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. 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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

No timeline events have been ingested for this record yet.

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 10 June 1998

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 10 June 1998

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 10 June 1998

  Open at official source

Sponsors

No sponsors or actors listed by the source.

Related records

No cross-record relationships stored yet.