Mentor Submits Silicone Gel Breast Implant PMA Amendment to the FDA

Business Wire, August 31, 2004

SANTA BARBARA, Calif. -- Mentor Corporation (NYSE:MNT), a leading supplier of medical products in the United States and internationally, today announced that it had submitted to the U.S. Food and Drug Administration (FDA) an amendment to the Company's silicone gel breast implant Pre-Market Approval (PMA) application. The amendment is focused on providing additional information outlined in the revised guidelines issued by the FDA in January 2004, and on answering other questions raised by the Agency.

"I am pleased with the strength of the data in our PMA and with the quality and thoroughness of the information we have provided to meet the FDA's additional requests," commented Joshua H. Levine, President and Chief Executive Officer of Mentor Corporation. "We continue to have a positive dialogue with the Agency and look forward to working with them in support of the ongoing review process."

Mentor submitted its silicone gel breast implant PMA in December of 2003. In January 2004, the FDA issued revised guidelines for approval of silicone gel breast implants that requested additional scientific data and other information be submitted to supplement data requested in the FDA's original PMA filing guidelines. Mentor's submission included new long-term clinical data as well as additional pre-clinical data and other information responsive to these new guidelines.

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, Calif., 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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