S.2154 - Silicone Breast Implant Research and Information Act105th Congress (1997-1998)
|Sponsor:||Sen. Boxer, Barbara [D-CA] (Introduced 06/10/1998)|
|Committees:||Senate - Labor and Human Resources|
|Latest Action:||Senate - 06/10/1998 Read twice and referred to the Committee on Labor and Human Resources. (All Actions)|
This bill has the status Introduced
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Summary: S.2154 — 105th Congress (1997-1998)All Information (Except Text)
Introduced in Senate (06/10/1998)
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.
Establishes the President's Interagency Committee on Silicone Breast Implants to ensure strategic management, communication, and oversight of Federal policy formation, research, and activities regarding silicone breast implants.