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Spring renewal of breast implant PMA debate

This article was originally published in The Gray Sheet

Executive Summary

FDA General & Plastic Surgery Devices Panel will convene in April to review supplemental data on Inamed's silicone gel-filled breast implants, the firm says Dec. 6. Submitted to the agency in August, the data supports a PMA deemed "approvable with conditions" by the FDA panel in a 9-6 vote last year (1"The Gray Sheet" Oct. 20, 2003, p. 3). FDA's rejection of the PMA in January narrowed the race between Inamed and Mentor, which claims it expects a spring panel review of its own silicone implants. Like Inamed, Mentor filed supplemental data to its PMA in August, accounting for FDA guidance in January. The two firms could share a panel date...

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Inamed and Mentor will go before FDA's General & Plastic Surgery Devices Panel April 11-13 in Gaithersburg, Md., according to both firms (1"The Gray Sheet" Dec. 13, 2004, In Brief). In addition, Mentor will bring its implants before Health Canada's Expert Advisory Panel March 3-4; Inamed likely will share the date. The Canadian meeting will be closed to the public [Editors' note: Visit "The Gray Sheet" affiliate to view the FDA panel meeting live, or to order a DVD or videocassette]...

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