FDA Probes Metal Hip Implant Safety Issues Following Mass Lawsuits

By Sarah Mirando | June 28, 2012

Category: Pharmaceuticals

By Matt O’Donnell

As the number of metal-on-metal hip replacement lawsuits pile up against manufacturers like DePuy, Biomet, Johnson & Johnson and others, U.S. health regulators are hopeful the Food and Drug Administration will issue new regulation to aid the thousands of patients who have suffered serious harm as a result of prematurely failing metal-on-metal hip implants.

The FDA is on the second day of a two-day meeting to scrutinize the safety of metal-on-metal hip implants, which have been the subject of thousands of patient lawsuits, multidistrict litigation (MDL) and class action lawsuits. The agency reports that all-metal hip implant devices have been linked to almost 16,800 adverse events in the U.S. from 2000-2011, but regulators say this number should not be relied on as many doctors don’t report problems to the FDA.

DePuy, a unit of Johnson & Johnson, began recalling defective metal-on-metal hip devices in 2010 after it was found more than 12 percent failed within five years. About 74 percent of the 12,137 incident reports to the FDA in 2011 involved a DePuy hip implant, the agency reported. Johnson & Johnson faces more than 6,000 metal hip implant lawsuits. Thousands of patients have filed individual lawsuits as well as joined a DePuy metal-on-metal hip implant lawsuit MDL and DePuy hip implant class action lawsuits. Patients injured by metal-on-metal hip implants are deciding to hold the companies liable for failing to warn them of the risks, and for failing to adequately test the devices before making them available to so many patients.

Metal Hip Implant Side Effects

The most-reported metal hip implant side effect is premature failure requiring revision, or surgery to remove or replace the implant. More than 14,000 metal-on-metal hip implant revision surgeries have been performed, according to the FDA. Other common metal-on-metal hip implant side effects include dislocated hip, leaking of toxic substances from the metal hip implant, cancer, degenerative heart disease or cardiomyopathy, loss of bone strength or structure which can result in bone fractures, tissue death for any tissue surrounding the metal hip implant, non-cancerous tumors or pseudotumors around the metal hip implant, cobalt poisoning, metallosis or metal poisoning due to chromium or cobalt particles from the metal hip implant.

The FDA is working to combine data from foreign countries and the U.S. to determine which groups of metal hip implant patients are most problematic. Over the past two days the agency has been asking a panel of experts to recommend the best practices for monitoring patients with metal-on-metal hip replacement devices. The FDA also asked manufacturers like Johnson & Johnson, Zimmer Holdings and Biomet to conduct long-term, follow-up studies of more than 100 metal-on-metal hip implants on the U.S. market. Agency scientists say the metal hip implant studies will help “fill in the blanks” on a number of scientific questions, including the effects of metal particles that often seep into the bloodstream when the implants wear down.

Despite the FDA probe, medical experts say it could be at least a decade before the FDA has a clear picture of the problem, which could be too little too late for patients.

Metal Hip Implant Lawsuits

Patents who are experiencing metal-on-metal hip implant side effects should see a doctor immediately for treatment and possible hip implant replacement. They should also be aware that they have legal options for holding the manufacturer liable for the pain and suffering they’ve endured. If you are experiencing symptoms, experienced some or all of these symptoms, or already had your hip implant replaced, you should speak with a metal-on-metal hip implant specialist to see if you’re a good fit to file a hip implant class action lawsuit or an individual metal-on-metal hip replacement lawsuit.

If you would like more information about filing a metal hip implant class action lawsuit or would like to file a replacement hip implant lawsuit or join the DePuy hip implant lawsuit MDL, just go to the Metal-on-Metal Hip Replacement Implant Class Action Lawsuit Investigation page. You can submit your information, or your loved one’s, to metal hip implant attorneys who are actively investigating all claims regarding premature hip failure, cancer, degenerative heart disease, tissue death, metal poisoning and other metal hip implant symptoms. Metal-on-metal hip implant attorneys are waiting to talk to you now and the consultation is free. These lawyers don’t get paid unless you win or settle.

Updated June 28th, 2012

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