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Tuesday, Aug 25th

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F.D.A. Admits Error in Approving Knee Device

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The Food and Drug Administration admitted Thursday that it mistakenly approved a patch for injured knees last year after being pressured by members of Congress and the manufacturer.

Internal documents demonstrate that agency’s scientific reviewers repeatedly determined that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation.

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