Regulators’ Slow Response Exposed More Metal-on-Metal Hip Implant Patients to Serious Health Risks

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Parker Waichman LLP is reporting that regulators in the UK’s Medicines Healthcare products and Regulatory Agency (MHRA) knew about the risks associated with metal-on-metal hip implants long before the device was recalled. A report by The Science and Technology Committee called the MHRA’s delayed response “disappointing,” stating that many patients have suffered unnecessarily because of it.

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According to a report by Wales Online, problems with metal-on-metal hip implants have been apparent as early as 2007, when the issue was picked up by regulators in Australia.

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, is warning the public about the risks associated with metal-on-metal hip implants, including the DePuy ASR; this device came under scrutiny worldwide when it was recalled due to safety issues in 2010. Now, a new report shows that UK regulators were aware of problems associated with the implant long before it was recalled.

According to a report by Wales Online, problems with metal-on-metal hip implants have been apparent as early as 2007, when the issue was picked up by regulators in Australia. In 2009, the DePuy ASR was removed from the Australian market. The worldwide recall, however, was not issued until August 2010. In its report on the Regulation of Medical Implants in the EU and UK, The Science and Technology Committee criticized the MHRA’s delayed response, stating “It is disappointing that problems with metal-on-metal hip implants were picked up several years before the worldwide recall and it appears that the MHRA was slow in responding to data emerging from Australia. Because of that delay, many patients have suffered needlessly."

The DePuy ASR was recalled due to poor performance in a large number of patients. The problem with this implant, experts say, is that tiny pieces of metal break off from the device when the metal surfaces rub together. These cobalt and chromium ions get absorbed into the blood stream and nearby tissues, potentially causing muscle, bone and neurological damage.

Issues associated with metal hip implants began with the DePuy ASR, but now studies suggest that the problem applies to all metal-on-metal hip replacements. In fact, last May the U.S. Food and Drug Administration (FDA) asked 21 manufacturers to conduct post market studies on metal hip implants to assess their safety. In June, the agency gathered a panel of experts to weigh the risks versus benefits of the device. After a three-day meeting, the panel advised patients implanted with metal-on-metal hip implants to undergo annual physicals and imaging scans to detect damage to bone or tissue. The experts also recommended possible blood screening for metal ions.

In July, Orthopedics journal published a study analyzing failed metal-on-metal hip replacements, finding that the vast majority of revisions occurred within three years, which is relatively early within the post-op period. Research also suggests that metal-on-metal issues are problematic with both traditional total hip replacements (THR) and hip resurfacing, which is a newer metal-on-metal method that attempts to preserve more bone. According to a study published in the Lancet last month, hip resurfacing was associated with an “unacceptably high” rate of failure, particularly in women and men of smaller stature.

Parker Waichman LLP continues to offer free legal consultations to victims of defective medical devices, including DePuy ASR and other metal-on-metal hip implants. If you or a loved one experienced premature failure of your implant or other health problems associated with a recalled DePuy ASR Hip Implant or other metal-on-metal hip replacement device, please contact their office by visiting the firm's metal-on-metal hip implant injury page at Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).

Parker Waichman LLP 
Gary Falkowitz, Managing Attorney 
1-800 LAW-INFO  (800 529-4636)

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Gary Falkowitz, Managing Attorney
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