FDA Releases Information from Mentor's Silicone Gel Breast Implant Approval Application

Main Category: Cosmetic Medicine / Plastic Surgery
Article Date: 13 Apr 2005 - 11:00 PDT

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Mentor Corporation (NYSE:MNT), a leading supplier of medical products in the United States and internationally, today announced that the U.S. Food and Drug Administration (FDA) has posted information related to Mentor'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, on its web site.

The information can be viewed by accessing a link on Mentor's web site, http://www.mentorcorp.com, or by accessing the FDA web site directly.

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 on Wednesday, April 13th.

About Mentor Corporation

Founded in 1969, Mentor Corporation is a leading supplier of medical products for the global healthcare market. The Company develops, manufactures and markets innovative, science-based products for the aesthetics, urologic specialties and clinical and consumer healthcare markets around the world. The Company's website is http://www.mentorcorp.com.

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