FDA posts silicone gel breast implant approval information

The U.S. Food and Drug Administration (FDA), has posted information on it's web site related to the Mentor Corporation's silicone gel breast implant pre-market approval (PMA) application, scheduled to be reviewed at a General and Plastics Surgery Devices Advisory Panel meeting April 11-13, 2005.

An important study by the company, the Core Gel Study, tracked the progress of 1,007 women who were implanted with silicone gel-filled breast implants for either augmentation, reconstruction or revision surgery.

The data submitted to the FDA includes information from the 3-year follow-up period as well as longer-term clinical data specific to the integrity of Mentor's silicone gel-filled breast implants. Mentor will present its data on Wednesday, April 13th to the panel.