Inamed gets FDA panel date
This article was originally published in The Gray Sheet
Executive Summary
Silicone gel-filled breast implant PMA will go before FDA's General & Plastic Surgery Devices Panel Oct. 14-15. Some patient advocacy groups, including the National Organization for Women, Public Citizen and the National Women's Health Network have raised concerns about Inamed's PMA, filed last December (1"The Gray Sheet, July 28, 2003, p. 10). Inamed's submission is based on data from 1,000 patients followed for at least three years. Competitor Mentor plans to submit its final module, based on two-year data, by year-end...