[Congressional Record Volume 144, Number 74 (Wednesday, June 10, 1998)]
[Senate]
[Pages S6042-S6043]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mrs. BOXER:
  S. 2154. 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; to 
the Committee on Labor and Human Resources.


          Silicone Breast Implant Research and Information Act

 Mrs. BOXER. Mr. President, today I am introducing a bill that 
will make a significant difference in the lives of millions of American 
women--the Silicone Breast Implant Research and Information Act. There 
is one basic reason for this bill: to make sure women have accurate and 
complete information so they can make informed decisions about their 
health.
  Each year, nearly 180,000 women are diagnosed with breast cancer in 
the United States. In total, approximately 2.6 million Americans live 
with breast cancer. When a women undergoes a mastectomy, she faces the 
decision of whether to have reconstructive surgery, and one important 
option she has is to have a silicone breast implant.
  Between 1 and 2 million women in the United States have received 
silicone breast implants over the last 35 years, as part of 
reconstructive surgery after mastectomy, or for cosmetic purposes.
  Many women with silicone implants have come forward with a variety of 
symptoms and atypical illnesses. Although research over the years has 
attempted to get to the bottom of this, we still don't have the answers 
women need and deserve.
  In 1992, the Food and Drug Administration restricted the availability 
of silicone breast implants because it had not received enough evidence 
to prove that these implants are safe. Currently, silicone breast 
implants are only available to women who have had breast cancer surgery 
or who have other special medical needs, such as a severe injury or 
birth defect. Women who need to have an implant replaced for medical 
reasons, such as rupture of the implant, are also eligible.
  These women should have access to the broadest possible treatment 
options--including breast implants. But it is just as essential that 
women can count on sound scientific research regarding the safety of 
implants. It is essential that the Federal Government coordinate its 
efforts on this issue to maximize the use of limited resources.
  This bill contains three components women need to make informed 
decisions about silicone breast implants--research, information, and 
coordination. It gives women not only options, but information and 
peace of mind.
  I am proud to introduce this bill in the Senate, and to be joined by 
Congressman Gene Green, who is introducing this bill in the House of 
Representatives. I ask unanimous consent that the full text of this 
bill be printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 2154

       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 ``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 them.
       (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 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.
       (9) 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.
       (10) 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.
       (11) According to a 1995 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.

[[Page S6043]]

       (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 Food, Drug and Cosmetic Act 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 on 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.

     SEC. 5. PRESIDENT'S INTERAGENCY COMMITTEE ON SILICONE BREAST 
                   IMPLANTS.

       (a) Establishment.--There is established an interagency 
     committee, to be known as the President's Interagency 
     Committee on Silicone Breast Implants (referred to in this 
     Act as the ``Committee''), to ensure the strategic 
     management, communication, and oversight of the policy 
     formation, research, and activities of the Federal Government 
     regarding silicone breast implants.
       (b) Composition.--The Committee shall be composed of--
       (1) an individual to be appointed by the President who 
     represents the White House domestic policy staff;
       (2) a representative, to be appointed by the Secretary of 
     Health and Human Services, from--
       (A) the Office of Women's Health at the Department of 
     Health and Human Services;
       (B) the National Institutes of Health;
       (C) the Food and Drug Administration; and
       (D) the Centers for Disease Control and Prevention;
       (3) a representative of the Department of Defense with 
     experience in the Department's breast cancer research 
     program;
       (4) representatives of any other agencies deemed necessary 
     to accomplish the mission of the Committee, including the 
     Social Security Administration if appropriate;
       (5) up to 4 individuals to be appointed by the President 
     from scientists with established credentials and publications 
     in the area of silicone breast implants; and
       (6) 2 women who have or have had silicone breast implants 
     to be appointed by the President.
       (c) Chairperson.--
       (1) In general.--The individual appointed under subsection 
     (b)(2)(A), or other official if the President determines that 
     such other official is more appropriate, shall service as the 
     chairperson of the Committee.
       (2) Duties.--The chairperson of the Committee shall--
       (A) not less than twice each year, convene meetings of the 
     Committee; and
       (B) compile information for the consideration of the full 
     Committee at such meetings.
       (d) Meetings.--The meetings of the Committee shall be open 
     to the public and public witnesses shall be given the 
     opportunity to speak and make presentations at such meetings. 
     Each member of the Committee shall make a presentation to the 
     full Committee at each such meeting concerning the activities 
     conducted by such member or by the entity that such member is 
     representing related to silicone breast implants.
       (e) Administrative Provisions.--
       (1) Terms and vacancies.--A member of the Committee shall 
     serve for a term of 2 or 4 years (rotating terms). A member 
     may be reappointed 2 times, but shall not exceed 8 years of 
     service. Any vacancy in the membership of the Committee shall 
     be filled in the manner in which the original appointment was 
     made and shall not affect the power of the remaining members 
     to carry out the duties of the Committee.
       (2) Compensation; reimbursement of expenses.--Members of 
     the Committee may not receive compensation for service on the 
     Committee. Such members may, in accordance with chapter 57 of 
     title 5, United States Code, be reimbursed for travel, 
     subsistence, and other necessary expenses incurred in 
     carrying out the duties of the Committee.
       (3) Staff; administrative support.--The Secretary of Health 
     and Human Services shall, on a reimbursable basis, provide to 
     the Committee such staff, administrative support, and other 
     assistance as may be necessary for the Committee to 
     effectively carry out the duties under this section.
       (4) Conflict of interest.--The members of the Committee 
     shall not be in violation of any Federal conflict of interest 
     laws.
       (f) Authorization of Appropriations.--There are authorized 
     to be appropriated such sums as may be necessary to carry out 
     this section.
                                 ______