FDA posts silicone gel breast implant approval information

Apr 6 2005

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.