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106TH CONGRESS

1ST SESSION S. 1075

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 SENATE OF THE UNITED STATES

MAY 19, 1999

Mrs. BOXER (for herself, Mrs. HUTCHISON, and Ms. LANDRIEU) 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 silicone breast implants, and to ensure that

women and their doctors receive accurate information

about such implants.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Silicone Breast Im5 plant Research and Information Act’’.

6 SEC. 2. FINDINGS AND PURPOSE.

7 (a) FINDINGS.—Congress makes the following find8 ings:
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1 (1) According to the Institute of Medicine, it is

2 estimated that 1,000,000 to 2,000,000 American

3 women have received silicone breast implants over

4 the last 35 years.

5 (2) Silicone breast implants have been used pri6 marily for breast augmentation, but also as an im7 portant part of reconstruction surgery for breast

8 cancer or other conditions.

9 (3) Women with breast cancer or other medical

10 conditions seek access to the broadest possible treat11 ment options, including silicone breast implants.

12 (4) Women need complete and accurate infor13 mation about the potential health risks and advan14 tages of silicone breast implants so that women can

15 make informed decisions.

16 (5) Although the rate of implant rupture and

17 silicone leakage has not been definitively established,

18 estimates are as high as 70 percent.

19 (6) According to a 1997 Mayo Clinic study, 1

20 in 4 women required additional surgery because of

21 their implants within 5 years of receiving such im22 plants.

23 (7) In addition to potential systemic complica24 tions, local changes in breast tissue such as hard25 ening, contraction of scar tissue surrounding im-
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1 plants, blood clots, severe pain, burning rashes, seri2 ous inflammation, or other complications requiring

3 surgical intervention following implantation have

4 been reported.

5 (8) According to the National Science Panel

6 Report released in December 1998, the current body

7 of research on silicone breast implants in immu8 nology, rheumatology, toxicology, and epidemiology

9 is inadequate to conclusively determine the effects of

10 silicone. The National Science Panel pointed to

11 many limitations in research methodology and data

12 analysis used in past studies clearly demonstrating

13 the need for future independent clinical research.

14 (9) According to the Institute of Medicine, con15 cern remains that exposure to silicone or other com16 ponents in silicone breast implants may result in

17 currently undefined connective tissue or autoimmune

18 diseases.

19 (10) A group of independent scientists and cli20 nicians convened by the National Institute of Arthri21 tis and Musculoskeletal and Skin Diseases in April

22 of 1997 addressed concerns that an association may

23 exist between atypical connective tissue disease and

24 silicone breast implants, and called for additional
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1 basic research on the components of silicone as well

2 as biological responses to silicone.

3 (11) According to many reports, including a

4 study published in the Journal of the National Can5 cer Institute, the presence of silicone breast implants

6 may create difficulties in obtaining complete mam7 mograms.

8 (12) According to a 1998 Food and Drug Ad9 ministration publication, although silicone breast im10 plants usually do not interfere with a woman’s abil11 ity to nurse, if the implants leak, there is some con12 cern that the silicone may harm the baby. Some

13 studies suggest a link between breast feeding with

14 implants and problems with the child’s esophagus.

15 (b) PURPOSE.—It is the purpose of this Act to pro16 mote research to identify and evaluate the health effects

17 of silicone breast implants, and to ensure that women and

18 their doctors receive accurate information about such im19 plants.

20 (c) RULE OF CONSTRUCTION.—Nothing in this Act

21 shall be construed to affect any rule or regulation promul22 gated under the authority of the Federal Food, Drug, and

23 Cosmetic Act (21 U.S.C. 321 et seq.) that is in effect on

24 the date of enactment of this Act relating to the avail25 ability of silicone breast implants for reconstruction after
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1 mastectomy, correction of congenital deformities, or re2 placement for ruptured silicone implants for augmenta3 tion.

4 SEC. 3. EXPANSION AND INTENSIFICATION OF ACTIVITIES

5 REGARDING SILICONE BREAST IMPLANTS AT

6 THE NATIONAL INSTITUTES OF HEALTH.

7 Part H of title IV of the Public Health Service Act

8 (42 U.S.C. 289 et seq.) is amended by adding at the end

9 the following:

10 ‘‘SEC. 498C. SILICONE BREAST IMPLANT RESEARCH.

11 ‘‘(a) INSTITUTE-WIDE COORDINATOR.—The Director

12 of NIH shall appoint an appropriate official of the Depart13 ment of Health and Human Services to serve as the Na14 tional Institutes of Health coordinator regarding silicone

15 breast implant research. Such coordinator shall encourage

16 and coordinate the participation of all appropriate Insti17 tutes in research on silicone breast implants, including—

18 ‘‘(1) the National Institute of Allergy and In19 fectious Diseases;

20 ‘‘(2) the National Institute of Arthritis and

21 Musculoskeletal and Skin Diseases;

22 ‘‘(3) the National Institute of Child Health and

23 Human Development;

24 ‘‘(4) the National Institute of Environmental

25 Health Sciences;
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1 ‘‘(5) the National Institute of Neurological Dis2 orders and Stroke; and

3 ‘‘(6) the National Cancer Institute.

4 ‘‘(b) STUDY SECTIONS.—The Director of NIH shall

5 establish a study section or special emphasis panel if de6 termined to be appropriate, for the National Institutes of

7 Health to review extramural research grant applications

8 regarding silicone breast implants to ensure the appro9 priate design and high quality of such research and shall

10 take appropriate action to ensure the quality of intramural

11 research activities.

12 ‘‘(c) CLINICAL STUDY.—

13 ‘‘(1) IN GENERAL.—The Director of NIH shall

14 conduct or support research to expand the under15 standing of the health implications of silicone breast

16 implants. Such research should, if determined to be

17 scientifically appropriate, include a multidisciplinary,

18 clinical, case-controlled study of women with silicone

19 breast implants. Such a study should involve women

20 who have had such implants in place for at least 8

21 years, focus on atypical disease presentation, neuro22 logical dysfunction, and immune system irregular23 ities, and evaluate to what extent if any, their health

24 differs from that of suitable controls, including

25 women with saline implants as a subset.
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1 ‘‘(2) ANNUAL REPORT.—The Director of NIH

2 shall annually prepare and submit to the appropriate

3 Committees of Congress a report concerning the re4 sults of the study conducted under paragraph (1).’’.

5 SEC. 4. EXPANSION AND INTENSIFICATION OF ACTIVITIES

6 REGARDING SILICONE BREAST IMPLANTS AT

7 THE FOOD AND DRUG ADMINISTRATION.

8 To assist women and doctors in receiving accurate

9 and complete information about the risks of silicone breast

10 implants, the Commissioner of Food and Drugs shall—

11 (1) ensure that the toll-free Consumer Informa12 tion Line and materials concerning breast implants

13 provided by the Food and Drug Administration are

14 available, up to date, and responsive to reports of

15 problems with silicone breast implants, and that

16 timely aggregate data concerning such reports shall

17 be made available to the public upon request and

18 consistent with existing confidentiality standards;

19 (2) revise the Administration’s breast implant

20 information update to clarify the procedure for re21 porting problems with silicone implants or with the

22 conduct of adjunct studies, and specifically regard23 ing the use of the Medwatch reporting program;

24 (3) require that manufacturers of silicone

25 breast implants update implant package inserts and
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1 informed consent documents regularly to reflect ac2 curate information about such implants, particularly

3 the rupture rate of such implants; and

4 (4) require that any manufacturer of such im5 plants that is conducting an adjunct study on sili6 cone breast implants—

7 (A) amend such study protocol and in8 formed consent document to reflect that pa9 tients must be provided with a copy of informed

10 consent documents at the initial, or earliest pos11 sible, consultation regarding breast prosthesis;

12 (B) amend the informed consent to inform

13 women about how to obtain a Medwatch form

14 and encourage any woman who withdraws from

15 the study, or who would like to report a prob16 lem, to submit a Medwatch form to report such

17 problem or concerns with the study and reasons

18 for withdrawing; and

19 (C) amend the informed consent document

20 to provide potential participants with the inclu21 sion criteria for the clinical trial and the toll22 free Consumer Information number.

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