FDA Advisory Panel Votes That Inamed's Gel-Filled Breast Implants PMA

    Business Editors/Health/Medical Writers

    SANTA BARBARA, Calif.--(BUSINESS WIRE)--April 12, 2005--Inamed Corporation (Nasdaq:IMDC), a global healthcare company, today announced that the General and Plastic Surgery Advisory Panel (Panel) of the U.S. Food and Drug Administration (FDA) recommended by a 5-4 vote the non-approval of the Company's premarket approval (PMA) application to market gel-filled breast implants in the United States.
    "We believe our clinical data and related information comply with the FDA's revised guidance document for breast implant PMAs, and therefore we are disappointed by the Panel's vote," said Nick Teti, Chairman, President and Chief Executive Officer of Inamed Corporation. "However, we intend to work with the FDA to address the PMA issues raised by the Panel during today's session."
    Mr. Teti noted that Inamed's Style 410 cohesive gel-filled breast implants are the subject of a separate PMA and were not part of the PMA under consideration today by the Panel.
    Inamed manufactures and sells gel-filled implants internationally in more than 60 countries. For more than a decade, gel-filled implants in the U.S. have been restricted to patients undergoing reconstruction or revision surgery and who are also participating in clinical studies.

    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. These 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 web site 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 April 12, 2005 and expressly disclaims any duty to update information contained in this press release.
    This press release contains additional forward-looking statements, including, without limitation, Inamed's anticipated product development program. 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.
    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.

--30--SW/la*

CONTACT: Inamed Corporation Declan Daly Executive Vice President and Chief Financial Officer 805-683-6761

KEYWORD: CALIFORNIA INDUSTRY KEYWORD: MEDICAL MEDICAL DEVICES SOURCE: Inamed Corporation

Copyright Business Wire 2005