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A recent article published by the New York Times indicates the Food and Drug Administration has ordered all manufacturers of metal-on-metal hip implants to conduct studies of patients who received the devices. The FDA is authorized to order this study under Section 522 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360l). This order comes amid rising concerns over the safety of metal-on-metal hip implants which have been linked to high early failure rates and severe health problems in some patients. The companies are expected to collect information from recipients of the devices to determine how often the devices are failing and if they are shedding high levels of metallic debris. The companies have 30 days to submit a proposal to the FDA regarding their plan to collect the required information.
The FDA issued a letter on May 6, 2011 to 20 manufacturers of metal-on-metal hip implants advising that they are invoking a rule requiring post market studies in cases where a hip implant’s failure could have serious health consequences. The agency’s action could prompt increased scrutiny of regulatory policies that allow medical products to be approved for sale with little, if any, clinical trials in patients. Many other countries maintain joint replacement registries to monitor the safety, efficacy and revision rates for artificial joints. The United States does not currently maintain a registry of this nature and until this recent order by the FDA, has lagged behind in its monitoring of devices that are approved under the 510k exception which does not require clinical studies prior to approval.
The FDA did not target a specific manufacturer but rather made a broad request to all manufacturers of metal-on-metal hip implants which included DePuy Orthopaedics, Zimmer, Stryker, Biomet and Wright Medical Technologies.
See the full article at http://www.nytimes.com/2011/05/11/business/11hip.html?_r=1&hpw
Attachments:
Letter from FDA regarding order for postmarket studies
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