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FDA Proposes More Regulation for Metal-on-Metal Hip Implants

By January 19, 2013

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The FDA has proposed new rules that would require metal-on-metal hips to provide proof of safety and effectiveness. Metal-on-metal hip components (the ball, stem and shell) are made from cobalt-chromium-molybdenum alloys. Metal-on-metal hip implants, which have been used in traditional hip replacements and in hip resurfacing systems, have shown a high rate of failure and problems caused by the shedding of metal ions which can occur as components rub on one another. The release of metal ions can potentially cause damage to bone or soft tissue that surrounds the implant and joint.

The new proposal, put forth on January 17, 2013, would require manufacturers of metal-on-metal total hip replacement systems to submit premarket approval applications. Metal-on-metal total hip replacement systems were marketed in the U.S. prior to 1976 legislation that gave the FDA premarket authority over medical devices. Learn more about the FDA proposal.

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