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Breast Implants
7-year deflation rate data filed for breast implants post approval survey study
September 5th, 2004
INAMED Corporation (IMDC) has filed 7-year deflation rate follow-up data with the U.S. Food and Drug Administration (FDA) for augmentation and reconstruction patients who are participating in the core clinical study of its Biocell Textured and Smooth Saline-Filled Breast Implants. The 7-year data are an interval update for product labeling that is required by the FDA as part of the Post Approval Survey Study that was a condition of approval for Inamed's saline-filled breast implants in 2000. The 7-year data build on the existing 5-year data that were previously filed with the FDA. At 7 years, the deflation rate for the Inamed...
Source: Medical Letter on the CDC & FDA (2004-09-05)
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