FDA panel questions the benefits of ReGen’s Menaflex meniscus repair implant

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FDA Panel Questions Knee Device  ...WSJ Online
An FDA panel of outside experts found that there isn't enough scientific evidence to come to a firm conclusion about the benefits of a knee device approved by the FDA in 2008.  The panel's statement highlights the agency's dilemma as it weighs whether it has authority to revoke a device's approval.

The chairman of the panel, orthopedic surgeon John Kelly of the University of Pennsylvania, cited inadequate and low-quality evidence about the effectiveness of the Menaflex implant made by ReGen Biologics Inc., and not enough information about the ...

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