Tort Claimants Comm statement, for the record

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Welcome to the Tort Claimants Committee website, last updated on October 16, 2003.Current EventsOCTOBER 16, 2003:On October 15, 2003, the FDA Advisory Panel, by a sharply divided Panel vote of 9-6, issued a recommendation that Inamed Corporation be permitted to sell silicone gel breast implants in the U.S. under very tight guidelines. The Panel's recommendation is just that -- a recommendation to the FDA. It is not binding and should not be considered an approval of the safety of silicone gel breast implants by the FDA. The FDA is not required to accept this sharply divided recommendation. Currently, the U.S. Government is seeking repayment from silicone gel breast implant manufacturers for medical expenses it paid for implanted women to have their leaking and ruptured silicone breast implants removed and for treatment for medical conditions related to silicone. The Tort Claimants' Committee strongly disagrees with the Panel's recommendation because of the known adverse consequences and injuries caused by silicone gel breast implants.This is a brief summary of the Panel's recommendation. The Panel noted a problem with Inamed's application to market silicone breast implants. As expressed by the Panel's chair -- Dr. Whalen of the Wood Medical School -- he was amazed that after all these years, Inamed had so little data. Inamed did not adequately explain why they had only two and three year data when research by the FDA and others showed implants rupture and break after 7 years.First, the Panel recommended that women who are implanted with silicone breast implants must receive detailed warnings that explain the known risks and adverse consequences caused by silicone breast implants. Inamed's data, for example, showed that after 3 years, up to 46% of silicone implant recipients needed additional surgeries because of painful scar tissue and other complications. Up to 25% of the women had to have the implants removed or replaced. The Panel's requirement that women receive detailed warnings is the kind of stringent warnings that the TCC has always claimed in litigation were required but which Dow Corning never gave.Also, the Panel recommended that women will need annual exams -- such as an MRI -- to be sure their implants haven't ruptured or begun leaking silicone gel. When implants rupture, they must be removed, the panel stressed. Published scientific data shows a high rate of rupture of silicone gel breast implants the longer they remain implanted. Women contemplating implantation with a silicone breast implant should know that they will have to pay for the implant's removal, the annual exam, and all other medical expenses associated with complications from the implants.Third, all implant recipients must be enrolled in a registry to track their health.What does the FDA Panel's recommendations mean regarding the Amended Joint Plan of Reorganization of Dow Corning? The Panel's recommendation will not have any effect on implant claimants who elect to participate in the Settlement Option. Claimants who choose to opt-out (reject) the Settlement Option and file a lawsuit in court against the Litigation Facility (a corporation that will assume all of the liability of Dow Corning) should consult with an attorney and carefully weigh all risks of litigation, just as they would do in any lawsuit that is filed. The Panel did not state that silicone gel breast implants are safe. Indeed, the Panel acknowledged the many known adverse consequences caused by silicone gel breast implants and were critical of Inamed Corporation for its lack of adequate long-term follow-up studies of implanted women.The TCC will update the website as we get more information.