FDA Implant Decision - from Sybil Goldrich

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"Sybil Goldrich, Command Trust Network" <info@...> wrote: Subject: FDA Implant Decision"Rogene Schorer" <saxony01@...>From: "Sybil Goldrich, Command Trust Network" <info@...>Date: Tue, 21 Nov 2006 14:03:26 -0500 (EST) Dear Rogene, The decision last Friday by the FDA to approve silicone gel filled implants shows disregard and insensitivity to women’s health and safety. Their decision is irresponsible. Nevertheless, we want you to know that this simply brings the issue to a new level that will require the same energy you have shown before. What we have seen at the FDA is an organization so broken it cares more for the profit of manufacturers and plastic surgeons than it does for safety and good science. Given that track record, we should not be surprised by this latest decision. We will continue the fight for safe implants worthy of human

use. Remember, we have had many successes. We have maintained a strong effort for safe implants based on real and independent science. In 1992 the moratorium was put in place because we wanted enough information to enable us to make informed decisions. With the approval FDA made clear in the Friday night press conference that women should anticipate additional surgeries and that implants will fail, causing silicone to escape into the body. The problem now is that they falsely declared implants safe and effective. FDA is requiring 10 years additional study on 40,000 women to study the lingering doubts about disease. While Friday’s decision is irresponsible, we have succeeded in raising the level of attention to careful evaluation higher than ever. We must remain vigilant to ensure that

the manufacturers complete their studies honestly. We are quite sure that if studies are valid and done completely that they will prove that we have been right all along. Your diligence and your support are as important now as they ever were. It is not time to give up. It is time to renew our resolve. I look forward to working with you. Warmest regards,Sybil If you no longer wish to receive e-mail from us, please click here.