Inamed Submits PMA for Its Next Generation Silicone Gel-Filled Breast Implants - and - Announces Pending Silicone Gel-Filled Breast Implants PMA Will Be Reviewed at an Upcoming FDA Panel Meeting

SANTA BARBARA, Calif. -- --Bio-Dimensional(TM) Cohesive Gel Matrix Style 410 PMA Submitted To FDA

--Supplemental Submission For Pending Silicone Gel-Filled Breast Implants PMA To Be Reviewed At Tentatively Scheduled Meeting Of The FDA's General and Plastic Surgery Devices Advisory Panel In April, 2005

Inamed Corporation (NASDAQ:IMDC), a global health care company, announced two significant events affecting its Breast Aesthetics franchise: 1) it has submitted a premarket approval application (PMA) with the U.S. Food and Drug Administration (FDA) for its "next generation" Bio- Dimensional(TM) Cohesive Gel Matrix (Style 410) breast implants; and 2) it has been notified by the FDA that its supplemental submission for its pending silicone gel-filled breast implants PMA will be reviewed at a tentatively scheduled meeting of the FDA's General and Plastic Surgery Devices Advisory Panel in April, 2005.

"Today's announcement represents a significant event for our company and demonstrates further progression of our Breast Aesthetics franchise in the United States," said Nick Teti, Chairman, President and Chief Executive Officer of Inamed. "As we were completing the Bio-Dimensional PMA filing, we learned from the FDA that they have scheduled our pending silicone gel-filled breast implant PMA for review by its independent Advisory Panel. The Panel will review the detailed supplemental data we submitted in August."

The Bio-Dimensional Cohesive Gel Matrix breast implants are "next generation" implants that are designed for memory and shape retention and are now in the third year of patient follow-up in the U.S. These products have been marketed outside the United States since the mid-1990's as the Bio-Dimensional Cohesive Gel Matrix (Style 410) and are the fastest growing breast implants product line in our company's international markets due to its features and added customization benefits.

Inamed's silicone gel-filled breast implants PMA was reviewed and recommended for approval by the FDA General and Plastic Surgery Devices Advisory Panel in October, 2003. In January, 2004, the FDA issued a not approvable letter to the company requesting additional information and also revised the guidance for the information to be included in PMAs for breast implants.

 


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