FDA

The FDA’s Regulation of Silicone Breast Implants

Posted on July 12, 2010 by Sidekick

We are including two documents that comprise the report from a hearing before a subcommitee of the Committee on Government Operation, House of Representatives.

FDA Regulation of Silicone Breast Implants Part 1 (PDF document)

FDA Regulation of Silicone Breast Implants Part 2 (PDF document)

The Report is titled Is the FDA Protecting Patients From the Dangers of Silicone Breast Implants? and was dated December 18, 1990.

The report is based on the subcommittee’s 3-year investigation of the FDA’s regulation of silicone breast implants, which was initiated by Chairman Ted Weiss. Because of his tragic death in September of this year, it was not possible to complete the report in time to release it as a committee report. Unfortunately, our investigation indicates that FDA continues to fail to safeguard implant patients, making it very important that this report be released in a timely manner. For that reason, it is being released as a staff report of the 102d Congress.
Thank you for your assistance.

Sincerely
Donald M. Payne
Chairman, Human Resources and
Intergovernmental Relations Subcommittee.

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