[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 961 Introduced in Senate (IS)]







107th CONGRESS
  1st Session
                                 S. 961

  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 SENATE OF THE UNITED STATES

                              May 24, 2001

  Mrs. Boxer 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 
  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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Breast Implant Research and 
Information Act''.

SEC. 2. FINDINGS AND PURPOSE.

    (a) Findings.--Congress makes the following findings:
            (1) According to the Institute of Medicine, it is estimated 
        that 1,000,000 to 2,000,000 American women have received breast 
        implants over the last 35 years. Because there has never been a 
        patient registry for breast implant recipients it is impossible 
        to more accurately determine the number of women who have 
        received breast implants. Yet, the American Society of Plastic 
        Surgeons estimates that in 1999 alone 82,975 women had breast 
        reconstruction following mastectomies and another 167,318 
        American women received breast implants for cosmetic purposes.
            (2) From 1985 until January 2000, FDA received 127,770 
        adverse reaction reports for silicone gel-filled breast 
        implants and 65,720 adverse reaction reports for saline-filled 
        implants.
            (3) Women need complete and accurate information about the 
        potential health risks and advantages of breast implants so 
        that women can make informed decisions.
            (4) Silicone breast implants have never been approved by 
        the Food and Drug Administration; saline breast implants, which 
        consist of a saline solution injected into a silicone envelope, 
        were approved by the agency in 2000 despite alarmingly high 
        complication and reoperation rates. After three years, 43 
        percent of the augmentation patients and 73 percent of the 
        reconstruction patients experienced local complications and 40 
        percent of the reconstruction patients were forced to undergo 
        additional surgery for local complications and device failure.
            (5) In 1998, the Food and Drug Administration opened a 
        criminal investigation following allegations that one of the 
        breast implant manufacturers was manipulating research data in 
        breast implant studies. When the Food and Drug Administration's 
        General and Plastic Surgery Devices Panel convened in March 
        2000 to consider market approval for saline implants, it was 
        not informed of the investigation. Although the manufacturer's 
        saline breast implant was approved by the Food and Drug 
        Administration in May 2000, the investigation remains open.
            (6) According to a 1997 Mayo Clinic study, within 5 years 
        of receiving such implants, 1 in 4 women required additional 
        surgery.
            (7) In 2000, research sponsored by the Food and Drug 
        Administration found that even among women who had not sought 
        medical treatment for implant problems, almost 70 percent had 
        at least one ruptured implant after 10 to 15 years. Silicone 
        was found to be migrating away from the implants in 21 percent 
        of those women. The FDA researchers concluded that ``the 
        relationship of free silicone to development or progression of 
        disease is unknown''.
            (8) A 1993 study by Dr. Suzanne S. Teuber et al., 
        University of California, published in The Journal of 
        Autoimmunity, investigated the influence of silicone breast 
        implants on the expression of anticollagen antibodies and found 
        a statistically significant incidence of anticollagen 
        antibodies in women with implants. The researchers concluded 
        that silicone breast implants should not be considered a benign 
        or immunologically inert material; serious implications may 
        result from their use.
            (9) The Institute of Medicine's 1999 study of silicone 
        breast implant safety found that local complications with 
        silicone breast implants were the primary safety issue, that 
        they have not been well studied, and that information on these 
        complications is crucial for women deciding whether or not they 
        want breast implant surgery. Concern remains that exposure to 
        silicone breast implants may result in currently undefined 
        connective tissue or autoimmune diseases.
            (10) A 2001 National Cancer Institute study found breast 
        implant recipients suffer from higher rates of lung and brain 
        cancer than other plastic surgery patients.
            (11) A 1999 case report by Dr. Suzanne S. Teuber et al., 
        University of California, published in The Journal of 
        Rheumatology, found evidence of silicone migration in women 
        with ruptured or leaking silicone breast implants. These 
        patients experienced severe local inflammation and 
        complications resulting from silicone migration to the axilla, 
        arm or abdominal wall. Researchers concluded that once silicone 
        gel leaves the implant, it is not biologically inert and in 
        some persons can elicit profound pathologic responses.
            (12) According to many reports, including a study published 
        in the Journal of the National Cancer Institute, the presence 
        of a silicone breast implant may create difficulties in 
        obtaining accurate and thorough mammograms because as much as 
        40 percent of the breast tissue can be masked by the implant. 
        This delays the early detection of breast cancer in women.
            (13) According to a 2000 Food and Drug Administration 
        publication, women of childbearing age who want to breast feed 
        should be aware of the negative impact of breast implants on 
        breast feeding. It is not known if a small amount of silicone 
        may pass from the silicone shell of an implant into breast 
        milk. If this occurs, it is not known what effect it may have 
        on the nursing infant.
    (b) Purpose.--It is the purpose of this Act 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 conclude its criminal 
investigation based on the allegations of wrong-doing by one of the 
implant manufacturers which ultimately may affect their products and 
the health of American women.
    (c) Rule of Construction.--Nothing in this Act shall be construed 
to affect any rule or regulation promulgated under the authority of the 
Federal Food, Drug and Cosmetic Act (21 U.S. 301 et seq.) that is in 
effect on the date of enactment of this Act relating to the 
availability of silicone breast implant for reconstruction after 
mastectomy, correction of congenital deformities, or replacement for 
ruptured silicone implants for augmentation.

SEC. 3. EXPANSION AND INTENSIFICATION OF ACTIVITIES REGARDING SILICONE 
              BREAST IMPLANTS AT THE NATIONAL INSTITUTES OF HEALTH.

    (a) Status of Existing Research.--The Director of the National 
Institutes of Health shall report to all appropriate committees of 
Congress on the status of the existing breast implant research funded 
by such Institutes within 90 days after the date of the enactment of 
this Act.
    (b) Amendment to Public Health Service Act.--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 of the following:

``SEC. 498C. BREAST IMPLANT RESEARCH.

    ``(a) Institute-Wide Coordinator.--The Director of NIH shall 
appoint an appropriate official of the Department of Health and Human 
Services to serve as the National Institutes of Health coordinator 
regarding breast implant research. Such coordinator shall encourage and 
coordinate the participation of all appropriate Institutes research 
including--
            ``(1) the Office of Research on Women's Health;
            ``(2) the National Institute of Allergy and Infectious 
        Diseases;
            ``(3) the National Institute of Arthritis and 
        Musculoskeletal and Skin diseases;
            ``(4) the National Institute of Child Health and Human 
        Development;
            ``(5) the National Institute of Environmental Health 
        Sciences;
            ``(6) the National Institute of Neurological Disorders and 
        Stroke; and
            ``(7) the National Cancer Institute.
    ``(b) Study Sections.--The Director of NIH shall establish a study 
section or special emphasis panel if determined to be appropriate, for 
the National Institutes of Health to review extramural research grant 
applications regarding breast implants to ensure the appropriate 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 understanding of the health 
        implications of both saline and silicone breast implants. Such 
        research should, if determined to be scientifically 
        appropriate, include multidisciplinary, clinical, case-
        controlled study of women with breast implants for at least 
        eight years whether it be one prosthesis or multiple, and 
        differentiate between women receiving implants for mastectomy, 
reconstructive or cosmetic purposes and include subsets of women with 
saline implants and silicone implants. Such a study should focus on the 
rate of local complications which includes capsular contracture, 
leakage, loss of nipple sensation, deflation and rupture as well the 
presentation of atypical symptoms, silicone migration, neurological 
dysfunction, and immune system irregularities, and evaluate to what 
extent if any, their health differs from that of suitable controls.
            ``(2) Annual report.--The Director of NIH shall annually 
        prepare and submit to the appropriate Committees of Congress a 
        report concerning the results of the study conducted under 
        paragraph (1).''.

SEC. 4. INTENSIFICATION OF ACTIVITIES REGARDING POSTMARKET RESEARCH OF 
              SALINE BREAST IMPLANTS AT THE FOOD AND DRUG 
              ADMINISTRATION.

    To ensure that the Food and Drug Administration conducts postmarket 
evaluations of saline implant manufacturers' data based on the 
postmarket recommendations made by the Food and Drug Administration's 
General and Plastic Surgery Devices Panel, the Commissioner of Food and 
Drugs shall report to Congress on the implementation status of the 
postmarket recommendations at 6, 12, and 18 month intervals after the 
date of the enactment of this Act and annually thereafter.

SEC. 5. EXPANSION AND INTENSIFICATION OF ACTIVITIES REGARDING SILICONE 
              BREAST IMPLANTS AT THE FOOD AND DRUG ADMINISTRATION.

    To assist women in receiving accurate and complete information 
about the risks of silicone breast implants, the Commissioner of Food 
and Drugs shall--
            (1) expedite the conclusion the agency's criminal 
        investigation into allegations of wrong-doing by one of the 
        implant manufacturers; brief appropriate Committees of Congress 
        on the findings and take appropriate action within 90 days 
        after the date of the enactment of this Act;
            (2) ensure that the toll-free consumer information line and 
        materials concerning breast implants provided by the Food and 
        Drug Administration are available, up to date, and responsive 
        to reports of problems with breast implants, and that timely 
        aggregate data concerning such reports shall be made available 
        to the public upon request and consistent with existing 
        confidentiality standards;
            (3) require that manufacturers of silicone breast implants 
        update implant package inserts and informed consent documents 
        regularly to reflect accurate information about such implants, 
        particularly the rate of local complications and ruptures of 
        such implants;
            (4) require that any manufacturers of such implants that 
        are conducting clinical studies on silicone breast implants--
                    (A) require its clinical investigators to provide 
                prospective patients with the Food and Drug 
                Administration's breast implant booklet;
                    (B) amend such study protocol and informed consent 
                document to reflect that patients must be provided with 
                a copy of informed consent documents at the initial, or 
                earliest possible, consultation regarding breast 
                prosthesis;
                    (C) amend the informed consent protocol to inform 
                women about how to obtain a Medwatch form and encourage 
                any woman who withdraws from the study, or who would 
                like to report such problem or concerns with the study 
                and reason for withdrawing; and
                    (D) amend the informed consent document to provide 
                potential participants with the inclusion criteria for 
                the clinical trial and the toll-free Consumer 
                Information number; and
            (5) appoint a special ad hoc patient information panel 
        that--
                    (A) convenes annually for the sole purpose of 
                reviewing breast implant information and advertisements 
                provided by the manufacturers and the Food and Drug 
                Administration to ensure consumer information is 
                thorough and accurate; and
                    (B) includes in its membership (but is not limited 
                to) saline and silicone breast implant recipients, 
                bioethicists, rheumatologists, and oncologists with 
                experience in both clinical care and research regarding 
                breast implants.
                                 <all>