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FDA Makes Metal-On-Metal Hip Manufacturers Collect More Data

In an uncharacteristic turn of events, the U.S. Food and Drug Administration (FDA) has required the manufacturers of metal-on-metal hip replacement systems to conduct further studies of their implants. The inquiry by the FDA is due to adverse health reports that acknowledge concerns for unusually high failure rates and severe health effects in patients.

In an interview conducted over the telephone, Dr. William H. Maisel, the deputy director for science at the F.D.A.’s Center for Devices and Radiological Health, acknowledged that this request represents the pinnacle of the agency’s authority to conduct studies of devices that have already been approved for sale. He continued by emphasizing that the FDA was interested in information regarding the entire category of implants, not any single manufacturer’s device.

In their request, the FDA has demanded that nearly 20 manufacturers of metal-on-metal hip replacement systems determine, whether or not, their implants are generating elevated levels of metallic debris. A catastrophic complication that can lead to debilitating soft tissue damage. Major hip implant systems included in the study were Zimmer Durom, Stryker, Biomet and Wright Medical.

Metal-on-metal hip replacement system components are typically made out of cobalt and chromium. However, these metals can potentially wear and diminish over a period of time and create minute shavings that can cause excruciating pain. Many patients may react adversely to these shavings, causing fluid to gather in the joint and muscles surrounding it. If left untreated or neglected, this reaction may cause severe pain and swelling around the joint which can damage muscles, bones, and nerves around the hip area. Due to the high failure rate in these devices, healthcare professionals estimate that metal-on-metal hip implants have accounted for one-third of all hip replacement procedures in the U.S.

Increased reports of adverse health events in patients who have received metal-on-metal hip replacements have led to a decrease in their use. News that the devices are prone to early failure rates and metallic debris more than justifies patient worries. Concerns were elevated even further when the British Orthopaedic Association, a professional medical group, estimated that the early failure rates for metal-on-metal hips was higher than expected, ranging from 12 to 15 percent within five years after surgery. Staggering statistic, considering artificial hips are designed to last for 15 years or more.

Dr. Maisel, an FDA official, strongly believes that these metal-on-metal devices serve a beneficial purpose to those who receive them. However, the reports of high failure rates warrant the need to conduct a broad review of the products. Accordingly, the FDA has given manufacturers 30 days to file a proposed plan as to how their study will be conducted. This request represents the largest group of studies that the FDA has ever asked for, regarding devices that have already been approved for sale.

Do I Have A Hip Replacement Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in hip replacement lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one was injured by a hip replacement, you may be entitled to financial compensation by filing a hip replacement lawsuit. For a free case review, please click the link below or call toll free 24 hrs/day 1-800-773-0849.

Categories: Product Liability
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