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Allergan Announces FDA Approval of INAMED(R) Silicone-Filled Breast Implants for Breast Augmentation, Reconstruction and Revision Surgery

IRVINE, Calif., Nov 17, 2006 (BUSINESS WIRE) -- Allergan, Inc. (NYSE:AGN) today announced that the United States Food and Drug Administration (FDA) has approved Allergan's INAMED(R) Silicone-Filled Breast Implants for use in breast augmentation, reconstruction and revision surgery. Until today, INAMED(R) Silicone-Filled Breast Implants were only available in the United States to women seeking breast reconstruction and revision surgery through clinical studies. The approval is a significant development for women in the United States who now have the same options that women in more than 60 countries have had for the last 25 years.

"Allergan is pleased that the FDA has further recognized the vast body of scientific evidence supporting the performance of these devices and has approved INAMED(R) Silicone-Filled Breast Implants for re-entry to the U.S. market," said David E.I. Pyott, Allergan's Chairman of the Board and Chief Executive Officer. "Our ability to offer surgeons in the United States a comprehensive portfolio of saline-filled and silicone gel-filled breast implants results in greater options for women considering breast augmentation, reconstruction or revision surgery."

Silicone gel-filled breast implants are among the most studied medical devices in existence, with thousands of peer-reviewed and published reports on studies, including robust epidemiological studies supporting their safe use. The safety of INAMED(R) Silicone-Filled Breast Implants is supported by the company's extensive pre-clinical device testing, their use in approximately 1,000,000 women worldwide and nearly a decade of U.S. clinical experience involving more than 80,000 women. Furthermore, silicone is used safely in the body in many medical devices and products, including pacemakers, heart valves, artificial joints and baby pacifiers.

"The FDA's decision confirms what we in the plastic surgery community have known for some time - silicone gel-filled breast implants are a safe and effective option for women seeking breast implant surgery," said Scott L. Spear, M.D., F.A.C.S., Chairman, Department of Plastic Surgery, Georgetown University School of Medicine, Washington, D.C. "For decades, I have had the ability to offer silicone gel-filled breast implants to my breast reconstruction patients. Now, with the FDA approval of INAMED(R) Silicone-Filled Breast Implants, I am able to offer a broader range of options to all of my patients, many of whom are seeking breast augmentation surgery following significant life events such as child bearing."