Wednesday, October 31, 2012

Metal-On-Metal Hip Implant Use To Be Suspended in Netherlands

Bernstein Leiphard

In light of growing concerns and studies showing the dangers of metal-on-metal hip implants, the Dutch Orthopaedic Association (NOV) has advised that doctors stop using all metal-on-metal hip implants with a large head of 36mm or greater. The NOV recommends that patients with metal-on-metal hip replacements attend annual check-ups, with an examination that includes measuring metal ion levels and X-rays. Depending on the results from the medical tests and the metal ion level measured, patients may be advised to undergo revision surgery to remove the implant.

The NOV isn’t the first health regulatory agency to weigh in on the risks of metal-on-metal hips. In June 2012, the U.S. Food and Drug Administration convened a special panel to discuss concerns about metal-on-metal hip systems, including problems with metallosis and high failure rates. Although the FDA did not issue an official ban of metal-on-metal devices, many orthopaedic surgeons spoke out against using the devices. Reports of metal-on-metal hip problems include higher than expected revision rates, and side effects such as soft tissue swelling, groin pain and tissue necrosis.

The U.K. medical regulatory agency, the MHRA, issued a medical device alert for metal-on-metal hip side effects in 2010. They released subsequent alerts warning doctors and patients about issues with the now recalled DePuy ASR hip implant and the high failure rates of metal-on-metal hip implants. They also recommended regular patient follow up and metal ion testing.
Dr. Susanne Ludgate, clinical director of the MHRA, noted that although a study in the British Medical Journal had called for a ban of all metal-on-metal hip implants, as an agency it was difficult to ban an entire class of devices. Health Canada had also issued an advisory on metal-on-metal implants. They recommended close monitoring of patients, especially for those at high risk for hip replacement failure.

Studies have also found problems with metal-on-metal hip resurfacing procedures. The 2012 report from the Australian Orthopaedic Association National Joint Replacement Registry found that metal-on-metal bearing surfaces in total hip replacements had higher failure rates than other bearing surfaces. A study published October 2012 in The Lancet medical journal concluded that metal-on-metal hip resurfacing failure rates were “unacceptably high” in women.

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