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FDA Advisors Discuss Metal-On-Metal Hip Implants

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Advisors to the U.S. Food & Drug Administration (FDA) have been meeting to discuss the safety of metal-on-metal hip implants. The controversial medical devices are at the center of a fiasco that has left many patients suffering with pain, ambulation issues, and the need for repeat surgeries, not to mention a growing number of lawsuits and recalls. The two-day advisory panel, which concludes today, convened yesterday to address side effect and safety issues associated with the devices that were meant to outlast their ceramic and plastic predecessors. The panel has been asked to issue recommendations concerning added warnings and other data for the hip systems and devices, including which patients would and would not benefit from being implanted with the all-metal devices, said the Wall Street Journal. Regulatory issues, including if stricter clinical testing is required, will not be discussed. All-metal hip replacement devices and systems were approved via a controversial fast-tracking procedure at the FDA called the 510(k) process. This fast-tracked approval enables new medical devices to make it to market with no clinical, human trials if the new device can be proven substantially similar to an existing, approved medical device. Major changes must undergo additional testing and hip resurfacing systems must undergo FDA’s pre-market approval process, which mandates clinical studies in humans, the Journal said. Metal device manufacturers touted the systems as being longer lasting and better for younger patients, and requiring less replacement surgeries, said NewsInferno. Older ceramic and plastic devices typically required replacement after about 15 years; metal devices were created to last about 20 years. Just the opposite occurred in many cases. Studies reveal early failure rates and significant complications within weeks and months of implant surgery, which can lead to a need for painful and expensive revision surgery and extended rehabilitation, noted NewsInferno. In many cases, replacing a faulty hip results in loss of full mobility. Some studies have revealed that metal-on-metal implants have failed prematurely in 13-30 percent of the cases. One such case involves Johnson & Johnson’s DePuy Orthopaedics Inc. ASR device, which was recalled in 2010. The 93,000 devices were associated with increased failure rates versus other implants and have led to some 6,000 lawsuits, said the Journal. Metal-on-Metal hip implant devices have been linked to metal breakdown when components wear against each other and release metal shards into patients bodies. This wearing, notes the Journal, can lead to severe inflammation, metallosis (a toxic build-up of heavy metals, such as cobalt) benign masses, and debilitating pain. “Could it be the size of the head when we are attributing all the problems to metal?” Raj Rao, a panel member from the orthopedic surgery department at the Medical College of Wisconsin, questioned, wrote the Journal. The panel had not officially begun addressing agency questions yesterday, but it was clear that, based on the vast number of devices and problems, there would be challenges compiling recommendations. “I don’t believe the failure mechanism of these devices is the same,” Edward Cheng, a panelist from the University of Minnesota Medical School and Cancer Center, told the Journal. Data prepared for the panel indicated that nearly 17,000 adverse event reports have been submitted to FDA over metal-on-metal implants from 1992 through 2011. Of these, 12,000 were submitted in 2011; 9,000 were associated with the DePuy ASR, said the Journal. Problems included a need for revision surgery, pain, joint relocation, and bone infections. Meanwhile, as NewsInferno said, the FDA has ordered 33 manufacturers of artificial joints to conduct post-market safety studies and many device makers have issued recalls or are facing lawsuits connected to the metal-on-metal devices. More than 500,000 Americans depend on these implants, such as the DePuy Orthopaedics ASR and Pinnacle models and models manufactured by Wright Medical Group, Zimmer Holdings, Biomet Orthopedics, and

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