![](media/image1.png){width="6.0in" height="0.9395833333333333in"}

May 8, 2008

Lee L. Zwanziger

Office of the Commissioner

Office of Planning (HFP--60)

Food and Drug Administration, 5600 Fishers Lane

(for express delivery: rm. 15--22)

Rockville, MD, 20857

Via: [**http://www.regulations.gov**](http://www.regulations.gov/)

**Comments of Consumers Union of the U.S. Inc.**

**Relating to direct-to-consumer advertising for medical devices**

**to the U.S. Food and Drug Administration**

**Risk Communication Advisory Committee**

**Docket No. FDA-2008-N-0226**

**Introduction**

Consumers Union (CU), the nonprofit publisher of *Consumer Reports*,[^1]
submits

the following comments in response to the Food and Drug Administration's
("FDA" or "Agency") Notice, entitled "Risk Communication Advisory
Committee; Notice of Meeting."[^2] In its current Notice, the FDA seeks
public comment to be provided to the Risk Communication Advisory
Committee to be considered

Our comments focus on the Committee's discussion of "direct-to-consumer
(DTC) advertising, including how it relates to communicating to subsets
of the general population, such as the elderly, children, and racial and
ethnic minority communities, and increased access to health information
and decreased health disparities for these populations."

Surgery to implant devices such as knee, hip, heart valves, and cosmetic
implants is becoming more common every year. Further, direct-to-consumer
advertising for these procedures has become quite prevalent. These
television and print ads routinely fail to give consumers fair warning
of the danger of infection posed by these operations or the expected
life span of the device. Many of these ads target the elder population
who are likely to experience mobility problems late in their lives and
are likely to have insurance coverage for such procedures.

**\
Consumers Union Recommendation**

Consumers Union (CU) recommends that the FDA require all print and
electronic advertisements, including Internet advertisements, for
implantable devices such as knee, hip, heart valves, cosmetic implants,
and other devices, warn consumers about

-   the very real danger of health care-acquired infections that can and
    do result from surgery and follow-up care, and

-   the expected life span of the device before failure occurs,

both of which can and do cause death or serious morbidity and
expense.[^3] Some health care facilities do a better job than others in
preventing infections and some make this information available to the
public as a result of State laws or voluntary disclosure.

We recommend that all such implanted device advertisements require a
warning such as the following:

> "The surgery and care involved in the placement of this device may
> result in an infection, or other adverse events, that can lead to
> death or injury. Be sure to ask your doctor and hospital about surgeon
> and facility infection rates. In addition, ask your doctor about the
> long-term failure rates so that you are aware of when the implant is
> likely to need to be replaced."

In reviewing these implantable device advertisements and websites, we
are concerned that the danger of adverse side effects---including
death---are consistently understated, and we hope that the FDA will
review the quality of all device ads. But our comments are only
recommending that consumers be given clear warnings about the dangers of
infection during and following such surgery and information about how
long the devices are likely to last, and that consumers be advised to
seek out facilities with the strongest anti-infection programs and
devices with long-term data about failure rates.

There is no question that many of these devices can restore high
quality-of-life in patients who have been suffering. We do not in any
way intend to discourage those in pain and facing loss of mobility,
etc., from seeking out medical advice on implants. But we do believe
that unintended side effects, which can include death, can be minimized
if the public is better educated to avoid facilities which are not
practicing the highest level of infection prevention practices. Placing
information about the danger of infection from surgery in device
advertisements will speed the day that America's surgical centers and
hospitals address this life-and-death problem.

> **[Discussion]{.underline}**

Below we discuss data and give examples of

-   death and injury from infection following implant surgery, and

-   device implant advertisements that fail to give adequate notice of
    these dangerous side effects.

**Studies show significant injury, morbidity and mortality following
implant surgeries**

In June 2006 our publication *Consumer Reports* carried an article,
\"Joint replacement: 1,001 patients tell you what your doctor can\'t,"
in which we noted that

> \"Five percent of respondents reported getting an infection shortly
> after surgery, a significantly higher rate than reported in some major
> studies. We can't tell from our survey whether those were serious
> deep-tissue infections or less worrisome surface infections. But those
> rates are consistent with what [Consumer Reports]{.underline} has
> found when we surveyed subscribers about their hospital stays for
> various procedures in the past \[described in a January 2003 hospital
> safety article\].\"

While we could not determine the type of infections from the survey
responses, the rate of infection was consistent with our earlier,
January 2003 \"hospital safety\" article.

Our December, 2007 issue included an article entitled "Medical devices
Problems on the Rise," that again makes the point that there are serious
consumer issues with the placement and use of some of these devices.

The CDC's National Nosocomial Infections Surveillance (NNIS) System
Report clearly shows hip and knee prosthesis surgery to be a serious
source of infection, in some cases a high-risk source, and in some of
the NNIS reporting hospitals, the infection rate may run as high as 5
percent or more.[^4]

Considering just the deadly methicillin-resistant *Staphylococcus
aureus* (MRSA)

infection, according to the Agency for Healthcare Research and Quality
(AHRQ), 'complication of device, implant or graft' was the third most
common of the 'principal diagnoses for hospital stays with MRSA
infection in 2004. While this category includes skin grafts, clearly
devices and implants contribute to the total of 23,500 reported 'stays
with MRSA infection.[^5]

Between 1991 and 2001 a study was performed on the 222,684 cases of
total knee replacements in California. In the first 90 days of
discharge, the study found 1,176 deaths (0.53% rate), 1,586 infections
(0.71%), and 914 pulmonary emboli (0.41%). *The rates were significantly
higher when surgery was performed in low-volume hospitals or on
above-average age or co-morbidity patients* \[emphasis added\].[^6]

A recent [Health Affairs]{.underline} article (citing a Medline Plus
website) stated:

> "More than 600,000 total knee replacements (TKRs) are performed
> worldwide each year; this number will likely rise because of the aging
> population and the expanding clinical indications. In most cases, TKR
> can relieve a patient's knee pain, increase the joint's range of
> motion, and improve quality of life. Nevertheless, the surgery carries
> risks of potentially life-threatening complications, including
> anesthesia-related problems, wound and joint infections, deep venous
> thromboses, injury to nerves and blood vessels around the knee, and
> the potential for future surgical revision."[^7]

Another recent study reviewed 2003 nationwide U.S. data to determine the
incidences of primary total, partial, and revision hip replacements, and
to assess short-term outcomes and factors associated with those
outcomes.[^8] This study found about a third of a million such hip
procedures.

> "The in-hospital mortality rates associated with these three
> procedures were 0.33%, 3.04%, and 0.84%, respectively. The
> perioperative complication rates associated with the three procedures
> were 0.68%, 1.36%, and 1.08% respectively, for deep vein thrombosis or
> pulmonary embolism; 0.28%, 1.88%, and 1.27% for decubitus ulcer; and
> 0.05%, 0.06%, and 0.25% for postoperative infection."

Rates of readmission for any cause within 90 days ran between 9% for
total replacement to 21% for partial. Clearly, these are very serious
operations, infections occur, and consumers need to consider these side
effects.

> **Real-life examples from people who suffered deadly infections**
>
> **after knee and hip replacement surgery**

For approximately four years, Consumers Union has been working through
its Stop Hospital Infections campaign at the state level to enact
legislation to require hospitals to publicly report their infection
rates. To date, 22 states have enacted public disclosure and infection
prevention laws. These laws vary in their details but all are designed
to empower consumers and health care providers to call attention to the
HAI problem and to take steps to lower the rate of infection. Numerous
implementation committees are choosing hip or knee surgeries as initial
measures to be reported to the public because of the frequency of the
operations and the fact that they are typically "clean" surgical
procedures.[^9]

We are also working at the Federal level in support of legislation to
establish a national hospital infection reporting program (HR 1174) and
to call special attention to the growing problem of
methicillin-resistant *Staphylococcus aureus* (MRSA) (HR 4214/S 2278).

Our Stop Hospital Infection campaign has been fueled by the experiences
and stories of our readership and people we have reached in the course
of our advocacy. We have accumulated over 2,000 stories of individuals
and families who have suffered injury and often death due to
hospital-acquired infections. A significant number of these cases
occurred following hip and knee transplantation surgery.

Attached to these comments are samples of the type of reports we have
received. As anyone can see, these infections have resulted in terrible
pain and suffering, and in too many cases, death.

**Financial Arrangements That May Discourage the Delivery**

**of Side Effect Warnings**

It is also important that advertisements carry a warning of the
potential for infection, morbidity, and mortality as a result of surgery
and implantation, because the system of payments between many device
companies and surgeons creates financial incentives to conduct the
surgery. These same incentives to use various devices may well have the
effect of minimizing warnings and cautioning patients about other
solutions (such as weight loss, pain medication, physical therapy,
etc.). Our concern is based on recent reports of huge consulting fees to
certain surgeons. It is reported that nationally, "more than 40 surgeons
or groups each received at least \$1 million in payments" in 2007.

"Federal prosecutors said the industry has a long history of showering

gifts on surgeons, making it necessary for companies to fully disclose
all

of their consulting contracts....the U.S. Attorney's spokesman said the
Justice

Department is continuing its investigation 'into the practice of certain

doctors.'"[^10]

We raise the issue of industry "consulting fees," because it calls into
question the objectivity of the physician "learned intermediaries" to
fully inform patients of the downsides of such surgeries. This potential
problem is another reason to require advertisements to carry warnings.

**Other Government Agencies are Responding**

**to the Danger of Hospital-Acquired Infections**

**But More Needs to be Done by the FDA to Warn Consumers**

Other Department of Health and Human Services agencies recognize the
importance of fighting hospital-acquired infections and empowering
consumers to understand the dangers of infection and the efforts
individual facilities are taking to fight infection.

For example, as part of the hospital payment update program, hospitals
must report three surgical infection prevention [process]{.underline}
measures, which are then reported on the CMS website, under "Hospital
Compare." The three measures are (1) whether an antibiotic is started an
hour before surgery, (2) whether the correct antibiotic is used, and (3)
whether it is discontinued at an appropriate time after surgery. While
Consumers Union believes it is most important to report actual infection
rates, we do urge consumers to check this website to see how hospitals
perform on these process measures. We believe it is important because we
have found within a single state, variations among hospitals of as much
as 80 percentage points.

The NIH's National Institute of Arthritis and Musculoskeletal and Skin
Diseases provides some pamphlet-type information to consumers, such as
"Joint Replacement Surgery and You, Information for Multicultural
Communities." We do not know how many consumers use or read these
materials, but it is interesting to note that on page 8 of this 16-page
publication, the first major side effect listed is infection, but the
description utterly fails to adequately warn of how serious---how
fatal---this problem can be: [^11]

> "Joint replacement is usually a success in more than 90 percent of
> people who have it. When problems do occur, most are treatable.
> Possible problems include:
>
> Infection: Areas in the wound or around the new joint may get
> infected. It may happen while in the hospital or after you go home. It
> may even occur years later. Minor infections in the wound are usually
> treated with drugs. Deep infections may need a second operation to
> treat the infection or replace the joint."

Clearly, these warnings do not convey the medical horror described by
some of our readers in the Attachment to these comments.

A Government Accountability Office report[^12], released during an April
2008 hearing of the House Committee on Oversight and Government Reform,
assessed that federal agencies were not doing enough to establish clear
priorities for preventing hospital-acquired infections. The report
called for stronger and more coordinated leadership to respond to these
infections which are among the top ten causes of death in the U.S.

**Examples of Advertisements that Fail to Provide Adequate Warnings of
Side Effects, and Especially Fail to Warn of Infection**

A [Wall Street Journal]{.underline} article of April 10, 2007 entitled
"New Medical-Device Ads; Old Concerns, Can a Knee Implant Be Sold This
Way. And Should It Be?" describes the growth of medical device
direct-to-consumer (DTC) ads. While we have no specific data on the
amount being spent on such ads, we believe from our personal
observations that there are numerous device implant advertisements by
manufacturers and individual surgical physician groups.

In a review of several print ads in major and minor national
publications, and several television advertisements, we found that the
warnings of side effects are generally non-existent or minimal, saying
such things as 'there are potential risks' and 'potential for
complications.' We found no advertisement that advised consumers of the
very real possibility of deadly infection or to seek out surgical
facilities with low infection rates.

While Biomet's website lists a separate risk page and gives a full
paragraph to possible complications, the website video of its TV
advertisement
([[http://www.biomet.com/patients/marylou_retton.cfm]{.underline}](http://www.biomet.com/patients/marylou_retton.cfm)),
featuring Mary Lou Retton, fails to mention (as of May 5, 2008)
infection or how serious the side effects can be.

Television ads posted on other websites, as well as other information on
these websites, offer relatively little or no specific warnings that we
could easily see in clicking through the sites:

-   [[http://www.journeyknee.com/commercial.cfm]{.underline}](http://www.journeyknee.com/commercial.cfm).

-   [[http://www.genderknee.com]{.underline}](http://www.genderknee.com/)

-   [[http://www.aboutstryker.com/files/StrykerCommercial06.wmv]{.underline}](http://www.aboutstryker.com/files/StrykerCommercial06.wmv)

**FDA Expected to Do More to Include Warnings in Advertisements**

The FDA Amendments Act of 2007 (PL 110-85) creates a new section 503B,
which includes stronger authorities for the FDA to require pre-review
and specific disclosures to ensure that consumers are warned in DTC
advertisements about potential dangers and side effects. Clearly,
Congress expects stronger FDA oversight of these advertisements. We urge
you to use this authority, and existing authorities, to review device
implant advertisements and require that they warn of the specific
dangers of infection, and advise patients to ask questions about
infection rates and infection prevention practices at the facility where
the implantation will take place.

Respectfully submitted:

Lisa McGiffert

Campaign Manager, Stop Hospital Infections

Consumers Union

[[www.StopHospitalInfections.org]{.underline}](http://www.stophospitalinfections.org/)

Austin, Texas, 512-477-4431 #115

**Attachment**

**Examples of stories collected by Consumers Union from patients who had
infections following hip or knee replacement**

**Northern California**

In Feb. 2006, my father had a hip replacement and contracted Methicillin
Resistant Staphylococcus Aureus (MRSA). Kaiser Permanente Hospital had
to replace the hip 3 times to get the infection under control. He also
contracted Pneumonia and Urinary Tract Infections during his stay at
this hospital. He continues to fight the Pneumonia and constant Urinary
tract infections. This whole experience has been a nightmare.... This
happened in Feb. 2006. It is now Jan. 2007 and my father is still in a
nursing home and will never walk again or come home.....

**Michigan**

I went to Bronson Hospital in Kalamazoo, Michigan to have a knee scope
before I was to have a knee replacement. After I went home from this
procedure, I started to have a lot of pain in my leg that I had the
scope in. I had only been home three days. Within a few minutes the pain
was so terrible that I was rushed to the Battle Creek Medical Hospital,
close to my home. I was in so much pain that I was not aware that I was
being sent by ambulance back to Kalamazoo, to intensive care at Borgess
Hospital. They had a special unit to try and save my life.

I spent three weeks in intensive care. My doctors did not think I would
live. However, a team of infectious doctors that worked diligently to
save me. I was later told that I had gotten this dreadfully painful
disease from a dirty instrument. I suffered pain for six months and was
unable to walk without a walker for three months. It took me three more
years of constant doctors appointments before I could even consider to
get my knee replaced.

I will be getting knee replacement during February of 2007. I was told
that my doctor will be treating the cement with antibiotics, so this
will not happen again. Due to this incident, I will always be
susceptible to infection for the rest of my life.

**Northern California**

I was given a hip replacement on April 21, discharged to a rehab site on
April 25, and returned home May 5. On May 16 I was re-admitted to the
hospital with a severe staph-Pos infection in the operated site, and had
to undergo a second surgery in which some of the new hip had to be
replaced. After one week in isolation I was fitted with a "Pic Line,"
and had to self-administer antibiotics for six weeks. My recovery was
very slow, and I have been told I will never be completely free of a
re-occurrence of the infection.

**Kansas**

I was 45, single and healthy, when I had a hip replacement in 2003. I
was told that I didn't have to worry about a Staph infection, because I
was young and healthy. Recovery from the hip replacement was very
difficult and I had a lot of pain. I went to see the surgeon every week,
wondering why I hurt so bad, and why I couldn't walk around very well.
He would take an X-ray, show it to me and tell me everything was fine,
and send me home. At 6 weeks, I was home alone, and my hip popped out
from the infection. I have never felt anything so excruciating in my
life. I returned to the hospital for 8 days, 2 operations, 2 blood
transfusions, and very little information. I was on 3 IV infusions and 3
oral antibiotics a day, for almost 4 months. I now have Lymphedema,
permanent damage to my lower lymphatic system, from the infection. I
will be dealing with compression hose, pain, lymphatic drainage,
wrapping both legs and stomach every day, and great risk of a new
infection, for the rest of my life.

**Massachusetts**

My mother has had artificial hips since age 17. As they wear they have
been replaced. In 2002 she had a replacement done and after was told she
had a staph infection. After several months on Vancomycin they decided
they would have to remove the components. While she had a "hanging hip"
her good hip dislocated and they operated on that hip. After 4 months
they said her cultures were clear of infection and put the hip back in.
Last fall they found infection again and took the hip back out. This
time they said it was an entrococcus infection and they didn't know how
she got it. She was again put on the Vanco. And recently was told she
was reading to have her hip put back in on 3/17/05. Well last Monday
they told her she has VRE in the good hip and now they want to take that
one out too and possibly both knees as well! She is giving up hope.

**Arizona**

\[I had had a\] total knee for 16 years and had worn out the plastic
pads. I went for PT approximately 2 weeks after surgery and my therapist
called my doctor twice to tell him that my knee felt very warm and that
he should look at it. About 5 months after the surgery, I had to check
myself into urgent care, as I could not put any weight on that knee due
to the pain. I had a temperature of 104 degrees and was given morphine
and transferred to a hospital. There they did blood tests and determined
that I had Staph infection that had spread into my blood. I was then
transferred to the hospital that did the revision surgery. My orthopedic
doctor withdrew the puss from my knee, did athroscopic surgery to clean
out the knee. Then in another surgery removed all of the total knee
hardware....

**Arizona**

My 81 year old mother broke her hip in April of 2004, had a partial hip
replacement and was recovering well. Six weeks after the surgery, her
hands swelled and turned red and painful. She was readmitted and given
many tests including nuclear medicine in order to find the site of the
infection. The physicians believed she had a bacteremia, but could never
determine just what caused it. Her white cell count soon after
admittance was over 20,000. She was hospitalized for over 100 days.
During her stay, she acquired 6 or 7 nosocomial infections. First she
acquired a Vancomcycin Resistant Enterococcus urinary tract infection.
She also got Klebsiella, MRSA, and Pseudomonas aeruginosa urinary tract
infections. Also, because she was on total parenteral nutrition for so
long she suffered candidaemia. Finally, due to the number of antibiotics
she received, she acquired highly resistant Clostridium difficile
diarrhea. She lost a great deal of weight because of the multiple
infections and never recovered enough to go home.....

[^1]: Consumers Union is a nonprofit membership organization chartered
    in 1936 under the laws of the State of New York to provide consumers
    with information, education and counsel about goods, services,
    health, and personal finance. Consumers Union\'s income is solely
    derived from the sale of Consumer Reports and ConsumerReports.org,
    its other publications and from noncommercial contributions, grants
    and fees. In addition to reports on Consumers Union\'s own product
    testing, Consumer Reports and ConsumerReports.org, with
    approximately 6.5 million combined paid circulation, regularly carry
    articles on health, product safety, marketplace economics and
    legislative, judicial and regulatory actions that affect consumer
    welfare. Consumers Union\'s publications carry no advertising and
    receive no commercial support.

[^2]: See 73 Fed. Reg. 22959 (April 28, 2008).

[^3]: The December 2007 issue of [Consumer Reports]{.underline}
    discusses the rise in reports of serious problems from various heart
    implantation devices, but does not discuss the serious problem of
    surgical infection. See attached article "Medical devices Problems
    on the rise."

[^4]: NNIS System Report, data summary from January 1992 through June
    2004, issued October 2004. Am J. Infect Control 2004; 32:470-485.

[^5]: AHRQ, Healthcare Cost and Utilization Project (H-CUP) Statistical
    Brief #35, July 2007, p. 8.

[^6]: SooHoo Nelson F; Lieberman Jay R; Ko Clifford Y; Zingmond David ,
    "Factors predicting complication rates following total knee
    replacement," J Bone Joint Surg Am 2006 Mar; 88(3): 480-485.

[^7]: Peter Juhn, Audrey Phillips, and Kathy Buto, "Balancing Modern
    Medical Benefits and Risks," Health Affairs, Vol. 26, No. 3,
    May/June 2007, p. 648.

[^8]: Zhan Chunliu; Kaczmarek Ronald; Loyo-Berrios Nilsa; Sangl Judith;
    Bright Roselie A., "Incidence and short-term outcomes of primary and
    revision hip replacement in the United States," J Bone Joint Surg
    Am. 2007 Mar; 89(3): 526-33.

[^9]: [[http://www.consumersunion.org/campaigns/CU%20Summ%20HAI%20state%20rpting%20laws%20as%20of%201-08.pdf]{.underline}](http://www.consumersunion.org/campaigns/CU Summ HAI state rpting laws as of 1-08.pdf )

[^10]: John Russell, "Docs bristle at suggestion of kickbacks; Feds
    probe orthopedic surgeons' fees from artificial device makers,"
    [Indianapolis Star]{.underline}, November 12, 2007.

[^11]: This omission is particularly distressing in a publication aimed
    at the minority populations, since MRSA is a particularly serious
    problem in some of these communities.

[^12]: "Health care associated infections in hospitals: Leadership
    Needed from HHS to Prioritize Prevention Practices and Improve Data
    on These Infections," March 2008;
    [[http://oversight.house.gov/documents/20080416112756.pdf]{.underline}](http://oversight.house.gov/documents/20080416112756.pdf)