The New York Times is reporting that the United States Food and Drug Administration has ordered all makers of metal-on-metal artificial hips to conduct studies of the implants. Over the past two years, researchers have linked the faulty metal-on-metal hip replacements to high rates of early failure and serious health effects, including soft-tissue damage and permanent disability in some patients.
FDA Orders Manufacturers to Conduct StudiesThe FDA's order forces makers of metal-on-metal hip implants to perform studies of patients who received the defective device to determine whether the implants are shedding high levels of metallic debris. Earlier this year, the British Orthopaedic Association found that the Depuy ASR hip implant was failing in one-half of the patients who received it within six years after implant. According to the New York Times, Dr. William H. Maisel, the deputy director for science at the FDA's Center for Devices and Radiological Health, has stated that the order marks the broadest use of the agency's authority to conduct studies of devices after approval for sale. The FDA is seeking information about all metal-on-metal implants, not any single manufacturers device. Dr. Maisel has stated that there are significant enough medical concerns to warrant a broad review. He points out that problems are specific to the metal-on-metal implants, which have been produced by 20 different manufacturers and broadly used in the United States. Dr. Maisel has explained, "Our concern is the product, not about a manufacturer." The FDA has indicated that postmarket studies are necessary where an implant's failure could have serious consequences. Other concerns are also apparent.
The agency's action could also prompt increased scrutiny of regulatory policies that allow implants like metal-on-metal hips to be approved for sale with little, if any, clinical testing in patients. In addition, the F.D.A.'s oversight of hip implants has lagged that in other countries where registries follow the failure rate of orthopedic implants in patients.
Metal-on-Metal Hip Implants Failing at Unusually High RatesMetal-on-metal hips implants use ball and socket components that are made from metals such as cobalt and chromium. Until the last couple years, when manufacturers began recalling metal-on-metal implants, these devices accounted for one-third of the 250,000 hip replacement procedures preformed each year in the United States.
But over the last two years, the use of [metal-on-metal] implants has fallen off in part amid reports that they were prone to early failure and that some patients had developed serious health problems related to particles of metallic debris that are shed by the devices as they wear.The New York Times reports that just this year, the British Orthopaedic Association reported that Johnson & Johnson's Depuy ASR hip implant was expected to fail in one-half of all patients who received it within six years after surgery. Depuy, which has recently undergone leadership changes, recalled the faulty hip implant last August. The British Orthopaedic Association has also reviewed hospital data.
[T]he early failure rate for all-metal hips made by other manufacturers was higher than expected, ranging from 12 to 15 percent within five years after implant. Artificial hips are designed to last for 15 years or more.Under the FDA order, manufacturers will have 30 days to submit thier proposed studies to the FDA and are "expected to collect information from patients who received the devices, including taking blood samples to determine the levels of metallic ion in their systems." The makers of the defective hip implants, including Zimmer, Stryker, Biomet, and Wright Medical, are also required to determine how frequently the devices are failing.
Free Legal ConsultationIf you or someone you know has experienced problems with a hip implant or other medical implant device, you may have a valid legal claim. Contact our office today to find out about your legal rights. All consultations are free. Our experienced and professional attorneys have helped hundreds of patients receive the recovery to which they are legally entitled. You should know your options and we can help. Call Joshua S. Kincannon at 1-877-ATTY-247 to speak to a hip implant litigation specialist or visit www.defectivejoints.com and submit a contact form.
2011-05-13 | Add a Comment
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