FDA Orders Studies of Metal-on-Metal Hip ImplantsMay 11, 2011 | Parker Waichman LLP
The U.S. Food & Drug Administration (FDA) is upping its scrutiny of metal-on-metal hip implants, following the highly-publicized recall of the ASR Hip Replacement System last year by DePuy Orthopaedics. According to a report from The New York Times, the FDA has ordered DePuy and 20 other device makers - including Zimmer, Stryker, and Biomet - to determine if their metal-on-metal hip implants are shedding dangerous amounts of chromium and cobalt into patients' blood streams.
Concerns have been growing for some time now that the shedding of metallic debris from metal-on-metal hip implants can cause side effects like metallosis and cobalt poisoning. Earlier this year, the FDA even launched a Website to address some of these concerns.
The potential side effects of metal-on-metal hip implants were highlighted last August, with the DePuy ASR hip implant recall. That recall was issued after data from a registry in the United Kingdom indicated a failure rate 12 percent within five years of implantation. Another metal-on-metal hip implant, the DePuy Pinnacle hip replacement, has allegedly also been linked to early failures.
In addition to the issue of metallic shedding, the FDA also wants DePuy and other manufacturers to look into the rate at which their metal-on-metal implants fail. Not one device is being targeted, rather the agency is looking at the whole class of devices, the Times said.
An FDA official told the Times that the order, which was conveyed via letter sent to device makers last week, "marks the broadest use of the agency’s authority to conduct studies of devices after approval for sale."
According to a report from Bloomberg News, a DePuy spokesperson said the company “is seeking further clarification from the FDA and considering how to best meet the agency’s requirements." In an email, a Zimmer official company was “working to understand the scope of the agency’s request,” while Stryker responded that it doesn't make metal-on-metal hips.
The manufacturers have 30 days to file proposed plans with the FDA, The New York Times said.