FDA Schedules Advisory Panel Hearing for Mentor's Silicone Gel-Filled Breast Implant PMA

Business Wire, Dec 6, 2004

SANTA BARBARA, Calif. -- Mentor Corporation (NYSE:MNT), a leading supplier of medical products in the United States and internationally, today announced that it has been notified by the U.S. Food and Drug Administration (FDA) that the Company's silicone gel-filled breast implant PreMarket Approval (PMA) application will be reviewed by an FDA Scientific Advisory Panel, scheduled for the Spring of 2005.

"We believe that the data from our core clinical study, together with the supplemental data we have provided, support the safety and effectiveness of these products. Mentor has a long heritage of innovation in surgical devices and patient care, and has been able to meet the increasingly sophisticated needs of physicians and evolving needs of patients," commented Joshua H. Levine, President and Chief Executive Officer. "We look forward to being able to offer an additional choice to women exploring options in breast augmentation and reconstruction."

Mentor filed the fifth and final module of its silicone gel-filled breast implant PMA in December 2003. In January 2004, the FDA issued revised guidelines for companies seeking to gain approval for silicone gel-filled breast implants. In August 2004, Mentor submitted an amendment to its PMA that focused on providing additional information outlined in the new January 2004 revised guidance document and on answering other questions raised by the Agency.

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 Aesthetics franchise includes prosthetic mammary implants for breast augmentation and reconstruction, and lipoplasty products for body contouring. Mentor's Urologic Specialties franchise includes surgical slings for the treatment of urinary stress incontinence, brachytherapy seeds for the treatment of prostate cancer, prosthetic implants for the treatment of erectile dysfunction and disposable surgical urology implants. The Company's Clinical and Consumer Healthcare franchise includes catheters and other products for the management of urinary incontinence and retention.

Mentor employs approximately 2,000 people around the world and is headquartered in Santa Barbara, California, with manufacturing and research operations in the United States, France, the Netherlands and the United Kingdom. The Company's website is www.mentorcorp.com.

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