Government health experts have said there are few reasons to continue using metal-on-metal hip implants, amid growing evidence that the devices can break down early and expose patients to dangerous metallic particles. The Food and Drug Administration recently asked its 18-member panel to recommend guidelines for monitoring more than a half-million patients in the United States with metal hip replacements. As we have written in prior issues, the devices were originally marketed as a longer-lasting alternative to older ceramic and plastic models. But recent data from the U.K. and other countries suggest they are more likely to deteriorate, exposing patients to higher levels of cobalt, chromium and other metals.
While the FDA has not raised the possibility of removing the devices from the market, most panelists said there were few, if any, cases where they would recommend implanting the devices. For decades nearly all orthopedic implants were coated with plastic or ceramic. But in the last ten years some surgeons began to favor all-metal implants. This came after laboratory tests suggested the devices would be more resistant to wear and reduce the chances of dislocation. But recent data gathered from foreign registries shows that the devices fail at a higher rate than older ceramic and plastic implants. There have been nearly 17,000 reports to the FDA of problems with the implants. In many cases invasive surgery is required to replace them. The pain and inflammation reported by patients is usually caused by tiny metal particles that seep into the joint, damaging the surrounding tissue and bone. At this juncture, the long-term effects of elevated metal levels in the bloodstream are not clear. However, some studies have suggested links to neurological and heart problems.
Each year, about 400,000 Americans get a hip replacement to relieve pain and restore motion affected by arthritis or injury. Metal hips accounted for about 27% of all hip implants in 2010, down from nearly 40% in 2008. Doctors have begun turning away from the implants because of several high-profile recalls, including J&J’s recall of 93,000 metal hips in 2010. According to the FDA’s experts, patients complaining of pain and other symptoms should get regular X-rays and blood testing for metal levels. But as the panelists pointed out, there are problems with the accuracy of blood tests. Also, there are difficulties interpreting the results. Unfortunately, there are no standard diagnostic kits on the market that test for chromium and other metals.
For patients who are not experiencing pain, annual X-rays are sufficient to monitor their implants, according to the panelists. If the FDA ultimately follows the group’s advice, U.S. recommendations would be less involved than those already in place overseas. Earlier this year, U.K. regulators recommended that all people who have the implants get yearly blood tests to make sure no dangerous metals are seeping into their bodies. FDA regulators have suggested they want to take more time to sort out the differences between various implants and patient groups before making recommendations.
Women and folks who are overweight are among the groups that are more likely to have an implant failure. With little definitive data on U.S. hip implants, the FDA has asked manufacturers like Johnson & Johnson, Zimmer Holdings Inc. and Biomet Inc. to conduct long-term, follow-up studies of more than 100 metal-on-metal hips on the U.S. market. It would have been helpful if there had been adequate pre-marketing testing of these devices before they hit the market.
If you need more information on this issue, contact Navan Ward, a lawyer in our Mass Torts Section who is handling hip cases, at 800-898-2034 or by email at Navan.Ward@beasleyallen.com.
Source: Associated Press
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