II

105TH CONGRESS

2D SESSION S. 2154

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

JUNE 10, 1998

Mrs. BOXER introduced the following bill; which was read twice and referred

to the Committee on Labor and Human Resources

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:
2

•S 2154 IS

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 them.

22 (7) In addition to potential systemic complica23 tions, local changes in breast tissue such as harden24 ing, contraction of scar tissue surrounding implants,

25 blood clots, severe pain, burning rashes, serious in-
3

•S 2154 IS

1 flammation, or other complications requiring sur2 gical intervention following implantation have been

3 reported.

4 (8) According to the Institute of Medicine, con5 cern remains that exposure to silicone or other com6 ponents in silicone breast implants may result in

7 currently undefined connective tissue or autoimmune

8 diseases.

9 (9) A group of independent scientists and clini10 cians convened by the National Institute of Arthritis

11 and Musculoskeletal and Skin Diseases in April of

12 1997 addressed concerns that an association may

13 exist between atypical connective tissue disease and

14 silicone breast implants, and called for additional

15 basic research on the components of silicone as well

16 as biological responses to silicone.

17 (10) According to many reports, including a

18 study published in the Journal of the National Can19 cer Institute, the presence of silicone breast implants

20 may create difficulties in obtaining complete mam21 mograms.

22 (11) According to a 1995 Food and Drug Ad23 ministration publication, although silicone breast im24 plants usually do not interfere with a woman’s abil25 ity to nurse, if the implants leak, there is some con-
4

•S 2154 IS

1 cern that the silicone may harm the baby. Some

2 studies suggest a link between breast feeding with

3 implants and problems with the child’s esophagus.

4 (b) PURPOSE.—It is the purpose of this Act to pro5 mote research to identify and evaluate the health effects

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

7 their doctors receive accurate information about such im8 plants.

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

10 shall be construed to affect any rule or regulation promul11 gated under the authority of the Food, Drug and Cosmetic

12 Act that is in effect on the date of enactment of this Act

13 relating to the availability of silicone breast implants for

14 reconstruction after mastectomy, correction of congenital

15 deformities, or replacement for ruptured silicone implants

16 for augmentation.

17 SEC. 3. EXPANSION AND INTENSIFICATION OF ACTIVITIES

18 REGARDING SILICONE BREAST IMPLANTS AT

19 THE NATIONAL INSTITUTES OF HEALTH.

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

21 (42 U.S.C. 289 et seq.) is amended by adding at the end

22 the following:

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

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

25 of NIH shall appoint an appropriate official of the Depart-
5

•S 2154 IS

1 ment of Health and Human Services to serve as the Na2 tional Institutes of Health coordinator regarding silicone

3 breast implant research. Such coordinator shall encourage

4 and coordinate the participation of all appropriate Insti5 tutes in research on silicone breast implants, including—

6 ‘‘(1) the National Institute of Allergy and In7 fectious Diseases;

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

9 Musculoskeletal and Skin Diseases;

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

11 Human Development;

12 ‘‘(4) the National Institute of Environmental

13 Health Sciences;

14 ‘‘(5) the National Institute of Neurological Dis15 orders and Stroke; and

16 ‘‘(6) the National Cancer Institute.

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

18 establish a study section or special emphasis panel if de19 termined to be appropriate, for the National Institutes of

20 Health to review extramural research grant applications

21 regarding silicone breast implants to ensure the appro22 priate design and high quality of such research and shall

23 take appropriate action to ensure the quality of intramural

24 research activities.

25 ‘‘(c) CLINICAL STUDY.—
6

•S 2154 IS

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

2 conduct or support research to expand the under3 standing of the health implications of silicone breast

4 implants. Such research should, if determined to be

5 scientifically appropriate, include a multidisciplinary,

6 clinical, case-controlled study of women with silicone

7 breast implants. Such a study should involve women

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

9 years, focus on atypical disease presentation, neuro10 logical dysfunction, and immune system irregular11 ities, and evaluate to what extent if any, their health

12 differs from that of suitable controls, including

13 women with saline implants as a subset.

14 ‘‘(2) ANNUAL REPORT.—The Director of NIH

15 shall annually prepare and submit to the appropriate

16 Committees of Congress a report concerning the re17 sults of the study conducted under paragraph (1).’’.

18 SEC. 4. EXPANSION AND INTENSIFICATION OF ACTIVITIES

19 REGARDING SILICONE BREAST IMPLANTS AT

20 THE FOOD AND DRUG ADMINISTRATION.

21 To assist women and doctors in receiving accurate

22 and complete information about the risks of silicone breast

23 implants, the Commissioner on Food and Drugs shall—

24 (1) ensure that the toll-free Consumer Informa25 tion Line and materials concerning breast implants
7

•S 2154 IS

1 provided by the Food and Drug Administration are

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

3 problems with silicone breast implants, and that

4 timely aggregate data concerning such reports shall

5 be made available to the public upon request and

6 consistent with existing confidentiality standards;

7 (2) revise the Administration’s breast implant

8 information update to clarify the procedure for re9 porting problems with silicone implants or with the

10 conduct of adjunct studies, and specifically regard11 ing the use of the Medwatch reporting program;

12 (3) require that manufacturers of silicone

13 breast implants update implant package inserts and

14 informed consent documents regularly to reflect ac15 curate information about such implants, particularly

16 the rupture rate of such implants; and

17 (4) require that any manufacturer of such im18 plants that is conducting an adjunct study on sili19 cone breast implants—

20 (A) amend such study protocol and in21 formed consent document to reflect that pa22 tients must be provided with a copy of informed

23 consent documents at the initial, or earliest pos24 sible, consultation regarding breast prosthesis;
8

•S 2154 IS

1 (B) amend the informed consent to inform

2 women about how to obtain a Medwatch form

3 and encourage any woman who withdraws from

4 the study, or who would like to report a prob5 lem, to submit a Medwatch form to report such

6 problem or concerns with the study and reasons

7 for withdrawing; and

8 (C) amend the informed consent document

9 to provide potential participants with the inclu10 sion criteria for the clinical trial and the toll11 free Consumer Information number.

12 SEC. 5. PRESIDENT’S INTERAGENCY COMMITTEE ON SILI13 CONE BREAST IMPLANTS.

14 (a) ESTABLISHMENT.—There is established an inter15 agency committee, to be known as the President’s Inter16 agency Committee on Silicone Breast Implants (referred

17 to in this Act as the ‘‘Committee’’), to ensure the strategic

18 management, communication, and oversight of the policy

19 formation, research, and activities of the Federal Govern20 ment regarding silicone breast implants.

21 (b) COMPOSITION.—The Committee shall be com22 posed of—

23 (1) an individual to be appointed by the Presi24 dent who represents the White House domestic pol25 icy staff;
9

•S 2154 IS

1 (2) a representative, to be appointed by the

2 Secretary of Health and Human Services, from—

3 (A) the Office of Women’s Health at the

4 Department of Health and Human Services;

5 (B) the National Institutes of Health;

6 (C) the Food and Drug Administration;

7 and

8 (D) the Centers for Disease Control and

9 Prevention;

10 (3) a representative of the Department of De11 fense with experience in the Department’s breast

12 cancer research program;

13 (4) representatives of any other agencies

14 deemed necessary to accomplish the mission of the

15 Committee, including the Social Security Adminis16 tration if appropriate;

17 (5) up to 4 individuals to be appointed by the

18 President from scientists with established credentials

19 and publications in the area of silicone breast im20 plants; and

21 (6) 2 women who have or have had silicone

22 breast implants to be appointed by the President.

23 (c) CHAIRPERSON.—

24 (1) IN GENERAL.—The individual appointed

25 under subsection (b)(2)(A), or other official if the
10

•S 2154 IS

1 President determines that such other official is more

2 appropriate, shall service as the chairperson of the

3 Committee.

4 (2) DUTIES.—The chairperson of the Commit5 tee shall—

6 (A) not less than twice each year, convene

7 meetings of the Committee; and

8 (B) compile information for the consider9 ation of the full Committee at such meetings.

10 (d) MEETINGS.—The meetings of the Committee

11 shall be open to the public and public witnesses shall be

12 given the opportunity to speak and make presentations at

13 such meetings. Each member of the Committee shall make

14 a presentation to the full Committee at each such meeting

15 concerning the activities conducted by such member or by

16 the entity that such member is representing related to sili17 cone breast implants.

18 (e) ADMINISTRATIVE PROVISIONS.—

19 (1) TERMS AND VACANCIES.—A member of the

20 Committee shall serve for a term of 2 or 4 years (ro21 tating terms). A member may be reappointed 2

22 times, but shall not exceed 8 years of service. Any

23 vacancy in the membership of the Committee shall

24 be filled in the manner in which the original appoint25 ment was made and shall not affect the power of the
11

•S 2154 IS

1 remaining members to carry out the duties of the

2 Committee.

3 (2) COMPENSATION; REIMBURSEMENT OF EX4 PENSES.—Members of the Committee may not re5 ceive compensation for service on the Committee.

6 Such members may, in accordance with chapter 57

7 of title 5, United States Code, be reimbursed for

8 travel, subsistence, and other necessary expenses in9 curred in carrying out the duties of the Committee.

10 (3) STAFF; ADMINISTRATIVE SUPPORT.—The

11 Secretary of Health and Human Services shall, on

12 a reimbursable basis, provide to the Committee such

13 staff, administrative support, and other assistance

14 as may be necessary for the Committee to effectively

15 carry out the duties under this section.

16 (4) CONFLICT OF INTEREST.—The members of

17 the Committee shall not be in violation of any Fed18 eral conflict of interest laws.

19 (f) AUTHORIZATION OF APPROPRIATIONS.—There

20 are authorized to be appropriated such sums as may be

21 necessary to carry out this section.

Æ