Silicone Breast Implant Research and Information Act

Summary: Silicone Breast Implant Research and Information Act - Amends the Public Health Service Act to require the Director of the National Institutes of Health (NIH) to: (1) appoint an official of the Department of Health and Human Services to serve as the NIH coordinator regarding silicone breast implant research; (2) establish either a study section or special emphasis panel for NIH to review extramural silicone breast implant research grant applications to ensure research design and quality, as well as quality intramural research; and (3) conduct or support research to expand the understanding of the health implications of silicone breast implants. 
Directs the Commissioner of Food and Drugs to: (1) take specified steps to make updated information about the risks of silicone breast implant available to the public, via the toll-free Consumer Information Line and other means; (2) revise the breast implant information update to clarify the procedure for reporting implant problems; (3) require manufacturers to update implant package inserts and informed consent documents regularly with accurate information; and (4) require any manufacturer conducting an adjunct study on implants to take specified measures with respect to informed consent documents, including informing women on how to obtain a Medwatch form and encouraging women who withdraw from the study, or who would like to report a problem, to submit such a form.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Silicone 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 
        silicone breast implants over the last 35 years.
            (2) Silicone breast implants have been used primarily for 
        breast augmentation, but also as an important part of 
        reconstruction surgery for breast cancer or other conditions.
            (3) Women with breast cancer or other medical conditions 
        seek access to the broadest possible treatment options, 
        including silicone breast implants.
            (4) Women need complete and accurate information about the 
        potential health risks and advantages of silicone breast 
        implants so that women can make informed decisions.
            (5) Although the rate of implant rupture and silicone 
        leakage has not been definitively established, estimates are as 
        high as 70 percent.
            (6) According to a 1997 Mayo Clinic study, 1 in 4 women 
        required additional surgery because of their implants within 5 
        years of receiving such implants.
            (7) In addition to potential systemic complications, local 
        changes in breast tissue such as hardening, contraction of scar 
        tissue surrounding implants, blood clots, severe pain, burning 
        rashes, serious inflammation, or other complications requiring 
        surgical intervention following implantation have been 
        reported.
            (8) According to the National Science Panel Report released 
        in December 1998, the current body of research on silicone 
        breast implants in immunology, rheumatology, toxicology, and 
        epidemiology is inadequate to conclusively determine the 
        effects of silicone. The National Science Panel pointed to many 
        limitations in research methodology and data analysis used in 
        past studies clearly demonstrating the need for future 
        independent clinical research.
            (9) According to the Institute of Medicine, concern remains 
        that exposure to silicone or other components in silicone 
        breast implants may result in currently undefined connective 
        tissue or autoimmune diseases.
            (10) A group of independent scientists and clinicians 
        convened by the National Institute of Arthritis and 
        Musculoskeletal and Skin Diseases in April of 1997 addressed 
        concerns that an association may exist between atypical 
        connective tissue disease and silicone breast implants, and 
        called for additional basic research on the components of 
        silicone as well as biological responses to silicone.
            (11) According to many reports, including a study published 
        in the Journal of the National Cancer Institute, the presence 
        of silicone breast implants may create difficulties in 
        obtaining complete mammograms.
            (12) According to a 1998 Food and Drug Administration 
        publication, although silicone breast implants usually do not 
        interfere with a woman's ability to nurse, if the implants 
        leak, there is some concern that the silicone may harm the 
        baby. Some studies suggest a link between breast feeding with 
        implants and problems with the child's esophagus.
    (b) Purpose.--It is the purpose of this Act 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.
    (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.C. 321 et seq.) that is in 
effect on the date of enactment of this Act relating to the 
availability of silicone breast implants 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.

    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 the following:

``SEC. 498C. SILICONE 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 silicone breast implant research. Such coordinator shall 
encourage and coordinate the participation of all appropriate 
Institutes in research on silicone breast implants, including--
            ``(1) the National Institute of Allergy and Infectious 
        Diseases;
            ``(2) the National Institute of Arthritis and 
        Musculoskeletal and Skin Diseases;
            ``(3) the National Institute of Child Health and Human 
        Development;
            ``(4) the National Institute of Environmental Health 
        Sciences;
            ``(5) the National Institute of Neurological Disorders and 
        Stroke; and
            ``(6) 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 silicone 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 silicone breast implants. Such research should, 
        if determined to be scientifically appropriate, include a 
        multidisciplinary, clinical, case-controlled study of women 
        with silicone breast implants. Such a study should involve 
        women who have had such implants in place for at least 8 years, 
        focus on atypical disease presentation, neurological 
        dysfunction, and immune system irregularities, and evaluate to 
        what extent if any, their health differs from that of suitable 
        controls, including women with saline implants as a subset.
            ``(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. EXPANSION AND INTENSIFICATION OF ACTIVITIES REGARDING SILICONE 
              BREAST IMPLANTS AT THE FOOD AND DRUG ADMINISTRATION.

    To assist women and doctors in receiving accurate and complete 
information about the risks of silicone breast implants, the 
Commissioner of Food and Drugs shall--
            (1) 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 silicone 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;
            (2) revise the Administration's breast implant information 
        update to clarify the procedure for reporting problems with 
        silicone implants or with the conduct of adjunct studies, and 
        specifically regarding the use of the Medwatch reporting 
        program;
            (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 rupture rate of such implants; and
            (4) require that any manufacturer of such implants that is 
        conducting an adjunct study on silicone breast implants--
                    (A) 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;
                    (B) amend the informed consent 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 a problem, to submit a Medwatch form to 
                report such problem or concerns with the study and 
                reasons for withdrawing; and
                    (C) amend the informed consent document to provide 
                potential participants with the inclusion criteria for 
                the clinical trial and the toll-free Consumer 
                Information number.