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...