[NOW Action List] Prevent Approval of Unsafe Implants: Call FDA

Support NOW's Work |	April 4, 2006	| Tell a Friend

Action Needed All NOW Actions NOW's Work on Breast Implants		Prevent Approval of Unsafe Implants: Call FDA, Senate on Wednesday, April 5 After much delay, the FDA may be moving closer to approval of silicone breast implants manufactured by Mentor Corp. The safety of these implants is currently under investigation by the FDA. We cannot allow the FDA to approve silicone breast implants before the investigation into their safety is complete. Help prevent this tragedy by calling FDA Commissioner Andrew von Eschenbach and your senators on Wed., April 5. As you may know, two whistleblowers have come forward alleging that the rupture rate provided to the Food and Drug Administration (FDA) by breast implant manufacturer Mentor Corp. was skewed. One of the claims is that textured silicone gel breast implants made by Mentor have a design flaw that results in a higher rupture rate. Another claim is that the higher rupture rate has not been accurately reported to the FDA. These allegations are of utmost concern to NOW because we have heard from many women who have become seriously ill when their silicone gel-filled breast implants ruptured. If the whistleblowers' reports prove accurate, approval of silicone implants SHOULD NOT GO FORWARD. The FDA's Acting Commissioner, Andrew von Eschenbach, has requested an investigation by the FDA Office of Criminal Investigations (OCI). We believe this is an important first step in assessing the veracity of these allegations. However, FDA may approve Mentor's silicone breast implants BEFORE the investigation is complete. Action Needed: Therefore, it is time to turn up the heat on Commissioner von Eschenbach and the Senate. On Wednesday, April 5, we would like your help for a national phone-in protest. Let's see if we can flood their switchboards. We need to let them know that we aren't going away. We are asking you to make three phone calls -- one to Commissioner von Eschenbach's office and one to each of your senators -- to voice your objections to FDA approval of silicone breast implants. And spread the word to you friends and families to make calls too! Call FDA Commissioner Dr. von Eschenbach: 1-888-463-6332; Press option 3 "contact employee" and ask the operator for von Eschenbach's office What to Say: I am calling to voice my concern that the FDA has expressed its intent to approve silicone breast implants made by Mentor Corporation -- despite the lack of safety data and despite serious allegations that the company misrepresented safety information. Please DO NOT issue a final decision on approval before ALL allegations have been thoroughly investigated. Women's health and lives depend on it. Call Your Senators: Call the Capitol Switchboard at 1-202-224-3121 and tell the operator what state you live in and that you wish to speak with your senator (or get your senator's direct number). Tell the receptionist in your senator's office that you would like to speak to the Health Legislative Assistant. You may have to leave a voice mail with the message below if the Health Legislative Assistant is not available for you to convey the message directly. After completing this call, call your other senator and say the same thing. What to say: I am calling to voice my concern that the FDA is about to approve silicone breast implants made by Mentor Corporation-- despite the lack of safety data and despite serious allegations that the company misrepresented safety information. Please ask Acting Commissioner von Eschenbach NOT to issue a final decision on approval before ALL allegations have been thoroughly investigated. Women's health and lives depend on it. Thank you for stepping up your activity to help us as we approach the FDA's decision day.
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