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.

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

2 This Act may be cited as the ‘‘Silicone Breast Im3 plant Research and Information Act’’.

4 SEC. 2. FINDINGS AND PURPOSE.

5 (a) FINDINGS.—Congress makes the following find6 ings:

7 (1) According to the Institute of Medicine, it is

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

9 women have received silicone breast implants over

10 the last 35 years.

11 (2) Silicone breast implants have been used pri12 marily for breast augmentation, but also as an im13 portant part of reconstruction surgery for breast

14 cancer or other conditions.

15 (3) Women with breast cancer or other medical

16 conditions seek access to the broadest possible treat17 ment options, including silicone breast implants.

18 (4) Women need complete and accurate infor19 mation about the potential health risks and advan20 tages of silicone breast implants so that women can

21 make informed decisions.

22 (5) Although the rate of implant rupture and

23 silicone leakage has not been definitively established,

24 estimates are as high as 70 percent.
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1 (6) According to a 1997 Mayo Clinic study, 1

2 in 4 women required additional surgery because of

3 their implants within 5 years of receiving them.

4 (7) In addition to potential systemic complica5 tions, local changes in breast tissue such as hard6 ening, contraction of scar tissue surrounding im7 plants, blood clots, severe pain, burning rashes, seri8 ous inflammation, or other complications requiring

9 surgical intervention following implantation have

10 been reported.

11 (8) According to the National Science Panel

12 Report released in December 1998, the current body

13 of research on silicone breast implants in immu14 nology, rheumatology, toxicology, and epidemiology

15 is inadequate to conclusively determine the effects of

16 silicone. The National Science Panel pointed to

17 many limitations in research methodology and data

18 analysis used in past studies clearly demonstrating

19 the need for future independent clinical research.

20 (9) According to the Institute of Medicine, con21 cern remains that exposure to silicone or other com22 ponents in silicone breast implants may result in

23 currently undefined connective tissue or autoimmune

24 diseases.
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1 (10) A group of independent scientists and cli2 nicians convened by the National Institute of Arthri3 tis and Musculoskeletal and Skin Diseases in April

4 of 1997 addressed concerns that an association may

5 exist between atypical connective tissue disease and

6 silicone breast implants, and called for additional

7 basic research on the components of silicone as well

8 as biological responses to silicone.

9 (11) According to many reports, including a

10 study published in the Journal of the National Can11 cer Institute, the presence of silicone breast implants

12 may create difficulties in obtaining complete mam13 mograms.

14 (12) According to a 1998 Food and Drug Ad15 ministration publication, although silicone breast im16 plants usually do not interfere with a woman’s abil17 ity to nurse, if the implants leak, there is some con18 cern that the silicone may harm the baby. Some

19 studies suggest a link between breast feeding with

20 implants and problems with the child’s esophagus.

21 (b) PURPOSE.—It is the purpose of this Act to pro22 mote research to identify and evaluate the health effects

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

24 their doctors receive accurate information about such im25 plants.
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1 (c) RULE OF CONSTRUCTION.—Nothing in this Act

2 shall be construed to affect any rule or regulation promul3 gated under the authority of the Federal Food, Drug and

4 Cosmetic Act that is in effect on the date of enactment

5 of this Act relating to the availability of silicone breast

6 implants for reconstruction after mastectomy, correction

7 of congenital deformities, or replacement for ruptured sili8 cone implants for augmentation.

9 SEC. 3. EXPANSION AND INTENSIFICATION OF ACTIVITIES

10 REGARDING SILICONE BREAST IMPLANTS AT

11 THE NATIONAL INSTITUTES OF HEALTH.

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

13 (42 U.S.C. 289 et seq.) is amended by adding at the end

14 the following:

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

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

17 of NIH shall appoint an appropriate official of the Depart18 ment of Health and Human Services to serve as the Na19 tional Institutes of Health coordinator regarding silicone

20 breast implant research. Such coordinator shall encourage

21 and coordinate the participation of all appropriate Insti22 tutes in research on silicone breast implants, including—

23 ‘‘(1) the National Institute of Allergy and In24 fectious Diseases;
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1 ‘‘(2) the National Institute of Arthritis and

2 Musculoskeletal and Skin Diseases;

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

4 Human Development;

5 ‘‘(4) the National Institute of Environmental

6 Health Sciences;

7 ‘‘(5) the National Institute of Neurological Dis8 orders and Stroke; and

9 ‘‘(6) the National Cancer Institute.

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

11 establish a study section or special emphasis panel if de12 termined to be appropriate, for the National Institutes of

13 Health to review extramural research grant applications

14 regarding silicone breast implants to ensure the appro15 priate design and high quality of such research and shall

16 take appropriate action to ensure the quality of intramural

17 research activities.

18 ‘‘(c) CLINICAL STUDY.—

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

20 conduct or support research to expand the under21 standing of the health implications of silicone breast

22 implants. Such research should, if determined to be

23 scientifically appropriate, include a multidisciplinary,

24 clinical, case-controlled study of women with silicone

25 breast implants. Such a study should involve women
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1 who have had such implants in place for at least 8

2 years, focus on atypical disease presentation, neuro3 logical dysfunction, and immune system irregular4 ities, and evaluate to what extent if any, their health

5 differs from that of suitable controls, including

6 women with saline implants as a subset.

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

8 shall annually prepare and submit to the appropriate

9 Committees of Congress a report concerning the re10 sults of the study conducted under paragraph (1).’’.

11 SEC. 4. EXPANSION AND INTENSIFICATION OF ACTIVITIES

12 REGARDING SILICONE BREAST IMPLANTS AT

13 THE FOOD AND DRUG ADMINISTRATION.

14 To assist women and doctors in receiving accurate

15 and complete information about the risks of silicone breast

16 implants, the Commissioner on Food and Drugs shall—

17 (1) ensure that the toll-free Consumer Informa18 tion Line and materials concerning breast implants

19 provided by the Food and Drug Administration are

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

21 problems with silicone breast implants, and that

22 timely aggregate data concerning such reports shall

23 be made available to the public upon request and

24 consistent with existing confidentiality standards;
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1 (2) revise the Administration’s breast implant

2 information update to clarify the procedure for re3 porting problems with silicone implants or with the

4 conduct of adjunct studies, and specifically regard5 ing the use of the Medwatch reporting program;

6 (3) require that manufacturers of silicone

7 breast implants update implant package inserts and

8 informed consent documents regularly to reflect ac9 curate information about such implants, particularly

10 the rupture rate of such implants; and

11 (4) require that any manufacturer of such im12 plants that is conducting an adjunct study on sili13 cone breast implants—

14 (A) amend such study protocol and in15 formed consent document to reflect that pa16 tients must be provided with a copy of informed

17 consent documents at the initial, or earliest pos18 sible, consultation regarding breast prosthesis;

19 (B) amend the informed consent to inform

20 women about how to obtain a Medwatch form

21 and encourage any woman who withdraws from

22 the study, or who would like to report a prob23 lem, to submit a Medwatch form to report such

24 problem or concerns with the study and reasons

25 for withdrawing; and
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1 (C) amend the informed consent document

2 to provide potential participants with the inclu3 sion criteria for the clinical trial and the toll4 free Consumer Information number.

5 SEC. 5. PRESIDENT’S INTERAGENCY COMMITTEE ON SILI6 CONE BREAST IMPLANTS.

7 (a) ESTABLISHMENT.—There is established an inter8 agency committee, to be known as the President’s Inter9 agency Committee on Silicone Breast Implants (referred

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

11 management, communication, and oversight of the policy

12 formation, research, and activities of the Federal Govern13 ment regarding silicone breast implants.

14 (b) COMPOSITION.—The Committee shall be com15 posed of—

16 (1) an individual to be appointed by the Presi17 dent who represents the White House domestic pol18 icy staff;

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

20 Secretary of Health and Human Services, from—

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

22 Department of Health and Human Services;

23 (B) the National Institutes of Health;

24 (C) the Food and Drug Administration;

25 and
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1 (D) the Centers for Disease Control and

2 Prevention;

3 (3) a representative of the Department of De4 fense with experience in the Department’s breast

5 cancer research program;

6 (4) representatives of any other agencies

7 deemed necessary to accomplish the mission of the

8 Committee, including the Social Security Adminis9 tration if appropriate;

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

11 President from scientists with established credentials

12 and publications in the area of silicone breast im13 plants; and

14 (6) 2 women who have or have had silicone

15 breast implants to be appointed by the President.

16 (c) CHAIRPERSON.—

17 (1) IN GENERAL.—The individual appointed

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

19 President determines that such other official is more

20 appropriate, shall service as the chairperson of the

21 Committee.

22 (2) DUTIES.—The chairperson of the Com23 mittee shall—

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

25 meetings of the Committee; and
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1 (B) compile information for the consider2 ation of the full Committee at such meetings.

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

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

5 given the opportunity to speak and make presentations at

6 such meetings. Each member of the Committee shall make

7 a presentation to the full Committee at each such meeting

8 concerning the activities conducted by such member or by

9 the entity that such member is representing related to sili10 cone breast implants.

11 (e) ADMINISTRATIVE PROVISIONS.—

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

13 Committee shall serve for a term of 2 or 4 years (ro14 tating terms). A member may be reappointed 2

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

16 vacancy in the membership of the Committee shall

17 be filled in the manner in which the original appoint18 ment was made and shall not affect the power of the

19 remaining members to carry out the duties of the

20 Committee.

21 (2) COMPENSATION; REIMBURSEMENT OF EX22 PENSES.—Members of the Committee may not re23 ceive compensation for service on the Committee.

24 Such members may, in accordance with chapter 57

25 of title 5, United States Code, be reimbursed for
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1 travel, subsistence, and other necessary expenses in2 curred in carrying out the duties of the Committee.

3 (3) STAFF; ADMINISTRATIVE SUPPORT.—The

4 Secretary of Health and Human Services shall, on

5 a reimbursable basis, provide to the Committee such

6 staff, administrative support, and other assistance

7 as may be necessary for the Committee to effectively

8 carry out the duties under this section.

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

10 the Committee shall not be in violation of any Fed11 eral conflict of interest laws.

12 (f) AUTHORIZATION OF APPROPRIATIONS.—There

13 are authorized to be appropriated such sums as may be

14 necessary to carry out this section.

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