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Oregon Woman Sues Over Injuries Allegedly Caused by Biomet Metal-On-Metal Hip Implant

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An Oregon woman is suing over injuries she alleges were caused by a Biomet metal-on-metal hip implant. The lawsuit was filed on her behalf by the national law firm, Parker Waichman LLP and names Biomet Orthopedics, LLC, Biomet, Inc., and Biomet, LLC as defendants. The woman alleges that she suffered pain and had to undergo revision surgery to remove and replace her defective Biomet M2a Magnum hip implant.

The lawsuit—filed on July 2 in the U.S. District Court for the Northern District of California (Case No. 3:12-cv-3476)—alleges that the Biomet M2a Magnum Hip Implant System is defective and causes the implant to shed excessive amounts of cobalt and chromium, which may cause device rejection.

According to the complaint, the woman was implemented with the device on April 29, 2008 and, that at that time, more than 100 reports of adverse events were associated with the M2a Magnum and reported to the U.S. Food & Drug Administration (FDA); Biomet knew the M2a Magnum hip device was defective. On July 5, 2010, the woman underwent a complex, risky, and painful revision surgery to remove the failed implant.

The complaint also alleges that due to the defective design, manufacture, and composition of the M2a Magnum System, the plaintiff’s hip implant failed, causing her severe pain; that the system suffers from a design or manufacturing defect that causes excessive amounts of cobalt and chromium to wear and corrode from device, leading to implant rejection; and that device rejection causes pain, looseness, and dislocation, and causes the device to squeak and pop. Meanwhile, within the joint, the metal reaction often causes fluids to accumulate and soft tissue and bone to die. The lawsuit also alleges that that the Biomet hip replacement was not adequately tested before being sold, and that Biomet continued to sell the device even after receiving hundreds of complaints that it had failed, forcing patients to undergo painful and risky revision surgeries. More than 350 reports of adverse events associated with the M2a Magnum Hip System have been filed with the FDA, to date.

Metal-on-metal hip replacement devices such as the M2a Magnum hip have been the subject of growing safety concerns since the August 2010 worldwide recall of the DePuy Orthopaedics’ ASR Hip Resurfacing System and ASR Acetabular System. In fact, in June, an FDA report revealed that its review of recent data suggests that metal-on-metal hip replacement systems are likelier to fail than other hip implant devices. According to the agency, metal-on-metal hip replacement devices were linked to some 16,800 adverse event reports from 2000 to 2011. More than 14,000 reports involved revision surgery to remove a failing metal-on-metal hip implant.

In 2011, metal-on-metal hip implant complaints made to the FDA totaled 12,137, compared with only 6,332 associated with other types of hip replacement systems.

Last month, the FDA’s 18-member Orthopaedic and Rehabilitation Devices Panel met for two days to examine the safety of metal-on-metal hip implants, amid concerns that the device have the potential to expose patients to dangerous levels of metallic debris. According to a report from the Associated Press, the panel stated it could see few reasons to continue using the devices and recommended that metal-on-metal hip implant recipients experiencing pain and other symptoms receive regular X-rays and blood testing for their metal levels. Patients implanted with the devices should undergo yearly X-rays to monitor their implants, regardless of symptoms, the panel noted.

A report published in the British Medical Journal (BMJ) indicated that the panel also urged the FDA to see that the public—those considering hip replacement surgery and those fitted with all-metal devices—be provided with more information, including additional warning notices on device labels. One advisor, Scott Evans, a clinical trials statistician at Harvard University, noted that while ample data on hip implants exist, data is typically derived from observational studies and registries “with high levels of uncertainties,” but did maintain that there exists a need for appropriately designed prospective studies to answer the remaining questions about the safety of all-metal hip implants, otherwise “we are going to continue to dance around the true answers.”

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