Tell Congress the FDA Must Consider Whistleblower Evidence on Implants

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Command Trust network <info@...> wrote: Subject: Rogene Tell Congress the FDA Must Consider Whistleblower Evidence on Implants"Rogene Schorer" <saxony01@...>From: "Command Trust network" <info@...>Date: Tue, 24 Oct 2006 14:07:17 -0400 (EDT) Demand that the FDA Thoroughly Examine Safety Evidence Take Action! FDA Must Stop Ignoring Evidence that Silicone Implants Are Not Safe In mid-October 2006, a chemist formerly employed by Mentor Corp. accused the company of withholding unfavorable safety data about silicone gel breast implants from the FDA, which is currently deciding whether to approve these implants. How did the FDA respond to these new allegations? It said the

safety data wasn't requested by the FDA and therefore isn't relevant, according to the watchdog consumer group, Public Citizen. This is outrageous! If you’re as outraged as we are by FDA’s response, you should let Congress know. WRITE TO YOUR MEMBERS OF CONGRESS NOW to tell them that you expect the FDA to thoroughly examine any evidence that a medical product is not as safe as its manufacturer says it is, REGARDLESS OF WHETHER OR NOT THEY ASKED FOR THE INFORMATION. Background Silicone gel breast implants have never been approved by the FDA because they have not been proven safe and effective. However, the FDA permits Mentor and Allergan Inc. (maker of Inamed implants) to

sell silicone gel breast implants to women who lose breasts to cancer or have breast deformities. A year ago the FDA announced its intention to approve silicone gel breast implants made by these two companies, but ONLY if certain conditions could be met. Until a final decision is announced, the alternative is saline breast implants, which are approved by the FDA as “reasonably safe.” Similar allegations of unfavorable safety data being withheld were made by a Mentor engineer in December 2005, but the new allegations are more specific and are made by a chemist who himself conducted much of the research he has discussed in his allegations. According to Public Citizen, the chemist told the FDA in June 2006 that Mentor under-reported the amount of silicone gel seeping out of the implant into the body and failed to inform the FDA that the platinum used to make the implants is potentially dangerous, that the implant shell weakens more than they reported, and the implant becomes more dangerous over time. Covering up these facts puts women in danger. As a result of not reporting these allegations in Canada, the Canadian health agency approved silicone gel breast implants on October 20, a week after the allegations were published in the U.S. media. We must avoid a similar, dangerous decision in the US! Your Congressional representatives MUST hear from you as soon as possible! Please enter your ZIP code and send a message to Congress now! If you can add your

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