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 also evaluate current asymptomatic patients every six months and be aware of certain patients who are at risk for increased device wear.
The new recommendations follow last June’s unprecedented meeting of the FDA’s orthopedic advisory panel, warnings of implant failures from overseas, product recalls and thousands of lawsuits pending against the makers of the hips.
Recommendations for Orthopedic Surgeons–According to the FDA Recommendations:
Before Surgery
Select a metal-on-metal hip implant for your patient only after determining that the benefit-risk profile of using a metal-on-metal hip impla...
