What was the basis for FDAs decisions to approve silicone gel-filled breast implants made by Allergan and Mentor?
Scientific information in the PMAs demonstrated that there is a reasonable assurance that Allergan (formerly Inamed) and Mentor’s silicone gel-filled breast implants are safe and effective and that there is adequate information about these products to enable women to make informed decisions about whether to get them. FDA’s decision was based on: a thorough review of the companies’ Core Studies, including three years of data for Mentor and fours years of data for Allergan a thorough review of the companies’ other clinical information, such as data from the Adjunct Studies (open access studies for reconstruction and revision patients), and international studies a thorough review of the companies’ laboratory testing data a thorough review of the published scientific literature on silicone gel-filled breast implants inspections of the manufacturing facilities of both companies to ensure that the implants will be manufactured according to the Quality System Regulations (http://www.fda.gov/c
Related Questions
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- What was the basis for FDAs decisions to approve silicone gel-filled breast implants made by Allergan and Mentor?
- What was the basis for FDAs decisions to approve silicone gel-filled breast implants made by Allergan and Mentor?
