or 
Mentor
Files FDA Submission for Breast Implants
SANTA BARBARA, Calif.--(BUSINESS WIRE)--Dec. 12, 2003--Mentor Corporation (NYSE:MNT)
today announced the filing of the Clinical Module, the fifth and final module,
of its Pre Market Approval Application (PMA) seeking approval of Mentor Silicone
Gel Filled Breast Implants with the U.S. Food and Drug Administration (FDA).
"I am pleased with the Mentor team that completed the scientific studies
to finalize this application, and I am very proud of the clinical results,"
said Maher Michael, M.D., Medical Director and Vice-President of Clinical and
Regulatory Submissions for Mentor Corporation. "The submission of this
module completes our PMA application and I believe it confirms the safety and
efficacy of Mentor's breast implants."
Josh Levine, President and Chief Operating Officer, added, "We are excited about what this means for patients, physicians and our industry overall. I think the FDA will be pleased with our clinical data and I hope we will gain market approval in the near future, although we cannot predict the timetable that the FDA will follow. After FDA review and approval, women seeking breast reconstruction, augmentation or revision will have more choices available to them. The ability to select products tailored to specific patient needs will aid better post-operative outcomes."
According to the American Society of Plastic Surgeons, over 236,000 women had their breasts enhanced through augmentation procedures last year, and 74,000 women underwent breast reconstruction with implants following mastectomy procedures.
Further information about breast implants is available on Mentor's website, www.mentorcorp.com
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