I
106TH CONGRESS
1ST SESSION
H. R. 1323
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
MARCH 25, 1999
Mr. GREEN of Texas (for himself, Mr. SHERMAN, Mr. SANDERS, Mr.
DEFAZIO, Mr. FROST, Mr. LAFALCE, Mr. BENTSEN, Mr. SANDLIN, Mr.
BALDACCI, Ms. STABENOW, Mr. FILNER, Mr. BROWN of Ohio, Mrs.
MALONEY of New York, Mr. UNDERWOOD, Ms. PELOSI, Mr. WAXMAN,
Mr. SHOWS, Mr. JEFFERSON, Mr. LAMPSON, Mr. MCNULTY, Ms.
DEGETTE, Mr. HORN, Ms. JACKSON-LEE of Texas, Mrs. THURMAN, Mr.
FORD, Ms. CARSON, Mr. GILMAN, Mr. MALONEY of Connecticut, Mr.
RANGEL, Mr. ENGEL, Ms. NORTON, Ms. RIVERS, Mrs. EMERSON, Ms.
KAPTUR, Mr. PAYNE, Mr. WYNN, Mr. PALLONE, Mr. GONZALEZ, Mrs.
WILSON, Mr. WHITFIELD, Mr. HULSHOF, and Mr. KIND) 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 hard-
ening, contraction of scar tissue surrounding im-
plants, blood clots, severe pain, burning rashes, seri-
ous inflammation, or other complications requiring
surgical intervention following implantation have
been reported.
(8) According to the National Science Panel
Report released in December 1998, the current body
of research on silicone breast implants in immu-
nology, rheumatology, toxicology, and epidemiology
is inadequate to conclusively determine the effects of
silicone. The National Science Panel pointed to
many limitations in research methodology and data
analysis used in past studies clearly demonstrating
the need for future independent clinical research.
(9) 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.
(10) A group of independent scientists and cli-
nicians convened by the National Institute of Arthri-
tis 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.
(11) 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.
(12) According to a 1998 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 Federal 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 sili-
cone 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