FDA Releases Information From Mentor's Implant Application
Mentor, a supplier of medical products in the U.S. and internationally, announced that the FDA has posted information related to Mentor's silicone gel breast implant premarket approval (PMA) application on its web site.
Mentor's pivotal Core Gel Study followed 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.
The FDA General and Plastic Surgery Devices Advisory Panel meeting is scheduled for April 11-13, 2005. Mentor is scheduled to present its data to the FDA April 13.