Inamed Revises FDA Implant Bid

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http://www.forbes.com/business/healthcare/feeds/ap/2005/07/18/ap2142887.html

Inamed Revises FDA Breast Implant Bid 07.18.2005, 09:18 AM Inamed Corp. said Monday it has revised its premarket applications for certain silicone gel breast implants, after a Food and Drug Administration panel narrowly rejected the medical device maker's data. Inamed said it is final discussions with the FDA to allow expanded access of its Style 410 silicone gel implants. The company revised its application for the implant by providing three-year follow-up data and additional imaging information, along with European rupture data for implants that have been in place for five to nine years. The company said the Style 410 model has been available outside the United States for about 10 years. Inamed also said that it would end clinical study

availability of its Style 153 breast implant, which accounted for less than one percent of company sales last year. The company also modified its responsive gel application by separating data for eight round and the shaped Style 153 investigational devices. Inamed also included new 10- to 12-year European data for these styles. In April, the same FDA advisory panel that criticized Inamed's data did vote to recommend that rival Mentor Corp.'s silicone-gel breast implants be approved for the U.S. market, under certain conditions. In 1992, the FDA banned the use of silicone gel-filled breast implants after some women reported health problems such as chronic pain, memory loss, migraines, fibromyalgia and autoimmune-related thyroid disease. The FDA has said it will continue to review the safety of silicone gel-filled breast implants. __________________________________________________