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FDA Meeting will Scrutinize Metal-on-Metal Hip Devices

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The U.S. Food and Drug Administration will begin a two-day meeting on Wednesday to evaluate the safety and efficacy of metal-on-metal hip replacement devices, following thousands of adverse event reports of pain and premature failure that can result in patients having to undergo risky revision surgery to remove and replace the device.

Earlier this year, the British joint registry issued a notice that metal-on-metal hip devices should not be used, citing data that showed the devices often needed replaced sooner than alternative ceramic or plastic-joint devices.

The FDA said they would make a recommendation after reviewing all available data. The FDA chief scientist for medical devices, Dr. William Maisel told the Associated Press, “Why look at a single registry when there’s data from around the world? This is an opportunity for us to look at all the available information so that we can have a thoughtful conversation about what clinical recommendations can be made.”

Previously, the FDA requested metal-on-metal hip manufacturers to conduct long-term follow up studies on device implants in the U.S. market, the AP reported, giving the FDA more information about the integrity of the devices, as well as the effects of metal debris that may seep into the bloodstream as the devices wear.

breakinglawsuitnews.com disclaimer: This article: FDA Meeting will Scrutinize Metal-on-Metal Hip Devices was posted on Tuesday, June 26th, 2012 at 9:47 pm at breakinglawsuitnews.com and is filed under Medical Device Lawsuits.

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