demonstrate the safety and efficacy of these implants. Over
15 years of study show no link exists between silicone and systemic
illness.

What has changed in the last 20 years are the devices, the surgical
techniques, and the role of plastic surgeon as both physician and
educator. And, most importantly, we now encourage the shared
responsibility of the patient to maintain good breast health by
follow‑up exams and replacement of their implants as necessary.

The devices used today have evolved dramatically from those of the \'70s
and \'80s. I can tell you that the devices, surgical techniques, and our
preoperative patient evaluation have changed so dramatically that my
reoperation rate at five years is less than three percent.

But what about the patients? How do you get American women between 18
and 80 to choose a board‑certified plastic surgeon to understand the
concept that a breast augmentation is not just a boob job and every
pretty blonde does not have to be a D‑cup? Here\'s where a new
generation of plastic surgeons under a new generation of leadership has
made their greatest strides.

Manufacturers in the plastic surgery societies have in place courses
that teach the techniques that reduce the reoperation rates. We have
published algorithms that can help reduce the cycle of reoperations for
implant complications. And we have created Web sites where American
women can research their choices and become fully informed of their
potential risks and benefits of implants, even before they step into a
doctor\'s office.

Women demand and deserve a better level of health care. No medical
device lasts a lifetime. And technology now exists, such as MRIs, that
can evaluate the integrity of silicone implants as they age.

Even with these changes, we cannot force American women to choose a
board‑certified plastic surgeon or return for follow‑up care, just as we
can\'t force adults to quit smoking, lose weight, or wear their safety
belts. But we should not limit the use of an implant that has been shown
to be safe and effective in study after study because it is used for
aesthetic reasons, purely for the enhancement of a woman\'s self‑esteem.

No different is it from drugs for erectile dysfunction. Their sole
purpose is to improve a man\'s self‑esteem and quality of life and were
approved by the FDA without controversy.

As a plastic surgeon, I have performed thousands of implant surgeries
using both silicone and saline. I have found silicone to be safe and
effective and far superior.

In 1876, William Welch, the founder of Johns Hopkins Medical School
said, \"In the end, our preconceived beliefs must change and adapt
themselves.\" The facts of science will never change. I base my medical
decisions on fact, and the FDA should do the same.

I urge the panel to make a determination on evidence‑based science, not
politics and emotions, and leave the choices up to individual women and
their physicians.

CHAIRMAN CHOTI: Thank you.

Next speaker?

BETH: My name is Beth, and I have no conflict of interest. To protect my
family\'s privacy, I thought long and hard about whether I should come
and testify today. I decided that because of my concern for children
born to implanted mothers, I would come at my own expense to tell you
how I became convinced that the platinum and other toxic chemicals found
in breast implants have harmed my health and that of my two young
daughters.

For privacy, I will refer to them as \"Muffin.\" She\'s seven.
\"Stinkerbelle\" is nine. Both of my girls have tested for lupus due to
their extremely high platinum levels, especially Muffin. We have been
told that her bones are deteriorating. Here is my story.

After ten years of implantation, a chronic cough caused my right implant
to herniate outside the scar tissue. Due to numerous symptoms, including
hair loss and swollen lymph nodes. My implants were removed in \'92
without replacement.

Two years later I became pregnant with my third child, then my fourth. I
was plagued with autoimmune symptoms during these pregnancies, swollen
lymph nodes throughout my body, and weight loss. I was so ill in this
last pregnancy with Muffin that my doctor informed me that she was
living off my body fat.

Published research shows that platinum is stored in the fat of
breast‑implanted women. I am convinced this is why Muffin has an even
higher lupus score than I do. And even her platinum level is higher than
mine, so high that I cannot say it out loud at this hearing.

I also understand that ionized platinum can cross the placenta. And
significant levels of platinum are found in breast milk. I breast‑fed
both of my daughters.

Since that time, my health has deteriorated. Some of my symptoms and
diagnosis include asthma, photosensitivity, hives, throat swelling, and
lupus, lung and bone pain.

My two children born before I had implants are very healthy, while
Muffin and Stinkerbelle are constantly reacting as if they have multiple
allergies when they have none. They endure bladder problems,
photosensitivity, eczema, intense bone pain that wakes them up in the
night screaming, lung pain, asthma, chronic pneumonia. Their lives and
health have been forever altered.

As a mother who faces an unknown future for health consequences for
herself and her young daughters, I ask you to vote no on this PMA
application.

CHAIRMAN CHOTI: Thank you.

Good morning.

MS. SHEPPARD: Good morning. My name is Audrey Sheppard. I live locally
and have no financial conflicts.

For four years, 1996 through \'99, I directed the FDA Office of Women\'s
Health. As a result of my professional involvement with silicone breast
implants, I regard sharing my perspective an ongoing responsibility. I
hold the agency and you in high regard and am optimistic about your
making scientifically sound judgments.

My role at OWH, nearly a decade ago, requested by and partnering with
the Center for Device Leaders, was to chapion and obtain full funding to
conduct what became the critically important FDA rupture study. Its
findings have resulted in a better understanding of the frequency of
these devices rupturing over time.

You will be briefed ‑‑ and there has been reference to it already ‑‑ on
the results. Suffice it to say that over time more than 65 percent of
women in the study were found to have at least one ruptured implant and
over 21 percent had silicone gel outside the capsule in one or both
breasts. The latter finding is particularly concerning since the effect
of silicone on the tissues and in development or progression of disease
remains unknown.

After leaving the agency five years ago, I have advised and assisted
women\'s health and other women\'s nonprofits and projects and from this
vantage point will share three requests. One, follow the science.

Even the company\'s data, which you know will put on the best face, will
not dispute a significant rupture rate nor other consequences of having
these devices for years. These are not lifetime devices and, as such,
without regular and too frequent resurgeries are not safe and effective,
as intended.

Two, pay close attention to FDA\'s own documents and data. A number of
documents on the CDRH Web site, including ‑‑ and I have the names, but
you can find them. These themselves are damning information that is
based on scientific research, decades of experience, tens of thousands
of adverse event reports. And it also includes disconcerting
photographs.

Please don\'t discount this body of material with the argument that the
devices are much improved today. Make certain there is data to prove it.

And, number three, please believe your own eyes and ears when you see
the dozens of sincere women whose health has been compromised standing
before you. Of course, you will also hear from those who are highly
satisfied. Their experience does not provide reason enough to open
implants to wide use for augmentation, even by teenage girls.

To summarize, the health and well‑being of some of America\'s women and
girls will be affected, even if they won\'t know it for years to come,
by your decisions.

Thank you.

CHAIRMAN CHOTI: Thank you.

Good morning.

MS. GREEN: I\'m Bettye Green. I\'m the President of African American
Women in Touch. And I am a breast cancer survivor. And I chose
reconstruction after a mastectomy. However, I believe breast cancer
patients deserve more information than they are getting.

Fortunately, there are many more options than there used to be for
breast cancer patients. More than three out of four are eligible for
lumpectomy. So relatively few women with breast cancer have a need to
undergo a mastectomy in the last few years or in the coming years.

And, fortunately, women who undergo mastectomies have two other
alternates to silicone breast implants. They can choose saline breast
implants, which have a lower complication rate and are easier to remove
when they break, or they can choose an autologous tissue transfer, a
very popular procedure that moves tissue, in fact, from the abdomen or
other areas to create a breast that is much more natural looking and
feeling than a breast implant reconstruction.

Over the years, FDA panels have heard from some breast cancer survivors
about the mental health benefits of silicone breast implants for
mastectomy patients who want to reconstruct their breasts, but now that
there are so many choices, do silicone breast implants offer benefits
that are greater than other options, so great that they are more
important than safety?

Research by Dr. Julia Roland of the National Cancer Institute and her
colleagues found no difference in the quality of life of women who
underwent lumpectomies, women who underwent mastectomies, and women who
have had mastectomies with reconstruction.

Even more surprisingly, the women who had reconstruction felt their sex
lives had been harmed more than mastectomy patients. If we look at the
data presented by Inamed and Mentor, these findings make sense.

Most reconstruction patients require a lot of complications. They report
more autoimmune symptoms two years after implants, such as joint pain
and mental confusion, compared to before getting breast implants.

According to a study of women who had reconstruction five years earlier,
most implant patients were no longer satisfied. In contrast, most of
these autologous tissue transfer reconstruction patients remain
satisfied. The implant makers remind us that their studies show that
patients are satisfied.

But as a cancer survivor, a nurse, and a leader of a national group for
breast cancer patients, I can tell you that most breast cancer patients
don\'t tell their plastic surgeons that they are unhappy. They have been
through cancer. Most don\'t like to complain about how they look now,
especially in a study when being honest will not help them in any way
and could potentially harm their relationship with their doctor.

I have another concern that nobody has mentioned and that is very
important. There are very few African American women or Asian American
women in the Inamed or in the Mentor study. For example, there are only
six African American breast cancer patients in the Inamed core study and
only five Asian American women.

This is a big problem because African American and Asian women are more
likely to develop a cheloid scarring. This scarring tendency could
potentially increase the risk of capsular contracture as well.

African Americans are also at an increased risk of autoimmune diseases.
So it is essential that silicone gel breast implants not be approved
until they are carefully studied on women of color.

In summary, research suggests that women who have had reconstruction
after mastectomy do not have a higher quality of life than women who do
not undergo mastectomy. Their sex lives seem to suffer more, not less.

Independent researchers found that the majority of implant
reconstruction patients are not satisfied five years later. These
findings are more credible than those funded by implant companies.

In one study, reconstruction patients were ten times as likely to commit
suicide as mastectomy patients who do not undergo reconstruction. More
African American and Asian American women need to be included in breast
implant study, especially studies of breast cancer patients. Neither
Inamed nor Mentor have studied enough women of color to determine if the
risks are any different for them compared to white women.

Thank you so much for listening.

CHAIRMAN CHOTI: Thank you, Ms. Green.

Next? Yes?

MS. KUECK: Good morning. My name is Jana Kueck, and I\'m a registered
nurse from Branson, Missouri and a sister of an injured breast implant
consumer. I\'ve been a registered nurse for 21 years. My background
includes labor and delivery, newborn nursery, and assisting new mothers
as a former breast‑feeding educator. I have no financial relationship
with the PMA sponsors, their products, and their competitors.

Numerous studies have found that breast‑feeding provides newborns with
essential nutrition and improved resistance to infections. By impeding
or preventing breast‑feeding, implants have become a public and
pediatric health problem as they are essentially depriving newborns from
these benefits.

According to the Institute of Medicine, any kind of breast surgery,
including breast implant surgery, makes it three times more likely that
women trying to breast‑feed will have inadequate milk supply or
lactation insufficiency.

In a study conducted by Marianne Neifert and colleagues of the
University of Colorado at Madison, women who had breast surgery were
three times more likely to have lactation insufficiency than those that
did not have surgery. The doctors compared the rate of weight gain of
breast‑fed infants born to mothers who either did or did not have
previous breast surgery. Mothers whose babies did not gain at least one
ounce per day or required supplemental feedings with formula were deemed
to have lactation insufficiency.

Interestingly, the women who had breast surgery through an incision in
the nipple area or periareolar incision had a higher incidence of
problems. Those women were more likely to suffer from insufficient milk
supply.

I frequently have observed decreased milk production in mothers of
breast‑implanted surgery. In addition, implanted mothers\' infants also
had difficulty latching onto the breast due to the firmness, usually
caused by capsular contracture, even a mild contracture, from the
implants.

We don\'t know how silicone breast implants affect what is in the
mother\'s milk, but it is certainly worthy of more study. Recent
research suggesting platinum in breast milk due to the platinum used as
a catalyst in silicone breast implants concerns me a great deal.

Because of what is known and what is yet not known about the risk of
implants on breast‑feeding, I am asking you to vote against the approval
of Mentor\'s and Inamed\'s application. Voting against approval will
support women\'s health and the health of precious newborns.

CHAIRMAN CHOTI: Thank you.

Next? Good morning.

DR. GOLDBERG: Good morning. Thank you for the opportunity to highlight a
few scientific issues pertinent to the panel\'s review of gel implant
safety.

I\'m Eugene Goldberg. I direct the Biomaterials Center at the University
of Florida. I have no financial interest in breast implants. I traveled
here at my own expense.

My group has conducted research on the biocompatibility of silicone
implants for more than ten years. In addition to my comments here, I
have appended more information for you.

We published the only large cohort clinical evaluation of gel implants.
This is a meta analysis of about 10,000 implants from 42 different
papers. A high prevalence of rupture and additional surgeries was found.
A plot of failure versus time showed 29 percent of rupture at 5 years
and 70 percent of rupture at 17 and a half years. When the next slide
comes up, you will see that.

One of every three women with implants required additional surgery
within six years due to pain, hardness, disfigurement, or rupture. In an
FDA‑NIH study using MRI plus explant surgery, Brown and coworkers
confirmed our results. They found 69 percent rupture at 16 and a half
years. And that falls directly on our implant rupture curve that is
shown up there.

A Mentor consultant states that \"Rupture is a critical safety
parameter,\" but Inamed in a letter to the FDA says that rupture is \"an
unintended patient outcome.\" Frequent additional surgeries are truly
also unintended, but both pose major safety risks.

Inamed now tells us that surgical damage is the leading cause of
failure. If so, why aren\'t gel implants properly designed for normal
surgical procedures? Inamed\'s 4‑year clinical results show still a high
10‑22 percent rupture, despite a presumably thicker shell with phenyl
siloxane as a barrier. Short‑term rupture is actually not much lower
than reported before.

Also note that crazing and cracking of phenyl siloxane coatings can
occur after four to five years. And the barrier properties and strength
may deteriorate as a result after five years. Four‑year clinical data
are not adequate.

Finally, an increased risk for cancer of the lung, cervix, and brain is
reported for gel implant recipients. It is simply not reasonable for
Inamed to blame this on lifestyle with no scientific evidence. This is
another potentially serious problem, and it must be resolved.

Thank you.

CHAIRMAN CHOTI: Thank you.

Good morning.

DR. WOOLEY: Good morning. I\'m Paul Wooley. I\'m Professor of Orthopedic
Surgery, Immunology, and Biomedical Engineering at Wayne State
University in Detroit. I have no financial ties with the sponsors or any
of their competitors.

I would like to address the issue of latency and, in particular, the
adjuvant effects of silicone. My group has been studying this for about
a decade.

The hypothesis that we address is that silicone as a rather sticky
substance, proteins, normal proteins of the body, can adhere to
silicone. And minor conformational changes in the protein can result in
the development of autoantibodies. And such autoantibodies may be
significant in the pathology of connective tissue disease.

I have four publications in leading journals on the subject. And I would
like to update the panel on the studies that we have conducted since
they last met.

In our early studies, we demonstrated that silicone implantation in mice
did result in autoantibodies, but those autoantibodies did not alter the
disease process in either arthritis or lupus. However, our third study
clearly demonstrated in a long‑term implantation in mice that disease
was indeed exacerbated.

To take those studies to the human, we studied VP shunts in children and
demonstrated adjuvant effects with the development of an autoantibody
that was associated with an increased revision rate. However, the data
that I have made available to you today is the first study that we have
done in silicone breast implant material.

Paired samples of breast explant material, silicone explant material,
and sera were made available to us from Dr. Fred Miller and Terry
O\'Hanlon at the NIH. These were provided in a blinded manner. We did
not know which sera went with which breast implant, and we did not know
the diagnosis or reason for the explantation.

Three of them it turned out the patients had either an autoimmune or a
connective tissue disease. Three of them were clinically normal at the
time of explanation.

We used a published and recognized method of removing the proteins from
the silicone surface and we used the sera in a Western blot assay to
assess whether the patient has a reaction against any of the adherent
proteins.

Our findings were we believe quite significant. A novel 205‑kilodalton
protein was removed from the surface of these explanted materials and
was found to be immunologically active.

It turns out that this ‑‑

CHAIRMAN CHOTI: If you could sum up, please?

DR. WOOLEY: Yes.

‑‑ that this protein was associated with either MGUS or mixed connective
tissue diseases. However, the antibody to that protein was also detected
in patients who were clinically normal at the time of explanation. This
antibody is not present in normal women.

Thank you.

CHAIRMAN CHOTI: Good morning.

MS. HEIDE: Good morning. My name is Terry Heide. And I\'m reading a
statement on behalf of a patient who couldn\'t be here today.

\"My name is Nancy Reuben Greenfield, and I am sorry that medical issues
have kept me away from delivering this speech personally. I want to
thank the panel for giving me an opportunity present my support for
silicone breast implants.

\"First I need you to know that Inamed Corporation generously and
compassionately sponsored my book, When Mommy Had a Mastectomy, which is
designed to help parents and children through the trauma of breast
cancer and the process of recovery.

\"I am actually not one to talk about breasts in general, let alone in
public. I have always been a tomboy. I got a sports bra because I had
to. But along the way, I became a woman and a mother. And I will always
consider nursing my children as one of the true highlights of my life.

\"When I was 39, I got breast cancer and needed a double mastectomy. I
wasn\'t sure what I would do after the mastectomies. I decided staying
flat wouldn\'t suit me. And prosthetics are a great idea, but I have
enough trouble finding my keys. So I decided on breast reconstruction,
and I appreciated the fact that as a breast cancer survivor, I had the
choice between silicone and saline implants.

\"My plastic surgeon highly recommended silicone implants because his
patients raved about their comfortability and he saw no differences in
terms of their safety.

\"When you have breast cancer and you have children, at some point you
have to tell them. My children were five and seven at the time, and
there was no book that could help me. So I decided to write one.

\"Writing it was easier than getting it published. Even when I found a
publisher, there were no funds available for the project. It was then
that my publisher and I came up with the idea of asking the manufacturer
of my implants if they would be interested.

\"Based on my research, silicone has no worse or better effects on the
body than saline. Based on my personal experience, my silicone implants
are really comfortable.

\"Frankly, I don\'t really understand the FDA research on silicone
implants. They are already on the market for breast cancer patients.
They have proved to be safe. And women are very satisfied with the
results.

\"Why should breast cancer be the determining factor on the use of
silicone implants? It seems more like moral judgment on why people
choose to have implants, rather than an issue of science and medicine.

\"The choice to have silicone implants shouldn\'t be a consolation prize
after breast cancer. Any woman who changes her breasts, for whatever
reason, should have the option to use silicone implants.

\"I ask you today to approve silicone implants for any woman who wants
or needs them. Let all women be treated equally. Nancy Reuben
Greenfield.\"

CHAIRMAN CHOTI: Good morning.

MR. GOOZNER: Good morning. My name is Merrill Goozner, and I am the
Director of the Integrity in Science Project at the Center for Science
in the Public Interest.

Integrity in Science seeks to focus public attention on the issue of how
financial conflicts of interest are affecting the objectivity of the
scientific process, especially through federal scientific advisory
committees, such as this one.

While CSPI is largely self‑funded through its newsletter, the Integrity
in Science Project I run receives additional funding from several
foundations. None of these outside foundations have a particular
interest in this issue or, I might add, in medical issues generally.

The Federal Advisory Committee Act prohibits people with conflicts of
interest from serving on committees providing scientific advice. The
logic behind this provision is that a person sitting in judgment of a
body of evidence should not simultaneously be employed by an entity with
a stake in the outcome.

The law allows for an agency to grant waivers if a scientist expertise
is deemed necessary for the committee, which has happened in this case,
a point I will return to in a second.

The law also requires that committees be balanced as to points of view,
a recognition that even when there isn\'t a direct conflict of interest,
a person\'s outside employment can influence their outlook on the
questions at hand. The scientific literature is very clear on the impact
of financial conflicts of interest on the outcome of science.

With this by way of background, allow me to address the makeup of this
Committee. This Committee is smaller, yet similar, in makeup to the last
committee evaluating the silicone gel breast implants. Its permanent
roster includes Dr. Michael Miller.

According to your own statement this morning, Dr. Miller\'s institution
has received \$25,000 from Inamed, one of today\'s petitioners, for his
role in producing an educational CD‑ROM about breast reconstruction
surgery.

I have viewed video excerpts from that CD‑ROM. In it, Dr. Miller states,
and I quote, \"At this time, a number of good studies have been
completed and there are others ongoing that show implants do not cause
disorders, such as cancer or autoimmune diseases. Based on these
studies, we are confident that breast implants are safe.\"

It would appear based on this evidence that Dr. Miller not only has a
conflict of interest but has a point of view about the evidence he is
about to hear regarding the safety and efficacy of these products.

The purpose of waivers is to allow scientists to serve when their
expertise is deemed critical to the Committee\'s deliberations. In no
way can Dr. Miller\'s expertise be considered unique. He is one of four
plastic surgeons on this Committee, which brings me to the second issue
of concern about this makeup.

The Federal Advisory Committee Act requires that committees be balanced.
Eighteen months ago, after the last committee voted nine to six in favor
of allowing the silicone gel breast implant on the market, with all four
plastic surgeons on the committee voting in favor, the chairman of that
committee, Dr. Thomas Whalen, wrote then FDA commissioner, Mark
McClellan, decrying the committee\'s lack of balance. Specifically, he
noted, \"Even in academic settings, plastic surgeons may stand to
increase their own income with the use of these devices.\"

Whether one agrees with that statement or not, the fact is that the
number of plastic surgeons on this committee is double the number of
physicians who treat the diseases that might arise from the use of these
devices. Where is the balance?

The Center for Science in the Public Interest is extremely disappointed
that the FDA chose to overlook the conflicts of interest and has created
an unbalanced panel to evaluate the evidence on this issue. The FDA has
again created a situation where the final vote will be clouded by the
perception that some members had conflicts of interest that my have
influenced the vote.

CHAIRMAN CHOTI: Thank you.

Good morning.

MR. COMPTON: Good morning. I\'m Phil Compton, and I\'m Community
Organizer for our Florida Consumer Action Network, a grass roots
consumer organization with more than 40,000 members statewide. I come
here today with no financial ties to either sponsor or any of their
competitors.

Following the October 2003 panel, the chairman of the advisory panel,
Dr. Thomas Whalen, took the highly unusual step of writing a public
letter to then FDA commissioner Mark McClellan. This is the first time
that a chairman of an FDA advisory committee ‑‑ and there are literally
hundreds of them spread over the 5 operating centers of FDA ‑‑ has
written such a public letter in at least a decade. This letter was
reported on the front pages of major newspapers across the country.

For the new members of the panel, here is what Dr. Whalen wrote, \"Dear
Dr. McClellan, on October 14 and 15 of this year, I chaired the General
and Plastic Surgery Devices Advisory Panel in Gaithersburg, Maryland for
consideration of a PMA by Inamed Corporation for silicone gel breast
implants.

\"As I am sure you are aware, the panel voted nine to six that this PMA
was approvable, and the matter is now under consideration for action at
the CDRH. I write to express as the panel chair my very strong
reservations concerning this vote, having thoroughly reviewed the PMA,
heard my scientific colleagues on the panel, as well as the
presentations of Inamed and the FDA, and having intently listened to all
of the over 100 individuals who gave public testimony.

\"At its essence and as is mandated by federal code, the mission of an
FDA panel and then the FDA itself acting upon the panel recommendation
is really elegantly simple: To judge that the company bringing the PMA
before them has demonstrated with reasonable assurance that the product
under consideration is both safe and effective. Effectiveness was
demonstrated and is almost self‑evident.

\"Long‑term safety, the concern that prompted the removal from the
market 11 years ago, was clearly not demonstrated. And to approve this
device poses threats to women that are clearly unknown.

\"In my opinion, there is at least one facet of long‑term danger that
was established during the panel: Specifically the obscuration of
surrounding normal breast tissue to mammographic detection of breast
cancer. The reoperation rates and other local complications from
silicone leaking outside the breast area have also been established by
FDA scientists and are not minor considerations for a cosmetic device.

\"Moreover, despite the sophistication of the Institute of Medicine\'s
report, all of what was considered by them reflected low‑quality data in
the age of evidence‑based medicine.

\"It is incumbent upon the FDA to demand that the manufacturer establish
in a rigorous prospective, controlled study that these devices, despite
their established breakage and leakage rates, are safe in the long term.
If that is deemed to not be feasible for the company, then they should
abandon pursuit of approval. However, the company\'s track record
suggests that they are capable of such research but have not been
sufficiently motivated to complete it.

\"The plethora of approval conditions that had my head spinning during
panel deliberations is proof that even those who voted the PMA as
approvable are deeply concerned about the lack of long‑term safety data
on this product. What will motivate the company to follow these FDA
requirements?

\"Most upsetting was when an FDA official admitted, at my pressing, that
there is little, if any, remedy for the FDA if demands to demonstrate
long‑term safety are not carried out by the company.

\"I need not point out to you in your position what the term
\'FDA‑approved\' represents to our citizenry. Once this horse is out of
the barn, indeed for a second time, there will be no recourse.

\"I have the utmost respect for my colleagues on the panel, one and all.
This most assuredly includes the four well‑respected and knowledgeable
plastic surgeons. Certainly, it was essential to include board‑certified
plastic and reconstructive surgeons when considering a PMA on breast
implants.

\"On the other hand, it serves the reputation of the FDA in general and
the standing of the panel process, in particular, exceedingly poorly to
have had all of the plastic surgeons vote the PMA as approvable on such
a close vote. Even in academic settings, plastic surgeons may stand to
increase their own income with the use of these devices. To cite a worn
aphorism, it just does not play well in Peoria.

\"In closing, I must add that the issue of medical care of women who
suffer complications from these implants is extraordinarily troubling.
Costs for removal of these implants and for extra‑capsular silicone can
be enormous and are very rarely covered by a health plan. This is a
public health issue of no small import that must be addressed should the
FDA second this misguided panel decision.

\"I have been honored to be a part of the General and Plastic Surgery
Devices Advisory Panel these past few years, and have been extremely
impressed by the devotion and professionalism of those in your agency.

\"I regret that the final chapter of my FDA experience was this one and
implore you and Drs. Feigal and Witten to not approve this PMA. I would
be delighted to provide any further information if you desire it.

\"Sincerely yours, Thomas V. Whalen, M.D., Professor of Surgery and
Pediatrics.\"

Now, there are two questions each of you should ask. What did the Center
for Devices and Radiological Health do to find out what happened here
and to correct it? If FDA did nothing, then how can the agency expect to
have an impartial advisory committee meeting?

Thank you.

CHAIRMAN CHOTI: Good morning.

DR. PARISIAN: Good morning. I\'m Dr. Suzanne Parisian. I am speaking on
behalf of Pro‑Choice Alliance for Responsible Research. I formerly was a
chief medical officer for Office of Device Evaluation, Center for
Devices and Radiological Health at FDA. I\'m a physician. I\'m
board‑certified in pathology. And I\'m author of FDA Inside and Out.

Thank you for considering my testimony. I have no conflicts of interest
with any of the applicants or their competitors.

When FDA denied Inamed\'s marketing application in 2003, it followed by
releasing a guidance document requesting ten years prospective data for
primary augmentation, reconstruction, and revision populations.

FDA provided methods for mechanical testing, requested rupture rates,
and longer clinical studies, addressing areas which FDA indicated were
critical to the assessment of safety.

FDA expressed concerns that implants were rupturing at unacceptably high
rates, that longer‑term health risks were still unknown, and silicone\'s
effect on the body was not yet fully studied.

Liquid silicone injection has not been found to be safe by FDA in other
application reviews. However, industry routinely dismisses FDA\'s
requests for long‑term data and continually ignores all the safety
concerns.

On average, women begin to report problems with their breast implants at
seven to ten years after implantation. Therefore, three to four‑year
studies with clinical data are not adequate to assess safety. We still
do not have the adequate long‑term safety data for silicone breast
implants. The manufacturer\'s application should be denied.

FDA first requested this safety information for silicone breast implants
in 1988 for products that had already been on the market 20 years.
Instead of science, valid data, and a concern for women\'s health, FDA
continues to be met with well‑financed and well‑organized resistance. If
FDA cannot compel PMA sponsors to provide the adequate long‑term safety
data for silicone breast implants before PMA approval, it will never be
obtained.

Improved manufacturing practices, quality controls, and informed
consents have been instituted through the efforts of CDRH\'s staff. I
know that. And this is for both the saline‑filled and the silicone gel
breast implants.

I know that sponsors tell FDA that the women are lost to follow‑up for
long‑term data because they\'re too embarrassed to talk about their
silicone breast implants with the companies. Yet, these same sponsors
can find these women in order to finance their breast implants and make
payments or they can suddenly locate data in Europe that they didn\'t
have before.

Although there are many inadequacies in these PMA applications, time
only permits me to make four brief and important points. First, neither
Inamed nor Mentor have come up with reliable safe rupture rates. They
have come up without good methods to detect rupture rates. And their
data does not reasonably predict the safety profile for each device over
its lifetime.

According to the FDA analysis of the industry data, three‑quarters of
implanted women will have at least one ruptured implant within ten years
of receiving the devices. Specifically, FDA has estimated that up to 93
percent of breast cancer reconstruction patients should receive at least
one broken implant. They will have, will expect to have, not receive.

Second, FDA should have the PMA sponsors obtain information about the
children. As we have been hearing, the children have been left out of
the guidance document. And we need further information about what
happens to the children born to women with silicone breast implants. No
woman would want to have a cosmetic surgery and then hurt her children.
And these products will be aggressively marketed to women, young women.
Now implants are being put in women younger than 18 years of age.

Third, implants can obscure mammographic imaging by hiding the breast
tissue. MRIs have been set as an alternative technology to screen these
women, but they\'re not always accurate. MRI doesn\'t always detect
rupture in these women. And there\'s conflict between rupture and
explants.

Additionally, it has been very misleading to the public to imply that
MRI facilities are trained, willing, or can be reimbursed for these
types of studies. The average cost of an MRI is \$1,890. So a
recommendation that women receive MRI is not inconsiderate in terms of
expenses. And also, young women do not routinely receive any kind of
imaging.

Fourth, FDA\'s approval, as I know, is the gold standard for the
American consumer. After the 2003 FDA panel meeting, FDA determined that
silicone breast implants were unsafe. The long‑term effects still have
not been adequately addressed by either sponsor as they continue to
ignore FDA guidance. You still do not have that safety data that you
thought was necessary 20 years ago. So please do not recommend approval.

Thank you very much.

CHAIRMAN CHOTI: Good morning.

MS. BAEKE: I am Suzanne Baeke. I am a registered nurse, patient educator
specializing in plastic surgery. I have no financial ties with any of
the breast implant manufacturers.

I chose to have breast implants seven years ago. Three years later, my
life with silicone gel breast implants would be best described as the
roller coaster ride from hell.

Each day brought with it new horrors: fevers up to 103, chills, memory
loss. Concentrating on everything became a problem, hair loss, repeated
bladder infections, zero sex drive, dry mouth, severe joint pain,
painful feet, and crippling muscle spasms to the point where I had to
have three deep tissue massages per week.

The mood swings were crippling, not just for me but my entire family. At
times I wished I were not alive. I suffered the chronic fatigue, yet
suffered from insomnia. I would at times have to pull into a parking lot
and shut my eyes for what I thought would just be a minute but turned
out to be 45.

I was evaluated by my rheumatologist at the Mayo Clinic for chronic
fatigue syndrome. MS, fibromyalgia, ankylosing spondylitis were all
considered. Members of the Committee, I would not have wished my life on
anyone, but I refuse to give up. I refuse to live this way. And I was on
a mission to find out what was wrong with me.

I bought every product on late‑night television that promised to fix me.
Eventually I found an endocrinologist, Dr. Bernard Rice. He performed on
me the most comprehensive evaluation I had ever witnessed. Eventually he
took me by the hand, took my husband, and said, \"Your wife needs
hormone replacement. The fact that you are still married is incredible.
Most men get out when things get this bad.\"

Dr. Rice is one of the pioneering investigators in the gradual but
debilitating effects of hypo‑ovarian syndrome. Call it premenopause if
you wish. All women begin to suffer the effects of low ovarian
testosterone production early in life, progressing until full menopause.
For me, the hysterectomy with an oophorectomy sped up this insidious
process.

Distinguished panel, I am here to set the record straight. It is no
coincidence the symptoms of which I suffered are identical to many of
the women testifying today. I submit that silicone implants have been
ridiculously maligned when more likely the culprit is the low
testosterone levels in the pre‑menopause and menopause patient. With
expert estrogen and testosterone replacement, all of my symptoms
immediately reversed. And I still have my silicone gel implants.

To the National Organization of Women, I challenge you. If your motives
are truly honorable, consider that you may be wrong. Read my lips. The
real problem afflicting millions of women is not silicone gel implants.
It\'s, rather, inadequate hormone replacement therapy.

Thank you.

CHAIRMAN CHOTI: Good morning.

DR. BAEKE: My name is Dr. John Baeke. I am a plastic surgeon with
extensive knowledge regarding silicone gel breast implants. I have no
conflict of interest.

Second slide. Please review my data carefully, paying close attention to
my low complication, reoperation, and zero deflation rates. I provided
full handouts out in the hallway for each one of the panel members. And
I invite you to please pick up one.

After the 2003 hearings, I was disheartened by the dearth of testimony
supporting the elective cosmetic surgery patients. I will not be shy in
standing up for these women. Organizations like NOW too often portray
women desiring breast enhancement as bimbos. Shame on you. The cosmetic
patient is typically careered, in her 30s, seeks multiple opinions, is
well‑versed on the subject, and on average requests only one and a half
cup size increase.

Slide. Surgeons performing breast augmentation do so not out of
financial motivation. Those guys can be found next door at the Botox
hearings. If we were purely profit‑motivated, cheaper, wrinkle‑prone
saline implants would suffice. As plastic surgeons, we are committed to
providing women with the most beautiful breasts possible. And that
requires silicone implants. If not for that simple fact, we\'d all go
home.

Slide. How extraordinarily hypocritical, if not insulting, to allow
silicone implants for the cancer survivor but not for the cosmetic
patient. To the mastectomy patient, the message is, \"You\'re going to
die of a disease anyway. So who cares?\" To the cosmetic patient, the
message is, \"Your plight is not to be taken seriously.\" It is arrogant
for anyone to believe a small‑chested woman is not experiencing real
pain because of her developmental misfortune.

Slide. What a double standard for feminist groups to promote a woman\'s
right to choose when it comes to issues of abortion but not to embrace
that same freedom when it comes to silicone implants.

Slide. Why is mere dozen‑word warning appropriate for cigarettes; yet,
for silicone implants, the bar is set higher?

Slide. Shame on the naysayers for the hypocrisy of condemning Inamed for
presumed insufficient data. Remember, the core and adjunct studies that
criticized were designed with the oversight of the FDA. At the same
time, these individuals have become masters of the melodrama, presenting
volumes of purely anecdotal, nonverifiable, oft exaggerated quips before
this esteemed Committee without ever undergoing any type of similar
scientific scrutiny.

Does it stand the test of logic that surgically removing implants would
lead to sudden improvement in symptoms when this is supposed to be a
disease caused by systemic‑wide dissemination of silicone?

Slide. One simple answer to this dilemma should satisfy all. Legislate a
standardized, comprehensive informed consent. Require its usage by all.
Then trust the sanctity of the patient‑physician relationship.

Slide. Since no one else will stand up and say it, I will. Companies
like Inamed should be commended for the millions they have invested in
research and development. The modern‑day silicone implant is safe to the
satisfaction of medicine and science alike. Thank you, Inamed.

MS. CUMMINGS: Good morning. Ladies and gentlemen, my name is Arlene
Nicole Cummings. I came here at my own expense today to tell you about
how breast implants have affected me.

At the age of 12, I had a breast tumor removed from my right breast.
This left me with an asymmetry problem that only got worse as I got
older and had my children.

Fixing my breast was something I had thought about for years. After I
was done having my children, I felt the time was right. I did a lot of
research online and found a great deal of information but nothing
personal. This is what prompted me to start implantinfo.com back in
1998, after my own surgery.

Implantinfo is now the largest community Web site for breast
augmentation patients where women can research the good and the bad
about breast implants and go through photos and stories of thousands of
other women.

I am here today primarily because I am a satisfied breast augmentation
patient. However, I never had the option of choosing silicone back in
1998. After years of talking to women and doing my own research, I now
believe silicone is a superior product in many ways. If I had the option
today, I would choose silicone over saline.

On my Web site, I have corresponded with countless women who, for many
reasons, probably should have had the silicone option but did not. They
were denied silicone implants, had an unsatisfactory result with saline,
and then had to have a second surgery to replace their saline implants
with silicone. So they actually had to have two surgeries to get the
result they wanted the first time.

I am also aware of the frustration surgeons feel because they cannot
give a patient what they know in some cases will produce a better result
for them.

The risk of a second surgery in my opinion is far greater than any
silicone implant would have posed. Ironically, breast cancer patients
already have compromised immune systems but for the most part can
receive silicone implants.

Are they at less of a risk of the supposed risks of silicone breast
implants? I believe silicone implants provide a far better result for
reconstruction. If these patients get better results with silicone
implants, shouldn\'t they be available to all of us? Women along with
their surgeons should be allowed to choose silicone or saline. We are
neither ignorant nor shallow, and we are not seeking breast augmentation
without informed consent.

We have researched the procedure for years. The average age of a woman
on my Web site is 34. Most of us are married with children and just want
to get back what we lost after pregnancy and nursing.

I believe in informed consent. And women should know all of the risks.
But in the end, after we review that information, let us decide along
with our surgeons silicone or saline.

I\'ve received dozens of e‑mails from women who wanted to be here today
in person but could not for many reasons. There are thousands of women
like me on implantinfo.com. And I encourage you to come to the Web site
to read more about us and to give us both the choice of silicone and
saline.

Thank you for your time.

CHAIRMAN CHOTI: Thank you.

MS. COLOMBO: Good morning. My name is Michele Colombo. I am 36 years
old, married, and I have one child. And I come here at my own expense.

For many years, I was dissatisfied with the size and appearance of my
breasts. I am a very self‑confident and educated person, but I have
always seriously considered improving my appearance by undergoing breast
augmentation.

I researched breast augmentation for approximately five years, including
reading the FDA Web site as well as other resources on the internet. In
doing so, I satisfied myself that silicone implants are a safe
alternative for my breast augmentation.

Due to a vocal minority in the early 1990s, silicone breast implants
were banned for sale to most ordinary people, like me, in the United
States. If I lived in Europe, I could get silicone breast implants
without any question. If I traveled to Europe, I could get silicone
breast implants and I could come back to the U.S. and live here with
them, even though they\'re unavailable here. If I had breast cancer, I
could get silicone breast implants, perhaps because those with breast
cancer are less prone to the purported risks of silicone breast
implants.

What\'s more, if I were a man, I could get silicone testicular implants.
And if I required shunts for medical reasons, it would also be made of
silicone.

Fortunately for me, in an ironic way, when I was seeking breast
augmentation options, I was able to qualify for silicone implants
because I have a congenital deformity. What does not make sense to me is
that silicone breast implants have been shown in numerous studies to
have no more long‑term health risks than saline breast implants and
other silicone devices.

Despite the fact that the FDA up until now has allowed some people to
get silicone and not others, I don\'t understand why someone else can
decide that they are safe for me or for a cancer patient but not safe
for someone else. In other words, a woman can make a decision about
safety of breast implants if they have cancer but not if they simply
want to improve their physical appearance.

I am here to tell you that the benefits to women, regardless of whether
they have cancer or some other arbitrary qualifying factor, are equal.
My life has improved dramatically since I had my surgery last year. My
sense of self has improved. And it has affected aspects of my life too
numerous to mention. I had a child after my breast augmentation with
silicone breast implants and breast‑fed him successfully.

I think it is time to reevaluate the true motivation for the ban on
silicone breast implants. The fact that breast cancer patients may
obtain them and cosmetic patients cannot exposes the true reason for the
ban. What is at stake is a moral judgment, rather than a medical one.

If my breasts are completely deflated from breast‑feeding, weight loss,
or age, improving my appearance with breast implants is deemed
unacceptable because it would be for vanity. If I had a mastectomy, it
would be acceptable because it could be justified as medically
necessary, although many women choose not to get implants after
mastectomy.

The difference is a moral one, not a medical one. I don\'t believe the
FDA is the right organization, if any, to determine what is morally
appropriate to do to our bodies. If the FDA is going to ban silicone
implants based on unacceptable risk, I think it is time to ban all
medicines which have side effects.

Why is my psychological desire to improve my appearance less important
than the desire of others to curb their appetites through approved
weight loss drugs, reduce heartburn, stop hair loss, et cetera? The
truth is it\'s just as important.

I urge you to remove the ban on silicone breast implants and let women
make informed decisions about their bodies the way millions of people do
every day with countless other devices and medicines approved by the
FDA.

Thank you for your time.

CHAIRMAN CHOTI: Thank you very much.

And at this point, we\'ll take a break of about 15 or 20 minutes. Let\'s
resume promptly at 10:30. Thank you.

(Whereupon, the foregoing matter went off the record at 10:10 a.m. and
went back on the record at 10:39 a.m.)

EXECUTIVE SECRETARY KRAUSE: I think we are about ready to start.
AnnMarie is here. Okay. I am going to turn the meeting back over to Dr.
Choti.

CHAIRMAN CHOTI: Good morning. May we have our next public speaker,
please? Remember, you have three minutes. And, just to remind you again,
the yellow light comes on with a 30‑second warning. And you need to stop
by the time the red light is on.

MS. CORBETT: Actually, I\'m representing an organization.

CHAIRMAN CHOTI: Okay. So five minutes.

EXECUTIVE SECRETARY KRAUSE: Are you Christianne Corbett?

MS. CORBETT: Yes, I am.

EXECUTIVE SECRETARY KRAUSE: Okay.

MS. CORBETT: Yes. Good morning. My name is Christianne Corbett. I am the
Program Coordinator at the National Council of Women\'s Organizations,
NCWO. NCWO is am umbrella group for 200 women\'s groups. And I am
speaking on behalf of the over ten million women nationwide that NCWO
represents.

NCWO is very concerned about the safety of medical products used by
women. The key question for this FDA advisory panel is whether silicone
gel breast implants are safe, whether the benefits outweigh the risks.

In my testimony, I will focus on what we know and don\'t know about
long‑term safety. We know from hearing testimony of the women at the
2003 panel meeting and again today that many of these women were very
happy with their implants for the first few years. But after seven or
more years, especially after their implants broke and started to leak,
many women reported serious problems.

Local complications are the best established problems. These
complications can be short‑lived, like most infections, or can be
devastating. Chronic pain is very difficult to live with.

Having breasts that are hard as rocks is not a goal for most women. And
if things go wrong and implants have to be removed, then what happens?

I have some photographs that I want to share with you. The photograph up
right now is a photograph of a 29‑year‑old woman who had her implants
removed after 7 years. She had capsular contracture that was so painful
that she decided to have her implants removed. This photograph is from
the FDA website.

Here is another woman ‑‑ you can go to the next slide ‑‑ who wasn\'t so
lucky. This woman\'s ruptured implant had leaked into her healthy
breasts. And when the silicone was removed, that is all that was left of
her breasts.

Now let\'s look at some long‑term studies of diseases. The National
Cancer Institute looked at thousands of women who had implants for at
least eight years. They found women with implants were twice as likely
to die from brain cancer, three times as likely to die from lung cancer,
and four times as likely to commit suicide compared to other plastic
surgery patients.

FDA\'s scientists did the best study of the health of women with
ruptured silicone implants. All the women in their study had breast
implants for at least six or seven years. So some had implants that had
been leaking for several years. They found that women with implants that
leaked outside the scar capsule were significantly more likely to report
fibromyalgia and several other painful connective tissue diseases.

Dow‑Corning paid for another study on ruptured implants, referred to as
the Danish study in the FDA review that was provided to you.
Unfortunately, the Danish study included only 23 women with implants
that leaked outside the scar capsule. They found that those women had
more pain and other problems than women whose implants were not leaking,
but because of the small sample size, those differences were not
statistically significant. The study is not conclusive because the
number of women with extracapsular leakage is much too small.

Implant makers often say that there are more than 100 studies of women
with implants and that these studies prove that implants are safe. When
they say this, they tend to ignore the studies that don\'t agree with
them, which tend to be the studies of women who had implants the
longest, such as the FDA and the NCI studies.

Most of the studies that the implant makers quote as proving safety were
funded by Dow‑Corning. Almost all of the studies in the often‑quoted
Institute of Medicine report, including the Mayo Clinic study and the
Harvard study, were funded by Dow‑Corning. And, like the Danish study I
mentioned, they tend to have rather small samples. And most studied
women who had implants for a short period of time. For example, the Mayo
Clinic study included only 749 women with breast implants, and only 375
of them had had implants for more than 7 years.

Autoimmune diseases take years to develop and be diagnosed. And the
sample would have to be larger to adequately study diseases that are so
rare in young women. You don\'t have to take my word for it. The authors
point that out themselves.

Listen to the testimony you will hear from the women today. It took
years for them to develop diseases after getting their silicone
implants. First, they had symptoms that they didn\'t take very
seriously. When they were tired or their joints hurt or they had trouble
concentrating, they thought that perhaps they just weren\'t getting
enough sleep or they were working too hard.

Those are the same symptoms reported by Inamed in their patients who had
implants for only two years. They aren\'t sick or diagnosed with
diseases like rheumatoid arthritis, but it will take at least a few more
years to find out if they will be.

One more thing is that almost all of the women in the core studies are
white. Women of every racial group got breast cancer, but only six
African American women and five Asian American women are in the Inamed
reconstruction study. Race is an important issue because African
American women are more likely to get autoimmune diseases than white
women.

In conclusion, not enough research has been done on large diverse
samples of women that proves that silicone breast implants are safe in
the long term. Because of this, on behalf of the National Council of
Women\'s Organization and the ten million women NCWO represents, I urge
you to vote against the approval of silicone breast implants.

Thank you.

CHAIRMAN CHOTI: Good morning.

MS. SILVERMAN: Good morning. My name is Virginia Silverman. This is my
daughter Eve. She is six years old. I am from Laguna Niguel, California.
Inamed paid for my flight here today. I am here today to talk about
choice, a woman\'s inherent right to choose what is right for her body.

In September 2001, just days after September 11th, I was diagnosed with
early‑stage DCIS breast cancer. After educating myself about the
aggressive nature of my cancer, my treatment options, recurrent
statistics, and my potential for complete cure, I chose to have a
bilateral mastectomy. As a result of my aggressive treatment choice, I
was cured of the disease with no need for chemotherapy, radiation, or
tamoxifen.

To expedite my recovery, I chose to initiate my breast reconstruction
during the initial cancer surgery. When I awoke from the operation, the
cancer had been excised and saline tissue expanders had been inserted.

During the 12 weeks following my mastectomy, saline was injected into my
expanders each week. As more and more saline was injected, the saline
implants proved to be extremely uncomfortable. The water was hard inside
its containers. And I experienced my breasts as inflexible, immovable
objects on my chest. With every movement of my body, I was acutely aware
of the foreign objects residing beneath my chin.

Finally, my tissue extension phase was over. And I received my permanent
silicone implants. I chose the Inamed silicone gel implants because I
was confident, then and now, after exhaustive research of their safety.

It has been three and a half years since I chose to cure myself of
breast cancer and place silicone gel implants inside my body. Compared
to the rigidity and discomfort of the saline implants, my silicone
implants are comfortable and pain‑free.

While the saline implants were annoyingly inflexible and hard, my
silicone implants are pliable and comfortable, contouring to both my
body and my clothing. They even move when I dance and exercise.

As the Vice President of Marketing for Lindora, America\'s leading
medical weight management company, it is my responsibility to be an
active advocate on behalf of women\'s health issues.

I stay abreast of the most current medical advancements leading to
healthier, happier lives for women everywhere. After over a decade of
diligent research showing virtually no health issues with the product, I
believe silicone gel implants should be available to all women, whether
they are breast cancer survivors or not.

In conclusion, on behalf of myself, my six‑year‑old daughter Eve, who is
with me today, and all women who are choosing to enhance their lives
through breast reconstruction or enhancement, I urge you to approve the
use of silicone gel implants for wide consumer use.

We have a right to decide what is right for our own bodies. I chose to
live by electing my double mastectomy. I chose to live well by selecting
silicone gel implants. I choose to be here today to encourage you to
give women here in America the opportunity to choose for themselves
which implant is right for their bodies.

Thank you very much for your consideration and your time today.

CHAIRMAN CHOTI: Thank you.

Yes? Next? Good morning.

DR. MAHARAJ: Good morning. I\'m Dr. Susan Maharaj, and I am a professor
of chemistry. I have no conflict of interest. Today I am presenting the
results of Maharaj 2004, Maharaj and Lykissa 2004, and Lykissa and
Maharaj 2005.

Next slide, please. Maharaj 2004. The results show that high levels of
platinum are present in silicone breast implant gel, shells, and in the
corresponding capsular tissue of women exposed to silicone breast
implants. The gel and shell platinum values in this study are much
higher than reported by manufacturers. Platinum tissue concentrations in
women exposed to silicone breast implants are higher than in tissue
samples of women not exposed to these devices. And, in fact, the values
do not overlap.

Next slide, please. Maharaj and Lykissa 2004 and Lykissa and Maharaj
2005. Mean platinum concentration in whole blood and urine samples of
women exposed to silicone breast implants was higher than in control
subjects.

Mean platinum concentration in whole blood and urine samples of children
conceived after their mothers were implanted was higher than in children
conceived before their mothers were implanted.

Next slide, please. Mean platinum concentration in hair, nails, and
sweat samples of women exposed to silicone breast implants and in
children conceived after their mothers were implanted were higher than
that of the general population and higher than in children conceived
before their mothers were implanted.

Mean platinum concentration in breast milk samples of women exposed to
silicone breast implants was much higher, about 100 times higher, than
samples from women not exposed to these devices.

Next slide, please. Mean platinum oxidation states in explanted silicone
breast implants occur mainly in the +2, +4, and +6 valence states. This
is a very important point. Manufacturers are claiming and FDA believes
that platinum is in the zero valence state. Mean platinum oxidation
state in whole blood samples of controlled subjects was mainly in the
zero oxidation state.

Next slide, please. Mean platinum oxidation states in whole blood and
urine samples of exposed women were mainly in the +2, +4, and +6
oxidation states. Mean platinum oxidation state in whole blood samples
of children conceived by mothers after implantation and in a brain
tissue sample of an exposed individual were in the zero, +2, and +4
oxidation states.

Next slide, please. In conclusion, my main three points are as follows.
Number one, the platinum concentration in gel and shell material of
silicone breast implants is actually much higher than reported by
manufacturers.

Number two, the platinum concentration in many different types of
samples is consistently higher in women exposed to silicone breast
implants than in non‑exposed individuals and is higher in children
conceived after implantation than in children conceived prior to
implantation.

And, number three, silicone breast implants contain highly reactive
forms of platinum.

Thank you very much.

CHAIRMAN CHOTI: Thank you.

MS. WOLF: Good morning. My name is Carolyn Wolf. I live in Virginia, and
I came here at my own expense. I have no conflicts of interest.

In 1972, after subcutaneous mastectomies, I had reconstruction with the
newest, best construction, silicone implants, that were safe and would
last my lifetime.

There were no problems in the beginning. By the seventh year, burning,
blister‑like growths started on my neck and boil‑like growths on my
forehead. Sixteen years after, three days were spent in ICU because of
severe burning chest pains.

By the 21st year, my family had noticed a change in personality. And I
had noticed cognitive changes. By the 25th year, though a non‑smoker, I
was coughing up hard, greasy, gold‑colored plugs. X‑rays showed chronic
obstructive pulmonary disease.

A military plastic surgeon checked me every year. I never connected my
problems with the implants until my left breast capsule collapsed 28
years after implantation. MRI showed both implants extensively ruptured.
Shortly thereafter, a glob of silicone moved from my breast into my
armpit, leaving an elongated swelling in its path. There was
excruciating pain.

In April 2000, vision was lost in my left eye for 45 minutes. Pain
continued in that eye until a long, stringy glob came out of it several
weeks later. Two similar strings were exuded from my left ear in the
30th year.

Explantation performed in 2000 showed the left implant measuring only
four centimeters. The scar capsules surrounding the implants contained
chronic inflammation and foam cells containing silicone. Few women had
implants as long as I.

I have been diagnosed with silicosis, rheumatoid arthritis, connective
tissue disease, Raynaud\'s, and silicone‑induced MS‑like syndrome with
neuropathy of the extremities.

My brain MRI shows more than 20 lesions. My silicone level is .11, more
than double what is normal. My platinum level is 20 times normal.
Silicone continued to be exuded from my nipples until simple
mastectomies to remove painful calcified tissue was performed six months
ago.

National Cancer Institute has conducted the only study of women
implanted for more than eight years. That found women are much more
likely to die of brain and lung cancers and suicide. If implants are so
safe, make sure that manufacturers prove that it is safe.

The studies you will hear about tomorrow do not prove that. The women
studied were not implanted for more than ten years. You have no control
over the advice given or not given by plastic surgeons. What happened to
me will eventually happen to thousands of women with silicone implants.
And please do not inflict this on another generation.

CHAIRMAN CHOTI: Thanks.

MS. KEELING: My name is Marlene Keeling. I am President and founding
Director of Chemically Associated Neurological Disorders, or CANDO. I
have paid my own way here because of my concern over toxic and
hypersensitizing chemicals that I am convinced are leaking or bleeding
from implants into not only the bodies of women but, even more
worrisome, their children born after implantation.

I was implanted with McGhan double lumen breast implants in 1978. I had
my ruptured implants removed in 1994, after I became convinced that my
implants were causing my swollen lymph nodes, hair loss, memory loss,
overwhelming fatigue, peripheral and demyelinating neuropathy. I was
perfectly healthy before I got implants, got sick, had my implants and
scar capsule removed in block and not replaced, got better.

When tested for platinum six years after explantation, my urine was
found to contain 36 parts per billion per liter of urine. Platinum was
found to leak from my implants. And platinum was also found in my hair,
nails, sweat, and blood.

The ionization or speciation of my platinum was +2 and +4. Dr. Joseph
Bubinak, a board‑certified hematologist and medical oncologist,
testified before a breast implant advisory board in 2002 regarding his
experience with the chemotherapy agent cisplatin.

Dr. Bubinak reported that he was astounded to learn that the catalyst
used to manufacture the silicone for breast implants was platinum
chloride, a highly reactive molecule and precursor to the chemotherapy
agent cisplatin. He stated that some breast‑implanted patients have the
same systemic complaints and side effects as cisplatin‑treated patients,
including fatigue; hair loss; loss of short‑term memory; rash; and other
allergic reactions; respiratory system problems; and peripheral
neuropathy, which is sometimes disabling.

Dr. Bubinak stated that the migration of reactive platinum alone could
explain capsule formation and tells the world that the chemicals in
breast implants are not inert.

Can you go to C? Dr. Maharaj has presented data from CANDO\'s research
project number 1 here today. Based on this research, it was determined
that urine was the least invasive, best method to test for platinum
levels in the body.

CANDO\'s research project number 2 has now tested the urine of over 50
breast‑implanted women and their children born prior to and after
implantation. I have copies of this raw data, which I can give to the
panel today.

Previously in a written submission, I gave the panel a copy of the
CDC\'s platinum urine study in the general U.S. population of over 1,000
people. And not one of them had over the level of detection of 0.04
parts per billion.

To quickly recap, the results of the raw data presented today, one child
born after implantation tested over 300 parts per billion. One woman
tested over 200 parts per billion 11 years after explantation. And nine
women and one child tested over 100 parts per billion.

The panel was also given a copy of Dow‑Corning\'s 1996 letter notifying
the EPA of substantial risk to their platinum catalyst used in breast
implants. Ionized platinum is on the list as being a suspected
neurotoxicant and immunotoxicant.

Mentor\'s most recent FDA‑approved product insert makes the following
statement, \"Toxicity studies are currently in progress by various
research facilities, universities, government agencies, the medical
community, and the medical device industry. Some of these studies are
conducted in animal models to determine potential immunotoxicity and
autoimmune issues related to silicone materials. There is the potential
that in the animal models being studied, immunotoxicity may result.\"

I submit it is not safe enough for the FDA to simply say it is not known
if a small amount of silicone may pass from the silicone shell of an
implant into breast milk. If this occurs, it is not known what effect it
may have on the nursing infant. We must protect our future generation,
who cannot make a choice.

Thank you.

CHAIRMAN CHOTI: Yes? Good morning.

DR. MAO: Good morning. My name is Jeremy Mao. I am Associate Professor
of Bioengineering and Cell Biology at University of Illinois. I come
here today with no financial ties to either the sponsor or any of their
competitors. My testimony today will be related to mechanical testing of
silicone breast implants.

I have reviewed the scientific and regulatory literature extensively on
mechanical testing of silicone breast implants. After review, it seems
that there is a shortage of data, mechanical testing of implants in
simulated in vivo environment.

The in vivo environment surrounding silicone breast implants is complex
and consists of fibrous capsules, many cytokines, protolytic enzymes.
The local chemical and physical environment, such as pH and temperature,
may also affect the outcome of mechanical testing.

There is experimental evidence that the in vivo environment weakens
silicone gel breast implant shells over time. Several articles published
in Plastic and Reconstructive Surgery and other journals have
demonstrated the need for performing mechanical testing in simulated in
vivo environment.

Silicone breast implants rupture for a variety of reasons. The
complexity of tissue‑borne mechanical stresses on implants is a result
of tension, compression, and shear stresses. In most previous mechanical
testing studies, only uniaxial mechanical forces are applied. This
represents only one of the multiple dimensions of mechanical stresses in
vivo.

Multidimensional forces may be used to simulate mechanical testing of
breast implants to adequately simulate the conditions in vivo in the
patient\'s body.

ASTM International has several guidelines for testing silicone breast
implants, such as tensile strength, ultimate elongation, and fatigue
life. However, in 1989, Plastic Surgery Subcommittee members stated that
the tensile and tear strength measurements are not particularly relevant
to the clinical circumstances under which implants rupture.

In addition, there is a need to examine whether there is a correlation
between MRI findings of rupture or potential rupture with mechanical
testing data. A recent article in the European Journal of Radiology
reports correlation between MRI findings of silicone breast implant
rupture and clinical examination at the time of implant removal.
However, it is known in the literature if there is a correlation between
MRI findings and implant rupture and mechanical testing of the implant
prior to and after implantation.

Mechanical testing prior to implantation could be useful reviewing what
type of implants are more susceptible to MRI‑detectable ruptures.

Thank you.

CHAIRMAN CHOTI: Yes? Good morning.

DR. MELMED: Good morning. I\'m Edward Melmed. I have no conflict of
interest. I am a plastic surgeon who has done breast implants since the
day they were introduced. I did my first year of residency in 1963, when
Cronin first introduced silicone implants. So I have seen the evolution
through the Cronin implant; the Jenny (phonetic) inflatable, which was a
balloon through to the silicone pads; the Dacron patches; Meme implants,
et cetera.

I wrote extensively about this in the Plastic and Reconstructive Journal
in the \'90s. But from 1992, I had a complete change‑around. I started
seeing the devastation and complications from breast implants. And since
1992, I have explanted over 800 women with breast implants. I wrote
about this in Plastic and Reconstructive Surgery in 1998.

My statistics that I wrote in 1998 showed a rupture rate at 10 years of
approximately 50 percent, a rupture rate at 15 years of 70 percent, and
a rupture rate at 20 years of 94 percent. My current figures show no
deviation from this. It\'s a time‑dose‑related phenomenon. Research that
shows two, three, or four years\' duration, my statistics show the same.
It shows a four percent rupture rate.

The problems become manifest the longer the implants are in. The
implants will rupture and just disintegrate. And sometimes no wall of
the implant can be found.

I have brought some short clips that I\'d like to just show in the
background of what implants really look like when you get into the
10‑15‑year rate of removal. The silicone will simply well out with no
visible evidence of any wall.

Now, if we take the statistics that are currently available,
approximately 330,000 women received breast implants in ‑‑ at least
2004. If we extrapolate that figure ‑‑ sorry. Let me backtrack and say
that if we accept that no medical device is safe ‑‑ and I think we must
say that ‑‑ then just assuming there\'s one percent failure rate, at 10
years, you\'re going to have 33,000 women with problems, which if it
becomes 3 percent is 100,000 women.

Now, no batch can be identified of what implants disintegrate. So we\'re
left with this uncertainty of the future of these women. So a girl of 16
who you are going to allow this device in is very different from the
70‑year‑old who has a hip prosthesis that might fail, a woman who is
going to be left with an inevitability of having four or five operations
in their lifetime.

Lastly, how do you recall implants? If I buy a new Ford and it has a
brake problem, the National Highway Traffic Safety will report it if
there was more than one percent failure rate. Here we\'ve got 17 percent
failure rate. How do we recall them?

Thank you very much.

CHAIRMAN CHOTI: Sir, we have a question here. Yes?

MEMBER LI: This is Steve Li, Dr. Melmed. Just one quick question. Your
rupture rates, was that your own personal experience of your own
patients?

DR. MELMED: That\'s our own personal experience in practice.

MEMBER LI: And roughly how many patients was that?

DR. MELMED: That was over 500 patients.

MEMBER LI: And just over what calendar period?

DR. MELMED: From 1992 until 2004.

MEMBER LI: Thank you.

CHAIRMAN CHOTI: Yes? Good morning.

DR. ZONES: Good morning. I\'m Dr. Jane Zones, a medical sociologist here
representing Breast Cancer Action as a member of its board of directors.

Breast Cancer Action is a national grassroots membership‑based education
and advocacy organization that works to make the changes necessary to
end the breast cancer epidemic. BCA has a corporate donations policy
that forbids us from accepting donations from any entity that might
present a conflict of interest. This includes not only all health
industries but organizations whose products or manufacturing processes
may contribute to cancer incidents generally.

We have no financial interest in the outcomes of these hearings.

Breast Cancer Action\'s major concern is the continued lack of data to
assure long‑term safety and the need for specific guidance for women
seeking reconstruction after mastectomy that would allow making an
informed decision about the silicone breast implants. In particular, we
are disturbed by the data supplied by the applicants on short‑term
complications and resurgeries that are particularly prevalent in women
undergoing reconstruction after mastectomy.

We are grateful for the care which the FDA staff analyzed the data
submitted by the applicants and agree with FDA\'s analysis that the
assumptions employed in industry\'s projections improperly minimize the
risk of rupture in the future.

We have many breast cancer‑related concerns with silicone breast
implants. Today, however, I would like to address a topic not specific
to breast cancer, which is post‑marketing surveillance.

At the October 2003 meeting of this committee, Inamed struck a deal that
promised ongoing follow‑up of women in their studies in return for a
conditional approval by the panel. This appeared to have been negotiated
with at least some on the panel behind closed doors during the night
before the vote. By early in the morning on the last day of that
meeting, dozens of copies of the proposed agreement had been duplicated
and were handed out to meeting participants.

Since the FDA Modernization Act authorized FDA to conduct post‑marketing
surveillance of drugs in 1997, hundreds of new drug reviews have
required Phase IV post‑marketing clinical studies as conditions of their
approval.

In their most recent report to Congress, the FDA indicates that over
two‑thirds of new drug approvals with open post‑marketing commitments
had not yet initiated required Phase IV studies.

The situation for medical devices is even less developed. In June 2002,
FDA announced plans to require manufacturers of some devices to conduct
post‑marketing surveillance for up to three years. Breast implants are
covered by this rule because the category includes medical devices
implanted for more than a year.

However, there is no reason to expect device manufacturers to be any
more compliant than pharmaceutical companies in their pursuit of
post‑market approval data. In fact, an article in the Wall Street
Journal less than two weeks ago quoted an internal report by FDA
scientists, saying that the CDRH had only limited procedures for
monitoring manufacturers\' progress and results.

Of 45 devices conditionally approved between \'98 and 2000, nearly
two‑thirds included no information about post‑marketing studies in
manufacturers\' annual reports to the FDA. Final results on over half of
studies that were known to be due had not been submitted.

FDA has little recourse where manufacturers either fail to meet
post‑marketing commitments or find evidence of greater risk except to
pull the product from the market. This has never happened with devices
nor, as far as I know, with drugs.

The dramatic removals we have witnessed in recent years have usually
involved whistle‑blowers, leaked documents, journalistic exposes, or
unexpected findings from post‑market studies designed to broaden
indications for use of the product.

Inamed and Mentor have proposed up to ten years of total follow‑up of
the women in their studies, but the medical device regulation has an
upper limit of three years, which, if effected, would preclude
prospective analysis of the effects of aging of the implants, which are
thought to rupture at increasing rates.

We urge the panel to act on the data that is now before you and not on
that which may be promised in the years ahead. The manufacturers know
that it is unlikely that you would ever be called to review post‑market
surveillance data in the future and that the consequences for less than
quality follow‑up or for findings of greater risk are minimal.

Women who are at risk for breast cancer or who currently are living with
the disease are depending upon you to hold these devices to a high
standard.

CHAIRMAN CHOTI: Thank you.

Next speaker, please.

MS. PAM DOWD: Hello. My name is Pam Dowd, and I have been asked to speak
on behalf of Cristy Warschaw, founder of Women in Health, one of the
largest support groups in southern California for silicone breast
implant women. Neither she nor I have any affiliation with Inamed or
Mentor. Neither of us have received monies from either company for this
testimony.

\"I, Cristy Warschaw, have had both Inamed and Mentor post‑1990 silicone
breast implants. I am unable to attend this hearing because of my
continued health problems associated with these implants.

\"My history is very simple. No health problems until November 1989,
when at age 28 I underwent a mastectomy with reconstruction with
silicone breast implants.

\"I had a family history of breast cancer and calcified fibrocystic
disease. I became ill as soon as the implants were placed. I had to stop
working as a medical administrator and stop my Master\'s degree program
at UCLA.

\"I have been on disability for most of the last 16 years. I have had
seven surgeries, all associated with the implants. As of today, at the
age of 43, I have undergone total mastectomy with no further
reconstruction because I am not a candidate for TRAM flap or any other
reconstructive surgery.

\"It has been discovered that I am one of a few people allergic to
silicone. If I even ingest milk, I can have an anaphylactic reaction as
silicone is used as a defoaming agent in processing. I cannot place any
silicous, silicones, dimethicones, or any cones on my body because I
will break out in a rash.

\"IV needles are coated with silicone, and I have not been able to keep
one in me for more than one day because of the silicone reacting and
inflaming the IV site.

\"Having been a support group leader for 12 years and having had both
manufacturers\' implants, I have done a lot of investigation on both
companies. My number one concern is the FDA 483 inspections. Inamed is
manufacturing its SBIs in Costa Rica. By what means is the FDA
inspecting this manufacturing plant?

\"Mentor\'s manufacturing facilities in Texas have failed viscosity,
dipping, and humidity control over and over again. Also, medical device
reporting has also proven to be a problem as well.

\"If the FDA is taking Inamed\'s chemistry and mechanical testing from
only Inamed\'s say, then this is a complete failure on behalf of the
FDA. It is also jeopardizing every woman receiving an SBI.

\"Neither company has ever been able to assure shell thickness during
the dipping process due to inability to control humidity. So they cannot
predict clinical outcomes, as requested by the FDA, because each lot
will produce a different result.

\"As a health care professional who has kept clinical data for FDA
experimentation and clinical trials, I have great anxiety in allowing
silicone breast implants to be placed back on the market.

\"Also, having been a support group leader and seeing women affected by
SBIs, I know how people fall out of the studies. Women will not see a
reason to follow up in‑house with a plastic surgeon at the recommended
intervals.

\"There is no way a physician can detect a silent rupture. MRIs cost
thousands of dollars. The study is already set up to fail. Women move.
Women with SBIs are being treated for cancer. Therefore, there is a
higher mortality rate for these women.

\"No guards are set in place to retrieve post‑mortem implants for study.
There is a strong possibility these women can lose health insurance and
will not return for follow‑up appointments.

\"Women will have a problem and not return to the same surgeon. They may
very well go to a surgeon who is not part of the study. What happens to
those implants?

\"Women do not relate their fatigue to implants and are seen by their
personal M.D.s for this and may not relate these to silicone breast
implants.

\"I have had four different surgeons and to this day and am in
possession of four of my five implants. The silent contained rupture was
not noticed on MRI two days before I had surgery. Four years after this
rupture, I had 15 granulomas relieved from my chest wall by yet another
surgeon.

\"There has never been an FDA PRP report filed on me or MDR report on my
rupture or fungus‑infected implants. I fell through all the loops. And
as a support group leader knowing about breast implants, how many of
these women will fall through the loops as well? Women with breast
cancer are too busy worrying about their lives to think about SBIs. They
just want to be whole again.

\"I could go on and criticize each part of the draft guidance for
industry and FDA staff saline, silicone gel, and alternative breast
implants, but that would take up more time than I have. It is my opinion
that neither company has met the FDA guidelines to demonstrate a
reasonable assurance of the safety and effectiveness of SBIs. Therefore,
they should deny approval.

\"After ten years of trying\" ‑‑

CHAIRMAN CHOTI: If you could sum up, please?

MS. PAM DOWD: Yes. I\'ve just got this one sentence.

\"After ten years of trying, yet just not making it, SBIs should be
removed from the market altogether.\"

MS. SMITH‑MILES: Good morning. My name is Rebecca Smith‑Miles, or Becky.
I am from northern Michigan. I am a registered nurse. My husband is a
radiologist. I have no conflicts of interest.

I had silicone implants put in over 15 years ago. Within two years, I
developed capsular contracture and experienced intense pain. My plan to
be more beautiful was ironic in that I was uglier by the day. I had
larger breasts, but they were hard, painful, and ugly. I was ashamed for
even my husband to see them.

Within seven years of getting the implants, I was diagnosed with an
atypical neurological disease. Eight years after being implanted, I had
my implants and scar capsules removed. They had ruptured. And the
plastic surgeon attempted to retrieve all of the leaked silicone, but he
was unsuccessful.

If I had been included in the three‑year and four‑year studies at that
time, only capsular contracture and pain would have been picked up, not
the rupture and not the systemic problems.

I have gone from being a very athletic and active person to being
physically inactive and at times bedridden. I worked daily prior to
getting implants. Now I\'m on disability. And sometimes I\'m even unable
to perform my daily household tasks, simple tasks.

I have severe overwhelming fatigue, joint and muscle aches, pain, dry,
scratchy eyes, skin rashes, numbness in my calves and toes, hair loss,
night sweats, and daily headaches. I am easily confused and have a
constant fog in my head.

My skin develops rashes and reacts to previously normal substances. I
have blister‑like eruptions in my fingers that are intensely painful.
And along with the pain comes burning and itching and total intolerance
to any pressure. I can\'t use that finger. I scratched it and scratched
it until the top came off. And then I felt with my tongue a tiny sliver
of crystal. When I got that crystal out, it healed immediately.

I fear that I have silicone crystals running throughout my body, and I
wonder what kind of damage it has done to my internal organs. I had
silicone leakage in my chest, axillary lymph nodes down my arms.

My last surgery a year ago removed silicone after an ultrasound located
it in my chest and breasts. I had a lemon‑sized portion of my right
breast tissue removed as a result of the leaking silicone from the
rupture over ten years ago. The surgery has made that right breast
noticeably smaller, but it\'s worth it.

My life since getting implants has changed completely. My social and
family lives have suffered. I can no longer be a normal wife, mother, or
grandmother. Even so, I\'m lucky because my husband is a physician, and
we are not financially devastated by my disability.

I beg you, as you make this very important decision, think not only of
my experience but also of the lives of other women, your friends, your
relatives, who may end up like me. Silicone breasts are not worth the
known risks, let alone the unknown long‑term risks.

Thank you. Any questions?

CHAIRMAN CHOTI: Thank you very much. Good morning.

MS. DALY: Good morning, ladies and gentlemen. My name is Anna Daly, and
I\'m from Nashville, Tennessee. I was asked to come and speak to you
today by my plastic surgeon, Dr. Melinda Haws, of the Plastic Surgery
Center of Nashville, and the Inamed Corporation, who provided my
transportation and lodging.

On December 30th of 2003, I had my very first mammogram. On January 26th
of 2004, I was diagnosed with ductal carcinoma, breast cancer, on my
left side. Though the cancer was still fairly small and had not yet
spread, it was labeled as high‑grade and aggressive. And I was not yet
40 years old, with a 2‑year‑old and a 4‑year‑old at home.

After speaking with my family and the doctors involved, we decided the
best option would be to undergo a bilateral mastectomy with immediate
reconstruction using tissue expanders, which I did on February 13th. The
choice was made because of the nature of the cancer, the probability of
it recurring on the opposite side, and the symmetry that would be
provided by doing both sides at once.

During the next five months, we discussed and researched my implant
options: saline versus silicone, smooth, textured, and size. The tissue
expanders that I received were saline‑filled. And my experience with
them was not a pleasant one. I did not like the fact that I could hear
the liquid sloshing in my chest, nor feel the saline moving from side to
side as I walked, caused several cases of severe motion sickness that I
did not want to repeat.

Appearance was also considered. I didn\'t like the way the saline‑filled
implants have a tendency to ripple. And the profile of the implants did
not appeal to me. So I made my decision.

After signing a waiver regarding the possible side effects and enrolling
in a research study to be conducted over the next five years, I had my
tissue expanders removed. And I chose to have silicone‑filled implants
on July 1st of last year.

I like the projection of my breasts that the silicone‑filled implants
provide because it is very natural. The feel is also very natural to the
touch. And they are as close to the feel of my own breasts that I could
have imagined.

After going through the invasive nature, trauma, and emotional upheaval
of a mastectomy, appearing and feeling normal become very important to
you. Important also is the fact that I have a choice in the type of
implants that is to be placed in my body.

So many choices are already made for you when you are faced with a
cancer diagnosis. Knowing that I could help choose the way I would look
coming out of this was very empowering and very uplifting.

My request of you is to clear the way for silicone implants to be a
choice for all women, reconstruction or augmentation, research study or
not. We all deserve to feel beautiful and, if not beautiful, at least
normal.

CHAIRMAN CHOTI: Good morning.

MS. ANTOLICK: Good morning, ladies and gentlemen. My name is Karen
Antolick. And I live in Columbus, Mississippi. I have no conflicts of
interest.

My desire for implants began at the age of 15. And then at the age of
22, I took my savings along with a small loan and had silicone breast
implants placed.

I was told by my plastic surgeon that sometimes implants could hard and
have to be replaced but that if I massaged my breasts as instructed,
that this was most likely not going to happen. I was told that breast
implants were a lifetime investment and safe. I also did not receive any
literature outlining the potential risk.

I thought that my life could only improve with implants. And after my
surgery, I felt implants were the best thing that had ever happened to
me.

Within the first year, however, I began having serious medical problems.
Over the years, I was in and out of doctors\' offices with various
symptoms: chronic fatigue; memory loss; migraines; chronic pain; hearing
loss; burning in my chest; and numbness in my lips, hands, and feet. I
did not know, nor did the doctors, that most of these symptoms are
autoimmune symptoms and common with breast implant patients.

The pain and burning in my chest along with nipple discharge became so
severe that I went to a plastic surgeon to have the implants removed.
Once removed, my doctor told me that both implants were ruptured,
capsulated, and had been leaking for many years.

During the surgery, she removed lymph nodes because they had become
contaminated with silicone. This was very surprising to me because each
year my mammogram showed that my implants were intact.

I am not unusual. I now know that FDA study found that most augmentation
patients had at least one broken silicone implant within ten years. And
silicone migrates outside of the breast capsule for 21 percent of women
with implants.

I was young and naive when I received implants. I didn\'t have the
foresight to see that my health is much more important than my breast
size. Instead of providing me with self‑esteem, like I thought, they
provided me with a life of pain and dependency.

Now, 23 years later, I can no longer work as I used to. I had to move
closer to my parents so that they could help care for my children.
Probably the most difficult change I have had to come to terms with is
not being able to care for and enjoy my children the way that a mother
should.

Please make sure that young girls who are considering implants will not
have to sacrifice their health for a certain body type like I did. Thank
you for your time and consideration.

DR. TEBBETTS: Good morning. Dr. Choti, members of the panel, I am Dr.
John Tebbetts. I am a board‑certified plastic surgeon. And my testimony
this morning is based on 26 years of clinical experience performing
breast augmentation; 17 years of experience designing breast implants;
and my peer‑reviewed publications, which I have provided members of the
panel.

I have a conflict of interest but not with the devices here today. I
have designed devices for Inamed Corporation, received compensation as a
consultant. None of my devices are under consideration. And I am here
today to speak to you about an issue that really applies more to all
devices but has concerned me for some time.

For the past 15 years, through 3 PMAs for totally different devices,
surgeons, plastic surgery organizations, and manufacturers have not
improved the 15 to 20 percent 3‑year reoperation rates for primary
breast augmentation. I believe that one of the main reasons for that is
that our educational methods are not sound.

Although we have provided information and previous panels have made
recommendations about specific information to be provided, we are not
teaching patients and surgeons how to make decisions. We are not testing
to ensure that the information has been delivered. And we are not
providing incentives to assure implementation of best practices that we
know by peer‑reviewed results have been proven.

The bias characteristics affect outcomes in only a percentage of cases
while patient and surgeon decisions impact outcomes in every case,
regardless of the device and often far more than the device itself.

As we listen to saga after saga of compromised outcomes, we should be
asking ourselves, was it the device or was it the decision‑making
process of the patient and the surgeon. Could the saga have been avoided
or at least terminated early by simply applying endpoints, removing and
not replacing the implants?

The best indicators of quality of surgery are the patient experience and
reoperation rates. Today, over 80 percent of augmentation patients can
be out to dinner the evening of surgery without bandages, drains, pain
pumps, or narcotic pain medications.

And 96 percent of those patients can return to full normal activity the
next day with a 3 percent 7‑year reoperation rate. Most patients have no
idea that this level of outcome is routinely possible and even being
delivered by surgeons less than ten years in practices.

The processes and practices that generate these peer‑reviewed results
can directly impact outcomes and reoperation rates but only if they are
transferred through optimal education.

Improving patient outcomes requires accountability from those who make
decisions and from those who provide education and who want to provide
certification.

I hope that, as you consider these devices and other devices, you will
make strong recommendations in that regard. There are good solutions.
Time does not allow me to go into them today.

Thank you for your time and the opportunity to address the panel.

CHAIRMAN CHOTI: Thank you.

Good morning.

DR. FRAGEN: Good morning. I approached Inamed and Mentor and volunteered
to come here today to speak to the panel. I am a member of their
institutional review boards. And Inamed did provide for my
transportation. I am kind of a gray‑haired doc. And I thought it would
be interesting to give you my perspective.

My name is Ronald Fragen. I am a physician and surgeon who has been
performing breast implant surgery for 30 years. I practice in Palm
Springs, California. I have traveled across the country because I
believe women are able to evaluate the risks of breast implant surgery
and make their own decisions without restriction. To my knowledge, no
other country restricts the use of silicone gel implants and 60
countries have approved their use.

I was licensed to practice medicine in 1964 and began practicing
medicine in California in 1971. I have performed breast augmentation
surgery for 30 years.

Just so you know me, I was an Assistant Professor at the University of
California Medical School at Irvine for 20 years. I am the past
President of American Society of Cosmetic Breast Surgery, past President
of American Society of Liposuction Surgery, past President of California
Academy of Cosmetic Surgery, and a member of the board of directors of
both the American Academy of Cosmetic Surgery and the American Board of
Cosmetic Surgery. I have practiced exclusively cosmetic surgery for 20
years.

I have seen nearly every breast implant ever used. The current silicone
breast implants have been used in my practice since the mid 1980s, when
they were first introduced. I have patients who have had these implants
in for 20 years.

With the old implants, 20 to 25 percent of our breast surgeries every
year were revised problems, usually capsule contracture or rupture. In
the last 20 years, I cannot find 15 patients who have needed revision
surgery using the new gel implants.

I have done thousands of breast implants. The new implants have a
thicker shell and a coherent gel that doesn\'t run. The old implants had
a thin shell, more fragile, a gel that flowed like sticky molasses.
Since using the new implants, I have seen only one shell split. And that
gel did not leak. It behaved like cut Jell‑O. There was no leakage.

Do not mix the results from old implants and the new thick‑shelled
implants with coherent gel. These new implants are safe. By comparison,
aspirin is not safe. Skateboards, skiing, motorcycles, alcohol, tobacco,
and exhaust from automobiles I think are far more hazardous.

Women have many breast deformities: congenital; small; malformed
breasts; breasts that change after cancer surgery; and the largest
group, those whose breasts have become deflated skin sacs after
pregnancy.

Most of these patients I see fall in the latter category. They cannot
wear clothes they desire and often lose self‑esteem. They desire to
regain their shape. We allow women who have congenitally deformed
breasts and women who are cancer survivors to regain their shape using
silicone gel implants. These women and their surgeons pick the best
implant to fit their anatomy without restriction from the FDA.

Implants are safe for these people. Why do we trivialize post‑pregnancy
breast deformity and not allow these women and their surgeons free
access to the best implant for their particular anatomy? We should.

These implants are safe. Saline implants are stiffer. They ripple. And
they more often give a balloon‑like shape. However, they are easier to
implant. It\'s an easier operation for the surgeon than a silicone gel
implant is. A silicone gel implant is a better choice for the patient in
many instances, however.

CHAIRMAN CHOTI: If you could wind up, please?

DR. FRAGEN: Yes. These implants are a new and better machine and should
not be compared to the old implants. This is really a woman\'s issue.
The surgeons have no secondary gain to use silicone implants.

I just want to tell you that one of my reasons for going into medicine
was an aunt who started practicing medicine right after World War I
before the Nineteenth Amendment to the Constitution was enacted. That\'s
the women\'s right to vote. I\'m sure she would not have ‑‑

CHAIRMAN CHOTI: Sorry.

Next speaker? Good morning.

DR. KASPER: Good morning. My name is Anne Kasper. I have worked in
women\'s health for 30 years. I have been a breast cancer counselor for
four years in Bethesda, Maryland. I am also the Breast Cancer Counselor
for Mobile Medical Care, which serves the uninsured, low‑income, and
homeless of Montgomery County, Maryland. I am the Senior Editor of
Breast Cancer: Society Shapes and Epidemic, a book published in 2000.

The women I counsel who have faced breast cancer have one primary
concern. They want to survive this disease and live out their lives for
as long and as healthy as possible. Women want to be able to trust that
the treatments and recommendations given them by health professionals,
science, researchers, and drug and device manufacturers will halt the
progress of the disease and promote their health and well‑being. Few
women want to take any unnecessary risks with their health once they
have faced a diagnosis of breast cancer and endured its treatment.

For many women who have undergone the loss of a breast looking and
feeling normal and comfortable without further health risks involves no
more than a good mastectomy bra and well‑fitted prosthesis.

Many women who are offered breast reconstruction refuse it because they
don\'t want to undergo further surgery, anesthesia, risk of infection,
and recovery. They are also concerned that a breast implant will obscure
finding a breast cancer recurrence or that the implant will rupture and
further surgery will be needed.

There are also many more options than there used to be for breast cancer
patients who want to keep their breasts. More than three out of four of
the women who are newly diagnosed with breast cancer are eligible for
lumpectomy and, therefore, won\'t need reconstruction.

The number of women who need a mastectomy, instead of a lumpectomy, is
much smaller than it used to be. In addition, women who undergo
mastectomies have other alternatives to silicone breast implants. Saline
breast implants have a lower complication rate and do not cause, as far
as we know, the serious problems if they leak as to silicone implants.

Many women tell me that they don\'t want silicone breast implants
because they have never been proven safe specifically for women with
breast cancer. Having endured cancer in their bodies, women tell me that
the last thing they want to do is willingly introduce a foreign
substance that has not been proven safe over the long term, will rupture
in time, will leak silicone into the body, will interfere with
mammography, and may cause additional health problems as well as
repeated surgeries.

Implant makers tell us that women need silicone gel implants for their
emotional well‑being. Today you\'re hearing from patients who say they
want implants to help them feel better about themselves and that it
improves their quality of life. However, we know that there are no
studies to support that claim.

A study by Dr. Julia Roland and Dr. Patricia Ganz and colleagues
compared the quality of life of women who underwent lumpectomy, women
who underwent mastectomy, and women who had mastectomy with
reconstruction. They found no difference, no difference, in quality of
life between the three groups of women.

There were some differences in certain aspects of their lives, however,
but the reconstruction patients were not necessarily the happiest ones.
As I consider the needs of the cancer patients I work with, the lack of
long‑term safety data and the lack of evidence that breast implants
improve women\'s quality of life, I don\'t see a reason to approve
silicone gel breast implants.

I urge the FDA to once again deny approval to silicone breast implants.
If the companies finally develop a safer implant in the future, the FDA
can then reconsider.

Thank you.

CHAIRMAN CHOTI: Thank you.

Good morning.

MS. BEAGLE: Good morning. My name is Kitty Beagle. And I am here today
speaking on behalf of Anna Carpenter, who was, unfortunately, unable to
attend the meetings.

\"My name is Anna Carpenter. And I am a member of the Younger Women\'s
Task Force. The task force is a project of the National Council of
Women\'s Organization, which represents over 200 women\'s groups across
the nation. As a young woman in the age of cosmetic surgery, reality
shows, like \'The Swan,\' \'Extreme Makeover,\' and \'I Want a Famous
Face,\' I\'m here to talk about what kind of risk these devices pose to
women in my generation.

\"Our parent organization is the sponsor\" ‑‑

CHAIRMAN CHOTI: Excuse me. One moment. I wonder if the group who is
walking back there, if you could just hold off on that so we can hear
the discussion. Okay? The point is for the speaker to speak at the
podium if that would be all right. Thank you.

I\'m sorry. Continue.

MS. BEAGLE: Thank you.

\"Our parent organization is the sponsor of the Extreme Measures Tour, a
body image campaign which is traveling the campuses across the nation
featuring young women telling their peers about their personal
experiences with failed breast implants. The response has been
astounding.

\"On one Texas college campus, the school\'s volleyball coach asked that
the speakers would visit with the local girls\' high school team because
all of the players were insistent that they would receive breast
implants on their 16th birthday.

\"At a New Jersey campus, audience members told story after story of
young women receiving complication‑laden breast implants before rushing
sororities.

\"The extreme measures campaign Web site has received e‑mails from women
on campuses across the country asking that the tour visit their school.
Why is this happening? Why are women on college campuses so eager to
hear about their peers\' experiences with breast implants?

\"Look at the numbers. The American Society of Plastic Surgeons recently
reported that this past year, 3,962 augmentation procedures were
performed on women 18 years and younger, a shocking increase from the
roughly 400 procedures done on the same age group in 1994. Three
thousand, nine hundred, sixty‑two means approximately ten teenagers
receive breast implants every day.

\"According to manufacturers\' own data, 21 percent of these teens will
require reoperation within 3 years. That means that every day, 2 of
those teens going under the knife will be back on the operating table
within 36 months. That is not including the staggering numbers of young
women who will experience what is termed \'local complications.\'

\"Surgery is surgery. And it carries inherent risks, no matter how minor
the procedure is billed to be. Manufacturers state that breast implants
will need to be replaced every ten years.

\"A young woman who receives breast implants on her 18th birthday and
lives to be 88 will need at least 7 sets of implants in her lifetime,
each time paying out of pocket for the removal of the old sets and
implantation of the new sets, because health insurance rarely covers the
cost of problems related to breast implants.

\"Even more troubling, many insurance companies will not enroll a woman
with implants. Few teens can grasp the significance of what having
health insurance means, let alone how not having it could create extreme
financial hardships in the future.

\"As a young woman, it is also hard to understand the importance of
early detection and mammography. Mammography misses 55 percent of the
cancers in women who have implants. Will young women take this into
account when considering implants?

\"Although some cosmetic surgeon groups may not endorse silicone
implants for use in teens, I will remind you that the FDA does not have
a mechanism to police the sale of implants once restrictions are lifted.
I will remind you that Dr.\" ‑‑

CHAIRMAN CHOTI: If you could wind up, please?

MS. BEAGLE: Thank you.

CHAIRMAN CHOTI: Sorry. Thank you. I apologize, but we really need to try
to stay on time. Thank you.

Next? Good morning.

MS. HEIDE: Thank you. Good morning. And thank you for the opportunity to
speak here today.

My name is Terry Heide. I am 51 years old, married with no children. And
I work as the congressional liaison for the Department of the Army\'s
contracts for the reconstruction of Iraq.

I was diagnosed with breast cancer in January \'03. I had bilateral
mastectomies in July \'03 and reconstruction with tissue expanders. I
received my permanent silicone implants in October \'03 and have had no
health problems since.

I also have no financial interest in Inamed, Mentor, or any other
medical company. And neither Inamed nor Mentor nor anyone else is paying
any expenses associated with my appearance here today. Those are the
facts about me, but it is not who I am.

Who I am is an intelligent, educated, and compassionate woman who knows
her own mind. Who I am is a woman who has always made decisions, tough
decisions, using the best information available. Who I am is no
different than any other woman who has faced challenges and triumphs,
loss and recovery.

Like many other women, unfortunately, I had breast cancer. But, unlike
thousands of other women who are diagnosed every year, I did not require
chemo or radiation. I had my first surgical biopsy when I was 19 years
old. So I have been closely monitored my whole adult life.

I was lucky my cancer was caught early and was easily treated. I was
also lucky to have my choice of implants. And never once did I consider
any other option other than silicone.

I am well‑read regarding the science on silicone implants. And, again,
being in the business that I am, I am also well‑aware of the politics of
breast implants. This here today is about politics, not science.

Silicone is a common material in a wide variety of implantable medical
devices. And there are even acceptable medical uses of liquid silicone.
And none of these other products or uses have been restricted or banned.
It is only breast implants.

There are also many implantable medical devices that fail at a rate
equal to or greater than the rate at which silicone implants might fail.
And none of those other products have been restricted or banned. It is
only breast implants.

The reason I believe is because silicone breast implants are a woman\'s
health issue. And there is an assumption at work here that women are
incapable of making sound and rational decisions about their health or
their bodies, that somehow we need to be protected from ourselves simply
because we are women.

Silicone is the closest to real breasts. It looks the closest to real
breasts and feels the closest to real breasts. But it is not right for
everyone. The decision to have a mastectomy or reconstruction or
augmentation or saline or silicone implants is an individual decision
and one that can only be made in consultation with a woman\'s doctor.
But this here is not about science.

Yes, implants fail and planes crash and people get cancer. There is no
guarantee that life will be as we wish it to be. We all make decisions
every day about how we live our lives that involves risks. There are
hundreds of products out there made to make people feel more whole, such
as hip replacements and titanium rods that go into people\'s back. And
all of these things ‑‑

CHAIRMAN CHOTI: If you could sum up, please, for us? Thank you.

MS. HEIDE: Thank you.

CHAIRMAN CHOTI: Just sum up for us, if you would, please?

MS. HEIDE: Oh, yes. My concern is that I wish there was no breast
cancer. I wish we weren\'t here today. I wish that everybody had the
body and the breasts and the health that they wish for. But,
unfortunately, that isn\'t how life works.

And I am extremely concerned that the FDA would make women come here and
talk about this most private of things.

CHAIRMAN CHOTI: Thank you. I\'m sorry.

Next speaker? Good morning.

MR. MILLER: My name is Steve Miller. I have no conflict of interest. My
wife is here today. And she will be sharing her story about how silicone
implants she received for correction of a congenital defect have harmed
her.

I am reading this testimony on behalf of another man whose wife has also
suffered greatly due to silicone implants. I am here to read the
testimony of T. Wade Clegg of Panama City, Florida who could not be here
with us today. He has no conflict of interest.

\"My family life has been severely affected by my wife\'s disastrous
experience with silicone gel breast implants. That is why I wish to
share my thoughts with the Advisory Panel.

\"I believe that silicone gel is one of the most insidious and invasive
products ever allowed in the public marketplace. Silicone can migrate to
distant places within the body, such as the liver, thyroid, under the
arms, into the arms, and across the chest. Such was my wife\'s
experience.

\"For years, her neck would swell and diminish, blocking her breathing.
Her thyroid was removed, and the pathology report said it was Sjogren\'s
disease. She is now on permanent medication and must wear a 24‑hour
opium patch.

\"Sjogren\'s disease, by the way, can take years to diagnose. Only
long‑term studies will be able to show whether implants cause this
disease.

\"My wife was not informed about the dangers of silicone breast
implants. She is serving a life sentence of pain. Normal for my wife has
become a loss of physicality, loss of sleep, and diminished health,
which has led to massive medical bills, bankruptcy, the loss of our
farm, and a downward spiral resulted from silicone gel breast implants.

\"Most women do not know that silicone gel can calcify and mix into
breast tissue. The pain can be extreme, as in my wife\'s case. Once this
takes place, the surgeon has to literally scrape the silicone off the
chest cavity until there is nothing left. This was my wife\'s
experience.

\"My wife no longer has breasts. For women of childbearing age, this is
particularly devastating and can mean the inability to breast‑feed.

\"The FDA had questions about the safety of implants last year and
didn\'t approve the application for implants back then. The real
question is, have the manufacturers really answered all of these
questions in the space of one year? Since only four years worth of data
is being presented, I doubt it.

\"Please ask yourself, if the same question exists, then why are we
here? I plead with this FDA Advisory Committee to continue to restrict
silicone gel implants while research continues. Do not improve implants
which have not been proven safe for long‑term use. This is not about
aesthetics. It\'s about women\'s health.

\"Thank you.\"

MS. STANSELL: I was supposed to have five minutes.

CHAIRMAN CHOTI: Please go ahead. Yes.

MS. STANSELL: Okay. Thank you.

My name is Anne Stansell, and I have no conflicts of interest. I
represent a support group of about 45 women, all with experiences
similar to mine. One, Ann Palmer, a cancer survivor, was in the Mentor
study. When her silicone implants ruptured at about two years, she was
dropped from the study. And her record at Mentor and, thus, presented to
you tomorrow shows no adverse effects. Ann Palmer died of breast implant
complications in 2001.

I was diagnosed with breast cancer when I was 39. I underwent a
mastectomy, radiation therapy, and breast reconstruction with silicone
implants. Four doctors recommended that I get silicone implants. At the
time there was no research on silicone breast implants in cancer
survivors. But none of the doctors told me that. Not one of them told me
about the risks, the fact that they can rupture and leak silicone and
other chemicals into my body.

Because of these chemicals in my body, I now get severe headaches when I
am exposed to any common household products with phenolic disinfectant,
such as Lysol.

After six years, I started to get sick with joint pain, muscle pain,
skin problems, dry mouth, and dry eyes. My eyes are so dry that it has
caused a retina to tear. These are all autoimmune symptoms.

I was also diagnosed with an autoimmune symptoms called Grave\'s
disease. After fighting cancer, the new illnesses caused by my implants,
I then had to fight with my insurance company to have the implants
removed. You see, the law states that they must provide implants for
mastectomy patients. There is no law that says insurance companies must
replace them in case of rupture or remove them in case of adverse
effects.

When my implants were removed, half of one of them was gone. This is not
surprising given that Inamed\'s own data shows that 20 percent of
reconstruction patients experience ruptured implants within just three
years. Studies have shown that silicone can leak into the scar capsule
and the lymph nodes, even when the implants haven\'t yet ruptured.

After I had the implants removed, I started to slowly get better. This
is also typical. I have read a study by National Cancer Institute
researcher Dr. Noreen Aziz which shows that most women with implants who
have rheumatological symptoms get better when their implants are removed
and not replaced. If their implants were replaced, most got worse.

I am not fully recovered, unfortunately. In addition to continued
fatigue, the many surgeries to put in and remove my implants had left me
with such chest tenderness that I cannot have anything more than a soft
t‑shirt on my chest. Now prosthetics even are out of the question.

This controversy has been going on for 15 years. The whole new
generation is now being seduced into believing these products are safe
when they are not.

No significant improvements have been made in silicone breast implants
in the last 15 years. This is the same product with new advertising and
new hype. Just because these manufacturers have created a market for
their products with advertising and TV makeover shows does not mean the
product is safe.

If you want to help breast cancer patients, please insist on long‑term
safety data before approving this product. You owe it to us older women
who have suffered for years and years and to the young women who will
suffer for many years if you approve this product.

CHAIRMAN CHOTI: Thank you.

Yes? Good morning.

DR. TAYLOR: My name is Dr. Joy Taylor. I was a hospice physician. I have
no financial ties to the manufacturers or their competitors.

I had breast implants for 18 years before I became ill. A CT scan showed
bilateral ruptured implants, and I was diagnosed with pleurisy and
pulmonary fibrosis. I then began collecting autoimmune disorders.

I was diagnosed with Hashimoto\'s thyroiditis, Sjogren\'s syndrome,
autoimmune diseases that attack the thyroid, the salivary, and the tear
glands. I also developed polymyositis, a coagulopathy, Alzheimer\'s‑like
symptoms, severe fatigue, MS symptoms, constant tinnitus, and Crohn\'s
disease.

My colon was perforated in several places and had to be removed. I was
in ICU for over six weeks and on life support and had every complication
possible.

The ICU doctor told my family that in 30 years, he had never seen anyone
in my condition survive. He told my family to make arrangements for my
funeral. I lived through that crisis, but there were more to come
because my body was producing antibodies that attacked me.

In addition to all of this, I suffer the debilitating disease porphyria.
There are only two ways to get porphyria: exposure to heavy metals, like
platinum; or heredity. I have no family history of porphyria. Platinum
exposure causes malfunction of the immune system.

Since my implants ruptured, I have had ten surgeries. My family has
planned my funeral twice. And I am unable to practice medicine. I regret
my decision to get implants. And I am alive today because of the
skillful, caring doctors and many prayers. The ICU doctor says I am a
miracle, and he is right.

Please don\'t approve silicone implants until they are adequately tested
long‑term and proven safe. Women, after all, have the right to have
accurate information on which they may make an intelligent decision.
Women\'s health and lives depend on it.

CHAIRMAN CHOTI: Excuse me. Were you representing an organization for
that session?

DR. TAYLOR: Yes, Platinum Awareness.

CHAIRMAN CHOTI: Thank you very much.

Yes? Next speaker, please. Good morning.

MS. MARSHALL: Good morning. Good afternoon. Hello. My name is Cindy
Marshall. Here\'s my story, which is, sadly, just one of literally
hundreds of thousands of similar stories.

Silicone gel implants have destroyed my precious, priceless health,
drastically changing forever the quality of my life. Women like me are
proof of the truth.

I still remember the words that board‑certified plastic surgeon spoke to
me, \"These implants are safe to last a lifetime.\" What a wonderful
21st birthday gift, \"You\'ll forever love how you\'ll look and feel.\"
If only his words were true.

I first experienced flu‑like symptoms, hair loss, bone pain, fatigue,
which resulted in countless doctor appointments. I had three mammograms,
beginning in 1997, then in 2000, last in 2003.

The last mammogram indicated that my silicone gel breast implants were
leaking and ruptured. I had to get explanted quickly and was in May
2004. By this time, it was too late. The damage was already done. My
silicone gel breast implants had leaked and ruptured, leaving me with
currently irreversible damage, silicone poisoning, and
silicone‑associated disease.

Here are just some of the numerous symptoms, conditions, and diseases:
swollen lymph nodes; hair loss; chronic bone muscle; skin tissue and
organ pain; connective tissue disease; arthritis; scalp, face, body
rashes; vision problems; blood in stools; blood leakage from breasts;
chronic weakness, fatigue; Raynaud\'s syndrome; irreversible brain
damage, demyelinating disease; MS‑like.

I used to have a business in home health care. Now I am the patient. I
experience scary, unpredictable episodes and attacks during these times
in which I have slurred speech, severe termor, difficulty walking or
fall down, and even episodes of paralysis.

I must depend on others for my daily needs because of my difficulty
performing. I have difficulty performing even the simplest of tasks:
using the bathroom, showering, dressing, and feeding myself. One of my
doctors now thinks I have lupus.

If I had been informed of the truth that silicone gel implants were
never proven safe, that they leak, rupture, and bleed toxic substances
into the immune system, contain close to 40 known toxic chemicals, mind
you, not meant for human consumption, never ever would I have consented
or allowed them to be put into my body.

I\'m only 37, a single mom of 3 beautiful girls. I just want to be here
for Brooke, Erica, and Danielle. My children who need their mommy fear
for their mommy, who fears for every young girl and woman everywhere.

FDA, please support public health safety and not the industry poisoning
the public. Thank you.

CHAIRMAN CHOTI: Thank you.

Next speaker?

DR. MILLER: My name is Dr. Claudia Miller. I have no financial interests
in this hearing, and I\'m here at my own expense. I\'m actually a
professor at UT Health Science Center in San Antonio. I\'m an
allergist/immunologist. And my research is focused on people who report
chronic disabling symptoms following some environmental exposure, the
symptoms you have heard about today.

I have served as a consultant to the Department of Veterans Affairs on
Gulf War veterans, the EPA on sick buildings, the National Institute of
Dental and Craniofacial Research on temporomandibular joint implants,
where, by the way, you see similar kinds of complaints.

What unites ill Gulf War veterans, sick building occupants, and patient
with implants who are having problems is the fact that following a
well‑defined exposure event, a subset, not every one, a subset of them,
go on to lose their prior natural tolerance for a wide variety of
substances that are structurally unrelated.

Thereafter, common foods, medications, alcoholic beverages, caffeine,
chemical inhalants, like diesel exhaust, and fragrances you have heard
about today, exposures that never bothered people before suddenly
trigger symptoms in them. And these can be disabling.

This two‑step disease process ‑‑ you can go to the next slide ‑‑ has
come to be known as toxicant‑induced loss of tolerance, or TILT. It does
not appear to matter whether the exposure that initiated this, which is
at the bottom of the right‑hand slide, was endogenous or exogenous. The
body\'s response is remarkably similar.

Next slide. We have reported on 87 individuals with surgical implants,
three‑quarters of them with breast implants. Sixty‑nine percent reported
rupture. Seventy‑eight percent had one or more implants removed. Of
those who had undergone explanation, less than ten percent reported
their health status as greatly improved.

Next slide. Using a validated questionnaire, we found that the symptom
severity scores of implant recipients rivaled those of the environmental
exposed groups we were studying. And there were four of those.

Next. Compared to controls, implant recipients reported much more severe
adverse responses to everyday chemical exposures as well as having
problems with various foods, medications, alcoholic beverages, and
caffeine.

We are a couple of slides behind. Go ahead. Next slide and then the next
one. Thank you. And then the next one. Toxicant‑induced loss of
tolerance is a new paradigm for environmentally induced disease that
differs from classical toxicity and allergy.

Affected individuals may be completely unaware of the intolerances
resulting from this because of a phenomenon we call masking. If a person
is reacting to many different things and having symptoms as a result of
those, then the symptoms may overlap in time. And, consequently, they
feel sick all of the time, often reporting chronic fatigue or flu‑like
illness that won\'t go away.

Recent Canadian studies show that genetic polymorphisms may determine
who is more vulnerable to developing this illness. And in September ‑‑
next slide ‑‑ I will be chairing a meeting on the toxicant‑induced loss
of tolerance sponsored by two NIH institutes where we\'ll be discussing
various aspects, clinical models, animal models, and so on, in order to
understand this problem better in providing you with a questionnaire
that I showed a moment ago to help physicians and researchers better
understand this problem.

And I will be happy to provide you with any references. Thank you.

CHAIRMAN CHOTI: Thank you. And I would like to thank all of the speakers
this morning for their time. We are going to take a lunch break now. We
are going to resume promptly at 1:15. Thank you.

(Whereupon, at 12:05 p.m., the foregoing matter was recessed for lunch,
to reconvene at 1:15 p.m. the same day.)

A‑F‑T‑E‑R‑N‑O‑O‑N S‑E‑S‑S‑I‑O‑N

(1:21 p.m.)

EXECUTIVE SECRETARY KRAUSE: We are going to start the afternoon session
off. Dr. Choti is going to go over the instructions for the speakers one
more time. And then we\'ll get started. Thank you.

CHAIRMAN CHOTI: Good afternoon. So this is the start of the open session
for the afternoon. Just to remind again, the speakers, either five
minutes or three minutes depending. We\'re going to really try to stick
to the time.

Just so I don\'t have to be the heavy here, watch the monitor. At 30
seconds before, the yellow light will go on. When your time is up, the
red light will go on. If you\'re not finished, I will instruct you to
summarize quickly. If not, the microphone will be cut off.

Again a reminder for those of you since it\'s important to maintain a
transparency, you\'re encouraged to let us know whether you have any
financial relationship with any organizations that may be related to
this, including mentioning whether your travel, lodging, or other
expenses were covered. You don\'t have to do it. You\'re still entitled
to speak, but you\'re encouraged to do so.

Why don\'t we go ahead and start with our first speaker? Thank you.

MS. GLENN: Thank you, Doctor.

My name is Linda MacDonald Glenn. And I am testifying today on behalf of
the Women\'s Bioethics Project, a nonprofit, nonpartisan public policy
institute dedicated to ensuring that women\'s voices, health, and life
experiences are brought to bear on ethical issues in health care and
technology.

I am a biomedical ethicist, attorney, educator, and long‑time patient
advocate. I spent 20 years as an attorney, a prosector, government
adviser, and general practitioner. During that time, I was called to the
field of biomedical ethics, both personally and professionally. I went
back to school to switch my career to biomedical ethics.

Upon graduating in 2002, I went to the American Medical Association,
where I was a senior fellow at the Institute of Ethics. I hold a faculty
appointment at the University of Vermont. And I was recently given the
honor of being named a Woman\'s Bioethics Project scholar. I have no
financial conflict of interest.

\"Tell me what you don\'t like about yourself.\" This catch phrase is
the opening line to the controversial TV drama \"Nip/Tuck\" that sums up
a plastic surgeon\'s attitude towards his patient. The implication is
that plastic surgeon can fix what you don\'t like about yourself.

And while we\'re not here today to talk about plastic surgery, we are
here to talk about the new silicone breast implants, which manufacturers
have promoted as a woman\'s choice; in other words, \"Let us help you
feel better about yourself.\" But, as I will follow up and explain, the
FDA\'s summary of the manufacturer\'s own reports indicate that this is
a hollow promise.

There are some key ethical issues involved in your decision today.
Issues of long‑term safety and truly informed consent are the primary
concerns.

In biomedical ethics, there are four principles that are weighed and
balanced against each other to arrive at an ethically sound decision.
Those are the principles of autonomy, the right of control over your own
body; benefit, the good that is accomplished from the treatment and the
application of technology; no harm, the risks and burdens of the
treatment; and justice, a question of fair and equitable access.

The public relations firm hired by the breast implant companies came up
with a slogan, \"Women have the right to choose breast implants, which
chooses to emphasize autonomy. However, if autonomy were the only
principle to be considered, there would be no need for the FDA. And
there would be no protection against the claims of charlatans and those
peddling magic elixirs.

The slogan \"The right to choose\" implies a benefit that a woman will
feel better about herself and her appearance, but, in fact, the data
submitted by Mentor Corporation does not bear out that benefit.

Mentor\'s own data and the data that Inamed provided in 2003 both showed
that on most measures, women feel the same about themselves and their
lives two years after getting breast implants compared to before getting
breast implants. That is consistent with other research as well, as
shown in the FDA summary of Mentor\'s reports on pages 66 to 73,
indicating there is no measurable benefit for women who have received
breast implants.

To quote, in summary, the literature does not provide strong scientific
support that breast implants have a measurable psychological and
psychosocial benefit for women seeking breast augmentation. Each study
had serious flaws, including the apparent exclusion of participants with
adverse outcomes. This was true for augmentation and reconstructive
patients.

The summary on page 73 explains that Mentor did not provide adequate
literature that evaluates the short‑term or long‑term psychological or
psychosocial benefits of breast implants as a reconstructive procedure.

The burdens and potential risks are substantial, not only the risks of
invasive major surgery but also serious questions about long‑term safety
issues regarding silicone leakage, silicone migration, and resulting
autoimmune disorders.

Research of women with implants for at least six years found that one in
five women had silicone leaking outside the scar capsule and didn\'t
even know it. Clearly, more studies on long‑term safety need to be done.

In terms of ethically sound decision‑making, this is what I would call a
slam dunk for the Committee. Autonomy, the right to choose, is not a
factor when the benefits are not measurable and the burdens and risks
are significant. The path this Committee ought to take is clear. These
implants should not be approved until clear benefits and long‑term
safety are established.

Thank you for your thoughtful consideration in listening today.

CHAIRMAN CHOTI: Thank you.

Next speaker? Good afternoon.

DR. OPPENHEIMER: Hi. My name is Marcy Oppenheimer. I am a recent medical
school graduate, and I work in health policy. I reviewed the publicly
available Inamed and Mentor data. And I have no conflicts of interest.

I would like to focus your attention on one aspect of the
manufacturer\'s applications dealing with the benefits or the
effectiveness of implants. And, actually, my comments follow on those of
previous witnesses.

Any benefits of this product are emotional. However, they can be
studied, like any other medical question. Just as data are necessary to
evaluate the risks of implants, data are necessary to evaluate the
benefits. Anecdotes are not sufficient.

The anecdotes about implant problems that you have heard today do not
prove the product is unsafe. They simply raise questions about the
adequacy of the safety data. Likewise, there has been a lot of anecdotal
evidence that implants have benefit for quality of life. But in the case
of the benefits of implants, the data clearly show otherwise.

FDA and other experts have pointed out significant gaps in the research
about implant safety. No one has raised similar questions about the
validity of the research on emotional and psychological benefits. In
fact, these data do appear to be adequate to answer the question of
whether implants provide a measurable benefit. And the answer they point
to is no.

To show effectiveness, manufacturers presented patient satisfaction
data, which consisted of asking patients two years after they had had
their surgery whether they would have the surgery again. By this
measure, almost all patients were satisfied.

These data are of limited scientific merit, however, because of the
patients\' initial bias towards the surgery as well as their bias
towards justifying their decision to undergo surgery.

However, both Mentor and Inamed also used standardized, validated
questionnaires that assessed issues such as self‑worth and emotional
well‑being. These questionnaires were answered before implant surgery
and then two years afterward.

As you can see from the Mentor data on the screen, using multiple types
of analyses of emotional benefit, the results do not support the
conclusion that there is such a benefit attributable to implants.

The Inamed data are similar to Mentor\'s. The published literature, like
the manufacturer\'s data, also contains no compelling scientific support
for a measurable benefit of implants according to the FDA reviewers in
the summary statement of Mentor\'s data.

So what evidence is there in support of the benefit of implants?
Anecdotal evidence and patient satisfaction data of questionable
scientific merit.

In the age of evidence‑based medicine, is this evidence enough to
balance the proven risks as well as the potential but unproven risks of
this purely cosmetic product? This is your question.

Thank you.

CHAIRMAN CHOTI: Thank you.

Yes?

MS. VOLPE: Thank you for allowing me to present this statement. I am
Margaret Volpe, a breast cancer survivor with a silicone breast implant.
I have no financial ties to manufacturers or health care providers and
am not being reimbursed for my appearance here.

I am a volunteer representing Y‑ME National Breast Cancer Organization.
Y‑ME has no financial ties with either of these manufacturers. Y‑ME is
committed to providing support and accurate information to empower
individuals touched by breast cancer so they can select the most
appropriate options in conjunction with their health care provider.

Y‑ME\'s comments concern silicone implants for breast reconstruction or
other medical need. We have no opinion on silicone implants for cosmetic
purposes. We are not endorsing a product or manufacturer but feel
strongly that silicone breast implants should be more widely available
as an option for patients requiring reconstruction.

Options for reconstruction are limited. TRAM flap reconstruction is
major abdominal surgery with a painful recovery period, leaving patients
without their abdominal muscles. Many patients do not have this option
or do not want the surgery.

The latissimus dorsi reconstruction usually requires an implant. Other
reconstructive procedures using autologous tissue often prove unsuitable
for many patients.

Saline implants are available, but for many, they are unsatisfactory. A
silicone implant gives a more natural look and feel. Y‑ME emphasizes the
need for a range of treatment options so that each patient can choose
what best fulfills their needs. And patients who have had mastectomies
do not have mammograms.

Please adhere to the science when evaluating silicone breast implants.
In 1999, the Institute of Medicine\'s exhaustive and definitive review
of existing research found no evidence that silicone breast implants
caused cancer or disease and no convincing evidence that silicone
produces an immunologic response. The report stated such diseases or
conditions are no more common in women with breast implants than in
women without them.

The U.S. Court\'s National Science Panel and several European government
scientific panels issued similar findings. NCI\'s large analysis,
recently published in the New England Journal of Medicine, concluded
there is no evidence of an association of silicone gel‑filled breast
implants with connective tissue diseases or other autoimmune or
rheumatic conditions.

Another NCI study found no evidence linking implants with breast or
other cancers. Several long‑term epidemiological studies in Scandinavia
and Australia also found no association between silicone breast implants
and connective tissue or autoimmune diseases.

Another study found the use of implants in post‑mastectomy patients with
early‑stage breast cancer did not adversely impact survival in women
under the age of 65. These women were followed for a median of over 12
years. Over 4,000 patients participated in the study.

Other studies have demonstrated improved quality of life for patients
wanting implants for reconstruction. Our hotline receives calls from
elderly patients who want reconstruction as well as from younger
patients.

Y‑ME urged its patients to fully understand the risks and benefits of
any medical or surgical choice. No medical device lasts forever. Shunts,
pacemakers, artificial knees and joints have an expected life span and
possible complications, including capsular contracture.

Patients must be aware of such side effects as capsular contracture,
potential rupture, and the need for replacement. Doctors must provide
accurate information about the risks and benefits of silicone implants.
There must be long‑term follow‑up and data collected.

Privacy‑protected patient registries and physician training are vital
along with timely communication of significant findings to consumers,
patients, and providers.

Until the cause of breast cancer is found and the disease is eradicated,
making implants no longer necessary, breast cancer survivors or those
needing prophylactic mastectomy must be assured the right to select
appropriate and effective medical therapies or devices.

Y‑ME urges you to act based on the science alone. Thank you.

CHAIRMAN CHOTI: Yes?

MS. MORRIS: My name is Andrea Morris. I am 46 years old. I want to thank
the FDA for ensuring the safety of silicone implants and for their
concern about women\'s health issues.

I would like to state for the record that I have had breast
reconstruction and that I have been part of the Mentor Corp. research
trial since August 2002.

Mentor has not asked me to testify, nor have they provided me with any
financial incentive. I am here to testify solely as a two‑time breast
cancer survivor and as an advocate for other women affected by breast
cancer.

I serve on the board of Living Beyond Breast Cancer, a nonprofit
national organization whose mission is to empower all women affected by
breast cancer to live as long as possible with the best quality of life.

I was first diagnosed with breast cancer 9 years ago, at the age of 37,
and again 3 years ago, at the age of 43. When I was diagnosed, I was
devastated. I had numerous conversations with my team of physicians to
discuss and evaluate my treatment options.

I decided to have a bilateral mastectomy. However, this meant I would no
longer have my breasts, the ones that had been part of my body for 43
years.

My plastic surgeon discussed the various reconstruction options. He
explained the risks of using silicone implants and the benefits. We
reviewed the issues involved in years of product liability litigation,
including the risk of ruptures. He believed silicone implants were safe.
He also felt they made the breasts look and feel more natural. Clearly
concerned about the risks of one option over another, I also believe it
is very important to look better so that you can feel better.

The breast reconstruction, which I elected, involved bilateral
submuscular tissue expanders. This procedure involved being expanded
numerous times with saline. At the end of the expansion process,
silicone implants were inserted. The expansion process was not fun. In
fact, at times I was in excruciating pain. However, the end result was
worth the pain.

Having breast cancer has had a profound impact on my life. It has forced
me to make many life‑altering decisions. It has made me realize that the
quality of life is paramount. What is the point of undergoing major
surgery in which your body is cut and mutilated if one\'s quality of
life is compromised?

I will continue to live with the potential risks of having silicone
implants, but every day I wake up and have the benefit of feeling
confident about myself and am a complete woman.

I have great admiration for myself and other breast cancer survivors who
have the courage to speak out publicly about their illness and ordeals.
We are teachers, role models, and a source of inspiration for other
women diagnosed with breast cancer today, tomorrow, and in the years to
come until this awful disease is eradicated.

I recommend availability of silicone implants for breast cancer
reconstruction along with continued study into the long‑term
health‑related concerns. I believe other women should have the same
opportunity to make their own decision on the use of silicone implants
for breast cancer reconstruction.

Thank you for your time.

CHAIRMAN CHOTI: Thank you.

Yes?

DR. BERG: Dr. Choti, members of the panel, I am Dr. Wendie Berg, a
radiologist specializing in breast imaging. And I have served on the
Radiologic Devices Panel of the FDA previously.

I wanted to just review the literature on screening for breast cancer in
women with implants. If I could actually go two slides forward, please?
My credentials are in the paperwork.

Mammography is the only screening test to date which has been shown to
reduce deaths due to breast cancer. And across numerous randomized
controlled trials, there has been overall a 40 percent reduction in
breast cancer mortality among women who are actually screened.

Next. Importantly, screen‑detected cancers have a much better prognosis
than those that are clinically found with 50 percent of screen‑detected
cancers found with good prognosis, translating to 95 percent 20‑year
survival compared to only 19 percent of those that are clinically found
having good prognosis and nearly half having a poor prognosis with 40
percent 20‑year survival.

Next. Also, the lymph node status of the breast cancer correlates with
survival. And in the trials where there was a benefit to screening
mammography, you can closely correlate that, the reduction in mortality
with the reduction in node‑positive cancers.

Next. Importantly, mammography and implants, there are issues of
limitations. All implants, including both saline and silicone implants,
hide some of the breast tissue, requiring both routine and displaced
views to be obtained, resulting in twice the radiation dose to the
patient for every mammogram performed.

Implants cause mass effect on the remaining breast tissue and reduce the
compression that we can achieve, which results in poorer quality
mammograms as well as increased radiation. And the patients, of course,
often experience pain and contracture, which limits the ability to
position and compress the breast.

It\'s worse if the implants are in subglandular location. It\'s better
for mammography if they\'re in subpectoral, behind the muscle, position.
And in some women, there is so little breast tissue to start with that
the mammography is just not possible after implant.

There is patient concern about rupture and discomfort, resulting in
non‑participation in mammographic screening. Here is an example of a
patient who did have a mammogram that was successful in depicting her
small focus of cancer that was manifest as calcifications. This was
DCIS.

The next slide, however, shows another patient who with the implant we
were unable to obtain any visualization of the breast tissue. And, in
fact, you can see on the right her cancer adjacent to the implant on
ultrasound only. This was a lump that she felt and was, therefore,
clinically detected.

Even after removal of the implants, we can have severe limitations to
mammography, as in this patient, who on the left‑hand side, had
extensive silicone granulomas in her breasts that mimic suspicious
masses, required further evaluation, and on the right‑hand side had
seroma.

Over several studies, there has been a reduction in the mammographic
sensitivity to the level of 45 to 57 percent. That\'s rather severe, 33
to 40 percent reduction overall. Cancers were more likely palpable. And
in one study, there were fewer in situ cancers. There\'s a trend toward
larger size and more node‑positive cancers.

This is the last issue here. These studies have not distinguished with
patients who have smaller breasts, dense breasts, contracture, or
subglandular implants. So there is a need for more studies.

Thank you.

CHAIRMAN CHOTI: Dr. Berg, can I ask you a question?

DR. BERG: Yes.

CHAIRMAN CHOTI: You mentioned that women with implants may not be as
compliant for screening.

DR. BERG: That\'s correct.

CHAIRMAN CHOTI: Do you have data on that?

DR. BERG: I don\'t think there\'s been any systematic study on that
issue, to my knowledge, but on a frequent basis, at least weekly, I get
phone calls from women demanding to have an MRI, instead of a mammogram.
It\'s not the standard of care. It\'s a \$1,000 to \$3,000 test, instead
of a \$70 test. It\'s not practical for screening. Ultrasound can be
done, but it does not find DCIS. And so this is another issue.

Many of the women who do do mammography have severe pain and
contracture. They\'re not thrilled to come back for their mammograms
next year.

CHAIRMAN CHOTI: But you\'re not familiar in the radiology literature
that the compliance, the percent of women that follow breast cancer
screening is diminished in women who have implants?

DR. BERG: I don\'t know that it\'s been systematically studied. I think
that\'s one of the problems.

CHAIRMAN CHOTI: Thank you.

Next?

MS. SCHECHTER: Hello. My name is Debbie Schechter. And I have no
conflicts of interest. I\'m here today as an attorney and a former
policy analyst and as the friend of a woman who had breast implants and
who killed herself.

Did she kill herself because of her breast implants? Research may help
us answer that question. Studies conducted in Finland, Sweden, and
Denmark each found that women who had breast augmentation were three
times as likely to commit suicide as other women their age in those
countries. Those findings seem eerily similar, making it hard to
dismiss.

The groups were matched in race and age, but women who have breast
augmentation may differ from other women in important ways that make
them more vulnerable to suicide.

National Cancer Institute scientists conducted a study of women who had
breast implants or other plastic surgery at least seven years earlier.
The breast augmentation patients were more than four times as likely to
kill themselves as other female plastic surgery patients.

Unlike the European studies, the NCI study was using a comparison group
with very similar health habits, socioeconomic status, and concern about
their appearance.

A fifth study of women in Denmark found that women with breast
augmentation were five to seven times more likely to take
antidepressants, compared to breast reduction patients and another
comparison sample.

One of the interesting aspects of these studies is that the four
European studies were all funded by Dow‑Corning, the silicone
manufacturer. They accurately reported the findings but would not
concede that implants might possibly cause suicide.

The funded a review article by Joseph McLaughlin that questioned the
findings, speculating that depression and other possible causes of
suicide probably were more common among the augmentation patients, even
before they had breast implants.

An article by Tom Joiner funded by the American Society of Aesthetic
Plastic Surgeons went even further, claiming that the suicide rate would
probably have been even higher had the women not been so fulfilled
because of their breast implants.

Knowing P. J. Brent, I have a different theory. P. J. was very ill. And
she felt very badly because she believed she was responsible for making
her daughters ill from breast‑feeding with implants.

P. J. did not have low self‑esteem. In fact, to the contrary, P. J. was
vibrant, articulate, peppy, loving, warm, helpful. I lived in her
community. And I can tell you that when news about her suicide spread as
quickly as you can imagine to the thousands who came to her funeral, the
one thing everybody said is that she is the last person in the world
that we would expect to commit suicide.

I spoke to her the week before she committed suicide. And she was
loving, concerned, peppy on the phone. She was an incredible human
being. I respected her and loved her. But her illness and the
frustration of lack of effective medical care for her conditions got to
her.

If you look at the data from Mentor Corporation, you will see that
breast implants do not make women feel better about themselves. Two
years later, implanted women feel worse or the same about their lives
and themselves. Inamed found the same result in the studies they
provided to the FDA in 2003.

Finally, do breast implants cause suicide? They might. In light of the
company\'s own data showing a decrease in quality of life after silicone
implants, shouldn\'t that question be answered more conclusively before
implants are approved by the FDA?

Thank you.

CHAIRMAN CHOTI: Yes?

MS. MILLER: I am Dawn Miller. I am from Massachusetts. I have no
conflicts of interest.

I had silicone breast implants in 1990 at the age of 20 as a part of a
correction for congenital deformity of my rib cage. It was recommended
by my surgeons that I have implants at age 16. I waited until age 20
because I felt I really needed to explore the safety of the devices
prior to surgery.

When I finally decided on reconstruction, an 80 cc silicone implant was
implanted on my left side and a 200 cc silicone implant was implanted on
my right side, filling in the cavity of my chest wall and creating a
normal‑appearing breast.

I consulted with four plastic surgeons prior to my surgery. And they
informed me that silicone was essentially synthetic sand, a building
block of life and completely inert in the human body. I was told that it
would take a severe physical trauma to rupture an implant.

In August of 2002, I experienced permanent hearing loss in my left ear
and problems with my equilibrium. In January of 2004, I began to have
heart arrhythmias. I never associated either of these conditions with my
silicone implants.

Two years later, in August 2004, my sister heard a news report that
scientists found high levels of platinum in some women who had silicone
implants. Women with these platinum levels were experiencing
neurological problems that included hearing loss.

At this time I contacted the manufacturer of my implants, Inamed
Corporation, and inquired about my implants. I was told, and I quote,
that \"The same materials, silicone elastomers for the shell and
silicone gel, are used in the fabrication of the Style 40 devices
today.\"

Very concerned, I sent a sample of my urine to the scientists who
performed the platinum testing on breast‑implanted women. My urine
tested positive for high levels of platinum.

My implants were removed last November. My surgeon told me that my left
implant was ruptured and leaking and my right implant appeared to be
intact. Free silicone was found in the skeletal muscle and connective
tissue taken from both my right and left sides. Platinum is a well‑known
neurotoxin, as reported in the literature. The hearing loss, equilibrium
problems, and heart arrhythmias I experience very closely resemble that
experienced by those exposed to platinum through chemotherapy.

I had silicone implants for 14 years. At no time did I suspect a
rupture. This is consistent with the FDA\'s study that showed that most
women with implants will have at least one ruptured implant within ten
years. And, just like me, the women in that study never knew they had a
ruptured implant.

The fear, the outrage, and the sadness are with me still. These same
feelings are shared by my family and friends, who support me through
this. It has been devastating to learn that the same implants that have
caused me harm are being considered for reintroduction to the open
market.

The industry\'s four‑year studies are completely inadequate because they
do not provide any information about the long‑term safety of these
products. I urge you to recommend that the FDA not approve these PMAs.

Thank you.

CHAIRMAN CHOTI: Yes?

MS. MASON: Hello. My name is Jill Mason. I want to thank the panel for
hearing my testimony today regarding my experience with silicone breast
implants.

I am a 59‑year‑old, married, and work as a surgical tech in my local
hospital\'s OR. My travel expenses have been paid for by the American
Society for Plastic Surgeons. I do not have any financial interest in
Inamed, Mentor, or their competitors.

I received my first silicone implants in 1989, only months before the
controversy started regarding silicone implants. I had small breasts for
a woman of my physical size and knew that one day I would get implants.

I chose silicone implants after talking with my plastic surgeon about
the benefits and risks of both saline and silicone implants. I chose
silicone implants because of their more natural look and feel. As a
surgical tech, I had seen saline implants. And they were hard and
unnatural looking.

Certainly I was concerned when the silicone implants were taken off the
market, but I didn\'t panic. I talked at length with my plastic surgeon
and my personal physician. With what information was provided to me
about the implants, my concerns were put to rest.

I continued to hear horror stories about silicone implants and saw women
on television who said these implants had ruined their lives. I
personally felt great and looked even better.

I think the issue has been greatly overstated. A few years ago, one of
my implants ruptured. The rupture was discovered during a routine
mammogram. After consulting with my plastic surgeon, I decided to wait a
few years, mainly because of financial consideration, and then have both
implants replaced, which I did on January 7th of this year.

Even after the rupture, I had absolutely none of the symptoms that I
have heard other women, whose implants had ruptured, complain about.
Like many other women here today, I believe women should be able to make
their own choice about what type of implants they want, but I am also
here because I believe the public has largely heard one side of the
story.

I understand that women with horror stories about their implants make
better reading and better viewing, but their story is not the only
story. And, from what I understand, their story is not supported by
science. My story and the story of thousands of other women, whose
voices have gone unheard, is one of complete satisfaction with our
silicone implants.

I hope that you take our side of the story to heart, but, more
important, I hope that the panel will let science, not emotion, put an
end to this debate.

I appreciate this opportunity to share my thoughts. Thank you.

DR. WELLS: Good afternoon. My name is James Wells. I am a
board‑certified plastic surgeon practicing in Long Beach, California.
I\'m a past President of the American Society of Plastic Surgeons. I am
not a consultant for either company. The society has paid my travel. I
use products from both companies.

I represented ASPS before the October 2003 panel hearing on silicone
implants. My concern then, as it is today, is our patient safety, but
this time around I have an additional concern: the potential subversion
of the review process.

I fear that the current climate of questioning the credibility and
trustworthiness of physicians who serve on government panels may
ultimately undermine the process. When a physician is singled out
because of a perceived conflict when, in reality, this individual may be
best qualified to evaluate safety, we are doing a tremendous disservice.

FDA panels are particularly designed to represent expertise and judgment
relevant to the product under review. We cannot let special interest and
private agendas overshadow what we are here to evaluate. We must allow
the panel to base its decision on scientific evidence, not on special
interest, emotions, or anecdotes. That is what our patients expect and
deserve.

After the FDA issued its 2004 draft guidance document, ASPS has sought
ways to identify ways in which we can help answer some of the questions
regarding the safety, efficacy, and utilization of this device. I will
provide a brief overview of our activities.

First is the ongoing refinement of our educational programs relating to
breast augmentation with silicone gel‑filled implants. Our primary
educational objective is to provide knowledge that physicians need to
achieve optimal levels of safety, post‑surgical outcomes, and patient
satisfaction. There is a focus on physician responsibility for patient
outcomes and efforts to improve overall rupture rates.

The second critical area is the informed consent resources and the
breastimplantsafety.org Web site that has been developed to educate and
inform our patients about the risks and benefits of breast augmentation
and reconstructive surgery. The Web site is under continuous evolution.
And new material is added as indicated.

Preoperative education regarding risk, alternatives, consequences, and
benefits is integral to successful outcomes and patient satisfaction.
Informed consents with algorithmic approaches are available to assist in
the physician‑patient decision options, including implant choices,
surgical options, complications, financial responsibilities, and
reoperation choices.

The third key area of activity is the development of a practice
parameter guideline of treatment principles for patients with silicone
implants. The practice parameter is based on the most recent scientific
literature and expert opinion. It describes principles of practice that
meet the needs of patients with silicone gel‑filled breast implants.

The fourth area of activity is post‑market monitoring. The 2004 guidance
documents suggest post‑market monitoring as a possible approval
requirement. ASPS and ASAPS have recently achieved an agreement with the
two manufacturers on a set of principles for voluntary post‑market
surveillance of patients with silicone breast implants. This would
involve a third party administrator and participation from organizations
representing radiology, rheumatology, and others, to name a few.

Plastic surgeons and manufacturers recognize that post‑market
surveillance is an important policy consideration for all device
approvals.

Finally, the fifth area of focus has been a review of the scientific
literature relating to breast implants. We have updated the bibliography
that was submitted to this panel in October of 2003. The literature to
date supports the use of silicone gel‑filled implants as a choice for
women desiring cosmetic breast augmentation.

Plastic surgery has worked diligently to respond to the FDA concerns of
2003. We are committed to educating our physicians while taking a
leadership role in the development of appropriate follow‑up mechanisms.

Today we have heard and will hear from numerous individuals and groups
opposed to all women being allowed the choice of the silicone gel
implant. Much of the opposition testimony is grounded in junk science.
What we have not heard is scientific support regarding this systemic
health problem.

The ongoing adjuvant studies since 1992 have now enrolled over 150,000
women combined. And the 13‑year experience from those patients with the
devices you are reviewing this week, not the previous devices, has not
produced a dramatic rise in either ruptured devices or women with the
tragic stories you will hear over the course of this panel.

This device has been reviewed, re‑reviewed and in the opinion of many is
expected to be the perfect device, free of failure, free of adverse
surgical outcomes, and perfect for all. That is an impossible goal to
obtain. An ethical decision does not require a perfect device but an
informed choice in discussion.

Virtually every surgical specialty uses some type of silicone device. An
ophthalmologist injects silicone oil for retinal detachment. Men have
unrestricted access to a silicone device for penile insertion or
testicular replacement. Neurosurgeons and orthopedic surgeons use
silicone devices. Dermatologists are injecting liquid silicone
subcutaneously in an off‑label use. Yet, in the United States, we only
allow women with cancer or anatomical deformities or failed saline
devices to access a silicone gel device.

If the device is satisfactory for some, why not for all? This is a
question you must resolve. It is a question I cannot answer for my
patients because in my mind, there is no rationale.

Patient safety and satisfaction are primary goals of plastic surgeons.
We believe that implants are an informed choice, offer health‑related
quality of life benefits for numerous women. Respectfully, I ask the
panel to recommend approval so that our patients can have that choice.

Thank you.

CHAIRMAN CHOTI: Thank you.

Dr. Newburger? She has a question, sir.

MEMBER NEWBURGER: Dr. Wells, I have downloaded the Web site that ASPS
and ASAPS ‑‑

DR. WELLS: Right.

MEMBER NEWBURGER: ‑‑ have made to provide information to potential
patients. The Web site has a section on risks, but the only risks that
you mention in it are surgical risks. But instead of providing
statistics on capsular contracture, rupture, or other surgical
complications, you tell patients to ask their doctors.

Now, my thought is that as the professional society, you all should be
providing that information in the Web site. And if you don\'t, then can
we really count on physicians to do that?

And I have a second question, which is, do you offer any help to
patients who can\'t afford to remove their ruptured implants as a
society?

DR. WELLS: Well, in regard to your first question about data and
statistics, yes, we will eventually add all of that material. The
implant site is a relatively new site and will be upgraded continually.
And the kinds of suggestions that you are making are welcome. And we
would take any input from the FDA to amplify the Web site. Your Web site
contains a lot of that information, and patients can also go to that
information.

As regards offering help to patients, it has been under discussion. No
policy decisions have been made, but we would enter into discussion with
the FDA advisory panel and discuss it further. It is not a closed
option.

CHAIRMAN CHOTI: Thank you.

DR. GUY: Good afternoon. My name is Dr. Roxanne Guy. I am a practicing
plastic surgeon in Melbourne, Florida. And I am also Vive President of
the American Society of Plastic Surgeons. The society is covering my
travel expenses for this presentation.

I have used silicone gel breast implants for over 22 years and have been
using the third generation gel implants under the study protocols of
both manufacturers. I received no compensation from either manufacturer.

In March of this year, in order to get a sense of the experience of
practicing plastic surgeons throughout the country, the ASPS faxed an
11‑question survey regarding the implants being reviewed today to its
membership. This slide summarizes the methodology.

The membership was not given any of the manufacturers\' study data on
these implants. The responses are based on their experience and
expertise.

Nine hundred six questionnaires were returned. A survey summary was
distributed to the panel, which I will synopsize briefly. Approximately
80 percent of the responding plastic surgeons have personally used these
third generation implants since 1992. Fifty‑nine percent of the surgeons
experienced this generation of gel implants as less prone to capsular
contracture. Thirty‑five percent were unsure. And only six percent felt
that they were not necessarily less prone to contracture.

On the issue of rupture, 93 percent responded that they rarely or never
experienced significant local problems. Please note the second slide.
Regarding follow‑up care, 75 percent felt that patients with these
implants should be advised to be seen by a plastic surgeon every one to
two years. Please see the third slide. The average suggested follow‑up
time was every 1.9 years.

There was consensus on the question of monitoring for implant rupture,
with 85 percent agreeing that this should be accomplished by physical
exam followed by appropriate radiological tests as determined by the
examining surgeon.

That testing could, of course, include MRI scanning. Respondents were
divided, though, on the issue of routine MRI screening for silent
rupture with half suggesting that routine screening was not necessary.
Responses from the other half ranged from one to ten years, with a mean
of seven years. Please see the fourth slide.

There was broad agreement; that is, 92 percent, that the availability of
these implants is important to provide patients with the highest quality
of care. Fully 98 percent agreed that patients should be able to
participate with their surgeons in their choice of medical care, and 97
percent felt that patients should have access to these implants. This
last slide illustrates these three points.

The survey results represent a cross‑section of the experience of
practicing plastic surgeons with these third generation gel implants.
What are these surgeons telling us? They\'re telling us that this
generation of implants is vastly improved from previous generation
implants, that they\'re safe and appropriate for use for their patients,
that they have a keen interest in follow‑up patient monitoring, and that
they feel these implants should be added to their options for patients
in order to provide them with the best care.

Most importantly, they\'re telling us that their patients are fully
capable of making an informed decision and that selection of these
devices remains a personal decision made between an informed patient and
her surgeon.

I wish to thank the panel for their attention.

CHAIRMAN CHOTI: Thank you.

DR. BASH: My name is Dr. Deborah Bash. I am the head of cosmetic surgery
at the Mayo Clinic in Scottsdale, Arizona and an assistant professor at
Mayo Clinic College of Medicine. I am a full‑time practicing plastic
surgeon. I am here representing myself. And I have no financial interest
in the sponsors. ASPS is reimbursing me for my travel expenses.

I have been in practice since 1992. And a very large part of my practice
is breast surgery. I have been a participant in the FHA silicone gel
breast implant adjunct study since 1992.

I bring a very unique perspective to this hearing in that I am a plastic
surgeon, an educator, a scientist, and a woman who has had breast
augmentation with silicone gel breast implants.

I had a breast augmentation for cosmetic reasons with silicone gel
implants 20 years ago, when I was a third year medical student, with
implants that are not under discussion today. At that time, silicone gel
implants were the most common device used for the procedure.

After more than ten years of no problems, I electively chose to have
them replaced in 1999 with the next generation of silicone gel implants,
which are the implants you are addressing today. Most of the tragic
stories you are hearing are related to the implants that precede devices
you are now considering.

Since my second breast augmentation in 1999, I have done well, with no
complications. I have never attempted suicide. I do not have
fibromyalgia, lupus, scleroderma, rheumatoid arthritis, brain cancer or
lung cancer, esophageal motility problems, neurologic problems. My teeth
aren\'t green. My hair isn\'t falling out. And I can fully function as a
highly trained and competent surgeon at a very respected medical
institution.

I have yearly mammograms, as recommended by the American Cancer Society.
And I was well‑aware in 1985 that my implants would not last forever.
And I will have my implants replaced again with silicone as they age.

My experience as a surgeon and as a patient puts me at a uniquely
credible position to discuss breast augmentation with my patients. I
rely on science and factual data and speak to my patients openly and
honestly. I always tell them that I have silicone breast implants and
that I chose to have my implants replaced with silicone. In other words,
I put my money where my mouth is.

While my experience allows me to relate to my patients at a different
level, I am frustrated that they do not have access to the same options
that I had. All of my patients wishing implants are shown both silicone
and saline. And for those who qualify for silicone, almost all choose
the silicone because of their more natural feel.

As a plastic surgeon, I am obligated to inform my patients about the
risks of any surgical procedure or device. Likewise, patients must be an
integral part of the decision‑making process. However, I have a
difficult time explaining to my patients why some women are allowed
silicone and some are not because of the FDA concerns about safety of
the device.

I strongly believe that women should have the option to choose the type
of implant surgery or device that works for them when adequately
informed of the risk and benefits. I am fortunate. I had that option in
1999. That is my choice. Make it an option for all women.

Thank you.

CHAIRMAN CHOTI: Dr. Bash, may I ask you a quick question. Do you
recommend to your patients that they be routinely changed every ten
years or whatever interval you ‑‑

DR. BASH: I do. I recommend ten years. I say that they won\'t last
forever and the recommended time is ten years.

CHAIRMAN CHOTI: Even without any evidence of a leak, you would recommend
to your patients to change them out at ten years?

DR. BASH: I do.

CHAIRMAN CHOTI: Okay. Thank you.

Yes? Good afternoon.

DR. JEWELL: Good afternoon. My name is Dr. Mark Jewell. I\'m
President‑Elect of the American Society for Aesthetic Plastic Surgery.
I\'m here today speaking as their official representative. The society
will reimburse my expenses for travel from Eugene, Oregon.

I have no financial ties to industry or medical associations. I am a
clinical investigator for both Inamed and Mentor implant studies and
have received funding for staff administrative support for these
studies.

The American Society for Aesthetic Plastic Surgery also shares the
concerns that you have heard earlier today by Dr. James Wells, who spoke
just before me. It would be a disservice to patients that afterwards it
was determined that this was a flawed process due to agency bias,
misrepresentation of evidence, and absence of plastic surgeons on the
panel.

Today I will address the topic of patient choice and informed consent. I
am the lead author for the last ten years of the patient consultation
resource book used by plastic surgeons for informed consent. Given the
complexities of decisions involving breast implant surgery and the wide
range of surgical techniques used, discussions regarding informed
consent have become extremely important in addressing exactly what are
the dimensions of risk and patient accountability with the clinical
decisions made involving breast implant surgery.

Traditionally this has been a process of defining surgical procedures,
its alternatives, and risks. The patient would then sign a consent
indicating that the procedure was being performed with their consent.

It is known that even a patient may sign a consent form. It does not
necessarily mean that they will in the future remember being informed
about potential complications, need for reoperation, and who is
responsible financially for future treatment.

Validation of informed consent and management of patient expectations
all come down to placing the patient at the center of the
decision‑making process that involves breast implants.

There are newer dimensions of informed consent that are extremely
pertinent when it comes to implanted medical devices, patient
expectations, and reoperative surgery. The placement of breast implants
absolutely ensures that there will be at least one operation in the
future to take care of potential problems or replacement.

The five dimensions of informed consent that are expanded are what are
the pertinent undesirable outcomes. These can relate to surgery or a
medical device, additional advisory information regarding future need
for reoperation is needed.

Second, how permanent is the potential undesirable outcome? The possible
severity, remedy, and permanence all are factors that affect a
patient\'s decision. In some situations, the best choice involving
reoperative breast surgery may be implant removal.

Third, when might the unwanted outcome occur? Negative outcomes may
occur in the perioperative period or later Patients often think of
future risks and immediate risks differently.

Fourth, what is the probability of an adverse event occurring? Now, we
can predict the frequency of adverse events that were involving silicone
breast implants.

And, fifth, how significant is the unwanted outcome to the patient?
Patients will inevitably rate subjective badness differently. However,
some patients may underestimate or overestimate the significance of a
particular risk. It is important in this situation for the patient to
facilitate an accurate perception of objective data.

In the case of breast implants, the following issues need to be
emphasized. Like other medical devices, breast implants do not last a
lifetime and failure can occur. Additionally, there are other known
problems that can occur, such as capsular contracture, that may
influence reoperation.

The vast majority of implant‑related issues are local in nature and
treatable. They are, nevertheless, important considerations for any
woman contemplating breast implant surgery. Patients must be informed
that surgeons cannot control dynamics between implants and soft tissues
and biological healing related to implants.

Patients need to understand the difference between inherent risks of
medical devices and potential complications associated with surgical
procedures. Patients are also entitled to know the clinical consensus of
the scientific community regarding safety, efficacy, and reoperation of
breast implants when making informed choice.

This must be a balanced process hearing both the risk and reward of a
procedure. Patients should be aware that women undergoing breast
augmentation and breast reconstruction often experienced self‑esteem and
greater self‑confidence.

I would offer the panel informed consent documents from the 2005 edition
of the ASPS patient consultation resource book that relates to breast
implant surgery. These cover informed consent documents for primary gel
augmentation, a codicil for patients seeking larger than recommended
implant size, mastopexy, capsulotomy, capsulectomy, and implant removal.
I have also included a flow chart, which details the process of informed
consent.

Thank you.

CHAIRMAN CHOTI: Yes, question, Dr. Newburger?

MEMBER NEWBURGER: Thank you.

Dr. Jewell, I was very pleased to see the ASPS\' Web site with
statistics. It was certainly very helpful to me. I was intrigued by the
fact that your Web site reports over 4,200 young women under the age of
18 having had breast implants. And there is a classification of the
reasons for the surgery under age 18, including tubular breast deformity
and Poland syndrome, in addition to 40 percent having it just for
cosmetic reasons alone.

Is there an algorithm that your society uses to do this classification,
degree of asymmetry or something like that?

DR. JEWELL: Well, first let me correct the matter with regards to those
statistics. Our statistics are for women 18 years of age and younger. So
I can\'t tell you exactly how many women under the age of 18 had breast
augmentation ‑‑

MEMBER NEWBURGER: Okay.

DR. JEWELL: ‑‑ surgery versus reconstructive things. So this would
technically be a patient one day before she is 19 and younger. So I
can\'t really give you those numbers, nor do we have algorithms with
regards to tubular breast, Poland syndrome, or asymmetry.

Thank you.

CHAIRMAN CHOTI: Yes? Thank you. Please?

DR. COLLINS: Members of the panel, good afternoon. My name is Dr. Dale
Collins. I am a board‑certified plastic surgeon, Associate Professor of
Surgery, and Director of Breast Oncology Services at Dartmouth Medical
School.

I have no personal financial relationship with any implant manufacturer.
I participate in two clinical trials of silicone breast implants: the
Mentor adjunct and CPG implant studies.

ASPS paid for my travel. And I am here to discuss the findings from the
published research that currently exist on silicone gel‑filled implants.

Like my colleagues, I fully support the FDA\'s ongoing regulatory
process. Through monitoring the scientific literature on breast
implants, our specialty supports sound science and is able to guide
directed research projects in areas of identified concern. Plastic
surgeons have actively supported scientific research on the safety and
efficacy of breast implants as well as the psychological impact of
breast augmentation and reconstruction.

A document summarizing the current literature has been submitted for the
panel\'s information. The body of knowledge that currently exists
supports the use of silicone gel implants as a choice for women desiring
breast surgery.

As you are aware, the Institute of Medicine report in 2000 found no
evidence of an association between silicone implants and systemic
disease, echoing dozens of peer‑reviewed investigations.

Specifically, the report concluded that silicone implants do not cause
major health problems, such as lupus or rheumatoid arthritis. Other
significant findings conclude that silicone implants do not pose a
threat in breast‑feeding or to unborn babies.

The report represents a comprehensive and unbiased review of the breast
implant safety by top experts in a variety of medical fields. Three
years later, the NIH issued a report to Congress on the status of its
research on the long‑term health effects of silicone breast implants.
They did not find sufficient evidence to support a relationship between
breast implants and connective tissue disorders.

The report found that women with silicone breast implants are no more
likely than the rest of the population to develop cancer, immunologic
diseases, or neurological problems. It also cited a National Cancer
Institute finding that women with breast implants show a slight decrease
in risk for breast cancer.

As a woman and as a physician, I am aware that breast implants, both
saline and silicone, may cause localized problems for some patients. And
in some cases, this may require additional surgery or other
intervention.

However, despite these facts, scientific studies over the years support
the safety and effectiveness of these devices for augmentation and
reconstruction. Moreover, patient satisfaction with the surgical
outcomes remains high.

Like other implantable medical devices, breast implants may not last a
lifetime, but women who understand this fact may choose to undergo
breast implant surgery.

In closing, let me add that I have been an attending surgeon for ten
years with a practice limited to breast reconstruction for the past
five. My primary goal in appearing here today is to implore the panel to
make silicone breast implants accessible to those women who make an
informed choice to use them, either in reconstruction or in breast
augmentation.

Thank you for the opportunity to speak here today.

DR. YOUNG: Good afternoon. My name is Leroy Young. I am testifying today
for the Aesthetic Surgery Education and Research Foundation, or ASERF. I
am a board‑certified plastic surgeon in private practice in St. Louis,
Missouri and serve as a committee chair in various capacities for both
the American Society of Plastic Surgeons and the American Society for
Aesthetic Plastic Surgeons.

I currently have no financial ties with any implant manufacturer. In the
past, I have received research funding from several implant
manufacturers, including McGhan, and have served as a consultant to
breast implant manufacturers.

I use implants in my medical practice. I chair the North American Breast
Implant Registry and co‑chair the International Breast Implant Registry,
which I will be discussing in some detail today. My travel expenses were
paid by ASERF.

Our specialty has demonstrated a long‑term commitment to data collection
and patient follow‑up. The National Breast Implant Registry, or NABIR,
was created in 2000 for data collection on all implant types and
procedures, specifically patterns of use and indications for procedure,
implant or explant.

A later presentation by my colleague Richard D\'Amico will outline a
post‑market surveillance concept plan that would meet a
panel‑recommended condition and build on the experience and commitment
of NABIR.

NABIR has evolved since its inception to a dynamic Web‑based tool with
participation from more than 316 surgical facilities and over 21,000
women. The registry is now linked to an innovative outcomes data
collection program called TOOPS, Tracking Operations and Outcomes for
Plastic Surgeons, a shared initiative of the American Society of Plastic
Surgeons and the American Board of Plastic Surgery.

The internet data collections mechanism provides valid clinical and
practice information to plastic surgeons and allows the individual
surgeon to compare his or her outcome against national benchmarks.

NABIR has played a leadership role in international collaboration on
breast implant data collection. The European Union has mandated that its
member countries have breast implant registries. And plastic surgery
societies in several countries have endorsed NABIR as the model of
choice.

As a result, the International Breast Implant Registry was formed to
allow collaborative data collection and analysis between U.S., European,
South American, and Australian organized plastic surgery. We believe
that NABIR is quickly becoming a world standard for an electronic breast
implant registry.

NABIR has a number of key features that will likely be integral to a
post‑market surveillance tool. It is secure, internet‑based, and
HIPAA‑compliant. It is administered by a neutral third party. The
registry is voluntary, and data submitted is anonymous, protecting the
patient\'s and the surgeon\'s privacy and confidentiality.

A variety of data elements are tracked, including physician of implant,
incision location, and well as indications for implant or explant, such
as rupture, change in size, and migration. Collected data also
encompasses method of tumor indication as well as level of staging as
applicable. In the future, there may be an added value in integrating
patient satisfaction and quality of life data collection.

Having had personal involvement in a large‑scale online survey funded by
ASERF, we were able to collect a wealth of previously unavailable data
on women undergoing or considering this surgery, particularly as relates
to patient satisfaction with their choice.

The opportunities in a registry like NABIR are very exciting as a
post‑market surveillance tool. As there is no legislative mandate in the
United States for compulsory implant registries, we promote voluntary
reporting by plastic surgeons to NABIR as an important tool for ongoing
research and data collection.

We support the FDA\'s review process and believe a strong post‑market
surveillance process similar to our National Breast Implant Registry can
play a significant role. Preliminary meetings with the FDA and industry
have been supportive of collaboration on the registry. We welcome the
opportunity to build on the success of the National Breast Implant
Registry.

Thank you.

DR. CASAS: I am Dr. Laurie Casas, Communication Commissioner for the
American Society for Aesthetic Plastic Surgery, also called ASAPS. My
travel expenses to this hearing were paid by ASAPS.

I am a full‑time Associate Professor of Surgery at Northwestern
University Feinberg School of Medicine in Chicago. I have published
extensively on breast surgery topics. I have participated in a
soon‑to‑be‑published multi‑site prospective outcome study on patient
satisfaction following cosmetic procedures.

I am a board‑certified plastic surgeon in clinical practice for more
than 15 years. Therefore, a portion of my income is derived from breast
implant surgery. I have no financial ties to any implant manufacturer.

To correct the record, I would like to state there are not four plastic
surgeons on this panel, only one. The second plastic surgeon panelists
felt forced to resign after concerns regarding possible conflict of
interest.

I am here today on behalf of the many thousands of patients who tell me
that breast implants have made a positive difference in their lives.
Given the proven level of safety and efficacy of breast implants, I am
in full support of the FDA\'s approval of these devices along with the
FDA\'s continued oversight.

I feel that patient education, safety, and satisfaction are of primary
importance. I believe strongly that a woman\'s right to choose breast
implants is paralleled by her right to be fully informed about the risks
and the benefits.

There is a growing body of knowledge and evidence that suggests that
cosmetic surgery, such as breast augmentation, leads to an improvement
in at least three areas of psychological functioning: body image,
quality of life, and depressive symptoms.

The results of 2 surveys of more than 5,000 women with or considering
breast implants were published in the Aesthetic Surgery Journal, the
ASAPS\' peer‑reviewed clinical publication.

Results of both surveys show that women\'s expectations were met by this
procedure. Ninety‑two percent said they are happy about their decision
to get breast implants and report positive effects on their overall
appearance. Eighty‑nine percent said that augmentation completely or
mostly met their expectations. Ninety‑four percent said they would
recommend breast augmentation to friends or family members. The survey
showed that 82 percent reported an improvement in their self‑confidence.

An increasing number of women today are choosing breast augmentation to
restore and enhance their appearance, over a million in the last decade
alone. It is important to note that over 95 percent of the women seeking
breast augmentation come to me for 2 principal reasons. The first is a
woman who finds that her once normal breasts have lost considerable
volume after pregnancy and lactation and are not in proportion to the
rest of her body. The second reason is a woman who comes to us for
breast augmentation because she has grown into adulthood with no breast
development at all. She feels her breasts are out of proportion to her
body.

What I hope this panel will come to understand is that this experience
parallels mine. The research has shown that the vast majority of women
who have had breast augmentation would make the same choice again. The
high satisfaction rate and the determination of so many women to undergo
a surgery with the knowledge that it is not a perfect operation suggests
just how strongly they feel.

I\'d like to sum up by just saying silicone breast implants clearly
provide women with options for self‑fulfillment. And breast augmentation
produces a high level of patient satisfaction. I fully support the
FDA\'s ongoing review of implant safety and efficacy and rely upon the
agency\'s evaluation of the current science regarding breast implant
products.

MS. BRANSON: Hi. My name is Kerri Branson. I traveled from North Aurora,
Illinois. I\'ve come here on my own expense, and I have no financial
relationships with the PMA sponsors. I am a married 35‑year‑old
stay‑at‑home mother with 4 children under the age of 7. My husband is a
teacher.

In 1990, at the age of 20, I underwent bilateral breast augmentation. I
received silicone gel implants over the muscle. Over the next year, both
my breasts developed severe capsular contractions. I was never in any
pain, and my breasts had no obvious deformities.

The only uncomfortable situations were lying on my stomach and hugging
another person for the fear they could fear my contractions. To me, it
felt like they were two oranges between myself and the person that I was
hugging.

I lived with this for 14 years and I breast‑fed all 4 of my children
with no worries because I had all of the facts. In June of 2004, I
decided I was done having children. I wanted to firm up what childbirth
had done to my body. So I decided for a second time to seek breast
augmentation.

After doing extensive research and consulting with my new doctor, we
decided to utilize silicone gel implants once again, but with this time
a new approach I wasn\'t familiar with from a previous experience.

I underwent my bilateral capsulectomy with an implant exchange but this
time underneath the muscle. Both old implants were removed completely
and intact. I was given all the information about silicone, and my
doctor taught me how to care for my implants. This included strict
inactivity for several weeks of my upper extremities, massage therapy,
dietary supplements, and an excellent follow‑up care with mandatory
frequent physician visits. My doctor worked closely with me and still
does to make sure that my recovery goes smoothly.

I am completely comfortable about my decision. One year later, after my
surgery and following the strict regimen of my new phone doctor, I am
doing wonderfully with no contractures in sight.

I attribute my previous scar tissue buildup to my own ignorance and also
to my first doctor, who did not teach me how to take care of my implants
to prevent contractures, because I had little or no follow‑up care.

I am ecstatic with my new results. I am in excellent health. And I have
never ever regretted my choice. I feel fortunate I am one of the small
groups of women who get a choice between silicone or saline.

My wish is that every other woman seeking breast augmentation will have
access to this information so that she can be assured that she is given
the right care and education about how to take care of her implants. She
will feel great and have the excellent results that I achieved this past
year.

I hope my testimony will prove that with education being the key, this
informed decision of silicone versus saline should be a choice between
women and her doctor, just as many other important decisions about a
woman\'s own body have been in our country for years.

Thank you for your time and for listening to my story.

DR. D\'AMICO: Mr. Chairman, Dr. Choti, members of the panel, my name is
Richard D\'Amico. I am a plastic surgeon. And I represent the American
Society of Plastic Surgeons, the ASPS. I have no financial ties to
either corporation. My travel has been paid by ASPS. My topic is
post‑market surveillance with a new breast implant registry. My remarks
will amplify the remarks of Dr. Wells and Dr. Young.

We believe there is sufficient data to support women\'s right to choose
silicone gel‑filled implants. However, we also believe post‑market
surveillance of this device will be essential to reassure the public
regarding its long‑term safety and effectiveness.

To better understand a successful device registry, we studied the
experience of other similar programs, including the Uterine Artery
Embolization Fibroid Registry and the National Adult Cardiac Surgery
Database.

We also built on the experience of the North American Breast Implant
Registry, which was established by our Plastic Surgery Educational
Foundation five years ago and which was just described by Dr. Young.

On March 14th of this year, we met with executives from Mentor and
Inamed Corporations and agreed upon six principles for post‑market
monitoring. Number one, industry will provide financial support to an
ASPS‑ASAPS‑sponsored third party breast implant registry.

Number two, the registry will seek to collect information on each device
implanted. Patients will also be encouraged to participate in
longitudinal studies in key areas, including rupture, silent rupture,
gel migration, capsular contracture, reoperation, and quality of life.
Emphasis will be placed on creation of a valid database.

Three, the registry would be housed and managed by a reputable third
party clinical research organization, such as the Duke Clinical Research
Institute, with whom we have recently had preliminary discussions on
this topic.

Number four, an oversight committee will be representative of the
scientific and medical community, the FDA, the public, and industry.
Medical specialties, such as radiology and rheumatology, with specific
interest in implants will be invited to assist in design and
implementation. The registry\'s multi‑disciplinary scientific panel will
establish scientific and reporting guidelines and meet annually to
review the data.

Five, public accountability and access are essential. Routine reports
would be submitted to FDA. Summaries and published studies could be
posted on a publicly accessible Web site, such as
www.breastimplantsafety.org. And, six, the highest priority will be
placed on confidentiality and data security.

We look forward to FDA comments. And I thank you for this opportunity to
address the panel.

CHAIRMAN CHOTI: Yes. Thank you.

Please?

DR. HAECK: I am Dr. Phil Haeck. Thank you for allowing me to speak. I am
a plastic surgeon in private practice in Seattle, Washington. I am the
Editor of Plastic Surgery News. I am a member of the Board of Directors
of ASPS. And I am also Chair of the Health Policy and Practice Committee
of ASPS. I have no financial interest in Inamed or Mentor. And ASPS paid
my travel expenses.

I am here to give you a brief overview of our new practice parameter:
treatment principles of silicone breast implants. You have a copy of
that. I would like to review in principle the following aspects of this
treatment parameter.

Infrequent sequelae unique to silicone breast implant surgery have been
challenging to diagnose and treat for plastic surgeons for over 40
years. These unique conditions can lead to patient dissatisfaction;
possible implant removal, with or without replacement; and increased
costs associated with reoperation.

The practice parameter focuses on the diagnosis, treatment, and
management of several unique long‑term effects of silicone breast
implants that may occur months or even years after insertion of the
implant. These conditions include breast pain, late infections, rupture,
and capsular contracture.

Breast pain is a symptom that can be associated with other conditions or
a condition itself after breast augmentation and should not be
dismissed. Breast pain after augmentation can be attributed to a variety
of causes, including rupture, infection, calcification around the
implant, and capsular contracture.

Patients experiencing breast pain should undergo serial examination and
a workup of the symptoms. Mammography, ultrasound, or MRI examination
may be necessary to determine the status of the implant and the source
of the pain.

If the cause of the pain cannot be determined, symptomatic treatment
should be ordered and reexamination taken at intervals to reassure the
patient and surgeon that rupture has not occurred.

The signs and symptoms of late infection are often vague and can lead to
delay in diagnosis and treatment. In the past, the treatment for late
infection typically involved removing the breast implant, treating the
infection, and replacing the implant at a later date.

Currently treatment recommendations are based on the severity of the
infection and range from empiric antibiotics for erythema and fever to
culture‑specific IV antibiotics and hospitalization for signs of sepsis.

In addition to IV antibiotics, the management of severe infection
usually involves removal of the implant, along with surgical drainage.
If patients choose to replace the implants, new implants may be inserted
once the breast and pocket have been sterilized.

Another condition, unexplained or spontaneous implant rupture, can
occur, even in patients without rupture risk factors. Our practice
parameter reviews the steps needed to be taken when signs of rupture
occur, such as mammography and MRI.

Though there is no consensus or scientific literature to support the
routine screening for patients with silicone implants that have no
indication of rupture, we are now recommending routine reexamination of
all women with implants every three to five years and routine
radiographic studies at ten years, followed subsequently as needed or at
five‑year intervals.

Infection, hematoma, silicone bleed, and individual tendency to
hypertrophic scarring are thought to be predisposing factors for
capsular contracture. Plastic surgeons are in consensus that using the
well‑known Baker\'s Scale of creating implants on a I to IV basis, grade
III and IV contractures are rare but need to be treated.

However, there are large variations in the timing and methods of
treatment, which must be tailored to the individual patients\' needs and
range from no treatment to removal with or without replacement. These
varied events tend to be unique to each patient, both in terms of onset
and treatment response, leading to difficult decisions that must be made
by both the patient and physician.

CHAIRMAN CHOTI: If you could sum up, please, for us?

DR. HAECK: There are treatment options available which foster the
safety, efficacy, and patient satisfaction of silicone breast implants.

Thank you.

DR. TAFRA: Good afternoon. Members of the General and Plastic Surgery
Devices Panel, my name is Lorraine Tafra. I am a breast surgeon
practicing in Annapolis, Maryland and the Director of the Anne Arundel
Medical Center Breast Center in Annapolis as well as the immediate past
President of the American Society of Breast Surgeons.

I am proud to represent the 66,000 fellows of the American College of
Surgeons and wanted to thank you for this opportunity to offer breast
surgeons\' perspective on the issue of silicone gel‑filled breast
protheses for patients who are considering breast reconstruction or
augmentation procedures.

I am a board‑certified general surgeon and would like to state at this
time I have no financial relationship with silicone or implant medical
device manufacturers.

Today I would like to focus my comments on breast reconstruction and
augmentation as procedures that improve quality of life for many
patients. New medical techniques and devices have made it possible for
surgeons to create a breast that can come close in form and appearance
to matching a natural breast.

Frequently reconstruction is possible immediately following breast
removal or mastectomy so the patient wakes up with a breast already in
place, having been spared the experience of seeing herself with no
breast at all.

The availability of breast reconstruction gives the woman an option over
which she has some control during a very challenging time of her life.

As a surgeon, I spend a good portion of my time surgically removing
breasts. I can tell you the psychological impact of losing that organ
that is so visible to oneself and to others and that is so closely
linked to gender identify is universally negative, no matter what the
age.

The medical and cosmetic issues of removing this organ are inextricably
linked. And returning that organ to a normal‑appearing state can be
crucial.

But no two patients are the same. My patients are old. They\'re young.
They\'re large‑breasted. They\'re small‑breasted. After mastectomy, some
have thick flaps. I\'m referring to the thickness of the skin that we
leave behind. Some have thin flaps.

Most patients are asymmetrical. Sometimes the cancer side is the smaller
side. Sometimes it\'s the larger side. One patient may have as her
highest priority the new breast\'s appearance. Another may only be
concerned that it feels like a normal breast. There is no universal
reconstruction that works for everyone. And the more options we have,
the better we can tailor our procedures.

Both breast reconstruction and augmentation provide enormous benefits to
women, including improved self‑image and sense of normalcy. But, as is
true with any operations, patients must think carefully about their
expectations and discuss those with the surgeon.

The American College of Surgeons has had a longstanding commitment to
improving the quality of surgical patient care and to enhancing patient
safety. Consequently, we look forward to hearing more about the data
collected by the manufacturer on the safety of silicone gel‑filled
breast implants. And we welcome FDA\'s review of these new safety data.

If these devices prove to be unsafe, we certainly would not support
their use in patients. Patient safety is and always will be the primary
concern of the college. But we also feel strongly that decisions that
effectively limit patient options must be made on the basis of solid
scientific evidence.

We are concerned that procedures with benefits that are life‑enhancing,
rather than life‑saving, are occasionally viewed by many as somewhat
less important. Breast implants should be regarded as any other medical
device that is considered by this panel.

Further distinctions should not be made between their use for
reconstruction or for augmentation purposes. Why is this device deemed
safe for reconstruction patients but not for those seeking augmentation?
What message does this send to our breast cancer patients?

And, following more than ten years of clinical studies and trials, if
conclusive data are not found showing that these devices pose a
significant risk to our patients, we believe the choice to use them
should be made available to consenting patients.

The college also agrees that it is vital for any woman considering a
breast implant procedure to be well‑informed of all possible risks
associated with the procedure as well as with the device being used.

Women must be informed, for example, that breast implants do not last
forever, that complications can occur, and that additional operations
may be necessary. Consequently, we support this panel\'s continued
efforts to ensure that breast implant patients have access to
comprehensive and comprehensible material that can be used in making
truly informed decisions about these procedures.

To conclude, let me say again that all surgeons are obliged to be and
the vast majority are scrupulous in providing their patients with the
information they need to truly informed consent for any operation.

We are truly hopeful that the information collected by the manufacturer
of these devices will contribute significantly to these efforts and help
to resolve the continuing uncertainty about their safety.

Thank you again for the opportunity to appear here today. And I can take
any questions.

CHAIRMAN CHOTI: Thank you, Dr. Tafra. That\'s all. Thank you.

MS. WILLSON: Good afternoon. My name is Shirley Willson. I want to thank
the panel for hearing my testimony today regarding my experience with
breast augmentation.

I am 53 years old, and I am a mother and a wife. I am also an office
manager. I am here representing myself. ASPS has paid my travel
expenses. I do not have any financial interest in Inamed, Mentor, or
their competitors.

I have always been small in stature, and I have always had very small
breasts. For many years, I have been under the false impression that
breast augmentation was beyond my reach and only special and fortunate
women could achieve such wonderful results. I found that not to be the
case.

My opportunity presented itself while working in a plastic surgeon\'s
office. I experienced firsthand women having breast augmentation
procedures. I would see the fantastic results these women would obtain
from their surgery. They would leave the office after surgery feeling
better about their bodies and about themselves.

So after several years of contemplation, I decided that breast
augmentation was the right decision for me. About six years ago, I spoke
to my plastic surgeon and decided to go ahead with the procedure that I
had been thinking about for years. I did a great deal of research on the
procedure and what options I would have.

I did not expect my life to change dramatically because I was going to
have larger breasts. I knew going in there that there are no guarantees
with any kind of surgery, but I wanted to look better. I wanted to fill
out a bathing suit or a tank top for once in my life. And I knew that
this goal was within my reach. I had seen countless other women do it.

I had the surgery, and it was a success. I love my new body and am more
confident because of it. I wish I had the courage to do it years
earlier. My only regret is that when I decided to have the surgery, the
only option available to me was saline implants. While I am very happy
with my implants, I would have liked to have been given the chance to
choose between saline and silicone for myself.

Looking back, I think that if silicone had been offered to me, I
probably would have chosen it, not that saline was a bad option. I have
had my implants for six years, and I am still quite pleased with them.
The only problem I have is they are beginning to wrinkle. But I think
the choice of what type of implant to put in my body should have been
left up to me.

I know that I will probably have to replace my implants one of these
days. And when I do, I hope that I will have the choice between silicone
and saline. If I have that choice, I will once again do my research. I
will have to discuss the pros and cons with my doctor and my husband,
but I wanted to have that choice available.

I sincerely appreciate your time and the opportunity to share my
experience with you. Thank you.

DR. GLASBERG: Good afternoon, Mr. Chair, panel members. And thank you
for allowing me to address the panel today. My name is Scot Glasberg,
and I am a board‑certified cosmetic and reconstructive plastic surgeon
from New York City.

I am here testifying today as an individual but must note in the
interest of full disclosure that I have served as a consultant for the
Mentor Corporation.

As a physician, I not only see my role in this discussion as a disciple
of the research and science surrounding breast implants but also as a
patient advocate. I believe patients have the right to the most current,
accurate, and scientifically sound information.

Therefore, I am here today to share my scientific opinion and serve as
the voice for my patients who cannot attend this hearing and speak for
themselves.

The time has come for the FDA to accept the overwhelming data and
science collected during the last 13 years that show the safety and
efficacy of silicone breast implants.

The multiple randomized prospective studies that have been performed,
including the 1999 IOM report and last year\'s report from the National
Cancer Institute, show no demonstrable link between silicone gel breast
implants and health or safety concerns for women.

The proven safety record of silicone breast implants should be heard and
contemplated. Historically the consideration of silicone gel‑filled
breast implants has been an emotionally charged and controversial
discussion. Now it is time to get past the rhetoric and focus on the
reality, the science, and the data.

Patients, understandably, have a tremendous respect for the FDA and
these processes. They rely on the FDA to evaluate the data on their
behalf. And approval by the FDA would go a long way to lifting existing
barriers and make patients feel more secure about these medical devices.

I have been placing silicone breast implants in patients as part of the
adjunct study. And the medical outcomes have been excellent. It is
impossible to ignore the clear superiority of silicone breast implants
in comparison to saline implants. They are softer, more life‑like, and
much more accurately mimic the soft tissue of a woman\'s breast.

Perhaps most importantly, my professional experience has been both that
the capsular contracture rates and the rates of rupture are actually
significantly less than even those of saline implants. In fact, many
patients gain access to silicone implants because of their problems with
saline breast implants.

I must also take into account the overwhelming satisfaction my patients
experience with these medical devices. While silicone breast implants
are available through small, limited studies, a vast subset of patients
still cannot meet the criteria for inclusion.

Despite the increased amount of time involved with additional paperwork,
I continue to place these patients into these studies because as a
physician, I must do what is best for my patients. I truly believe based
on the medical evidence and my particular experience in the superiority
and safety of these medical devices.

From my practice experience, I feel that the FDA approval will also
serve a subset of patients who have not had the ability or opportunity
to gain access to these vital medical devices. In my practice alone, I
have many women who are waiting for approval of silicone breast
implants.

The mission of the FDA is \"to protect the public health by assuring the
safety and efficacy of medical devices, to advance the public health,
and to help the public get the accurate science‑based information they
need to improve their health.\"

I put forth to you today that the FDA has the opportunity to fulfill its
mission statement. By simply focusing on the data and the science and
approving silicone breast implants for general use, we have the
opportunity to advance the health and well‑being of millions of women
today.

Thank you for your time and consideration.

MEMBER BLUMENSTEIN: I\'d like ‑‑

CHAIRMAN CHOTI: Yes? A question.

MEMBER BLUMENSTEIN: This is Brent Blumenstein. You mentioned multiple
randomized studies. Could you please describe those to me?

DR. GLASBERG: If one looks at the general literature, including the IOM
report, there is good evidence there in randomized fashion that shows
that these are safe and effective devices.

MEMBER BLUMENSTEIN: I was unaware of randomized studies. That\'s what
I\'m focusing on.

DR. GLASBERG: I apologize. I should have said prospective studies.

CHAIRMAN CHOTI: Yes?

DR. ROTH: Members of the General and Plastic Surgery Devices Panel, I am
Dr. Malcolm Roth. I am a board‑certified plastic surgeon practicing in
Brooklyn, New York. I have no financial relationship with any implant
manufacturer. ASPS has paid my travel expenses.

I have been in practice since 1988. During my plastic surgery residency,
I had extensive experience with saline and silicone gel implants for
reconstruction as well as cosmetic breast augmentation.

When I completed my training and entered practice, I offered both types
of implants to my patients. In each case, I discussed the options in
great detail with each of my patients. I provided literature to each
woman, particularly the concerns about the safety of silicone.

When the moratorium went into effect in 1992, I reached out to every
patient whom I had performed breast implant surgery on. I offered to
speak with them on the phone or in person at no charge and with no time
limit. Nobody called to ask questions, and nobody came in to discuss the
concerns in person.

When ASPS had a live teleconference at that time during the moratorium
on silicone breast implants to inform patients and answer questions and
I personally called each woman to inform them of the time and place and
that I would be there, only one patient came.

Afterwards that patient told me that the teleconference was a waste of
time. She told me what all of my patients were telling me. She said that
I had informed her extensively of the possibility of health risks and
local problems and that she had made a choice to have silicone gel
breast implants. She made her decision based on the science available at
that time and having been fully informed before her surgery. The junk
science which was being promulgated at that time did not change her
views or otherwise affect her decision.

Now, 13 years later, the scientific studies have failed to demonstrate
that women with these devices have greater health risks than women
without implants. For many women who choose to have breast implants,
silicone gel is more likely than saline to result in the natural
appearance and feel of the reconstructed or enhanced breast.

I believe that if patients are educated about the risks and benefits of
breast implant surgery and they receive preoperative materials and
consent forms, women in this country should have the right to choose for
themselves.

Post‑market monitoring of the device should be continued in order to
assure patients of the long‑term safety of the device. A breast implant
registry can and should play a significant role in post‑market
monitoring.

I have two daughters. And while they have not indicated a specific
interest in breast enhancement surgery, if they were so inclined, I
would advise them to get silicone gel implants.

But since neither of them is likely to fit the criteria currently in
place, they would have to have the surgery outside of the United States.
It is remarkable to me that the U.S. is the only country where they
would not be able to make this choice for themselves. It is time to let
women in this country choose for themselves.

Thank you.

MS. GANDY: Good afternoon. My name is Kim Gandy, and I am President of
the National Organization for Women. NOW is the oldest and largest
women\'s rights activist organization in the United States, advocating
for women\'s equal rights, economic and social well‑being, and for
women\'s health.

The National Organization for Women and myself represent only our own
501(c)(4) nonprofit organization. And my appearance today is
underwritten by our 550,000 members and contributing supporters.

To be blunt, it\'s disappointing that we find ourselves here today. Just
last year, the Food and Drug Administration made it clear that there was
insufficient long‑term safety data on silicone gel breast implants. And
here you are again, and here we are again reviewing another petition for
market approval, a little more than a year later, still without
long‑term safety data.

What sort of message is the Food and Drug Administration sending to the
public and to industry petitioners when it backs down so quickly on its
demands for patient safety? Inamed\'s less than four years of data is
not sufficient to demonstrate long‑term safety.

FDA reviewers agree that little can be learned about rupture and other
aspects from studies of such short duration. And, indeed, the company\'s
data that has been reviewed by the agency shows substantial evidence
that these devices are not safe for women.

The agency reviewers estimate that between 74 percent and 93 percent of
the implants under study will rupture within 10 years. Those projects
and the absence of sufficient clinical data are solid reasons to
recommend against allowing these implants to be marketed generally.

Aside from the prospect of frequent implant rupture, there is the
equally serious problem of slow leakage. Silicone particles and
chemicals from the implants can and do seep into the body. Inamed\'s own
data submitted for the 2003 panel reported significant problems with
silent rupture, local complications, connective tissue disorder signs
and symptoms, and reoperations. There are too few properly designed
studies that have been conducted to determine exactly what effect
silicone gel has on human physiology.

Especially troublesome to us is the lack of knowledge about the effect
of the chemical constituents of silicone gel in pregnant women on the
developing fetus and lack of information about the transmission of
potentially harmful substances to breast‑feeding infants through breast
milk, all of which are items that we recommended last year for inclusion
in guidance to the industry for further study. Such studies should also
include following children born to women with silicone gel implants to
evaluate health or developmental problems resulting from exposure in
utero or exposure through breast milk.

Another area of concern relates to the difficulties that these implants
pose for accurate mammogram readings. According to a five‑year
evaluation of seven mammography centers involving thousands of
mammograms, breast implants obscure and greatly reduce the accuracy of
mammogram readings.

As reported in the Journal of the American Medical Association, 55
percent of breast cancers in this study went undetected in women with
breast implants. That\'s 67 percent greater than the number that went
undetected in women without implants.

Our national commitment to reduce the incidence of breast cancer could
be undermined by the implant industry\'s media campaign to sell more
implants. And the dramatically higher rate of implant rupture and
complications experienced by post‑mastectomy as compared to augmentation
patients seems a cruel consequence for women who have survived a
life‑threatening battle with breast cancer.

This panel has already heard and will continue to hear the heartbreaking
stories of women who became seriously debilitated after receiving breast
implants. Many of these women can no longer work or take care of their
families due to grave health problems.

Stories exactly like this from NOW members is what started our inquiry
into this issue three years ago. I urge the panel members to consider
how the availability of well‑based long‑term clinical data and an
effective regulatory process could have changed these women\'s lives.

These women are asking the FDA to take responsibility for regulating an
industry that cannot or will not regulate itself. In this specific
instance, reneging on the reasonable requirements required last year in
approving these implants could result in devastating health
consequences. Such a public health catastrophe is preventable, and women
are counting on you to prevent it.

Thank you.

MEMBER MILLER: Dr. Choti?

CHAIRMAN CHOTI: A question. Dr. Miller?

MEMBER MILLER: May I ask a question, Ms. Gandy? I appreciate hearing
from you today. I\'m curious. You know, your organization is funded by
gifts, I believe, charitable types of gifts. Do you have any idea what
percent of the gifts that you receive are related to this issue on your
annual giving? I assume women are ‑‑

MS. GANDY: A fraction.

MEMBER MILLER: There are many people in the country who ‑‑

MS. GANDY: I think a fraction of a percent. We have a women\'s health
project that occasionally gets dedicated gifts. I think the largest
grant our women\'s health project has received in many years was about
\$300,000 for the work that we did on tobacco, tobacco use in women.

MEMBER MILLER: So do you have any way to determine the specific concerns
of those who decide to support your organization in terms of whether
they\'re concerned about one issue or this issue? Is there any way to
determine that in how you organize yourself?

MS. GANDY: No. I mean, not in terms of our individual contributions. We
are about a \$5 million organization, and over 99 percent of our income
comes from gifts from individual members, \$5,000 and under.

They are average gift organizationally. If you add it all up and divide
it by the total number of gifts, our average gift is about \$42.

MEMBER MILLER: Okay. All right. Thank you.

CHAIRMAN CHOTI: Yes?

MS. COPPOLA: Hi. My name is Kyle Coppola. And I am an ordinary woman who
people say accomplished an extraordinary thing. Before I talk about
that, first I would like to say that it is a privilege to be here today.
And, second, ASPS has paid my travel expenses here. I do not have any
financial interest in Inamed, Mentor, or their competitors.

So what is it that I, a 46‑year‑old, middle class, working wife and
mother, have achieved? It is that I used to weigh 434 pounds. I repeat:
434 pounds. I lost 300 pounds on my own through diet and exercise, and I
am currently in the 5th year of maintaining that weight loss.

When I reached my goal, I felt very deformed. The years of yo‑yo dieting
and excess weight had virtually destroyed my skin\'s elasticity. With
all of the loose skin, I looked like a Sharpei puppy. The breasts I had
were almost nonexistent. And you could see my chest wall right through
my skin. No amount of diet or exercise was going to fix this. I wanted
and I needed plastic surgery.

So over the past four years, I have undergone a series of operations,
starting with my arms, then my abdomen and breasts, and then my lower
body.

I am here today to speak to you about the breast surgery I had. I could
have opted just for a breast lift, but because of the lack of breast
tissue, I opted to include an augmentation.

As a result of this, I had a choice to make: silicone or saline. My
knowledge about implants pre‑surgery was very limited. And I knew I
needed to become informed. My career is in research and science. So I
know how to review data, and I did.

I looked at all of the pros, and I looked at all of the cons. I also
turned to my physician for guidance. She answered my questions. She
brought up topics I had not thought of. She showed me implants. And she
gave me written materials. I also spoke with women who have had
implants. My physician took the time to make sure that I was fully
informed. And I truly believe that I was given factual, unbiased, and
complete information.

In the end, saline implants did not appeal to me because I felt the
result would be undesirable. More importantly, after my thorough
research, I did not feel that there was compelling evidence for me to
reject silicone implants.

So my final decision was in silicone. And in 2001, I underwent breast
mastopexy and augmentation. Because of a shift in implant position, I
had a revision four months later. This would have happened with any
device.

Other than the revision, I have had no problems with my implants, none
whatsoever. There is no wrinkling. And in my opinion, my breasts look
and feel natural.

Through the restorative nature of this surgery, I now like my figure.
And I love the shape my implants provide. I am healthy. I repeat: I am
healthy. I feel confident. And, best of all, I no longer feel as if I am
pretending to be thin.

I believe strongly in research and in choice. In an effort to aid in
research, I am a participant in a Mentor study for silicone implants.

CHAIRMAN CHOTI: Sorry. If you could try to wrap it up a little bit?

MS. COPPOLA: Okay. I am hopeful that my positive experience will help to
offset some of the horror stories and to provide some balance.

I am not saying that silicone implants are right for everyone. What I am
saying is that I believe a person should have the opportunity to make a
choice. I believe that choice and education are the keys.

Thank you.

CHAIRMAN CHOTI: Yes. Good afternoon.

DR. JOHNSON: Hi. My name is Dr. Nancy Johnson. I\'m a 50‑year‑old
board‑certified anesthesiologist from Shreveport, Louisiana. I am
testifying today as an individual with a strong opinion concerning
silicone breast implants. My travel expenses were paid for by ASPS. I am
not receiving compensation from any breast implant manufacturer, nor do
I have a financial interest in such companies.

After completion of my residency at Baylor College of Medicine in
Houston, Texas, I began private practice in 1983. I was one of those
women who said I would never have breast augmentation. I was happy with
my nice B‑cup breasts.

I\'ve provided anesthetic care for many, many women undergoing breast
augmentation, in addition to those whose implants have ruptured and
required replacement. After observing pre and post‑operative results, I
was more than happy to add my name to the surgery schedule. I was fully
informed of the risk involved.

I don\'t think many people realize how strong breast implants are. One
afternoon, there was a plastic surgeon and I that went to school
together. We took one of each brand of implants and ran over them with
his car. I was amazed that not a single one of them ruptured. What a
startling example of a controlled scientific study but a true story,
nonetheless.

I decided to have breast augmentation in 1985. And I can truly say that
I have never had a single day of regret. I had surgery on Thursday,
returned to work on Monday without difficulty. I\'ve never experienced
any discomfort secondary to my implants. I am completely unaware of
them. And my health is excellent.

When my second child was born, my breasts did not return to their
pre‑pregnancy shape. I began to develop a capsular contracture around my
right breast. And in August of 2004, I had my implants removed and
replaced with new silicone breast implants. Both implants had ruptured
and encapsulated around the silicone.

As a physician, I do not believe that silicone floats around the body.
One only has to observe the way the body walls off the rupture, just as
it does in response to any foreign body.

I know a number of women, both friends and patients, who have had
silicone breast implants removed and replaced with saline. Not a single
one of them was pleased with the exchange. The saline implants are hard,
cold, heavy, and do not feel natural.

My next door neighbor had her silicone implants replaced with saline
after she was not given the option of silicone. After she observed my
results, she scheduled her surgery for the next week.

I have many stories about friends preferring silicone. But the bottom
line is in my opinion, as a physician, my patients are not pleased with
saline once they see and feel the difference of the silicone breast
implants.

I could not be more pleased with my new implants. My husband, who is an
ob/gyn, is also thrilled. My breasts appear now the same as they did in
1985.

I have a 16‑year‑old daughter who is flat‑chested and greatly desires
augmentation when she is old enough. But she was mortified when she knew
I was going to say this. Until she has the option of silicone breast
implants available, I will not allow her to have the procedure. She
should have the right to choose after informed consent, as should each
and everyone who considers this procedure.

Thank you for allowing me the opportunity to express my opinion.

CHAIRMAN CHOTI: Thank you.

Next speaker, please.

MS. FISHER: My name is Coni Fisher. I am 61 years old. I am a business
development manager for VISX, the company that manufacturers the Excimer
laser for laser eye surgery in California. I have worked in health care
for over 30 years. I am very familiar with surgical complications, the
informed consent process, and the FDA approval process. I have no
financial interest in breast implant manufacturers. And my travel
expenses have not been reimbursed by any related entitles.

I am here because I hope my testimony will change the current choices
for primary breast augmentation material. I feel compelled to speak, as
I know many individuals that are very unhappy with the feel, appearance,
and less than natural result of saline implants and wish they could have
had the same opportunity I had in 1985.

I had silicone breast implants 20 years ago. I have never regretted the
decision. I have never understood why they were taken off the market
with no statistical hard medical information to support the withdrawal.

I was appalled at legal advertisements for class action lawsuits in
ridiculous settlement amounts. The negative media coverage had my own
family urging me to have my implants removed, which I never considered.
And should I need them to be removed and replaced, I would again choose
silicone.

I recall my absolute relief to learn that when silicone was no longer a
choice for primary implants, that should I require surgical removal for
leakage, I could again have silicone.

My decision was cosmetic to restore ample appearance after
breast‑feeding my daughter from the decade before. I chose silicone
because they felt more natural. I can remember actually inspecting all
of the implants. I still remember during my decision‑making process my
mother‑in‑law, who had had a mastectomy and wore a prosthesis ‑‑ and it
was not made of saline ‑‑ how much more natural silicone was. And I\'m
glad I had that choice.

My plastic surgeon fully explained every risk, benefit, potential
possible complication, including the fact that future removal might be
necessary. I would gladly have signed an addendum to my informed consent
that I would not sue for future complications because I feel this is an
elective procedure that I did by choice.

One of my best friends, Nancy Johnson, who just testified before me, we
scheduled our surgeries on the same day. I developed a hematoma from
continued bleeding. I had to go back to the operating room. Minor
complication. After that, I have had no problems whatsoever.

I regret that women today don\'t have the same empowerment of choice and
can only receive saline, which I felt was an inferior product 20 years
ago. I believe American women deserve the same choices as those around
the world and that I had.

I did not send my friends and family to Canada for Lasik surgery before
the FDA approval process, a process that works and that is based on
statistical medical outcomes.

I regret that negative medical outcomes received more attention, and I
hope that the panel hears the silent testimony of the thousands of women
like myself with silicone implants living busy, healthy, and happy
lives.

Thank you so much for allowing me to testify.

MR. SAMP: My name is Richard Samp. I am chief counsel of the Washington
Legal Foundation, a public interest law firm that devotes a significant
portion of its resources to issues affecting health care delivery in
this country.

Among WLF\'s members are doctors and medical patients who seek access to
innovative drugs and medical devices shown to be reasonably safe and
effective for their intended uses. WLF regularly litigates in support of
the public\'s right of access to such products.

Neither I nor WLF has any financial arrangement with either Mentor or
Inamed or anyone else in connection with my testimony. I paid my own
transportation costs in coming here today.

My expertise is as a lawyer who specializes in administrative law
issues. I do not have medical expertise and, therefore, have no basis
for telling you whether silicone gel‑filled breast implants are safe and
effective.

What I can tell you is that basic tenets of administrative law prohibit
FDA from conditioning approval of the pending PMAs on provision of the
vast amount of clinical data contemplated by FDA\'s January 2004 draft
guidance. In particular, federal law does not permit FDA to deny PMAs to
the two applicants based on an alleged need to provide on a preapproval
basis the additional long‑term clinical data outlined in the draft
guidance. Rather, any such long‑term clinical data may be required at
the post‑approval stage only.

WLF reaches that conclusion because any effort to impose greater than
three years of follow‑up clinical data would be inconsistent with the
manner that FDA has treated all similar PMAs. It is an elemental
principle of administrative law that the reason decision‑making mandated
by the Administrative Procedures Act requires federal agencies not to
depart from precedence in a sudden and unexplained way any decision to
impose vastly increased follow‑up clinical data requirements on silicone
breast implants on a preapproval basis would constitute just such an
unwarranted departure from precedence.

WLF has submitted written comments that provide a more complete
explanation of our legal analysis. The PMAs submitted by Mentor and
Inamed included follow‑up data for at least three years
post‑implantation. The study protocols required Inamed and Mentor to
continue to collect follow‑up data for many years to come.

Both PMAs were complete when FDA issued their draft guidance in January
2004. That document focused considerable attention on long‑term clinical
follow‑up for implant recipients. In particular, FDA sought clinical
information regarding: one, how and when a breast implant will suffer
complications over the course of time; and, two, the health consequences
of complications over time, particularly with respect to failure.

The evidence suggests that complete data to answer queries raised by the
draft guidance are not now available and will not be available for at
least another five years.

The health consequences of medical device failures is, of course, a
legitimate safety concern. Nonetheless, such concerns much be examined
in the context of concerns inherent in FDA approval of any PMA.

All implantable products and prostheses eventually fail, whether by
rupture, breakage, or other forms of malfunction. Such failure, whether
it occurs soon after implantation or many years later, in many cases
will entail significant health risks.

However, WLF is unaware of any instance in which FDA has required
preapproval clinical testing of an implantable or prosthesis
specifically designed to demonstrate when the product is likely to fail
due to wear and tear and to measure the health consequences of such
failure. Nor is WLF aware of any instances in which FDA has required
preapproval long‑term clinical follow‑up testing of a duration that even
approaches the number of years it would require here.

In the vast majority of cases of which WLF is aware, FDA required
preapproval clinical data of no more than two years. Those cases
included products with risk‑benefit profiles similar to that for breast
implants, such as inflatable penile prostheses and testicular
prostheses.

An agency is not free to permit two sets of similar products to run down
two separate tracks, one more treacherous than the other, for no
apparent reason. The APA\'s reasoned decision‑making requirement
mandates that FDA not impose clinical data requirements for breast
implants that it has not imposed for similar products.

Moreover, Congress has prescribed the approval standard for medical
devices. A product need not meet an absolute safety requirement. It only
need be reasonably safe.

Thank you very much.

DR. KINNEY: Good afternoon. I am Brian Kinney, M.D., from Los Angeles,
California, a Clinical Assistant Professor of Plastic Surgery at UCLA
and USC Schools of Medicine, a board member of the American Society of
Plastic Surgeons and President‑Elect of the Plastic Surgery Educational
Foundation. I have no consulting or financial ties to any companies\'
breast implant efforts. And the Plastic Surgery Educational Foundation
has paid for my expenses to appear.

Since the panel last met, we have heard from you that surgeons should
decrease reoperation rates and improve physician and patient education.
I would like to present to you what we have done in our first four
courses and what we plan to do in the upcoming year.

From 2001 to 2003, our educational activities have included
instructional panels, lectures on the latest in breast surgery for
reconstruction and augmentation, incorporating the use of silicone gel
implants. The objectives for these various programs are in appendix A.

The overall content of these educational activities has included current
regulatory status of gel implants, the advantages of gel versus saline,
patient selection and consent, preoperative planning, interoperative
technique, management of complications, and comprehensive patient care
issues. The objective has been to provide the knowledge for patients to
reduce the rate of reoperation and operative damage to the implant,
achieve optimal levels of safety, improve post‑surgical outcomes and
patient satisfaction, and support the effective tracking of patients
after surgery.

An initial four‑hour comprehensive course specifically focused on
silicone gel was held in Vancouver in April of 2004. In August 2004, the
Sante Fe Breast Symposium contained programming related to gel implants,
including the regulatory status of silicone, evolution of devices, and
matching patients with appropriate devices. After these courses, the
need for educational balance related to manufacture of data was
obtained.

As part of an ongoing review, the Vancouver, of course, resulted in
recommendations for adding components to ensure that surgeons obtained
the necessary information for the use of gel implants if and when they
return to the mass market.

From our discussions with the FDA, we implemented eight safety and
educational checkpoints: one, addition of reconstruction to the overview
of proper surgical technique; two, addition of FDA terminology in the
agenda to match overall education objectives; three, addition of more
patient‑monitoring information inclusion in the educational objectives;
four, addition of clinical recognition of ruptures and solutions,
including MRI surgical removal, et cetera, and inclusion in educational
objective descriptions; five, increased informed consent information;
six, addition of recommendations for long‑term patient follow‑up; seven,
addition of cancer and tissue disease content; and, eight, addition of
management of complications.

The second course focused on breast surgery was held in Philadelphia in
October 2004 at our annual meeting. This symposium contained limited
programming on gel implants.

A third four‑hour comprehensive course on silicone gel was held during
the annual meeting in October, matching the outline of the comprehensive
Vancouver course, enhanced with updates based on our discussions with
the FDA and a personal visit by a number of us as well.

A fourth focused course will be provided to plastic surgeons in May 2005
in New Orleans. A comprehensive course is planned for August 2005 in
Santa Fe. And a one‑hour panel and a separate four‑hour course are
planned for our annual meeting in September 2005 in Chicago. Derivative
materials from the August and/or September courses, including an
educational DVD, and online learning modules are planned.

In anticipation of possible FDA approval, advance discussions have been
held with industry on joint training. These could consist of additional
programs containing balance procedural related education information
from physician speakers followed by satellite symposium presentations
from manufacturers on techniques related to specific devices and their
use.

We would collaborate on training materials, to include test questions
that could complement training programs for the purposes of
certification. The objective for this collaborative effort would be to
reflect complete and consistent training information throughout
educational activities, implant packaging, and patient education, media,
and materials.

The overall goal of all educational initiatives for us is to meet the
global needs for uses of any device that would be approved on the market
and to ensure efficacy and patient safety.

We are focused on supporting plastic surgeons by providing the most
current educational guidance available related to technology,
peer‑reviewed materials, physician‑to‑physician communications and
research, course objectives, including training on development, better
consultation techniques, and assisting the patient with topics such as
distilling the package inserts, body changes, breast‑feeding, and
returning to activities of daily living. Life educational programs, as
well as distance learning opportunities, provide physicians with the
most current credible scientific information available.

Thank you very much for speaking to you.

CHAIRMAN CHOTI: Thank you.

Next speaker?

DR. McGUIRE: Good afternoon. I\'m Dr. Michael McGuire. I represent the
American Association for the Accreditation of Ambulatory Surgery
Facilities, or AAAASF. I am the immediate past president of AAAASF. They
are paying my expenses for attending today\'s session. I have no
financial interest in Inamed, Mentor, or their competitors.

AAAASF is the largest organization accrediting office space surgery
facilities in the United States. We currently have 1,000 facilities
accredited across the country. We are also recognized as a deeming
agency for federal and Medicare certification. And we have over 30 such
facilities as well.

In our facilities, approximately 1,500 plastic surgeons operate under
all forms of anesthesia. Our standards require that all surgeons using
our facilities must be board‑certified by a board recognized by the
American Board of Medical Specialties. They must perform only those
procedures recognized by their board as part of their training. And they
must hold equivalent hospital privileges for all surgery done in the
facility.

We also require a 100 percent compliance with all of our standards for
accreditation and for our annual reaccreditation. One of our standards
requires semiannual reporting of all complications and mortality in each
facility to our central office.

An internet‑based system has been in use for the past six years of this
mandatory reporting. This allows us to accumulate a wealth of data about
the safety of surgery performed in our facilities. These data were the
basis of a major report that was published in plastic and reconstructive
surgery in May 2004, which documented an incidence of mortality and
complications comparable to that in hospitals for similar procedures.
There was only one death in every 58,810 procedures, or .0017 percent.

Using this data source, we have recently extracted the relative
incidence of mortality and complications related to breast implant
surgery. A review of over 913,000 procedures performed in our facilities
during the period 2001 to 2004 revealed that more than 246,000 of these
included breast implant surgery, in some cases performed with other
procedures.

Analyzing these procedures, we found no operative deaths. There were two
deaths in the postoperative period. Neither was related to the breast
implant surgery. One occurred ten hours after surgery relating to an
acute asthmatic attack. And a second occurred five days after a combined
surgery that included abdominoplasty, or tummy tuck, and lipoplasty.
This mortality was secondary to pulmonary embolism, blood clots to the
lung, which is a known possible complication of abdominoplasty and
lipoplasty, and was not related to the breast implant surgery.

There were 1,730 unanticipated problems in this group, for an incidence
of one per 143 procedures, or 0.7 percent, less than 1 percent. The
majority of these problems were hematomas, blood collections, in 1,059
of the cases. And other complications included wound infections, healing
problems, and 37 cases of pneumothorax, or partial lung collapse.

Treatment of these 1,730 problems required hospitalization in only 142
cases. And all recovered without any long‑term effects.

This analysis demonstrates the great safety of breast implant surgery
done in accredited office‑based ambulatory surgery facilities. There
were no operative deaths and none in the postoperative period that were
related to the breast implant surgery.

More than 244,000 patients, greater than 99 percent, had no
postoperative problems. And none of the problems that were encountered
in the less than one percent of the group that did have a problem
resulted in any long‑term consequences.

Thank you for allowing me to make this presentation.

CHAIRMAN CHOTI: Thank you. We\'ll now take a 15‑minute break. And let\'s
promptly be back here at 20 minutes \'til. Thank you.

(Whereupon, the foregoing matter went off the record at 3:23 p.m. and
went back on the record at 3:45 p.m.)

EXECUTIVE SECRETARY KRAUSE: We are going to go on now. Okay. Dr. Choti?

CHAIRMAN CHOTI: If everyone is ready, let\'s resume with our next
speaker. Good afternoon.

DR. SCHNEIDER‑REDDEN: Good afternoon. My name is Dr. Petra
Schneider‑Redden. I\'m a board‑certified plastic surgeon practicing in
Hattiesburg, Mississippi. I\'m a member of the Board of Directors of the
American Society of Plastic Surgeons. I have no financial ties with any
of the implant manufacturers. I do use implants in my practice. ASPS has
paid my travel.

I am here today to discuss an issue that is so important to many women
who choose breast implant surgery: patient quality of life. For plastic
surgeons, patient safety and satisfaction are primary goals. We believe
that making an informed choice for breast implants offers health‑related
quality of life benefits for numerous women.

Breast implant surgery can have significant psychological benefit when
it cosmetically improves appearance, corrects a loss in breast size
following pregnancy or nursing, or rebuilds breast shape after breast
cancer.

The choice is very personal for women. Each woman must decide if the
benefits of the implants will meet her goals following careful
consideration of the risks and potential complications.

Studies show that overwhelmingly women are happy with their breast
implants for augmentation and reconstruction, even if they have some of
the side effects related to the surgery.

In talking with my patients, many choose silicone implants for an
improved result or a more natural look or feel similar to natural breast
tissue. While this device is primarily available to my reconstructive
patients, there are many other women who would happily choose silicone
if it were available to them.

Simply speaking, I would not recommend this device to my patients if I
did not have full confidence in its safety. One of my disappointments as
a physician has been to tell my patients that the device is not
available to them, especially when I feel it would be the best choice.

Research supports that while patients choose to undergo this surgery for
many reasons, it has a positive effect on quality of life with
particular regard to sex life, body image, and mood.

Credible studies continue to demonstrate positive results regarding
concerns about appearance, stress relative to body image, and
interpersonal relations. Plastic surgeons strongly support the
importance of patients receiving accurate information about the risks
and benefits of this device.

Generally, breast implants, as with any other medical devices, do not
last a lifetime. And many patients will face the possibility of
reoperation. Accurate and thorough information can help my patients deal
with this and the other realities associated with breast implants, which
can, in turn, lead to greater patient satisfaction.

Our specialty has shown a commitment to ongoing research that will
optimize surgical outcomes as well as maximize patients\' long‑term
well‑being. The Plastic Surgery Educational Foundation is funding
research that includes formally developing and validating patient
satisfaction questionnaires for cosmetic and reconstructive breast
surgery patients. These tools will not only help make better patient
satisfaction measures but also provide our specialty with important
measurement tools to support clinical audits and ongoing practice
improvement. This and other studies are detailed in the literature
review submitted by ASPS.

Finally, with many women obtaining significant quality of life benefits,
the availability of silicone implants is an important choice. The
panel\'s decision will impact whether my patients have this choice in
their breast surgery options.

Thank you.

CHAIRMAN CHOTI: Thank you.

Next speaker?

DR. NAHABEDIAN: Good afternoon. My name is Maurice Nahabedian. I am an
Associate Professor of Plastic Surgery and am the current Director of
the Center of Aesthetic and Reconstructive Surgery of the Breast at the
Johns Hopkins Medical Institutions. I have no financial affiliation with
either company, and no company or organization is paying for my travel
expenses.

The purpose for my being here today is to advocate on behalf of my
patients that have or are interested in silicone gel breast implants.
This is based upon a significant body of scientific evidence and upon my
personal experience that silicone gel breast implants are safe and
effective devices that pose no adverse health risks to women who have
them.

Silicone gel breast implants have been extensively studied over the past
15 years and are now the most thoroughly investigated medical device in
medical history.

Over the past ten years, we have followed a path of reproducibility that
has clearly demonstrated that silicone gel breast implants are safe,
effective, and pose no adverse health risk. There is no reason to
suspect that future studies will not arrive at the same conclusions.

Therefore, when determining the fate of silicone gel breast implants, it
is important to rely on the science, which clearly supports the fact
that they are safe and not harmful.

The experience at the Johns Hopkins Hospital is the foundation for my
opinion. In my personal experience that dates back to 1997, 230 women
have had breast reconstruction using either a saline or a silicone gel
implant. Of these, 21 percent have had silicone implants, and 79 percent
have had saline implants.

In both groups, 90 percent of women have retained the original implant
with no adverse health effects. In no woman that had a silicone gel
implant was removal due to rupture. And in no woman with a silicone gel
implant was there a postoperative concern for any connective tissue
disorder.

I would, finally, like to convey that silicone gel implants provide real
benefits and that women should have the right to choose an implant that
will best suit their emotional, psychological, and physical
requirements.

One advantage of silicone gel when compared to saline is that the breast
will maintain a softer and more natural feel because silicone gel more
closely mimics the texture of the natural breast. Another advantage of
the silicone gel implant is there is much less palpable or visible
rippling and wrinkling when compared to the saline. It has been my
observation that silicone gel implants have improved the quality of life
for women who have received them.

To conclude, I would like to state that the scientific evidence is clear
and reproducible, demonstrating that silicone gel breast implants are
safe and effective devices that pose no adverse health risks for women
who have them. It is my hope that following these deliberations, women
will be allowed to make an informed decision regarding which implant to
choose.

Thank you.

CHAIRMAN CHOTI: Thank you.

Next speaker? Good afternoon.

MS. BROWN: Good afternoon. I\'m Zora Brown, founder and Chair of the
Breast Cancer Resource Committee. I founded BCRC after my own personal
battle with breast cancer to be an educational advocacy outreach and
support resource for African American women\'s organizations as well as
for women facing a breast cancer challenge. I have no financial interest
or gain associated with any of the PMA sponsors today, their products,
or their competitors.

My experience with breast cancer has its roots in family history and
began several generations before I was born. Three generations ago, when
my great grandmother was diagnosed with breast cancer, little was known
of this dreaded disease.

In my great‑grandmother\'s generation, breast cancer research was both
limited and lacking in its capacity to identify causes. Mammography had
not yet been discovered. Genetic factors had not been identified. And
the psychological consequences of breast cancer were barely understood.
Women who submitted to surgery were uncertain as to whether or not they
would awaken with or without a breast. Radical mastectomy was virtually
the only treatment option. And the survival rates were negligible.

When it came my grandmother\'s turn to suffer the same affliction, she,
too, lacked the knowledge and the benefits of subsequent medical
advancements to sustain her.

It would be yet another generation when my mother, also challenged with
breast cancer, would face some of the same limitations but who utilized
knowledge of family history and emerging medical advancements to
successfully treat the disease, knowledge that she passed along to her
offspring, knowledge that proved to be invaluable as each of her four
daughters were eventually diagnosed with cancer.

My sister Margaret had bilateral breast cancer at age 27. My sister
Velva when only in her mid 30s was diagnosed with breast cancer. Both
Margaret and Velva subsequently died from the disease. Neither had
breast implants or reconstruction.

My eldest sister Joyce was also diagnosed with breast and ovarian
cancer. She has had silicone gel breast implants for over 20 years. And
at age 68, she cares for my mother, who is now 90 years old.

I was diagnosed with breast cancer over 25 years ago, at age 31. Three
of my 18 adult nieces have also been diagnosed with breast cancer. One
has succumbed to this disease. One of my nieces underwent prophylactic
breast surgery 16 years ago and was reconstructed with implants.

My own story is replicated in the lives of high‑risk families across the
globe, families who every single day quietly and patiently confront the
ravages of breast cancer with far more courage and fortitude than I
could ever muster and with far fewer resources than I have at my own
disposal.

Women face so many challenges when confronting breast cancer. There is a
tremendous sense of loss, loss of confidence, dignity, and in the case
of mastectomy part of one\'s physical essence.

Through both my personal and professional experience, I realize the
importance of trying to preserve those things lost to breast cancer:
energy, control, hair, and breasts. Unfortunately, many breast cancer
patients aren\'t able to preserve all of these elements. Thus, in the
absence of preserving any of these items, a key concern of breast cancer
patients becomes preserving one\'s quality of life.

Part of our role at the Breast Cancer Resource Committee is educating
African American breast cancer survivors about the myriad treatment
options available to help mitigate the impact of these challenges.

It is important that the women be educated about the options available
to enable and inform participation in their treatment decisions. Given
that no treatment option is without risk, silicone breast implants
shouldn\'t be treated any differently than other treatment options
available to breast cancer patients. They should be informed about the
inherent risk just as they would any other options but not be denied the
opportunity to enjoy the quality of life benefits associated with breast
reconstruction.

Not only do breast implants have the function of benefitting those
stricken by breast cancer, but their availability can also benefit women
from high‑risk families and those who test positive for the breast
cancer gene who ought to pursue prophylactic mastectomy to reduce their
risk of getting breast cancer.

While one would hope that women would have better options than
voluntarily choosing mastectomy to avoid getting breast cancer, in the
absence of a true method of prevention, these women should have access
to all of the tools available given medical evidence that they pose no
greater threat to health than existing treatment options, such as
statistics indicating adverse events for implants exceeding those for
radiation and chemotherapy.

BCRC supports making breast implants available to patients given
evidence supporting their safety and recommends that patients be fully
apprised of any risk associated with their use. It is our opinion that
women should be armed with knowledge and empowered to make their own
decisions concerning how best to preserve their quality of life after
the devastation of breast cancer.

Thank you.

CHAIRMAN CHOTI: Thank you.

Next speaker?

DR. GOLDWYN: Mr. Chairman and members of the Committee, my name is
Robert Goldwyn. I served as Editor of the Journal of Plastic and
Reconstructive Surgery for about 25 years, precisely 25 years, from
January 1st, 1980 to January 1st, 2005. I am Clinical Professor of
Surgery at Harvard Medical School. I do not have a financial
relationship with any company, including those involved in these
hearings. My travel expenses, however, were paid by the American Society
of Plastic Surgeons.

Plastic and Reconstructive Surgery is the official peer‑reviewed journal
of the American Society of Plastic Surgeons. It has the goal and the
responsibility of informing readers about all important developments in
every discipline of plastic surgery, including breast, craniofacial,
hand, reconstructive, and cosmetic surgery. Significant papers covering
both clinical and laboratory research are invited for publication. PRS
is the most subscribed scientific publication in plastic surgery with a
circulation of slightly more than 10,000.

It is indexed by the National Library of Medicine, maintains the highest
citation or reference index in plastic surgery. It is published 14 times
a year. In 2004, we published 643 articles in 4,241 pages.

A literature review that was provided to you by Dr. Dale Collins
entitled \"Reviews of Selected Articles on Silicone and Saline
Implants\" summarizes, among others, more than 50 articles on breast
implants which have been published in the journal since 1961.

These articles cover a wide range of topics from surgical technique to
implant durability and other aspects of implants to management of
patients and their quality of life. Every submitted article is evaluated
almost always more than once by at least two, usually three to five,
reviewers and, when indicated, ‑‑ and that is almost always ‑‑ by a
biostatistician.

Relevance and excellence solely and not the nature of the findings
determine acceptance or rejection. I emphasize this point because the
journal holds scientific integrity as its highest and most important
value.

We exist to give clinicians and researchers data to improve patient care
and policy‑makers information to help direct public policy. The duties
of the editor and the editor of the board of Plastic and Reconstructive
Surgery have always extended beyond our obligations to merely authors
and readers but ultimately to patients and their well‑being, to which
all of us in every area of medicine must be unswervingly committed.

Thank you for this opportunity to address you.

CHAIRMAN CHOTI: Thank you.

Next?

DR. NORSIGIAN: Good afternoon. My name is Judy Norsigian. I am the
Executive Director of Our Bodies, Ourselves, also known as the Boston
Women\'s Health Book Collective, a nonprofit public interest, women\'s
health, education, and advocacy organization. For 35 years, we have
advocated for women\'s health from an evidence‑based and consumer
perspective, most notably through our major publication, Our Bodies,
Ourselves. We have no financial ties to either of the manufacturers or
their competitors.

Our organization\'s interest in breast implants goes back to the mid
1980s, when the late Esther Rome, my coworker, began to work with
hundreds of women, both locally and nationally, who believed that breast
implants caused some serious problems. Many of these women were
initially happy with their implants but later developed debilitating
conditions after five or ten years or more. Even today, many women
continue to have problems with more recent models. And we still do not
have adequate data that would allow women to make informed choices about
using these devices.

As we and others have said before, we do want choices, but we want safe
choices. Since the October 2003 panel that addressed the safety of
silicone gel implants, studies in mammography and platinum suggest new
challenges for women with silicone gel implants.

A study published in the January 2004 JAMA issue found that breast
implants interfere with mammography, missing 55 percent of breast
cancers in women with breast implants, compared to 33 percent in women
without implants. This fact alone provides a compelling reason for the
FDA to weigh carefully the risk‑benefit issues regarding these products.

Silicone breast implants have also been found to contain platinum. A
study published in the July 2004 issue of Analytical and Bioanalytical
Chemistry found very high levels of platinum in silicone gel as well as
the encasing materials, implant elastomer, double lumen, and foam,
materials that are in direct contact with the chest wall of patients.

Much media coverage has suggested that there are many studies showing
that breast implants are safe, but the largest, best designed studies do
show increased risks. Even the Breiting, et al., study of Danish women
noted substantial problems that call for further research. When read
carefully, this study is anything but a stamp of approval for silicone
breast implants.

Scientists at the FDA and NIH are among those who have called for more
research to answer many of the key questions that have been raised
repeatedly at FDA hearings. You should be joining them.

All assertions to the contrary, we simply do not have adequate data on
such conditions as fibromyalgia. Our recent experiences with premature
drug and device approval underscore how critical it is to take a
cautious approach.

Although saline implants are less ideal for many women, they do provide
a reasonable alternative while we await the findings of further
research. And such research must include women with implants for a
minimum of ten years, not an average of ten years.

Women\'s health and lives depend upon a careful assessment of these
devices. We urge the panel to require adequate safety data to be
collected before any decision to approve their use, especially in light
of industry\'s current marketing strategy of targeting younger women,
whose long‑term health status may depend upon your recommendation.

Thank you very much.

MS. HOWE: You\'ve got two Massachusetts people together here. Thank you
for this opportunity to testify. My name is Genevieve Howe, and I am a
member of the board of Massachusetts Breast Cancer Coalition.

The coalition defines breast cancer as a political issue and challenges
all obstacles to eradication of the disease. All board members are
volunteers for the coalition, and it does not accept financial or any
kind of support from pharmaceutical companies or any sources that profit
from cancer or contribute to environmental pollution. I have no
financial conflict of interest in this issue.

Although reconstruction after mastectomy represents only about 20
percent of breast implant surgeries, the devices play a significant role
in the lives of the 215,000 women diagnosed with breast cancer each
year.

I would like to address three concerns about silicone gel‑filled breast
implants: one, health risks due to lower sensitivity of screening
mammography; two, the very high rate of resurgeries and other
complications, especially in reconstruction patients; and, three, the
reluctance of organized plastic surgery and breast implant manufacturers
to accurately inform women about the nature and magnitude of the risks
involved in reconstruction with silicone implants.

Researchers generally agree that augmentation implants significantly
reduce the ability of radiologists to analyze breast tissue in
mammography, even when using special techniques.

Two sound studies, Miglioretti, et al.; and Brinton, et al., found that
women with implants who were later diagnosed with breast tumors did not
present with higher stage cancers. However, as Brinton accurately points
out, there are major differences between women who undergo breast
augmentation and those who don\'t.

Women who choose augmentation tend to be younger, to have a smaller
breast size, and less glandular tissue mass, and to have their first
child at a younger age than the adult female population as a whole. Each
of these factors associated with lower breast cancer risk, particularly
younger age.

In my written testimony, I have included a statement on conflicts of
interest by researchers making the improbable claim that silicone breast
implants can lower women\'s risk of developing breast cancer.

In their own data, both Inamed and Mentor find very high rates of
moderate, severe, or very severe complications within three years. These
complications are much more frequent in reconstruction patients than
augmentation patients.

Inamed reports one or more resurgeries in 21 percent of augmentation
patients and 39 percent of post‑mastectomy patients. That seems very
high to me. Four out of ten have one or more repeat surgeries within
three years.

Mentor\'s application shows resurgeries within 3 years on 15 percent of
augmentation patients and on 26 percent of post‑mastectomy patients.
Other local complications are also frequent. And many patients have more
than one type of complication. Inamed lists 21 types of moderate,
severe, or very severe complications, 6 of which were each experienced
by 20 percent or more of reconstruction patients.

In both of the pending applications, the manufacturers tend to minimize
the risks in patient information. For example, Inamed projects rupture
risk as linear without acknowledging deterioration in device materials
over time. And the company underestimates the decline in MRI sensitivity
and specificity. Mentor\'s glowing measures of satisfaction include
fewer than half of their original 251 reconstruction patients.

Organized plastic surgery has opened up a new dot‑org Web site,
breastcancersafety.org, claiming we place patient safety above all else.
The site\'s overview page links to a letter sent to this panel by 12
breast cancer advocacy groups, at least several of which have received
contributions from plastic surgery organizations and/or breast implant
manufacturers.

Given the plethora of biased information and research and the lack of
long‑term prospective studies, it is difficult to imagine women being
able to make truly informed decisions on silicone implants.

Judith Brady is a 67‑year‑old cancer activist in San Francisco. Both of
her breasts were reconstructed with silicone implants following a double
mastectomy nearly 25 years ago. She has been living with these implants
ever since and considers them to be \"a ticking time bomb,\" to quote
her, in her body.

When I asked her what advice she would offer to women considering
silicone implants, she said that, as far as reconstruction goes,
\"choose a plastic surgeon with great care.\"

As for women considering breast augmentation, she said, \"That I think
should be clearly avoided. In fact, I think doctors who do this surgery
should be strung up.\" That is not a response we advocate, but my point
is that our male‑dominated culture too often pressures women to risk
pain, suffering, and great expense simply to fit in.

We urge the FDA to deny the pending applications for widespread use of
silicone implants. We fear that a lack of caution by FDA in this matter
could lead to further unnecessary pain and suffering on the part of
women and additional years of costly litigation.

Thank you very much.

CHAIRMAN CHOTI: Thank you.

Next speaker?

DR. SATEL: Hi. My name is Sally Satel. I am a former research
psychiatrist, and now I am a scholar at the American Enterprise
Institute at a staff psychiatrist at a local clinic, both in Washington,
D.C. I have no conflict of interest regarding silicone breast implants.

I am speaking here today to contribute to the effort to keep the facts
separate from the hype and the emotion that distort this issue. The
facts, as I will cite very briefly, strongly suggest there is adequate
safety and that well‑informed consumers should be given the opportunity
to decide for themselves about this cosmetic option.

Before moving to data, which, of course, will summarize very briefly,
one has to wonder where the statements from the AMA, the American
College of Rheumatology, the American Cancer Society ‑‑ if silicone
implants were dangerous, I would think they would be speaking out and
presumably they would be present to dissuade approval if objective
aggregate data did not tell a different, less alarmist story than the
ones presented by individuals, who are focused today, understandably, on
their own poor health.

One of the major issues that you are considering now I understand is
whether leaked silicone is harmful. Clearly, no device lasts forever.
That is true. And early versions of the implants, the ones that have
been around since the \'70s, did rupture regularly at rates of between
50 and perhaps 80 percent after 15 years. But even then, generally the
silicone did not migrate past the fibrous capsule that normally forms
around the implant.

There are two key studies that have appeared over the last two years
that I think inform this issue in a profound way. The first appeared
last July in the Journal of Plastic and Reconstructive Surgery. I\'m
sure you\'re familiar with it. It was the first and only, to my
knowledge, published study to track over time women, individual women,
whose implants had ruptured, as detected by MRI.

These women had had their implants for a minimum of 12 years on average.
And the idea, of course, was to assess potential damage two years later.
This was a study in Danish women. After monitoring the 64 women who had
at least one ruptured implant, authors found no change in immunological
markers, indicators, of course, of connective tissue disease.

But most striking, in three‑quarters of the implants in those 64 women,
the rupture was contained within the fibrous capsule, and most of the
women did not even know the device had torn. In only four percent of
ruptured implants did a small amount of silicone leak.

The second important study was from 2003 in the Archives of Surgery.
This was the only study, again to my knowledge, that looked over time at
rupture incidence rates, as opposed to being a cross‑sectional study.
And the indication was that perhaps 20 percent of modern implants ‑‑
that\'s third and fourth generation devices ‑‑ ruptured within 10 years
of cosmetic augmentation. The FDA calculation of 93 percent rupture that
was discussed in the New York Times last week was based on a modeling
equation, but why is modeling when there is empirical evidence?

As you know, several respected entities have concluded no greater
incidence of connective tissue disease in women with ruptured implants
than those without implants, referring to the IOM report, the U.K.
review panel on silicone implants ‑‑

CHAIRMAN CHOTI: If you could sum up for us, please?

DR. SATEL: Okay. Basically if 50 percent of second generation implants
rupture ‑‑ and clearly many of those women were included in those
studies that I had just mentioned ‑‑ with some level of silicone
escaping into the tissues, we would expect a disproportionate prevalence
of CTD.

In summary, I believe the data about rupture rate and well‑replicated
inability to find a link ‑‑

CHAIRMAN CHOTI: I\'m sorry?

DR. SATEL: ‑‑ suggests an acceptable risk for informed consumers.

Thank you.

CHAIRMAN CHOTI: Thank you. Sorry. Please, speakers, if you could try to
keep to your time, that way we won\'t cut you off. I apologize.

Next speaker? Yes?

MS. BRADSHAW: Thank you. Good afternoon, ladies and gentlemen. My name
is Gina Bradshaw. And I would like to thank the panel in advance for
this opportunity to speak with you today of my experience with silicone
breast implants.

I am a 31‑year‑old woman who currently has silicone‑filled breast
implants. I would like to note that I am receiving no compensation from
any individual or group, monetarily or otherwise, in exchange for my
testimony today. ASPS has covered my travel expenses. I do not have any
financial interest in Inamed, Mentor, or their competitors.

A few years ago I felt the need to become healthier as I had become
tired of being overweight and ashamed of my body. Through a combination
of diet and exercise, I was able to achieve losing over 65 pounds.

After having lost that considerable amount of weight, I looked and felt
much better about myself and more comfortable in my own body. I could
wear clothes that I could never wear before when I was overweight. My
children were proud to show me off when I dropped them off at school
functions. And my husband appreciated my new figure.

However, the one part of my body that did not look better after the
weight loss was my breasts. The weight loss had also entailed losing a
lot of my breast tissue. And I was left with two empty sacs. Even with
my new slender figure, I was unable to wear some of the clothes I wanted
to because my sagging breasts did not look good in them. Despite all
efforts at improving my body image, I was left with feeling as though I
should do something about my breasts.

About three years ago, I began researching the available options to me.
After having compiled all of the information, I discussed the choices
with both the plastic surgeon and my husband and decided to undergo
plastic surgery for a breast lift with augmentation.

I was able to qualify for silicone implants because I was also having a
lift, breast lift, in addition to the augmentation. We decided that the
silicone implants had a softer, more natural feel and look than saline
implants.

I have had my implants for over three years, and I have experienced no
problems with them. And I am in very good health. They look and they
feel great. Although my husband and I have been together for many years
prior to my surgery, he even sometimes has a hard time remembering that
I have implants and that my breasts aren\'t natural.

I am proud of my body, and I have worked hard to make it look its best.
I eat right. I work out regularly. And I have had a breast lift and
implants so my breasts would look and feel as good as the rest of my
body did. I feel very strongly that women in America should be able to
make the same choice I did.

Women should be trusted to make informed decisions about their own
bodies. They should be able to meet with their doctors and obtain all of
the information about the risks and benefits of the procedures. And then
they should be able to make the decision that is right for their body
and their lifestyle.

Some years ago when I made the choice to live a healthier life, to get
into shape, and to eat well so that I could play with my kids and take
an active role in their lives, I also made a choice when I decided to
get these silicone breast implants. I decided that I wanted to be proud
of my entire body.

I know this was the right decision for me and my family. Whenever
somebody asks me about my experience, I let him or her know how happy I
am with my new breasts. I just hope that women in circumstances similar
to mine will have the same opportunity that I did to make a personal
decision based on all of the current available scientific information as
to which is right for them.

I sincerely appreciate your time and your opportunity to share my
experience with you today. Thank you.

CHAIRMAN CHOTI: Thank you.

MS. JAMES: Good afternoon. My name is Diane James. And I am here today
on behalf of the Jacobs Institute of Women\'s Health. We are not
supported by anyone with a financial interest in this matter.

The Jacobs mission is to promote excellence in women\'s health by
studying the interaction of medical and social systems, facilitating
informed dialogue and awareness among consumer and health providers and
promoting problem resolution and information dissemination of key
issues. It is from this perspective that the questions surrounding
availability of silicone breast implants are important to the institute.

The regulation history of breast implants is long and complex. Following
decisions made in the 1990s, use of silicone gel implants has only been
permitted among women who have been part of adjunct studies. The
limitation on use of these implants has been the result of numerous
unanswered questions; in particular, questions regarding long‑term
safety. These questions mandate carefully executed studies to acquire
the data needed for approval.

Now in 2005, this distinguished panel has been assembled to determine
once again whether questions related to the safety and effectiveness of
silicone gel implants from Inamed and Mentor have been adequately
investigated and if the accumulated data answer the safety questions
sufficiently.

The panel must determine whether the current data available for review
are sufficient to provide practicing physicians with the information
they need in order to recommend these breast implants and have
confidence that their use will not cause harm to their patients.

Physicians and other health care providers must know that the benefits
far outweigh the risks for an elective procedure requested by women who
often are young and in good physical health. The data must also be
sufficient to provide women contemplating breast implants with the
information they need in order to make a truly informed decision.

What are the key questions for which a physician must have answers?
These have been outlined in the guidance document issued by FDA on
January 13th, 2004. But clearly of prime importance is the question
regarding complication rates. Has the longstanding issue of implant
rupture during the lifetime of these devices been adequately addressed
in the core study?

Preliminary estimates from reviewers released to the public late last
week suggest that the rate of rupture of silicone implants within 10
years for women having reconstructive surgery may be as high as 93
percent. Among women undergoing breast implant surgery for other
cosmetic reasons, the rate may be as high as 74 percent.

This ten‑year estimate obviously includes women whose implants will
rupture long before ten years and raises questions about appropriate
ongoing surveillance and diagnostic testing that will be required at
regular intervals.

It also raises questions about who will pay for this surveillance. What
percentage of women will be able to afford appropriate diagnostic tests
and even further surgeries should health care coverage be unavailable
for what is generally categorized as an elective cosmetic procedure.

Imbedded in this critical safety issue is the persistent question of
what happens to the silicone when the silicone implants from Inamed and
Mentor rupture. Are there adverse health effects from the ruptures,
either local or systemic?

While an IOM committee in 1999 determined that there was little evidence
that silicone implants caused connective tissue disease, we must keep in
mind that this conclusion was based largely on retrospective data from
the nurses\' health study and from a case‑controlled database from the
Mayo Clinic.

Because of the study limitations related to the size and types of
studies used, the true risk of these conditions cannot be precisely
estimated. There may still be a small but significant increased risk of
some forms of connective tissue disease associated with the silicone
implants under review.

From the patient\'s perspective, it will be vital for physicians to have
these answers in order to openly and honestly discuss the risks and
benefits of this procedure.

Women must be informed regarding the expected incidence of rupture and
what rupture may mean in terms of the need for repeat surgeries. They
need to know about the process for removing gel‑filled implants
following rupture, discomfort they may experience, and the potential
long‑term health consequences should silicone gel leak. Women must also
have this information presented to them in a clear and concise fashion
that is part of the informed consent process itself.

The Jacobs Institute is concerned about the existing process and urges
the Committee to consider this in their deliberations. These concerns
arise from examining current saline breast implant patient brochures
provided by industry.

Subjected to a Fry analysis used by reading experts and those committed
to following clear health communication principles, as advocated by the
Surgeon General and the DHHS, this written information cannot be easily
understood by the majority of audiences in the United States.

According to the Fry analysis, the 42‑page brochure reviewed is clearly
written for college‑level individuals. This means women who are not able
to read health information at the college level will not be able to
fully comprehend the information provided.

We urge the Committee and the FDA to be certain that educational
materials describing risks and benefits are written at a level that most
women will understand.

In closing, we urge you, the Committee, to consider carefully the safety
and effectiveness requirement that Congress has mandated to the FDA in
determining whether devices should be permitted on the market.

Thank you for this opportunity.

MS. McDONOUGH: Good afternoon. My name is Mary McDonough. I am an
actress, a mom, and a founder of In the Know, a supportive and caring
community created by women in the entertainment industry to share
information about health, body image, and plastic surgery. I have no
conflicts.

Several of the plastic surgeons here today testifying have attempted to
differentiate between the older generation and the new third generation
of breast implants. It\'s important to point out to you that the new,
\"new,\" generation implants start in 1981. In October of 2003, Inamed
stated that there had been no changes in this product since 1991. Mentor
stated in their PMA that they have not changed their product since 1987.
So we\'re talking about a product that has virtually gone unchanged for
25 years.

I was only 23 when I got my silicone gel breast implants. Because after
my years of playing Erin on \"The Waltons,\" I really wanted to continue
my acting career, it was suggested to me that if I had larger breasts,
that might do the trick.

Within 24 hours of my implant surgery, I broke out in a rash. Then for
the first couple of years, my implants seemed like they were okay. Then
by year seven, I got more and more symptoms that have led to a diagnosis
of lupus.

Over the course of those ten years, I became more ill. And I felt like I
was dying. When I asked my doctor about removing the implants, he told
me that I would probably become too depressed. He also said that there
was no link between the implants and everything that I had.

Another plastic surgeon told me, \"Well, your breasts look and feel
great. You know, I wouldn\'t touch them, at least not with a knife.\"

I had a mammogram at 31 to see if my implants were ruptured, but the
mammogram came out clear. And then I had a breast MRI because it was
supposed to be more conclusive. And, according to the MRI, the implants
had not ruptured.

Inamed has said that if its PMA is approved, they will recommend an MRI
every one or two years to monitor the rupture, but no one tells you what
the physical experience of that MRI is like. It\'s long, and it\'s
uncomfortable. Basically you lie face down in a dark enclosed tube with
your breasts in these holes. And if you\'re in pain, like I was, it\'s
even worse.

The other thing that Inamed doesn\'t mention is that MRIs are very
expensive; on an average, \$1,890 according to Blue Cross. That\'s
\$1,890 of your own money because they are not covered by insurance.
Most women can\'t afford one MRI, let alone one every year or two.

Now, while Inamed has recommended the MRI, I don\'t see a plan that is
set up or fund to pay for these MRIs. Also, not all MRIs or facilities
are equipped to conduct the necessary procedures.

In clinical trials, the industry has been using very specific centers
with experienced radiologists. And even those centers don\'t always
detect rupture. And many women don\'t even find out they have a rupture
until their implants are removed.

The industry\'s own data shows a high false positive rate for rupture
detection through MRI. In the past, we have heard a 95 percent accuracy
rate with MRI. Yet, according to Inamed\'s core study, more than a third
of MRIs, 36 percent, falsely detect rupture. And such high rupture rates
and false positives of those high rates create unnecessary anxiety for
women and potentially unnecessary surgery.

In my experience, despite the fact that my MRI did not detect that my
implants had ruptured, I still decided to have them out. But when they
were removed, both of my implants were ruptured. And the outer shell had
completely disintegrated. And now, while I still suffer from lupus, the
farther I get away from my implant surgery, the better I feel.

I am not the only one with this experience. Other members of In the Know
have had similar MRI experiences where a rupture was present but not
detected.

MRIs are unreliable, expensive, and unpleasant. Inamed\'s recommendation
for yearly MRIs is both unrealistic and disingenuous for the women who
actually have to go through them.

Thank you very much for listening and for your time tonight. Thank you.

MS. NOONAN‑SARACENI: Hello. My name is Pamela Noonan‑Saraceni. I have no
conflicts of interest.

On July 5th of this year, I will be celebrating my 27th year as a breast
cancer survivor. However, I continue to live with the ramifications of
silicone gel implants.

In 1978, when I was only 25 years old, I was diagnosed with breast
cancer and had a modified radical mastectomy. I waited five years before
I decided to have silicone implant reconstructive surgery. I led an
active lifestyle, and I played tennis, jogged, and I taught aerobics.
And I had grown tired of the inconvenience and embarrassment caused by
my external prosthesis shifting and falling out of my bra.

I am a well‑educated woman. And I thought I had done my homework on
breast implants prior to my reconstructive surgery, but I was never
advised of any health risks associated with silicone breast implants or
the fact that there was a chance for additional surgeries. In fact, I
was told they would last a lifetime and complications were few, if ever.

Within three months of my initial reconstructive surgery, I was back on
the operating table. My body has formed a capsule around my implant, and
it had moved up to my collarbone.

The searing pain at the time caused my shoulder to freeze and become
immobile. The surgery seemed to help, but symptoms of physical illness
began to develop after that. At first, I attributed the fatigue, muscle
aches, and pain to just getting older. However, I was only 36 years old
at that time.

Before I had the implant permanently removed in 1994, ten years after my
initial reconstruction, I had to again wear a partial prosthesis.
Capsular contracture had again become a problem. And my breasts had
become lopsided and misshapen. The explanation was the fifth surgery at
my breast site.

I know that almost half of breast cancer patients with implants will
need one additional surgery due to serious problems that occur within
three years. And that is from Mentor\'s own data.

To date, my out‑of‑pocket medical expenses are approaching \$50,000. My
husband and I are self‑insured. And the insurance policy that we took
out carries an exclusion that I would not be covered for any illness or
disability related to my reconstructive surgery. The insurance company
understands that there are health risks associated with the breast
implants, and they are not willing to bear the financial cost.

Apparently the government also knows this. Last year the Department of
Health and Human Services settled with silicone breast implant companies
to recuperate the cost of caring for women made ill by silicone breast
implants. How can the FDA even consider approving these devices while at
the same time a sister agency sought financial compensation for harm
that they caused hundred of thousands of women?

Please do not recommend approval of this product until the companies
provide the long‑term data needed to prove their safety. Women across
America are counting on you, the FDA, to protect them.

Thank you.

CHAIRMAN CHOTI: Thank you.

Next speaker?

MS. RAMSPOTT: My name is Kathy Ramspott. Thank you for giving me the
opportunity to speak before this Committee. I would like to publicly
state that Inamed has provided the transportation and accommodations for
me so that I may address you today.

I would like to share my personal experience with the McGhan
silicone‑filled breast implant. I am a two and a half‑year breast cancer
survivor. When originally diagnosed, I sought the advice of a general
surgeon and asked him to recommend a plastic surgeon.

It was the plastic surgeon\'s recommendation to do reconstruction at the
time of the mastectomy. That was agreed upon. And after receiving my
five months of chemotherapy, the expander, which was inserted at the
time of the mastectomy, was removed and a saline implant inserted, my
first mistake.

I did not do my homework and just assumed that saline was my only
choice. Shame on me. I soon learned that the patient has to be their own
advocate and must do their research. Yet, when given a diagnosis of
cancer, your mind is not functioning in a normal manner.

Several months passed. I was acutely aware that the saline implant was
not what I was hoping it would be, extremely unnatural and unmovable. I
discussed this with my plastic surgeon and was asked to give this a full
year before making any decisions. I was told that sometimes it takes
that long for things to settle in.

I agreed to do this, even though I was not happy and not comfortable. I
also asked why I had not been told that I could have had a silicone
implant, and that should have been my choice. I was told that the saline
was the safest.

Due to other misunderstandings, I sought the consultation of two other
plastic surgeons: one at the same facility as the original plastic
surgeon and another at a completely different campus.

After meeting with Dr. Patricia McGuire of Parkcrest Plastic Surgery in
St. Louis, I realized I should have seen her initially. She explained in
great depth to my husband and me that she felt I was a good candidate
for the McGhan implant. She showed the actual implant to me and told me
to give it consideration. She also gave me the alternative implant
information.

I read the literature and decided that the McGhan implant was the
direction I wanted to follow. Last September, Dr. McGuire began my
reconstruction, and I have not regretted a moment since.

I realize this is not a subject that is discussed casually at a dinner
party, but when you are the unsuspecting patient facing this dilemma, it
is uppermost in your mind, not only your mind but your impaired body.

I have come to the conclusion that the most important aspect of this
conflict is that a woman has to be given all of the information that is
available so that she can make a choice. My first and foremost interest
regarding this hearing is that a woman has to be given her right to a
choice. This particular implant needs specific training for the surgeons
who will use it in their patients.

Yes, as a cancer patient, it is uppermost in my mind. This implant
should be available to the survivors. But there are other women out
there that need this implant for various other reasons.

If you were to look at photos of women that have breast imperfections
due to genetics, cancer, et cetera, you would understand.

CHAIRMAN CHOTI: If you could wrap up, please? Thank you.

MS. RAMSPOTT: Okay. In this age of body image, we continue to look at a
woman and question what is her bra size. As I stated above, this is
about choice.

I hope that sharing this information with the members of the Committee,
it will be of some help to you and other women faced with this dilemma.

Thank you again for letting me express my point of view.

DR. TAYLOR: Hello. My name is Anne Taylor. And I am here to provide the
panel my unique perspective on silicone gel breast implants.

I speak to you as a plastic surgeon who has placed more than 100 of
these devices, but my experience is not only as a surgeon. I am also a
patient. I have had both the saline and silicone gel devices. The ASPS
has paid my travel expenses today.

I first had saline implants placed about five years ago after the birth
of my first child, to address a loss in breast volume and ptosis. I
experienced the usual range of irritating problems with the saline
implants, including palpability, rippling, and thinning of tissue. These
were not medical issues. I was simply not happy with the way the saline
implants behaved. My patients have also complained about these problems
with heaviness, rippling, and unnatural feel of the saline implants.

Two years ago, in \'03, I opted to have my saline implants replaced with
silicone gel implants. And the difference is night and day.

I often use the analogy of cars to explain the difference between these
two types of implants. Both a Ford Taurus and a Mercedes will get you
from point A to point B, but we all understand the difference between
these two rides.

The gel implants are the Mercedes of the implants. They work better in
almost every way. There\'s no problem with rippling. There\'s no problem
with unnatural feel. They\'re softer, lighter, and more life‑like. The
breasts feel and move naturally. You can even lay on your stomach with
them. It\'s hard to describe the difference to someone who has not
experienced both, but I can tell you it\'s night and day.

In my practice, since 2002, I have participated in both the major
manufacturers\' studies, though I focus mainly on the Inamed device. I
have used them after mastectomy for reconstruction and for those with
congenital anomalies and also in patients, like myself, who have had
difficulties with their saline devices.

The patients are unanimous in their description of the gels. They\'re
softer, comfortable, and better. Because of the well‑publicized history
of the gel devices, most patients have some worries related to their
use, but when presented with the literature, including the NIH study,
they opt for the silicone gel implant. And my own personal history
certainly gives them peace of mind in this regard.

I have studied the science thoroughly. And it says these devices are
safe. Science should rule stronger than emotions. I am convinced of this
so strongly that I not only recommend them to my patients but I have
them in my own body.

There are issues with silicone implants, as with saline. I explain this
to my patients, that they can rupture and when they do, they have to be
replaced. Unlike saline implants, you might not know when the rupture
occurs. So I encourage them to have regular mammograms.

I have not noticed any difference in frequency of complications between
the devices. What I have noticed is the silicone gel implants accomplish
the goal of the device better. The science says they are safe. And my
experience is they are the superior device in every way.

Thank you.

CHAIRMAN CHOTI: Thank you.

Next speaker?

MS. HARRISON: Hi. My name is Jan Harrison, and I have no connections
with Mentor or Inamed at all.

I support bringing the silicone implants back on the market so that
women can have that option. To not have silicone implants on the market
is discriminatory to women who want them. I feel that silicone implants
feel and look more natural.

I chose to have breast augmentation in 1979. I had silicone put in on
top of the muscle. I never once had any regrets or problems with my
augmentation. I like the look and the feel of the silicone implants.

In 1991, I was involved in a water skiing accident, injuring my ribs and
my chest muscles. I had a mammogram done in 1993 that showed a possible
leakage. I was followed up six months later. Again it was confirmed that
the implant was ruptured. I never once had any signs of disease or any
medical conditions. The appearance of my breasts never changed, and I
continue to have my mammograms.

In December of 1995, approximately four years later, I decided to have
my implants exchanged with the advice of my physicians, Dr. Robert F.
Jackson. Dr. Jackson did my original augmentation.

In removing my implant, it was found that the right implant was ruptured
and I had some capsule formation. At that time, they were replaced with
saline because the silicones were not available.

With the saline implants, I developed severe wrinkling on both sides. It
was nothing you could see, but you could definitely feel the wrinkling,
and so could my husband. It was very bothersome to me. I did not like
the feel nor the appearance of the saline.

In 2004, I noticed that one side was considerably smaller than the
other. Dr. Jackson confirmed that the saline implant had ruptured. This
was nine years later.

On March 28th of 2004, I underwent replacement of my saline implants. At
that time, I requested that the silicone implants be put back in. I feel
that silicone implants look and feel more natural than the saline. I
feel silicone implants are more durable and more appealing to the eye.

It has been proven in literature as well as my own experience that
silicone implants cause no medical or health problems. I went several
years with my ruptured implants and had no ill effects. Not once did I
lose the size or shape of my breasts with silicone. I, however, did have
wrinkling and loss of size with my ruptured implant.

I also work for a surgeon who placed many silicone implants prior to
1990. None of those patients have had any health problems, to our
knowledge.

As a private citizen and a woman, I feel not to allow us to make our own
decisions and choices with our physician is discriminatory. The
self‑esteem achieved in the desire to better our appearance should be
our decision. I feel silicone is preferable and safe.

Thank you.

CHAIRMAN CHOTI: Thank you.

Please, next speaker, step up to the podium. Yes? Good afternoon.

MS. SCOTT: Good afternoon. My name is Shannon Scott. I have no conflict
of interest.

In 2002, I received silicone gel implants through Mentor\'s adjunct
study. To be in the study, a patient must have a deformity, have had a
mastectomy, or a problem with implants that need to be replaced. The
goal of the study is to evaluate short‑term complications. I wanted
implants for augmentation. Dr. Dennis Gaukin of San Diego stated that I
was eligible for reconstructive surgery in the adjunct study, even
though my only deformity was a nearly invisible blemish on my left
breast.

I was in perfect health prior to augmentation. Three months after I
began developing pain within my breasts, the implants started to harden.
A plastic surgeon performed a procedure in which he squeezed them to
break up the scar tissue.

In January of 2005, I was told by Mentor\'s patient service
representative that closed capsulotomies are not to be performed. This
procedure can cause the implants to rupture.

Dr. Gaukin is still a part of the adjunct study. He has refused to
provide me with any future medical care. I was told that I would receive
monitoring and medical treatment as needed through the adjunct study for
the next five years. This has not happened.

Since the implants, I have had muscle, joint aches, severe chest pain,
limited range of muscle motion, migraines, rashes, swollen lymph nodes,
fatigue, sensitivity to light, and considerable memory loss.

I am now bedridden approximately 95 percent of the time. And due to the
pain, I need assistance in even the most minor aspects of my life, such
as brushing my hair or even getting dressed. I cannot afford the
thousands of dollars it will take to have my implants removed.

This study is supposed to be monitored by the FDA. I did not receive
informed consent. The doctor did a forbidden procedure that could have
ruptured my implants, and now I can\'t afford to get them taken out.

I question how the FDA can allow this to happen to women. Dr. Gaukin\'s
medical records in my case are incomplete and inaccurate. If Mentor is
not provided data, such as in my case, you can assume that the clinical
trial study data is also incomplete and inaccurate.

How many cases like mine occur? How many people are too ill or have been
misdiagnosed or ended up committing suicide? Is the statistical data in
these studies?

It is my hope to prevent other young women, young healthy women, from
experiencing this nightmare. Thank you for your time.

CHAIRMAN CHOTI: Thank you.

Please, next speaker?

MS. JOHNSON: Good afternoon. My name is Marie Johnson. I am here on my
own behalf, and I have no conflict of interest.

After having and nursing two children, I was dissatisfied with the size
and appearance of my breasts. I am a very self‑confident, educated, and
successful person. And I want to look the best I can possibly look. And
so I decided on undergoing breast augmentation.

I discussed my options with my doctor and agreed that the most
natural‑looking and feeling implants would be silicone. And that\'s why
I agreed to be a part of the study. I believe it\'s a ten‑year study.

I\'m extremely satisfied with the outcome and have not had a single
problem in the over four years that I have had them. In addition, by
participating in the study, I am given the opportunity to have an annual
MRI on my breasts that are at no cost to me. I continue to also have my
mammograms, as suggested by my ob/gyn, and have had not any problems
with this test as a result of my implants.

I do not fully understand why silicone implants are still not permitted
for use without restrictions. Like many medical and/or elective
procedures, the risks are known and can be communicated to and
understood by potential patients.

Furthermore, to me it seems inconsistent that it\'s legal to smoke
cigarettes and consume alcohol, despite the known risks and devastating
consequences. However, Americans are given the choice knowing the risks.
It is unclear to me why the same choices are not available to patients
seeking this procedure.

I think it is time to put politics and hidden motives aside and
reevaluate the validity behind the ban on silicone breast implants. I
urge you to remove the ban on silicone breast implants and let women
make informed decisions about their bodies the same way millions of
people do every day with countless other devices, medicines, and legal
substances that are approved.

Thank you for your time.

CHAIRMAN CHOTI: Thank you.

Next speaker? Good afternoon.

DR. HYANS: Good afternoon. Mr. Chairman, members of the Committee, I am
Dr. Peter Hyans. I have been in practice as a board‑certified
reconstructive breast surgeon for the past 12 years. I do not have a
financial relationship with any company involved in these hearings. My
travel expenses were paid by ASPS.

Previous speakers have already presented their data and statistics.
However, I would like to talk about the women affected by your
decisions.

Lisa is a 32‑year‑old woman, mother of 2 children, recently diagnosed
with breast cancer. Mary is a 60‑year‑old woman, married for 40 years,
facing mastectomy. Karen is a 20‑year‑old woman born with a genital
deformity that left her with only one developed breast.

Although their histories may be different, all these women have in
common the difficult decisions facing them regarding their treatment.
Thoughts about surgery, chemotherapy, and possible radiation are
weighing on their minds.

Advancements in breast reconstruction have allowed these women and the
millions like them to feel good about themselves and their feminine
appearance following body‑altering surgery.

Fortunately, today there are many options available to women in their
situation. However, if a woman chooses to have reconstruction with a
permanent prosthesis that is not considered investigational, they have
been restricted to saline implants.

The most common comment that I hear from patients reconstructed with
saline implants is, \"These implants look and feel like implants, not my
own breasts.\" Often these implants are hard and firm. Often wrinkling
increases are visible. Many of my patients claim they are uncomfortable
and it limits them in terms of their physical activity.

Silicone implants, on the other hand, look and feel more natural. There
is no question in my mind or the mind of my patients that silicone is a
superior product compared to saline. My patients who have been
reconstructed with silicone implants appear more confident in their
appearance and the way their new breasts feel.

Having a more natural reconstructed breast allows women to more quickly
resume a normal life without dealing on a loss and feelings of
inadequate appearance.

At the time of their consultation, I counsel my patients on the risks
and benefits of silicone and saline implants. The present available data
regarding the safety record of these devices is discussed. Patients are
shown examples of both devices along with written literature and
pertinent Web addresses for more information.

Once most women have reviewed the available information and held both
devices in their hands, their choice is usually silicone. Despite the
fact that silicone implants have received negative press in the past and
are still considered investigational, this is the preferred choice of
most women in my practice.

As a reconstructive breast surgeon, I counsel about 70 to 80 new breast
cancer patients a year. Over the past four years, I have participated in
the National Breast Implant Registry, or NABIR. I have enrolled about 80
women in the silicone implant study and implanted approximately 140
silicone breast implants.

I have seen very few complications. I have not had a single deflation or
rupture of a silicone implant while involved in NABIR. I have had to
remove only two implants due to infection and one implant because of
capsular contracture.

During the same period of time, I have implanted approximately 120
saline implants in 55 women for reconstructive purposes. However, I\'ve
had to exchange about ten percent of these implants to silicone because
of patient dissatisfaction with wrinkling or firmness of their saline
implants.

I have also seen a much higher deflation rate with the same saline
devices.

CHAIRMAN CHOTI: If you can wrap up for us, please?

DR. HYANS: Please don\'t let sensationalism and hype created by the
media affect your decision regarding these valuable devices. I believe
the data speaks for itself. Let women as long as they are informed, like
Mary, Lisa, Karen, and the millions like them who feel comfortable about
their bodies, go forward with their lives without feeling
self‑conscious.

MS. DOWD: Good evening. My name is Pam Dowd, and I am reading on behalf
of Hilary Abigail Morrissey from Macon, Missouri. She does not have any
conflicts of interest. Here is Hilary\'s story.

\"I am just a 14‑year‑old. And I wanted my words to be heard. My mom,
Cindy Morrissey, had many sets of silicone gel breast implants starting
when she was a teenager. My grandparents gave the implants to my mom as
a birthday present because she had a congenital deformity of her chest.

\"Later I was born, and my mother breast‑fed me. I have had health
problems ever since. I have scleroderma. And I had my first skin biopsy
when I was six years old. This is not good when you are a kid because as
I get older, my scleroderma, skin, and bones are getting worse. This is
all very painful, and I do not like what is happening to my body.

\"I also have a very bad bone problem called an acral bone dysplasia. My
hands and my feet are the size of a 12‑month‑old baby\'s, and I have had
many fractures.

\"I want the breast implant companies to know that I do not like what
they did to me with their bad breast implants. Breast‑feeding with
implants makes kids sick, no matter what manufacturers want people to
believe. I am living this.

\"I asked my mom why I\'m like this. She explained to me that my
grandparents and her were not told the truth about implants when she was
a teenager and over the many years she had them in. She said the
companies did not do studies on the children and never will. She said it
had been the big cover‑up in medicine because breast implants are all
about money.

\"I also think that TV shows like \'The Swan\' and \'Extreme Makeover\'
make people and teenagers really hate themselves even more because when
you look in the mirror after watching shows like this, you begin to
think that a plastic surgeon can fix everything and make life better.
But they can\'t.

\"I wish a plastic surgeon could fix my hands and feet or take my
scleroderma, my swallowing problems, and the insulin‑resistant problems
away. But they can\'t.

\"It sure does not make me feel good every time I see a plastic surgeon
put a breast implant into one of these people on these types of shows.
They are shows to promote breast implants and make more money for
plastic surgeons and the companies.

\"I want the breast implant companies to know I forgive you for doing
what you have done to me and to others with your implants that have not
been studied. I hope and pray that the FDA and the panel will not
approve silicone gel breast implants. I will pray that God may open your
eyes to the truth that breast implants also harm children.

\"Thank you for listening to my voice.\"

CHAIRMAN CHOTI: Thank you.

Good afternoon, next speaker.

MS. LEVIN: Good afternoon. My name is Madeleine Levin. I am reading
testimony for Diane King, who could not be here today. We have no
conflicts of interest.

\"My name is Diane King. I am from Concord, California. I was a very
healthy 36‑year‑old woman when a plastic surgeon talked me into silicone
breast implants, instead of a reduction, because he felt I would hate
the scars.

I weighed 110 pounds, wore a size 36DDD, and he said breast implants
would easily solve the sagging and neck aches. I considered it
reconstruction, but he wrote \"augmentation\" on my surgical report,
even though I reduced my breast size.

I began to experience problems 13 years after my implantation. My energy
level dropped. I developed rashes, numbness in my arms and hands,
burning sensations in my chest, night sweats, dry mouth, and weight
gain.

Meanwhile, my physician said she was baffled and tried several
medications to fix me, including antidepressants. I got myself off all
medication after I met a woman who was dying from her silicone implants
and educated me.

I had 26 symptoms out of 52 on the list of silicone‑related illnesses.
When I took this information to my physician, she said there was no
official medical evidence to back it up. So she never suggested my
problems could be related to my implants.

By 1996, I could not lay flat. So my husband put adjustable beds in the
family room, where I slept for a year. I was only able to get out of bed
for a few hours each day. My skin tone became gray and yellow.

My HMO sent me to a rheumatologist, who diagnosed me with symptoms
classic to ruptured implants and fibromyalgia. My sonogram failed to
reveal the severe ruptures. And my HMO would not cover an MRI.

My removal and reduction in April of 1998 took almost six hours because
I was so severely ruptured that the silicone had to be ripped from my
chest muscles and peeled from my chest wall.

My health began to improve immediately. My cognitive problems cleared.
The gray puffy skin, rashes, and most of the pains disappeared. It has
been seven years since removal. And I am now realizing that I may never
return to the high energetic top relator I was before the rupture. And I
may have residual problems forever. But I am happy to be alive and
sleeping in my own bed.

I was not warned of anything other than standard complications from
surgery and anesthesia. There are more disclosures required to purchase
property than to have this surgery, which can destroy a person\'s
quality of life and ability to earn a living.

I feel the FDA has failed the women of this country by not requiring
proper disclosures prior to surgery and by not requiring long‑term
studies to disclose all of the possible risks associated with silicone
breast implants.

My implants cost my family a substantial amount of money, hopes for a
comfortable retirement. And, more importantly, we all suffered through
my illness and lost over ten years of quality life that we cannot get
back.

I implore you, do not allow more women to waste precious years of life
and significant amounts of money on a product that is not safe.

Thank you.

DR. TEITELBAUM: Chairman and distinguished members of the panel, my name
is Steven Teitelbaum. I am a board‑certified plastic surgeon from Santa
Monica, California. I do not have any financial relationship with any
implant manufacturer. And I paid for my own travel.

You have all been charged with a quite daunting task. Daunting? You\'ve
only had to decide whether the risks of silicone implants and the
benefits weigh out favorably. That sounds easy enough. In fact, the FDA
has approved implants and devices far more hazardous than anyone has
ever thought that silicone breast implants could possibly be.

Something here is clearly different. Why is there so much testimony? Why
is this room so full? This is it. It\'s that the risks and benefits of
this device are described in very different languages. And because the
languages are different, we cannot make a direct comparison. The risks
are described in quantifiable scientific terms, but the benefits are
described in vague sociological terms.

How can you, how can anyone offset the risk of an infection against
improved self‑esteem? You can\'t. You can\'t for anybody except for
yourself. Studies show silicone implants improve self‑esteem, but they
cannot tell you how much weight to give to self‑esteem. Some would argue
improving self‑esteem by surgery is of no value.

Others would say that self‑image is important to an individual\'s sense
of well‑being, as any truly medical issue. Putting a value on
self‑esteem requires a moral judgment, which I believe is inconsistent
with your task here because you should be scientific and apolitical. An
objective conclusion about this device, therefore, is impractical.

Since this surgery is elective, some suggest that you need to demand
more for this device than you might for a medically necessary device. I
see it the other way. With a medically necessary device, someone finds
themselves sick or in pain, and they have no way to evaluate the device
and due diligence it. They need you to do that for them.

But breast augmentation patients, they seek out these implants. They
think about it over many years, absorbing sources of data from many
places. They can due diligence this for themselves.

And this leads to the solution. Since a quarter of a million women
choose breast augmentation, I believe you should accept as axiomatic
that this is important, very important, and of value to some people.

Do we know the risks well enough to adequately inform women? The answer
is an unequivocal yes. Questions remain. There are unknowns. We never
know everything about anything. Just demand that the patients are told
where the data ends and where the unknown is. As long as patients know
what they know and what they don\'t know, they can make an informed
choice.

Arguing that the data is insufficient to allow a thoughtful choice
requires assumptions that the benefits do not outweigh those unknown
risks. You have, therefore, used your own value system, your own value
system, to unconsciously assign a low value to the benefits.

For some women, the benefits will not outweigh the unknown risks, but
for others, it will. That is their decision. Female plastic surgeons
prefer them predominantly when looking for themselves or loved ones.
This proves that the severity and rate of complications is so low and so
subtle that it does not rise to the level where the panel needs to
protect Americans from this option.

It is often implied that the testimony of a plastic surgeon is biased by
financial considerations. Actually, it is of no consequence at all to me
whether I use saline or silicone, but it is a consequence to my
patients. And that is why I am here.

I was moved by today\'s testimonies. But if you spend an hour in the
lobby of any medical office building, you would hear similar stories
from women who do not have implants.

CHAIRMAN CHOTI: If you could wrap it up, please?

DR. TEITELBAUM: I do not doubt the sincerity of these women. They are
looking and think they have found an explanation for why they have
developed the disease. But their belief is based upon faith. And this
panel should render a decision only based upon science.

Thank you.

MS. GOLDRICH: Good evening. My name is Sybil Goldrich, and I am the
Director of Command Trust Network.

First, I want to thank you all for sitting here for such a long time. I
know how difficult it must be to hear everybody\'s opinion. So I\'m
especially thankful to you.

We were established in 1988 to make sure that the most up‑to‑date
information was distributed about breast implants, both to women and to
decision‑makers in Washington. And I come here with no financial ties to
either the sponsor or to any of the sponsor\'s competitors.

In September of 2004, just seven months ago, these former silicone
breast implant manufacturers agreed to pay the federal government \$11.3
million to reimburse the government\'s cost for caring for women injured
by silicone breast implants. This U.S. Justice Department lawsuit made
it clear that silicone breast implants have cost the United States
government millions in medical expenses and have cost women even more in
terms of their health.

Also in 2004, the government received approximately \$10 million from
the Dow‑Corning bankruptcy estate in settlement of its claims for
reimbursement for medical costs by Dow‑Corning implants.

The government agencies that sought reimbursement included the United
States Department of Defense, the Department of Veterans Affairs, the
Indian Health Service, the Centers for Medicaid and Medicare Services,
and the Department of Health and Human Services, the very agency that
oversees the FDA. Even Inamed settled with the government to reimburse
Medicare. Inamed paid for the problems that they caused women.

Through all of these lawsuits, Department of Health and Human Services
certainly recognized the safety problems with silicone breast implants.
It sought compensation for the costs incurred from treating women with
complications caused by implants.

Women with silicone implants whose health care is paid through these
government agencies suffered serious complications from their implants.
And this caused the United States taxpayers millions of dollars.

But there are thousands and thousands of women who do not have health
care through these agencies and who have had problems with their
silicone breast implants. Too often their health insurance does not
cover the cost of MRIs to determine if implants have ruptured.

The cost of treating complications or of removing implants, even broken,
ruptured, or leaking implants, isn\'t covered. If you recommend that the
FDA remove the restrictions on these products, who is going to take care
of all of the women who experience complications and health problems in
these harmful products? What will the cost do to our already
overburdened health care system?

It is incongruous that less than a year after the Justice Department has
received over \$20 million from companies which formerly manufactured
implants, that the FDA would be here today considering Inamed\'s and
Mentor\'s requests to put these same very harmful products back on the
market without restriction.

How can the FDA even consider loosening restrictions on the sale of a
product that the Department of Justice has successfully sued due to
safety problems? Fortunately, the Department of Justice recognized that
silicone breast implants caused serious health problems and held the
industry accountable. I only hope that the FDA will follow their lead
and make sure that the women\'s health is not further jeopardized by
these devices.

Thank you.

CHAIRMAN CHOTI: Thank you.

DR. HESTER: Mr. Chairman, members of the Committee, I am Dr. T. Roderick
Hester, Jr. I am a plastic surgeon and Chief of the Division of Plastic
and Reconstructive Surgery of the Emory University School of Medicine in
Atlanta, Georgia.

I have been actively engaged in the practice of academic and clinical
plastic surgeon for 25 years, have no financial interest with any
company involved in these hearings.

I have been and continue to be an investigator in FDA‑approved
investigational device studies for both companies. I receive no personal
remuneration as an investigator. I traveled here at my own expense. My
overnight lodging was paid for by the American Society for Plastic
Surgery.

Over my years, I have utilized silicone gel and saline implants in more
than 3,000 patients for reconstructive and aesthetic purposes. There is
absolutely no question that in the reconstructive setting, gel‑filled
devices are far superior to saline. And this fact has, of course, been
recognized by the FDA in previous decisions, allowing women facing
reconstruction after mastectomy the choice of a gel‑filled implant.

In fact, even in more complex aesthetic situations, such as severe
breast asymmetry, mammary ptosis, capsular contracture, gel‑filled
implants, those considered an investigational device can be chosen.

As members of the panel may know, the number of women seeking aesthetic
breast enhancement has increased significantly since the early 1990s to
well over 300,000 in 2004. The vast majority of these women have not had
the choice of using a gel‑filled implant. I believe this should change,
and I will tell you why.

As I have previously stated, I have had the good fortune to be an
investigator in studies in which women could choose the so‑called third
generation devices for primary augmentation and would like to share my
personal experience.

Over four years ago, I began using third generation devices in IDE
studies. And at present, over 100 patients have had implantation. These
patients are closely followed with over 95 percent returning for
follow‑up.

A few facts. When given a choice after long consultation for the
comprehensive informed consent, 95 percent of patients choose the
gel‑filled device. Results with gel‑filled devices have been excellent.
Unlike saline implants, problems with implant palpability and wrinkling
have been almost nonexistent.

I have not seen a documented implant failure in this group. The
incidence of capsular contracture and overall revision rate have been
well under ten percent. Unlike saline implants, a gel‑filled device can
be used even in the thinnest of patients with excellent results.

In my practice, most patients who cannot be enrolled in a study are
choosing to wait, rather than to proceed with saline‑filled devices. I
can also report since third generation devices became available, I have
seen only one failure. And that was a surgically induced failure. In my
experience, patients with saline implants are significantly more likely
to require reoperation for implant patients, implant failure, and poor
results.

A final thought. Many patients in my practice who cannot at this time
choose a gel‑filled implants ask me a question, which is phrased
something like \"If there is any health risk for me to use silicone
implants, why will the FDA allow them to use it in patients who have had
cancer and whose health may not be as good as mine?\" Quite honestly, I
have trouble answering that question.

I believe the data has confirmed the safety of gel‑filled devices. And
my patients and all American women should have the right to choose a
gel‑filled device, whether for reconstructive or aesthetic purposes.

I thank you for your time.

CHAIRMAN CHOTI: Thank you.

Next speaker?

MS. LITWALK: My name is Katie Litwalk. I am reading testimony for Gloria
Borland, who is unable to be here today. She has no conflicts of
interest, and neither do I.

\"My name is Gloria Borland, and I live in Alpine, Texas. Everyone wants
to look their best. When I was younger, that was what motivated me to
get silicone breast implants.

\"I went to a plastic surgeon, who assured me that silicone breast
implants were safe and that they would make me look my best. I was told
that the silicone breast implants being used would last for the rest of
my life.

\"My doctor made it sound as if I was going to the beauty shop and
choosing a different hairstyle, but hairstyles are easy to grow out or
change. And I later found that the effects and symptoms of silicone
breast implants are not.

\"What I have experienced is a lifetime of additional surgeries and
pain, not at all the picture painted for me by my plastic surgeon. The
studies presented by the manufacturers show only the short‑term results
of silicone breast implants.

\"The women presenting today, including myself, are the long‑term
studies that failed to be conducted scientifically. As you listen to us,
you will note that most of the problems and complications we have
experienced began five to seven years after implantation.

\"Four years of data is not enough. The problems increase as the time
goes by and last long after what is left after the implants are removed.
We have experienced this.

\"We are the long‑term studies. When my silicone breast implants were
removed after 16 years, I already had neurological damage that was
irreversible. I experience chronic pain and am unable to work as a
result.

\"The implants that were removed from my body were badly ruptured.
Clearly they did not last my lifetime. I am, however, unable to live my
life. Perhaps that is what my plastic surgeon meant when he said that
they would last me a lifetime.

\"Plastic surgeons offer breast implants on the installment plan. Many
women will not be able to afford MRIs. They will still be paying off the
initial surgery. If their implants are ruptured, many can\'t afford to
have them removed.

\"How can the FDA possibly approve silicone implants with those kinds of
risks? Please think of the young women who trust the FDA to make
decisions for them about both the short‑term and long‑term safety of
products and do not recommend approval.

\"Thank you.\"

CHAIRMAN CHOTI: Thank you.

DR. MILLER: My name is Claudia Miller. I\'m a physician, and I\'m
actually testifying on behalf of a patient who is unable to be here. Her
name is Marlene Miller. I\'ll be reading her testimony.

\"My name is Marlene Miller. I had breast reconstruction with silicone
gel implants after a double mastectomy. I have no conflicts of interest.

\"Within six weeks of McGhan, experiencing extreme pain in my breast
area from an infection, and four months later the implants had to be
removed. After the explantation, I had to keep the incision site open
and clean by pulling the nipple up to open the hole and with the other
hand push the loose skin around to make the pus come out. I could see
through the hole and look at my chest wall.

\"Two years later I had new breast implants put in. Later that year, I
felt something snag in my bra. I found a stiff blue thread sticking out
through my skin under my left nipple. I pulled on it, and out came a
string that had three knots in it with a liquid that stretched like
rubber cement clinging to it. It stretched for about six inches before
breaking loose.

\"A surgeon took a sample of this gel and told me it was silicone. The
implant was immediately removed. And the surgeon found a flap‑like tear
through which the gel had extruded. He put in a new implant.

\"Five years later my implants were hard as rocks. Another surgeon told
me about a new silicone implant. He promised that they would never break
and were specifically made for reconstruction. So I gave them a try.

\"Soon afterward the headaches started, along with constant pain between
my shoulder blades. My hair started falling out. I developed allergies
to everything. I was tired all the time. I started coughing and vomiting
up mucus.

\"After seeing another plastic surgeon, who told me I had silicone
poisoning, I argued, saying that I had implants that could not rupture.
I had been promised.

\"He removed my implants. And the left implant had an enlarged L‑shape
rip in it. Silicone had spread throughout my chest cavity and had
adhered to the chest walls.

\"The surgeon said it was quite tedious just to remove what he could. He
put in new silicone gel implants. This time the cosmetic problems were
immediate. Within months, I was in so much pain and I was so deformed I
wanted to die. I had the implants removed, and this time they were not
replaced.

\"Inamed\'s and Mentor\'s own research shows high complication rates,
especially for mastectomy patients. The statistics don\'t really convey
how terrible these complications can be. Plastic surgeons might look at
my medical records and point out that even with all the problems, I kept
replacing my implants.

\"It\'s not because I was desperate to have breasts. It\'s because I was
promised they would be safe. I ask the plastic surgeons on this panel,
have you made promises to your patients like that?

\"I have had a long and ugly history with implants. I ask you to simply
adhere to the FDA\'s own guidelines when they rejected Inamed\'s
application in 2004. Do not approve these products without long‑term
safety data. No one should have to go through what I have gone
through.\"

Now, Marlene Miller also answered a questionnaire that I showed you
early in the day. And she said to me that she\'s had multi‑system
symptoms, musculoskeletal, airway, gastrointestinal difficulties, and
mood changes.

She\'s ill if she\'s exposed to pesticides, cleaning agents, and various
fragrances. She is new intolerances for various foods, caffeine adverse
reactions to many medications. And these new intolerances, as I told you
earlier, are the hallmark symptoms of this toxicant‑induced loss of
tolerance. And clearly they have impacted her in every facet of her
life.

Thank you.

CHAIRMAN CHOTI: Thank you.

MS. WILLIAMS: She has another one she is going to read. Can she just do
that?

CHAIRMAN CHOTI: Sure.

DR. MILLER: Again, I\'m reading for a patient who cannot be here. She is
too sick to be here today. She said she couldn\'t travel because of her
chemical intolerances.

\"My name is Beverly Ezra. Twenty years ago, I got silicone gel breast
implants. Within a year of implantation, I developed arthritis,
short‑term memory loss, and headaches. Several years ago, I lost my
sense of smell and some of my sense of taste.

\"My left implant ruptured in 1993 and was replaced with saline
implants. Four months later, a bilateral open capsulotomy was performed
and inflammatory fluid collections found in both breasts.

\"A lung X‑ray at this time identified soft tissue density with
significant scarring and calcification on the right lung. During this
time, I started to develop multiple chemical intolerances and was
diagnosed with spastic bowel.

\"My urine has been tested for platinum and found to contain 158 parts
per billion per liter of urine. My hair, nails, sweat, and so on, blood
have been tested as well and have been found to be positive also for
platinum.

\"Ten years after having implants, I was diagnosed with connective
tissue disease, organic brain syndrome with cognitive impairment,
atypical neurological disease, and a multiple sclerosis‑like syndrome.

\"My allergy tests indicate I am allergic to everything and I now react
to small amounts of everyday chemicals. My 1999 brain scan, SPECT scan,
came back as abnormal. And I was told that I have toxic encephalopathy,
dry eye syndrome, immune dysfunction, and autoimmune disorder, multiple
chemical intolerances, and elevated thyroid antibodies.

\"The Western blot blood test in 2000 showed I have markers for
sclerosis, lupus, and Sicca syndrome. I was also diagnosed with thyroid
disease of Hashimoto\'s nature.

\"I am now on total disability. And Social Security retrograded my
disability back to 1993, listing my impairment to be severe from
silicone toxicity.

\"There is no known way to get ionized platinum and silicone out of the
body. The platinum can cause systemic disease in humans as a result of
toxic and/or hypersensitivity reactions. Soluble salts of platinum are
the very potent chemical sensitizers.

\"I\'m currently considered high‑risk due to my chemical intolerances
and am denied the surgeries I now need. The medical community does not
know how to treat me. I react to most prescription medications or
chemicals. Some of these reactions are life‑threatening because my
throat constricts and I experience chest pains. Sometimes I cannot walk
or talk for up to almost a day at a time.

\"In conclusion, I ask that this panel vote no on approving gel‑filled
breast implants made with a platinum catalyst. I hope that no one has to
suffer the systemic disease symptoms that I have endured.\"

And as a further comment, she, again, answered some questions about her
intolerances because when I hear this, I say, \"Well, what things bother
you?\" And she gave a whole list of exposures that trigger symptoms in
her, including having severe responses to pesticides, cleaning agents,
fragrances that sound almost anaphylactoid; monosodium glutamate, making
her hands and feet swell; alcoholic beverages, even a tiny amount,
making her stuporous and sleepy; and adverse reactions to any
medications. What type would be of interest to the FDA.

I think the important thing ‑‑

CHAIRMAN CHOTI: If you could sum up? Thank you.

DR. MILLER: ‑‑ is that this is a subset of patients we are dealing with,
but the ones that are affected are affected very badly. And even though
they report multiple diagnoses, these things are very real for them.

Thank you.

MS. HANSON: My name is Sarah Hanson. I am reading testimony for Linda
Dintino, who could not be here today. She has no conflicts of interest
either.

\"My name is Linda Dintino. I was implanted with silicone breast
implants due to a prophylactic mastectomy because of fibrocystic
disease. At that time, I was told that I was at high risk for breast
cancer. Silicone breast implants were in my body for 13 years, until
they were removed. Before my implants, I was a very healthy woman.

\"Within two months of being implanted, I developed migraine headaches.
Even after that, I was athletic. I was an active mother of two boys, a
Cub Scout leader, and a secretary of the PTA.

\"Seven years after getting implants, I was too ill to continue these
activities, sadly. I could not lift my arms above my head. The pain was
too great. I literally had to sleep with pillows tucked between my
breasts while sleeping on my side because of the burning hot pain.

\"When the implants were removed from my body, I learned that my right
implant had ruptured and my left implant was leaking. I was left with a
big gaping hole in my right chest wall. My body would not heal properly.

\"I walked around with this hole in my chest four months. My scars were
open on both sides and would not close. Even the drainage holes where
the drain tubes were took longer than they should have to heal.

\"I dressed these holes in my body twice daily for four months while
green, oozing slime dripped from them. I can barely walk. I can no
longer do things like a normal person because of the excruciating pain
in my body.

\"The sad part is that the manufacturers and plastic surgeons don\'t
seem to care. I had hope in 2004, when the FDA refused to put silicone
implants back on the market and demanded long‑term safety data. I was
hopeful that the FDA was listening to us and acting on its
responsibility to protect the public from harm. But here we are again
with no long‑term research.

\"These manufacturers are not studying women, like me, who had implants
for a long time. I am one woman in a sea of thousands, all experiencing
the same problems. And the common denominator between us is the fact
that we all had silicone breast implants.

\"We need real research. We need answers. We need for this panel to take
a stand and demand that thorough research be done. If you approve
silicone breast implants, the FDA can\'t require the implant makers to
do additional studies. The implant makers will have only an incentive to
do research if required by the FDA.\"

MS. CAPLAN: Hello. I am representing Susan Scherr, who was unable to
attend today\'s meeting. I am Elyce Caplan, Education Director of Living
Beyond Breast Cancer. And I have no conflicts of interest.

\"My name is Susan L. Scherr. I want to thank the panel for the
opportunity to present my views. I have no conflicts of interest and
have not received any support from either of the sponsors.

\"I am speaking to you today as a 28‑year breast cancer survivor. I
received silicone gel breast implants in 1978 and 1988 as part of my
reconstructive surgery. I am also the former Director of Community and
Strategic Relations for the National Coalition for Cancer Survivorship
and continue to be active in the cancer community.

\"My comments today are on my own behalf and are limited to the approval
of silicone implants for reconstruction patients, specifically women
with breast cancer, breast disease, and other medical needs and use only
by qualified clinicians. I have no position on the use of these products
for augmentation.

\"I testified in favor of silicone gel breast implants for
reconstruction before FDA in the early 1990s and before the Institute of
Medicine in 1998 on behalf of NCCS. I testified again on behalf of NCCS
and 12 other organizations before this panel in October 2003.

\"Despite the documented long‑term safety of silicone gel breast
implants and the continued publication of numerous studies, reviews, and
reports, all concluding that there is no link between connective tissue
disease and silicone, these products are still not available to the vast
majority of American women.

\"An NCI study of over 7,000 women published in October 2004 again
reaffirmed these scientific conclusions. This panel has undoubtedly
reviewed all of these studies, reviews, and reports. And in the face of
such overwhelming evidence regarding the safety of silicone implants, it
is a mystery why these products remain unavailable as an option for
American women.

\"Silicone implants for reconstruction should not be held to a higher
standard than medical procedures in general or other approved medical
devices. Women should be able to have access if they receive accurate
information and give their informed consent before receiving silicone
implants. Limiting access to study participation does not make sense at
this point.

\"I support the right of each consumer and patient to consider options
for selection and then receive individualized treatment and care that
follows the approach she or he desires and believes is best.

\"Furthermore, I encourage consumers to make health care decisions in
consultation with an expert after receiving and understanding in‑depth
information of the benefits, risks, and uncertainties of a range of
state‑of‑the‑art options for care.

\"An important distinction for the panel to remember is that women with
breast cancer who choose implants typically make these decisions with a
different risk‑benefit analysis than those who choose implants for other
reasons.

\"After breast cancer, most women consider implants to be necessary not
optional, an integral component of their overall healing and recovery.
Consistent with these principles, I believe that silicone breast
implants should be available as an option for women requiring
reconstruction. Current options for post‑mastectomy reconstruction are
limited. And not all are suitable or possible for every women.

\"In conclusion, I recommend that the panel make silicone breast
implants generally available for reconstruction use for women with
breast cancer, breast disease, or other medical needs.

\"Thank you.\"

CHAIRMAN CHOTI: Thank you.

Yes?

MS. RAMSPOTT: My name is Kathy Ramspott. I addressed you earlier on my
own behalf. I have been asked to read a statement from a woman by the
name of Mary Ann Richards of Mount Pleasant, New Jersey.

\"Dr. Krause and members of the panel, I am a five and a half‑year
cancer survivor who chose to have a silicone implant after a mastectomy
in January 2000. By nature, I am very conservative. And because a
lumpectomy, while breast‑conserving and, therefore, the option I would
have preferred, was not the best choice for me medically, I chose a
mastectomy.

\"Between the time it was determined I would need a mastectomy and the
actual surgery itself, I did considerable research on the various types
of breast reconstruction that would be available to me. After extensive
research, I felt an implant would be the best option.

\"I then consulted two plastic surgeons and did considerable research as
to their qualifications and decided that I wanted Dr. Caroline Glicksman
to perform my reconstruction.

\"The initial expander was put into place following my surgery January
25th of 2000. It was a saline expander. And as it was filled with saline
solution, I found it extremely hard and uncomfortable.

\"As part of the cancer support group, I knew several other women who
had opted for the saline implants. And they, too, found them hard,
sometimes uncomfortable and somewhat disappointing.

\"Because the saline implant was uncomfortable, there was never a time I
was not conscious that I had breast cancer, a thought that was for me
very disconcerting.

\"When I mentioned this to Dr. Glicksman, she said I might be a
candidate for a silicone implant. She then gave me some literature, and
I did extensive research on the internet about the safety of silicone
implants.

\"After I did my homework, I felt that the silicone implant was the way
I wished to proceed. I discussed this at length with Dr. Glicksman. And
she gave me additional literature with both the advantages and
disadvantages of silicone implants as well as specific information and a
release should I decide to proceed.

\"I decided to proceed on May 26, 2000, had a McGhan silicone breast
implant. To date, I have been very pleased with the silicone implant and
have experienced absolutely no detrimental side effects. It is
comfortable, soft, and feels very natural. Unlike the saline implant, it
looks and feels natural, but I usually forget I am a cancer survivor.

\"I can\'t tell you the difference this makes in my life each and every
day. Each person handles their cancer experience in a different way. I
did not and do not want to remember each day that cancer was resident in
my body. With all the thoughts and fears that that entails, I thank God
for each day. And I want to live with positive thoughts.

\"I have continued to follow the research on silicone implants and am
very pleased that recent research in the U.S. has confirmed that there
is no link between silicone implants and increased risk of connective
tissue or neurological disease.

\"I am a responsible consumer. I am aware the expanders have to be
replaced after eight to ten years, much as a pacemaker or artificial
knee or hip that might need to be following those procedures.

\"I see Dr. Glicksman yearly and take antibiotics prior to dental
treatment. I have never for one minute regretted my decision with regard
to my silicone implant and feel strongly that other women, who have to
face the horror of a mastectomy should have available to them the
options that I have had.

\"It is for this reason that I am willing to testify before your
Committee about this very personal matter. Thank you for the opportunity
to present my point of view.\"

CHAIRMAN CHOTI: Thank you.

Yes?

MS. CAPLAN: Again I am Elyce Caplan, representing Linda Grover, who was
unable to attend today\'s meeting.

\"To whom it may concern: My name is Linda Grover, and I am writing as a
breast cancer survivor who has silicone breast implants. First, I would
like to start by saying I have not been sponsored to speak on this
matter by any company or doctor who has a special interest in silicone
breast implants. I feel very strongly in attending this meeting and
giving my opinion on this matter because of my circumstances.

\"I am now 43 and have been a breast cancer survivor for almost 7 years
now. Because of my family history, I chose to have a double mastectomy.
Because I was only 36 at the time, it was important to me to have the
most natural feel and look to my breasts that I could have.

\"I was encouraged at the time by my plastic surgeon to go with silicone
implants to get these results. It did not matter to me at the time what
all the negative press was on the implants. I just knew that after all I
had to go through with the mastectomy and chemotherapy, that in the end,
I wanted to feel as normal as possible.

\"I feel it was the best decision I could have made. They look
wonderful. They still feel very soft, unlike other women I know who have
gone through the same thing as I and chose saline implants. They now
feel the implants are hard and unnatural feeling. And most want them
replaced.

\"Women should be able to make their own personal choice based on full
information of the risks and benefits. All women after having breast
cancer and mastectomies that are going through reconstruction should
have whatever choice they want to feel as normal as possible again.

\"I hope all women in the future will have the same choices I did. To
this day, I have had no problems at all with my implants. And, honestly,
they look better to me than before my reconstruction except for a few
scars.

\"Furthermore, I have many friends with silicone breast implants who
have had them for years. And they have had no problems at all. I only
hope that the people who are so against this implant will never be in a
situation where they have to make the same decision as I did and not
have all of the choices of what is best for them to have a happy and
normal life.

\"Sincerely, Linda Grover.\"

Thank you.

CHAIRMAN CHOTI: Thank you.

At this point, we\'re going to stop for a dinner break. And we will
resume at 6:30. Thank you.

(Whereupon, at 5:30 p.m., the foregoing matter was recessed until 6:46
p.m.)