FDA will insist on a PMA submission for Metal-on-Metal Hips

METAL-ON-METAL HIPS TO REQUIRE PMA  (Orthopedics This Week)
The FDA has decided that makers of metal-on-metal total hip replacement systems should be ordered to submit premarket approval (PMA) applications.
On January 17, 2013, the FDA issued the proposed order along with a series of recommendations to orthopedic surgeons and patients thinking about getting a metal-on-metal hip or dealing with already implanted devices.
Orthopedic surgeons should take extra care in patient selection before using metal-on-metal hips and inform patients of the risks before using the implants. Surgeons should als...


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