Fw: Write to the FDA ... Demand longer FDA trials on silicone gel breast implants

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----- Original Message ----- From: ilena rose

ilena@...

Sent: Friday, August 29, 2003 7:13 AM

Subject: Write to the FDA ... Demand longer FDA trials on silicone gel breast implants

http://www.citizen.org/hot_issues/issue.cfm?ID=606

Write to FDA officials. Demand longer FDA clinical trials of silicone gel-filled breast implants to fully evaluate the health risks. FDA approval of silicone gel-filled breast implants based only on short-term clinical data could happen in the next few months. It is critical that the FDA hear from women on the need for longer-term clinical trials that assess potential long-term complications and

health risks throughout the life of the device.

An FDA review of clinical data from at least one manufacturer of silicone gel-filled breast implants based on only a few years of patient follow-up is expected before the end of the year. Yet, recent research and literature reports show strong evidence of the need for a continued assessment of the growing body of information on the short and long-term risks of these devices.

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