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* As of September, 2003, more than 500,000 incontinence repair procedures using GYNECARE TVT have been performed worldwide. More than 160,000 have been performed in the U.S. The device is proven safe and effective when used according to the Instructions for Use. GYNECARE diligently reports to the Food and Drug Administration (FDA) all serious injuries and deaths in accordance with federal regulations. As of September 26, 2003, GYNECARE had reported 377 Medical Device Reports (MDRs) to the FDA involving complications of surgery. These serious injury reports include any injury to a patien