(4) Silicone breast implants have never been ap-
proved 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 com-
plication and reoperation rates. After three years, 43
percent of the augmentation patients and 73 percent
of the reconstruction patients experienced local com-
plications and 40 percent of the reconstruction pa-
tients were forced to undergo additional surgery for
local complications and device failure.
(5) In 1998, the Food and Drug Administra-
tion opened a criminal investigation following allega-
tions 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 sa-
line implants, it was not informed of the investiga-
tion. Although the manufacturer’s saline breast im-
plant was approved by the Food and Drug Adminis-
tration 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 Jour-
nal of Autoimmunity, investigated the influence of
silicone breast implants on the expression of
anticollagen antibodies and found a statistically sig-
nificant incidence of anticollagen antibodies in
women with implants. The researchers concluded
that silicone breast implants should not be consid-
ered a benign or immunologically inert material; se-
rious implications may result from their use.
(9) The Institute of Medicine’s 1999 study of
silicone breast implant safety found that local com-
plications with silicone breast implants were the pri-
mary safety issue, that they have not been well stud-
ied, and that information on these complications is
crucial for women deciding whether or not they want
breast implant surgery. Concern remains that expo-
sure to silicone breast implants may result in cur-
rently 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 sili-
cone migration in women with ruptured or leaking
silicone breast implants. These patients experienced
severe local inflammation and complications result-
ing from silicone migration to the axilla, arm or ab-
dominal wall. Researchers concluded that once sili-
cone 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 Can-
cer Institute, the presence of a silicone breast im-
plant 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 Ad-
ministration publication, women of childbearing age
who want to breast feed should be aware of the neg-
ative 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 pro-
mote 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 promul-
gated 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 avail-
ability of silicone breast implant for reconstruction after
mastectomy, correction of congenital deformities, or re-
placement for ruptured silicone implants for augmenta-
tion.
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 ap-
propriate committees of Congress on the status of the ex-
isting 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 Depart-
ment of Health and Human Services to serve as the Na-
tional 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 In-
fectious 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 Dis-
orders 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 de-
termined to be appropriate, for the National Institutes of
Health to review extramural research grant applications
regarding breast implants to ensure the appropriate de-
sign and high quality of such research and shall take ap-
propriate action to ensure the quality of intramural re-
search 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 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 dif-
ferentiate 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, defla-
tion and rupture as well as the presentation of atypi-
cal symptoms, silicone migration, neurological dys-
function, 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 re-
sults of the study conducted under paragraph (1).’’.
SEC. 4. INTENSIFICATION OF ACTIVITIES REGARDING
POSTMARKET RESEARCH OF SALINE BREAST
IMPLANTS AT THE FOOD AND DRUG ADMINIS-
TRATION.
To ensure that the Food and Drug Administration
conducts postmarket evaluations of saline implant manu-
facturers’ 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 of the agency’s
criminal investigation into allegations of wrong-doing
by one of the implant manufacturers; brief appro-
priate 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 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 breast implants, and that timely ag-
gregate 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 ac-
curate information about such implants, particularly
the rate of local complications and ruptures of such
implants;
(4) require that any manufacturers of such im-
plants that are conducting clinical studies on silicone
breast implants—
(A) require its clinical investigators to pro-
vide prospective patients with the Food and
Drug Administration’s breast implant booklet;
(B) 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;
(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 inclu-
sion 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 ad-
vertisements 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 re-
cipients, 
bioethicists, 
rheumatologists, 
and
oncologists with experience in both clinical care
and research regarding breast implants.
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