Metal hip implants, the subject of thousands of consumer lawsuits, will have to navigate a longer U.S. review process and should only be offered to patients after safer options are considered, government regulators said.
The proposed tightening of regulations by the Food and Drug Administration would apply to metal-on-metal hip implants, which have a higher danger of causing tissue damage and complications than similar devices made from different material. Makers of all-metal, total-hip replacement products will now have to file approval applications for the strictest level of agency device review, the FDA said today in a statement on its website.
The hips are now being cleared through a less strenuous evaluation reserved for less risky devices, the agency said. The DePuy unit of New Brunswick, New Jersey-based Johnson & Johnson (JNJ) recalled 93,000 metal-on-metal hip devices in 2010 after more than 12 percent failed within five years. J&J faces more than 10,000 lawsuits related to the recalled hips in federal and state courts.
Metal particles in such hips can wear off the device and may cause bone and soft tissue damage, and some of the metal can enter patients’ bloodstream, the agency said. In May 2011, the FDA asked hip implant makers, such as J&J and Warsaw, Indiana- based Zimmer Holdings Inc. (ZMH), to conduct post-market studies.
The FDA doesn’t have enough data to specify the amount of metal ions present in blood that would produce an adverse effect though patients who think their hip isn’t functioning properly should be considered for metal ion testing. Adverse events related to the ion levels include skin rash, visual impairments, depression, kidney impairment and thyroid dysfunction, the agency said.
The regulator recommended patients receive radiographs at least every two years even if they aren’t experiencing any symptoms that would indicate the device is breaking down.
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