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What was the basis for FDAs decisions to approve silicone gel-filled breast implants made by Allergan and Mentor?

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What was the basis for FDAs decisions to approve silicone gel-filled breast implants made by Allergan and Mentor?

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Scientific information in the PMAs demonstrated that there is a reasonable assurance that Allergan (formerly Inamed) and Mentors 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.

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