or

March 01, 2004 01:00 PM US Eastern Timezone

Mentor Breast Implant Products Receive Full European Union Class III Medical Device Certification

SANTA BARBARA, Calif.--(BUSINESS WIRE)--March 1, 2004--Mentor Corporation (NYSE:MNT):

-- Approval Covers Saline and Silicone Gel-Filled Breast Implants and One-Stage and Two-Stage Tissue Expanders

-- New European Union Regulatory Requirements Met for Safety and Efficacy

Mentor Corporation (NYSE:MNT), a leading supplier of medical products in the United States and internationally, today announced that it had been notified that the Company's breast implant products had received full European Union class III CE Mark approval and recertification.

This certification of safety and effectiveness covers all of the breast implant products currently marketed and distributed by Mentor in the European Union including saline and silicone gel-filled breast implants, and the Company's Becker implants for single stage breast reconstruction. Products manufactured in Mentor's manufacturing facilities in Irving, Texas and in Leiden, The Netherlands, were both reviewed and certified.

"This Class III certification is the most rigorous level of review and approval by the European regulatory authorities and provides further evidence of the safety and effectiveness of our full range of breast implant products," commented Christopher Conway, Chairman and Chief Executive Officer. "We continue to focus on quality and innovation for the European market and for the other markets we serve worldwide."

Under its most recent directive, the European Union required that manufacturers of breast implant products submit clinical and other technical data to meet the Class III certification in advance of March 1, 2004, to continue sales in the European Union.