The U.S. Food and Drug Administration Orders Artificial Hip Manufacturers to Conduct Post Market Health Studies
The FDA orders hip manufacturers to conduct health studies in response to the growing realization that “metal on metal” artificial hip implants have been linked to high failure rates and severe health effects on numerous patients, the FDA has taken the unusual step of mandating all producers of “metal on metal” hips to do post-market studies of patients who received the devices to determine, among other things whether the implants are shedding high levels of metallic debris. The problem has resulted in patients becoming disabled.
Dr. William H. Maisel, the deputy director for science at the FDA’s Center for Devices and Radiological Health, said the order marks the broadest use of authority to conduct studies of devices after approval for sale. The Agency is looking at the entire category of implants, not those of any single manufacturer.
Metal on Metal hips, in which the ball-and socket components are made from metal like cobalt and chromium, account for about one third of the 250,000 hip replacement procedures preformed annually in the United States.
Under the order, companies are expected to collect information from patients who received devises, including taking blood samples to determine the levels of metallic ion in their systems. The companies are also being asked to determine how frequently the devices are failing.
Along with the DePuy division of Johnson & Johnson, other major producers of hip implants include Zimmer, Stryker, Biomet, Wright Medical and Smith & Nephew.
Attorneys at the Strick Injury Law and Mediation have worked with many individuals who have suffered ill effects associated with failed hip implants. If you or a family member have any questions associated with the use of these products we will be happy to answer any questions.