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Inamed Silicone Gel-Filled Breast Implants Approved as Class III Medical Devices in the European Union
SANTA BARBARA, Calif.--(BUSINESS WIRE)--Dec. 2, 2003--Inamed Corporation (Nasdaq:IMDC), a global healthcare company, announced today that the single lumen models of its silicone gel-filled breast implants have been certified as satisfying the European Union's (EU) safety and efficacy requirements for the most stringent classification, Class III Medical Device, months ahead of the March 1, 2004 deadline to continue sales.
"These implants were reclassified by the EU into the strictest category of medical devices for sale to the public," said Nick Teti, Chairman, Chief Executive Officer and President of Inamed. "We are gratified that these products have been determined by scientific review in the EU to be safe and effective."

The Commission of the European Communities, in its communication on Breast Implants dated November 15, 2003, states, "...Directive 93/42/EEC on medical devices...contains the essential requirements, in terms of quality and safety, which medical devices like breast implants have to meet, in order to ensure a high level of health protection." The Directive further states, "The Directive also contains obligations imposed on the manufacturer regarding labeling and information provided to the patient and the physician."

Four of the models and styles (McGhan Styles 40, 45, 110 and 120) that satisfy the EU's Class III certification requirements are the same breast implants that are currently under Premarket Approval review by the U.S. Food and Drug Administration (FDA). At its October 2003 meeting, the FDA's General and Plastic Surgery Advisory Panel of medical and scientific experts recommended that the Agency approve, with conditions, the general marketing of Inamed's silicone gel-filled breast implants in the United States. A decision by the FDA is pending.

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.