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HR 4028 105th Congress House Health Artificial implants Breast cancer Breast implants Clinical trials Commerce Communication in medicine Consumer education Defective products Department of Health and Human Services Economics and Public Finance Federal advisory bodies Federal aid to medical research Federal officials Government Operations and Politics Government paperwork Government publicity Health surveys Immunology and vaccination Informed consent (Medical law)

Silicone Breast Implant Research and Information Act

Introduced: June 10, 1998 See on congress.gov
 Everywhere this bill has been 4 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jun 29, 1998
Referred to the Subcommittee on Health and Environment.
Jun 10, 1998
Referred to the House Committee on Commerce.
Jun 10, 1998
Sponsor introductory remarks on measure. (CR E1089-1090)
Jun 10, 1998
Introduced in House
 Plain-English summary Congressional Research Service

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.

Authorizes appropriations.

What's happening now June 29, 1998

Referred to the Subcommittee on Health and Environment.

 Committees of jurisdiction 2