FDA Rules Post-market Surveillance on Metal-on-Metal Hip Replacement Systems On May 6, 2012 the Food and Drug Administration (FDA) issued a post-market surveillance order to 21 manufacturers of metal-onmetal (MoM) hip replacements, such as DePuy Pinnacle, which are marketed in the United States. The agency required that the companies must submit research protocols that address specific safety issues related to these devices. Data obtained from the studies will enable the agency to better understand these devices and their safety profiles, media reports say. The court also ordered DePuy officials to cooperate during the court trials.
The most disturbing concern is that a small number of metal hip replacements patients have developed symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system, and thyroid gland. The investigation showed that the chromium and cobalt ions leak into surrounding tissue and destroy muscle and bone, eventually spreading to lymph nodes, the spleen, liver and kidneys and potentially causing damage. The ions also had the ability to change a personĂ˘â‚Źâ„˘s chromosome, meaning genetic changes.
The FDA ruling to hip replacement manufacturers is not surprising. The orthopaedic community and the public have known for some time that metal-on-metal hip implants are encountering more than their share of problems. This issue has been played out extensively in the media, and patients are rightfully concerned. The FDA will evaluate thousands of medical devices each year and after FDA approval or clearance, they still receive and analyze information about how the devices perform in real world settings. When necessary, the agency will create independent scientific panels for additional expert advice on hard to understand safety issues so manufacturers may be able to understand how to address safety concerns.
Manufacturers, like DePuy Orthopaedics, must comply with the FDA order and submit a research plan within 30 days from receiving the FDA letter. The FDA then has 60 days to either approve the protocol or work with the manufacturer to amend the study design. The studies are to last at least 3 years. The FDA also encourages patients to participate in the new safety studies, whether or not they are having a problem with the devices.
The problems of DePuy Pinnacle hip replacement metal-on-metal systems have resulted in potential lawsuits and other class actions. However, a number of individuals have also complained of complications that may also be related to the design of the artificial hip. For more information, you may refer to the DePuy Pinnacle Hip Implant Lawsuit.
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