FDA Panel Backs Mentor Breast Implant

In a surprise move, a federal advisory panel on Wednesday approved a silicone-gel breast implant made by Mentor(MNT Quote), one day after rebuffing a similar device from Inamed(IMDC Quote).

If the Food and Drug Administration follows the lead of its advisory panel, the Mentor product would be the first silicone-gel implant approved for widespread use in the U.S. since 1992. The advisory committee voted 7-2 for the product.

The FDA usually follows the recommendations of its advisory panels, but it isn't bound by their suggestions. In October 2003, for example, an advisory panel endorsed an Inamed silicone-gel implant by a 9-6 vote; but the FDA voted against approving the device in January 2004. The FDA said the company didn't prove that the product would be safe over time. ...