INAMED Receives FDA Approvable Letter for Its Responsive Silicone Gel Filled Breast Implants

Business Wire, Sept 21, 2005

SANTA BARBARA, Calif. -- INAMED Corporation (Nasdaq:IMDC), a global healthcare company, today announced that it has received an "approvable letter" from the Food and Drug Administration (FDA) for its responsive silicone gel filled breast implants. The approvable letter stipulates a number of conditions that INAMED must comply with in order to receive FDA approval to market and sell responsive silicone gel filled breast implants in the United States.

"We respect the thoroughness of the FDA review process and are pleased with this decision. The conditions outlined in this letter are generally in line with our expectations and the discussions that took place at the October 2003 and April 2005 FDA advisory panel meetings, and we look forward to working with the Agency on a confidential basis in addressing them," said Nick Teti, INAMED Chairman, President and Chief Executive Officer. "If approved, these INAMED products will provide additional choices to satisfy and meet the needs of patients and surgeons in the U.S."

About INAMED Corporation

INAMED 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 or differ materially from those described in the forward-looking statements. INAMED is providing this information as of September 21, 2005 and expressly disclaims any duty to update information contained in this press release.

This press release contains additional forward-looking statements about regulatory matters related to INAMED's silicone breast implant products. These forward-looking statements involve risks and uncertainties, including unknown risks associated with the FDA approval process for the silicone gel breast implants, 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.

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, assumptions or otherwise. INAMED undertakes no obligation to review or confirm analysts' expectations or estimates or to state 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.

By including any information in this press release, INAMED does not necessarily acknowledge that disclosure of such information is required by applicable law or that the information is material.