Health
FDA OKs some silicone breast implants
NEWS IN BRIEF — Posted May 2, 2005
A Food and Drug Administration advisory panel that met in mid-April to provide advice to the agency on whether silicone breast implants should be sold more widely delivered a very mixed message.
The panel voted 5-4 April 12 against the approval of implants manufactured by the Inamed Corp. and reversed itself the next day in a 7-2 vote to approve sales of an implant manufactured by the Mentor Corp.
Since 1992, silicone implants have been available only to breast cancer patients participating in clinical trials because of concerns that silicone leaking from the implants could cause serious health problems.
Saline implants, judged to be the safer of the two, are the only implants available widely, and they have been criticized for looking less natural than the silicone implants.
The FDA advisory panel met in 2003 and voted to recommend that the silicone implants be approved, although only when a list of conditions was met. In January 2004, however, the FDA rejected that advice and denied approval of the implants, citing the need for additional data.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2005/05/02/hlbf0502.htm.
