I

107TH CONGRESS

1ST SESSION H. R. 1961

To promote 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 thoroughly review the implant manufacturers’ standing with the agency.

IN THE HOUSE OF REPRESENTATIVES

MAY 23, 2001

Mr. BLUNT (for himself, Mr. GREEN of Texas, Mrs. EMERSON, Ms. BROWN

of Florida, Ms. KILPATRICK, Mr. ISAKSON, Mr. DAVIS of Illinois, Mr.

MCCRERY, Mr. OXLEY, Ms. MCCARTHY of Missouri, Mrs. MALONEY of

New York, Mr. BONIOR, Mr. FILNER, Mr. BROWN of Ohio, Mr. GONZALEZ, Mr. MCNULTY, Ms. JACKSON-LEE of Texas, and Ms. CARSON of

Indiana) introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL

To promote 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 thoroughly

review the implant manufacturers’ standing with the

agency.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
2

•HR 1961 IH

1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Breast Implant Re3 search 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 breast implants over the last

10 35 years. Because there has never been a patient

11 registry for breast implant recipients it is impossible

12 to more accurately determine the number of women

13 who have received breast implants. Yet, the Amer14 ican Society of Plastic Surgeons estimates that in

15 1999 alone 82,975 women had breast reconstruction

16 following mastectomies and another 167,318 Amer17 ican women received breast implants for cosmetic

18 purposes.

19 (2) From 1985 until January 2000, FDA re20 ceived 127,770 adverse reaction reports for silicone

21 gel-filled breast implants and 65,720 adverse reac22 tion reports for saline-filled implants.

23 (3) Women need complete and accurate infor24 mation about the potential health risks and advan25 tages of breast implants so that women can make in26 formed decisions.
3

•HR 1961 IH

1 (4) Silicone breast implants have never been ap2 proved by the Food and Drug Administration; saline

3 breast implants, which consist of a saline solution

4 injected into a silicone envelope, were approved by

5 the agency in 2000 despite alarmingly high com6 plication and reoperation rates. After three years, 43

7 percent of the augmentation patients and 73 percent

8 of the reconstruction patients experienced local com9 plications and 40 percent of the reconstruction pa10 tients were forced to undergo additional surgery for

11 local complications and device failure.

12 (5) In 1998, the Food and Drug Administra13 tion opened a criminal investigation following allega14 tions that one of the breast implant manufacturers

15 was manipulating research data in breast implant

16 studies. When the Food and Drug Administration’s

17 General and Plastic Surgery Devices Panel convened

18 in March 2000 to consider market approval for sa19 line implants, it was not informed of the investiga20 tion. Although the manufacturer’s saline breast im21 plant was approved by the Food and Drug Adminis22 tration in May 2000, the investigation remains open.

23 (6) According to a 1997 Mayo Clinic study,

24 within 5 years of receiving such implants, 1 in 4

25 women required additional surgery.
4

•HR 1961 IH

1 (7) In 2000, research sponsored by the Food

2 and Drug Administration found that even among

3 women who had not sought medical treatment for

4 implant problems, almost 70 percent had at least

5 one ruptured implant after 10 to 15 years. Silicone

6 was found to be migrating away from the implants

7 in 21 percent of those women. The FDA researchers

8 concluded that ‘‘the relationship of free silicone to

9 development or progression of disease is unknown’’.

10 (8) A 1993 study by Dr. Suzanne S. Teuber et

11 al., University of California, published in The Jour12 nal of Autoimmunity, investigated the influence of

13 silicone breast implants on the expression of

14 anticollagen antibodies and found a statistically sig15 nificant incidence of anticollagen antibodies in

16 women with implants. The researchers concluded

17 that silicone breast implants should not be consid18 ered a benign or immunologically inert material; se19 rious implications may result from their use.

20 (9) The Institute of Medicine’s 1999 study of

21 silicone breast implant safety found that local com22 plications with silicone breast implants were the pri23 mary safety issue, that they have not been well stud24 ied, and that information on these complications is

25 crucial for women deciding whether or not they want
5

•HR 1961 IH

1 breast implant surgery. Concern remains that expo2 sure to silicone breast implants may result in cur3 rently undefined connective tissue or autoimmune

4 diseases.

5 (10) A 2001 National Cancer Institute study

6 found breast implant recipients suffer from higher

7 rates of lung and brain cancer than other plastic

8 surgery patients.

9 (11) A 1999 case report by Dr. Suzanne S.

10 Teuber et al., University of California, published in

11 The Journal of Rheumatology, found evidence of sili12 cone migration in women with ruptured or leaking

13 silicone breast implants. These patients experienced

14 severe local inflammation and complications result15 ing from silicone migration to the axilla, arm or ab16 dominal wall. Researchers concluded that once sili17 cone gel leaves the implant, it is not biologically

18 inert and in some persons can elicit profound

19 pathologic responses.

20 (12) According to many reports, including a

21 study published in the Journal of the National Can22 cer Institute, the presence of a silicone breast im23 plant may create difficulties in obtaining accurate

24 and thorough mammograms because as much as 40

25 percent of the breast tissue can be masked by the
6

•HR 1961 IH

1 implant. This delays the early detection of breast

2 cancer in women.

3 (13) According to a 2000 Food and Drug Ad4 ministration publication, women of childbearing age

5 who want to breast feed should be aware of the neg6 ative impact of breast implants on breast feeding. It

7 is not known if a small amount of silicone may pass

8 from the silicone shell of an implant into breast

9 milk. If this occurs, it is not known what effect it

10 may have on the nursing infant.

11 (b) PURPOSE.—It is the purpose of this Act to pro12 mote research to identify and evaluate the health effects

13 of breast implants, to ensure that women receive accurate

14 information about such implants and to encourage the

15 Food and Drug Administration to conclude its criminal

16 investigation based on the allegations of wrong-doing by

17 one of the implant manufacturers which ultimately may

18 affect their products and the health of American women.

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

20 shall be construed to affect any rule or regulation promul21 gated under the authority of the Federal Food, Drug and

22 Cosmetic Act (21 U.S. 301 et seq.) that is in effect on

23 the date of enactment of this Act relating to the avail24 ability of silicone breast implant for reconstruction after

25 mastectomy, correction of congenital deformities, or re-
7

•HR 1961 IH

1 placement for ruptured silicone implants for augmenta2 tion.

3 SEC. 3. EXPANSION AND INTENSIFICATION OF ACTIVITIES

4 REGARDING SILICONE BREAST IMPLANTS AT

5 THE NATIONAL INSTITUTES OF HEALTH.

6 (a) STATUS OF EXISTING RESEARCH.—The Director

7 of the National Institutes of Health shall report to all ap8 propriate committees of Congress on the status of the ex9 isting breast implant research funded by such Institutes

10 within 90 days after the date of the enactment of this Act.

11 (b) AMENDMENT TO PUBLIC HEALTH SERVICE

12 ACT.—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 of the following:

15 ‘‘SEC. 498C. 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 breast

20 implant research. Such coordinator shall encourage and

21 coordinate the participation of all appropriate Institutes

22 research including—

23 ‘‘(1) the Office of Research on Women’s

24 Health;
8

•HR 1961 IH

1 ‘‘(2) the National Institute of Allergy and In2 fectious Diseases;

3 ‘‘(3) the National Institute of Arthritis and

4 Musculoskeletal and Skin diseases;

5 ‘‘(4) the National Institute of Child Health and

6 Human Development;

7 ‘‘(5) the National Institute of Environmental

8 Health Sciences;

9 ‘‘(6) the National Institute of Neurological Dis10 orders and Stroke; and

11 ‘‘(7) the National Cancer Institute.

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

13 establish a study section or special emphasis panel if de14 termined to be appropriate, for the National Institutes of

15 Health to review extramural research grant applications

16 regarding breast implants to ensure the appropriate de17 sign and high quality of such research and shall take ap18 propriate action to ensure the quality of intramural re19 search activities.

20 ‘‘(c) CLINICAL STUDY.—

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

22 conduct or support research to expand the under23 standing of the health implications of both saline

24 and silicone breast implants. Such research should,

25 if determined to be scientifically appropriate, include
9

•HR 1961 IH

1 multidisciplinary, clinical, case-controlled study of

2 women with breast implants for at least eight years

3 whether it be one prosthesis or multiple, and dif4 ferentiate between women receiving implants for

5 mastectomy, reconstructive or cosmetic purposes and

6 include subsets of women with saline implants and

7 silicone implants. Such a study should focus on the

8 rate of local complications which includes capsular

9 contracture, leakage, loss of nipple sensation, defla10 tion and rupture as well as the presentation of atypi11 cal symptoms, silicone migration, neurological dys12 function, and immune system irregularities, and

13 evaluate to what extent if any, their health differs

14 from that of suitable controls.

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

16 shall annually prepare and submit to the appropriate

17 Committees of Congress a report concerning the re18 sults of the study conducted under paragraph (1).’’.

19 SEC. 4. INTENSIFICATION OF ACTIVITIES REGARDING

20 POSTMARKET RESEARCH OF SALINE BREAST

21 IMPLANTS AT THE FOOD AND DRUG ADMINIS22 TRATION.

23 To ensure that the Food and Drug Administration

24 conducts postmarket evaluations of saline implant manu25 facturers’ data based on the postmarket recommendations
10

•HR 1961 IH

1 made by the Food and Drug Administration’s General and

2 Plastic Surgery Devices Panel, the Commissioner of Food

3 and Drugs shall report to Congress on the implementation

4 status of the postmarket recommendations at 6, 12, and

5 18 month intervals after the date of the enactment of this

6 Act and annually thereafter.

7 SEC. 5. EXPANSION AND INTENSIFICATION OF ACTIVITIES

8 REGARDING SILICONE BREAST IMPLANTS AT

9 THE FOOD AND DRUG ADMINISTRATION.

10 To assist women in receiving accurate and complete

11 information about the risks of silicone breast implants, the

12 Commissioner of Food and Drugs shall—

13 (1) expedite the conclusion of the agency’s

14 criminal investigation into allegations of wrong-doing

15 by one of the implant manufacturers; brief appro16 priate Committees of Congress on the findings and

17 take appropriate action within 90 days after the

18 date of the enactment of this Act;

19 (2) ensure that the toll-free consumer informa20 tion line and materials concerning breast implants

21 provided by the Food and Drug Administration are

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

23 problems with breast implants, and that timely ag24 gregate data concerning such reports shall be made
11

•HR 1961 IH

1 available to the public upon request and consistent

2 with existing confidentiality standards;

3 (3) require that manufacturers of silicone

4 breast implants update implant package inserts and

5 informed consent documents regularly to reflect ac6 curate information about such implants, particularly

7 the rate of local complications and ruptures of such

8 implants;

9 (4) require that any manufacturers of such im10 plants that are conducting clinical studies on silicone

11 breast implants—

12 (A) require its clinical investigators to pro13 vide prospective patients with the Food and

14 Drug Administration’s breast implant booklet;

15 (B) amend such study protocol and in16 formed consent document to reflect that pa17 tients must be provided with a copy of informed

18 consent documents at the initial, or earliest pos19 sible, consultation regarding breast prosthesis;

20 (C) amend the informed consent protocol

21 to inform women about how to obtain a

22 Medwatch form and encourage any woman who

23 withdraws from the study, or who would like to

24 report such problem or concerns with the study

25 and reason for withdrawing; and
12

•HR 1961 IH

1 (D) 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; and

5 (5) appoint a special ad hoc patient information

6 panel that—

7 (A) convenes annually for the sole purpose

8 of reviewing breast implant information and ad9 vertisements provided by the manufacturers and

10 the Food and Drug Administration to ensure

11 consumer information is thorough and accurate;

12 and

13 (B) includes in its membership (but is not

14 limited to) saline and silicone breast implant re15 cipients, bioethicists, rheumatologists, and

16 oncologists with experience in both clinical care

17 and research regarding breast implants.

Æ