I
105TH CONGRESS
2D SESSION
H. R. 4028
To promote research to identify and evaluate the health effects of silicone
breast implants, and to ensure that women and their doctors receive
accurate information about such implants.
IN THE HOUSE OF REPRESENTATIVES
JUNE 10, 1998
Mr. GREEN introduced the following bill; which was referred to the Committee
on Commerce
A BILL
To promote research to identify and evaluate the health
effects of silicone breast implants, and to ensure that
women and their doctors receive accurate information
about such implants.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Silicone Breast Im-
plant Research and Information Act’’.
SEC. 2. FINDINGS AND PURPOSE.
(a) FINDINGS.—Congress makes the following find-
ings:
(1) According to the Institute of Medicine, it is
estimated that 1,000,000 to 2,000,000 American
women have received silicone breast implants over
the last 35 years.
(2) Silicone breast implants have been used pri-
marily for breast augmentation, but also as an im-
portant part of reconstruction surgery for breast
cancer or other conditions.
(3) Women with breast cancer or other medical
conditions seek access to the broadest possible treat-
ment options, including silicone breast implants.
(4) Women need complete and accurate infor-
mation about the potential health risks and advan-
tages of silicone breast implants so that women can
make informed decisions.
(5) Although the rate of implant rupture and
silicone leakage has not been definitively established,
estimates are as high as 70 percent.
(6) According to a 1997 Mayo Clinic study, 1
in 4 women required additional surgery because of
their implants within 5 years of receiving them.
(7) In addition to potential systemic complica-
tions, local changes in breast tissue such as harden-
ing, contraction of scar tissue surrounding implants,
blood clots, severe pain, burning rashes, serious in-
flammation, or other complications requiring sur-
gical intervention following implantation have been
reported.
(8) According to the Institute of Medicine, con-
cern remains that exposure to silicone or other com-
ponents in silicone breast implants may result in
currently undefined connective tissue or autoimmune
diseases.
(9) A group of independent scientists and clini-
cians convened by the National Institute of Arthritis
and Musculoskeletal and Skin Diseases in April of
1997 addressed concerns that an association may
exist between atypical connective tissue disease and
silicone breast implants, and called for additional
basic research on the components of silicone as well
as biological responses to silicone.
(10) According to many reports, including a
study published in the Journal of the National Can-
cer Institute, the presence of silicone breast implants
may create difficulties in obtaining complete mam-
mograms.
(11) According to a 1995 Food and Drug Ad-
ministration publication, although silicone breast im-
plants usually do not interfere with a woman’s abil-
ity to nurse, if the implants leak, there is some con-
cern that the silicone may harm the baby. Some
studies suggest a link between breast feeding with
implants and problems with the child’s esophagus.
(b) PURPOSE.—It is the purpose of this Act to pro-
mote research to identify and evaluate the health effects
of silicone breast implants, and to ensure that women and
their doctors receive accurate information about such im-
plants.
(c) RULE OF CONSTRUCTION.—Nothing in this Act
shall be construed to affect any rule or regulation promul-
gated under the authority of the Food, Drug and Cosmetic
Act that is in effect on the date of enactment of this Act
relating to the availability of silicone breast implants for
reconstruction after mastectomy, correction of congenital
deformities, or replacement for ruptured silicone implants
for augmentation.
SEC. 3. EXPANSION AND INTENSIFICATION OF ACTIVITIES
REGARDING SILICONE BREAST IMPLANTS AT
THE NATIONAL INSTITUTES OF HEALTH.
Part H of title IV of the Public Health Service Act
(42 U.S.C. 289 et seq.) is amended by adding at the end
the following:
‘‘SEC. 498C. SILICONE BREAST IMPLANT RESEARCH.
‘‘(a) INSTITUTE-WIDE COORDINATOR.—The Director
of NIH shall appoint an appropriate official of the Depart-
ment of Health and Human Services to serve as the Na-
tional Institutes of Health coordinator regarding silicone
breast implant research. Such coordinator shall encourage
and coordinate the participation of all appropriate Insti-
tutes in research on silicone breast implants, including—
‘‘(1) the National Institute of Allergy and In-
fectious Diseases;
‘‘(2) the National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
‘‘(3) the National Institute of Child Health and
Human Development;
‘‘(4) the National Institute of Environmental
Health Sciences;
‘‘(5) the National Institute of Neurological Dis-
orders and Stroke; and
‘‘(6) the National Cancer Institute.
‘‘(b) STUDY SECTIONS.—The Director of NIH shall
establish a study section or special emphasis panel if de-
termined to be appropriate, for the National Institutes of
Health to review extramural research grant applications
regarding silicone breast implants to ensure the appro-
priate design and high quality of such research and shall
take appropriate action to ensure the quality of intramural
research activities.
‘‘(c) CLINICAL STUDY.—
‘‘(1) IN GENERAL.—The Director of NIH shall
conduct or support research to expand the under-
standing of the health implications of silicone breast
implants. Such research should, if determined to be
scientifically appropriate, include a multidisciplinary,
clinical, case-controlled study of women with silicone
breast implants. Such a study should involve women
who have had such implants in place for at least 8
years, focus on atypical disease presentation, neuro-
logical dysfunction, and immune system irregular-
ities, and evaluate to what extent if any, their health
differs from that of suitable controls, including
women with saline implants as a subset.
‘‘(2) ANNUAL REPORT.—The Director of NIH
shall annually prepare and submit to the appropriate
Committees of Congress a report concerning the re-
sults of the study conducted under paragraph (1).’’.
SEC. 4. EXPANSION AND INTENSIFICATION OF ACTIVITIES
REGARDING SILICONE BREAST IMPLANTS AT
THE FOOD AND DRUG ADMINISTRATION.
To assist women and doctors in receiving accurate
and complete information about the risks of silicone breast
implants, the Commissioner on Food and Drugs shall—
(1) ensure that the toll-free Consumer Informa-
tion Line and materials concerning breast implants
provided by the Food and Drug Administration are
available, up to date, and responsive to reports of
problems with silicone breast implants, and that
timely aggregate data concerning such reports shall
be made available to the public upon request and
consistent with existing confidentiality standards;
(2) revise the Administration’s breast implant
information update to clarify the procedure for re-
porting problems with silicone implants or with the
conduct of adjunct studies, and specifically regard-
ing the use of the Medwatch reporting program;
(3) require that manufacturers of silicone
breast implants update implant package inserts and
informed consent documents regularly to reflect ac-
curate information about such implants, particularly
the rupture rate of such implants; and
(4) require that any manufacturer of such im-
plants that is conducting an adjunct study on sili-
cone breast implants—
(A) amend such study protocol and in-
formed consent document to reflect that pa-
tients must be provided with a copy of informed
consent documents at the initial, or earliest pos-
sible, consultation regarding breast prosthesis;
(B) amend the informed consent to inform
women about how to obtain a Medwatch form
and encourage any woman who withdraws from
the study, or who would like to report a prob-
lem, to submit a Medwatch form to report such
problem or concerns with the study and reasons
for withdrawing; and
(C) amend the informed consent document
to provide potential participants with the inclu-
sion criteria for the clinical trial and the toll-
free Consumer Information number.
SEC. 5. PRESIDENT’S INTERAGENCY COMMITTEE ON SILI-
CONE BREAST IMPLANTS.
(a) ESTABLISHMENT.—There is established an inter-
agency committee, to be known as the President’s Inter-
agency Committee on Silicone Breast Implants (referred
to in this Act as the ‘‘Committee’’), to ensure the strategic
management, communication, and oversight of the policy
formation, research, and activities of the Federal Govern-
ment regarding silicone breast implants.
(b) COMPOSITION.—The Committee shall be com-
posed of—
(1) an individual to be appointed by the Presi-
dent who represents the White House domestic pol-
icy staff;
(2) a representative, to be appointed by the
Secretary of Health and Human Services, from—
(A) the Office of Women’s Health at the
Department of Health and Human Services;
(B) the National Institutes of Health;
(C) the Food and Drug Administration;
and
(D) the Centers for Disease Control and
Prevention;
(3) a representative of the Department of De-
fense with experience in the Department’s breast
cancer research program;
(4) representatives of any other agencies
deemed necessary to accomplish the mission of the
Committee, including the Social Security Adminis-
tration if appropriate;
(5) up to 4 individuals to be appointed by the
President from scientists with established credentials
and publications in the area of silicone breast im-
plants; and
(6) 2 women who have or have had silicone
breast implants to be appointed by the President.
(c) CHAIRPERSON.—
(1) IN
GENERAL.—The individual appointed
under subsection (b)(2)(A), or other official if the
President determines that such other official is more
appropriate, shall service as the chairperson of the
Committee.
(2) DUTIES.—The chairperson of the Commit-
tee shall—
(A) not less than twice each year, convene
meetings of the Committee; and
(B) compile information for the consider-
ation of the full Committee at such meetings.
(d) MEETINGS.—The meetings of the Committee
shall be open to the public and public witnesses shall be
given the opportunity to speak and make presentations at
such meetings. Each member of the Committee shall make
a presentation to the full Committee at each such meeting
concerning the activities conducted by such member or by
the entity that such member is representing related to sili-
cone breast implants.
(e) ADMINISTRATIVE PROVISIONS.—
(1) TERMS AND VACANCIES.—A member of the
Committee shall serve for a term of 2 or 4 years (ro-
tating terms). A member may be reappointed 2
times, but shall not exceed 8 years of service. Any
vacancy in the membership of the Committee shall
be filled in the manner in which the original appoint-
ment was made and shall not affect the power of the
remaining members to carry out the duties of the
Committee.
(2) COMPENSATION; REIMBURSEMENT OF EX-
PENSES.—Members of the Committee may not re-
ceive compensation for service on the Committee.
Such members may, in accordance with chapter 57
of title 5, United States Code, be reimbursed for
travel, subsistence, and other necessary expenses in-
curred in carrying out the duties of the Committee.
(3) STAFF; ADMINISTRATIVE
SUPPORT.—The
Secretary of Health and Human Services shall, on
a reimbursable basis, provide to the Committee such
staff, administrative support, and other assistance
as may be necessary for the Committee to effectively
carry out the duties under this section.
(4) CONFLICT OF INTEREST.—The members of
the Committee shall not be in violation of any Fed-
eral conflict of interest laws.
(f) AUTHORIZATION
OF APPROPRIATIONS.—There
are authorized to be appropriated such sums as may be
necessary to carry out this section.
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