Guest guest Posted November 23, 2004 Report Share Posted November 23, 2004 Please circulate this to everyone you believe will support our cause! . . . This is beyond belief. The FDA plans approve silicone gel implants WITHOUT a hearing! Rogene ----------------------- Action Alert! FDA TO CONSIDER APPROVAL OF SILICONE BREAST IMPLANTS! More Safety Information Needed! ACTION NEEDED: EMAIL THE FDA TODAY! To take action click here: http://capwiz.com/commandtrust/mail/oneclick_compose/?alertid=6660561 The FDA is considering the approval of silicone breast implants without holding a public advisory hearing or requiring manufacturers to collect additional safety data! « We are REQUESTING that the FDA refrain from further consideration of the approval of silicone breast implants until the public has access to a finalized guidance given to the breast implant industry. This document was revised in January 2004 and opened for public comment. To date the FDA has not finalized this document! « We are also URGING the FDA to make the public fully aware of any forthcoming consideration of approval of silicone breast implants through the use of public advisory panel meetings, prior to approval. It is critical that the FDA uphold its commitment to protect women’s health! Please click below or go to www.commandtrust.com to send an email http://capwiz.com/commandtrust/mail/oneclick_compose/?alertid=6660561 TELL FRIENDS OR FAMILY MEMBERS TO EMAIL AS WELL -- EVERY EMAIL COUNTS! THE FDA NEEDS TO HEAR FROM THE PUBLIC ON THIS ISSUE. As Background In October 2003, the FDA considered approval of Inamed Corporation’s silicone gel-filled breast implants. The advisory panel convened by the FDA to review the application and make recommendations on approval ultimately voted by a slim margin to approve silicone breast implants, with specific conditions. The recommendation for “conditional” approval was only based on a long list of post-approval conditions outlined by the panel. In January 2004, the FDA announced that it would not grant approval of silicone breast implants until basic safety questions could be addressed. The agency commented that the conditions recommended by the advisory panel demonstrated the limitations in the clinical data and lack of established safety. FDA Guidance to the Breast Implant Industry At the time that FDA announced that it would not approve silicone gel-filled breast implants, the agency also released a revised draft Guidance to the Breast Implant Industry. The guidance outlines recommendations for clinical trials and provides the manufacturers with minimum standards for approval. According to the FDA, the new guidance document was intended to more clearly define FDA’s recommendations for breast implant clinical trials, approval applications and to reflect the availability of new information about the framework for assessing the safety and effectiveness of these products. Information that the FDA believed critical to this assessment included mechanical testing, modes and causes of rupture, clinical study information, post-approval requirements and labeling. Manufacturers Filed Amendments to the Original Applications In August 2004, Mentor Corporation and Inamed Corporation filed amendments to their original PMAs for silicone gel-filled breast implants, presumably in accordance with the newly revised guidance document to the breast implant industry. However, to date, a finalized version of the guidance document has not been made public. It is unacceptable for the FDA to now consider approval based on limited additional safety information and without providing the opportunity for the public to view new clinical data or approval standards set by the agency. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 23, 2004 Report Share Posted November 23, 2004 I fear until we have an administration that is not paid off by pharmaceutical companies, the FDA will be another arm of those corporations and will not protect consumers. > Please circulate this to everyone you believe will > support our cause! . . . This is beyond belief. The > FDA plans approve silicone gel implants WITHOUT a > hearing! > > Rogene > ----------------------- > Action Alert! > > FDA TO CONSIDER APPROVAL OF SILICONE BREAST IMPLANTS! > > More Safety Information Needed! > > ACTION NEEDED: EMAIL THE FDA TODAY! > > To take action click here: > http://capwiz.com/commandtrust/mail/oneclick_compose/?alertid=6660561 > > The FDA is considering the approval of silicone breast > implants without holding a public advisory hearing or > requiring manufacturers to collect additional safety > data! > > « We are REQUESTING that the FDA refrain from > further consideration of the approval of silicone > breast implants until the public has access to a > finalized guidance given to the breast implant > industry. This document was revised in January 2004 > and opened for public comment. To date the FDA has > not finalized this document! > > « We are also URGING the FDA to make the public > fully aware of any forthcoming consideration of > approval of silicone breast implants through the use > of public advisory panel meetings, prior to approval. > > It is critical that the FDA uphold its commitment to > protect women's health! > > Please click below or go to www.commandtrust.com to > send an email > http://capwiz.com/commandtrust/mail/oneclick_compose/?alertid=6660561 > > TELL FRIENDS OR FAMILY MEMBERS TO EMAIL AS WELL -- > EVERY EMAIL COUNTS! THE FDA NEEDS TO HEAR FROM THE > PUBLIC ON THIS ISSUE. > > As Background > > In October 2003, the FDA considered approval of Inamed > Corporation's silicone gel-filled breast implants. > The advisory panel convened by the FDA to review the > application and make recommendations on approval > ultimately voted by a slim margin to approve silicone > breast implants, with specific conditions. The > recommendation for " conditional " approval was only > based on a long list of post-approval conditions > outlined by the panel. > > In January 2004, the FDA announced that it would not > grant approval of silicone breast implants until basic > safety questions could be addressed. The agency > commented that the conditions recommended by the > advisory panel demonstrated the limitations in the > clinical data and lack of established safety. > > > FDA Guidance to the Breast Implant Industry > > At the time that FDA announced that it would not > approve silicone gel-filled breast implants, the > agency also released a revised draft Guidance to the > Breast Implant Industry. The guidance outlines > recommendations for clinical trials and provides the > manufacturers with minimum standards for approval. > According to the FDA, the new guidance document was > intended to more clearly define FDA's recommendations > for breast implant clinical trials, approval > applications and to reflect the availability of new > information about the framework for assessing the > safety and effectiveness of these products. > > Information that the FDA believed critical to this > assessment included mechanical testing, modes and > causes of rupture, clinical study information, > post-approval requirements and labeling. > > Manufacturers Filed Amendments to the Original > Applications > > In August 2004, Mentor Corporation and Inamed > Corporation filed amendments to their original PMAs > for silicone gel-filled breast implants, presumably in > accordance with the newly revised guidance document to > the breast implant industry. However, to date, a > finalized version of the guidance document has not > been made public. > > It is unacceptable for the FDA to now consider > approval based on limited additional safety > information and without providing the opportunity for > the public to view new clinical data or approval > standards set by the agency. Quote Link to comment Share on other sites More sharing options...
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