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

Business Wire, Dec 6, 2004

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.

About INAMED Corporation

Inamed (NASDAQ:IMDC) is a global healthcare company with over 25 years of experience developing, manufacturing and marketing innovative, high-quality, science-based products. Current products include breast implants for aesthetic augmentation and for reconstructive surgery; a range of dermal products to treat facial wrinkles; and minimally invasive devices for obesity intervention, including the LAP-BAND(R) System for morbid obesity. The Company's website is www.inamed.com.

Forward-Looking Statements

This press release contains, in addition to historical information, forward-looking statements. Such statements are based on management's current estimates and expectations and are subject to a number of uncertainties and risks that could cause actual results to differ materially from those described in the forward-looking statements. Inamed is providing this information as of December 6, 2004, and expressly disclaims any duty to update information contained in this press release.

Forward-looking statements in this press release include, without limitation, express and implied statements regarding Inamed's anticipated sales, research and development, product development and regulatory approval. These forward-looking statements involve risks and uncertainties which could cause actual results to differ materially from those expressed or implied here. Readers are referred to the documents filed by Inamed with the Securities and Exchange Commission, specifically the most recent reports which identify important risk factors that could cause actual results to differ from those contained in the forward-looking statements, including but not limited to: exposure to product liability and intellectual property claims; exposure to liabilities that may not be adequately covered by insurance or for which there is no insurance; potential negative publicity concerning product safety; potential fluctuations in quarterly and annual results; the effect of changing accounting and public reporting rules and regulations; volatility of Inamed's stock price; changes in the economy and consumer spending; competition from existing and/or new products; failure or delay of clinical trials; uncertainty in receiving timely regulatory approval or market acceptance for new products; dependence on a single supplier for each of Inamed's silicone raw materials, bovine and human collagen-based products, hyaluronic acid-based products, and botulinum toxin Type A products; failure to protect Inamed's intellectual property; adverse changes in the regulatory or legislative environment (both in the U.S. and internationally) affecting our business; and failure of some or all of our collaborative partners to perform. The information contained in this press release is a statement of Inamed's present intention, belief or expectation and is based upon, among other things, the existing regulatory environment, industry conditions, market conditions and prices, the economy in general and Inamed's assumptions. Inamed may change its intention, belief or expectation, at any time and without notice, based upon any changes in such factors, in Inamed's assumptions or otherwise. Inamed undertakes no obligation to review or confirm analysts' expectations or estimates or to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.