[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 961 Introduced in Senate (IS)]
107th CONGRESS
1st Session
S. 961
To promote research to identify and evaluate the health effects of
breast implants; to ensure that women receive accurate information
about such implants and to encourage the Food and Drug Administration
to thoroughly review the implant manufacturers' standing with the
agency.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
May 24, 2001
Mrs. Boxer introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To promote research to identify and evaluate the health effects of
breast implants; to ensure that women receive accurate information
about such implants and to encourage the Food and Drug Administration
to thoroughly review the implant manufacturers' standing with the
agency.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Breast Implant Research and
Information Act''.
SEC. 2. FINDINGS AND PURPOSE.
(a) Findings.--Congress makes the following findings:
(1) According to the Institute of Medicine, it is estimated
that 1,000,000 to 2,000,000 American women have received breast
implants over the last 35 years. Because there has never been a
patient registry for breast implant recipients it is impossible
to more accurately determine the number of women who have
received breast implants. Yet, the American Society of Plastic
Surgeons estimates that in 1999 alone 82,975 women had breast
reconstruction following mastectomies and another 167,318
American women received breast implants for cosmetic purposes.
(2) From 1985 until January 2000, FDA received 127,770
adverse reaction reports for silicone gel-filled breast
implants and 65,720 adverse reaction reports for saline-filled
implants.
(3) Women need complete and accurate information about the
potential health risks and advantages of breast implants so
that women can make informed decisions.
(4) Silicone breast implants have never been approved by
the Food and Drug Administration; saline breast implants, which
consist of a saline solution injected into a silicone envelope,
were approved by the agency in 2000 despite alarmingly high
complication and reoperation rates. After three years, 43
percent of the augmentation patients and 73 percent of the
reconstruction patients experienced local complications and 40
percent of the reconstruction patients were forced to undergo
additional surgery for local complications and device failure.
(5) In 1998, the Food and Drug Administration opened a
criminal investigation following allegations that one of the
breast implant manufacturers was manipulating research data in
breast implant studies. When the Food and Drug Administration's
General and Plastic Surgery Devices Panel convened in March
2000 to consider market approval for saline implants, it was
not informed of the investigation. Although the manufacturer's
saline breast implant was approved by the Food and Drug
Administration in May 2000, the investigation remains open.
(6) According to a 1997 Mayo Clinic study, within 5 years
of receiving such implants, 1 in 4 women required additional
surgery.
(7) In 2000, research sponsored by the Food and Drug
Administration found that even among women who had not sought
medical treatment for implant problems, almost 70 percent had
at least one ruptured implant after 10 to 15 years. Silicone
was found to be migrating away from the implants in 21 percent
of those women. The FDA researchers concluded that ``the
relationship of free silicone to development or progression of
disease is unknown''.
(8) A 1993 study by Dr. Suzanne S. Teuber et al.,
University of California, published in The Journal of
Autoimmunity, investigated the influence of silicone breast
implants on the expression of anticollagen antibodies and found
a statistically significant incidence of anticollagen
antibodies in women with implants. The researchers concluded
that silicone breast implants should not be considered a benign
or immunologically inert material; serious implications may
result from their use.
(9) The Institute of Medicine's 1999 study of silicone
breast implant safety found that local complications with
silicone breast implants were the primary safety issue, that
they have not been well studied, and that information on these
complications is crucial for women deciding whether or not they
want breast implant surgery. Concern remains that exposure to
silicone breast implants may result in currently undefined
connective tissue or autoimmune diseases.
(10) A 2001 National Cancer Institute study found breast
implant recipients suffer from higher rates of lung and brain
cancer than other plastic surgery patients.
(11) A 1999 case report by Dr. Suzanne S. Teuber et al.,
University of California, published in The Journal of
Rheumatology, found evidence of silicone migration in women
with ruptured or leaking silicone breast implants. These
patients experienced severe local inflammation and
complications resulting from silicone migration to the axilla,
arm or abdominal wall. Researchers concluded that once silicone
gel leaves the implant, it is not biologically inert and in
some persons can elicit profound pathologic responses.
(12) According to many reports, including a study published
in the Journal of the National Cancer Institute, the presence
of a silicone breast implant may create difficulties in
obtaining accurate and thorough mammograms because as much as
40 percent of the breast tissue can be masked by the implant.
This delays the early detection of breast cancer in women.
(13) According to a 2000 Food and Drug Administration
publication, women of childbearing age who want to breast feed
should be aware of the negative impact of breast implants on
breast feeding. 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.
(b) Purpose.--It is the purpose of this Act to promote research to
identify and evaluate the health effects of breast implants, to ensure
that women receive accurate information about such implants and to
encourage the Food and Drug Administration to conclude its criminal
investigation based on the allegations of wrong-doing by one of the
implant manufacturers which ultimately may affect their products and
the health of American women.
(c) Rule of Construction.--Nothing in this Act shall be construed
to affect any rule or regulation promulgated under the authority of the
Federal Food, Drug and Cosmetic Act (21 U.S. 301 et seq.) that is in
effect on the date of enactment of this Act relating to the
availability of silicone breast implant 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.
(a) Status of Existing Research.--The Director of the National
Institutes of Health shall report to all appropriate committees of
Congress on the status of the existing breast implant research funded
by such Institutes within 90 days after the date of the enactment of
this Act.
(b) Amendment to Public Health Service Act.--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 of the following:
``SEC. 498C. BREAST IMPLANT RESEARCH.
``(a) Institute-Wide Coordinator.--The Director of NIH shall
appoint an appropriate official of the Department of Health and Human
Services to serve as the National Institutes of Health coordinator
regarding breast implant research. Such coordinator shall encourage and
coordinate the participation of all appropriate Institutes research
including--
``(1) the Office of Research on Women's Health;
``(2) the National Institute of Allergy and Infectious
Diseases;
``(3) the National Institute of Arthritis and
Musculoskeletal and Skin diseases;
``(4) the National Institute of Child Health and Human
Development;
``(5) the National Institute of Environmental Health
Sciences;
``(6) the National Institute of Neurological Disorders and
Stroke; and
``(7) the National Cancer Institute.
``(b) Study Sections.--The Director of NIH shall establish a study
section or special emphasis panel if determined to be appropriate, for
the National Institutes of Health to review extramural research grant
applications regarding breast implants to ensure the appropriate 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 understanding of the health
implications of both saline and silicone breast implants. Such
research should, if determined to be scientifically
appropriate, include multidisciplinary, clinical, case-
controlled study of women with breast implants for at least
eight years whether it be one prosthesis or multiple, and
differentiate between women receiving implants for mastectomy,
reconstructive or cosmetic purposes and include subsets of women with
saline implants and silicone implants. Such a study should focus on the
rate of local complications which includes capsular contracture,
leakage, loss of nipple sensation, deflation and rupture as well the
presentation of atypical symptoms, silicone migration, neurological
dysfunction, and immune system irregularities, and evaluate to what
extent if any, their health differs from that of suitable controls.
``(2) Annual report.--The Director of NIH shall annually
prepare and submit to the appropriate Committees of Congress a
report concerning the results of the study conducted under
paragraph (1).''.
SEC. 4. INTENSIFICATION OF ACTIVITIES REGARDING POSTMARKET RESEARCH OF
SALINE BREAST IMPLANTS AT THE FOOD AND DRUG
ADMINISTRATION.
To ensure that the Food and Drug Administration conducts postmarket
evaluations of saline implant manufacturers' data based on the
postmarket recommendations made by the Food and Drug Administration's
General and Plastic Surgery Devices Panel, the Commissioner of Food and
Drugs shall report to Congress on the implementation status of the
postmarket recommendations at 6, 12, and 18 month intervals after the
date of the enactment of this Act and annually thereafter.
SEC. 5. EXPANSION AND INTENSIFICATION OF ACTIVITIES REGARDING SILICONE
BREAST IMPLANTS AT THE FOOD AND DRUG ADMINISTRATION.
To assist women in receiving accurate and complete information
about the risks of silicone breast implants, the Commissioner of Food
and Drugs shall--
(1) expedite the conclusion the agency's criminal
investigation into allegations of wrong-doing by one of the
implant manufacturers; brief appropriate Committees of Congress
on the findings and take appropriate action within 90 days
after the date of the enactment of this Act;
(2) ensure that the toll-free consumer information 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 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;
(3) require that manufacturers of silicone breast implants
update implant package inserts and informed consent documents
regularly to reflect accurate information about such implants,
particularly the rate of local complications and ruptures of
such implants;
(4) require that any manufacturers of such implants that
are conducting clinical studies on silicone breast implants--
(A) require its clinical investigators to provide
prospective patients with the Food and Drug
Administration's breast implant booklet;
(B) amend such study protocol and informed consent
document to reflect that patients must be provided with
a copy of informed consent documents at the initial, or
earliest possible, consultation regarding breast
prosthesis;
(C) amend the informed consent protocol 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 such problem or concerns with the study
and reason for withdrawing; and
(D) amend the informed consent document to provide
potential participants with the inclusion criteria for
the clinical trial and the toll-free Consumer
Information number; and
(5) appoint a special ad hoc patient information panel
that--
(A) convenes annually for the sole purpose of
reviewing breast implant information and advertisements
provided by the manufacturers and the Food and Drug
Administration to ensure consumer information is
thorough and accurate; and
(B) includes in its membership (but is not limited
to) saline and silicone breast implant recipients,
bioethicists, rheumatologists, and oncologists with
experience in both clinical care and research regarding
breast implants.
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