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Shezad Malik MD JD
Shezad Malik MD JD
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FDA: No Use for Metal-on-Metal Hips

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As a DePuy ASR Recall and DePuy Pinnacle Replacement attorney, I have written extensively about the inherent problems associated with metal on metal hips like the DePuy ASR, Pinnacle hip replacement models and others made by Biomet, Zimmer, Smith and Nephew and Wright.

According to the FDA health experts there is no compelling reason to continue using metal-on-metal hip implants. There is overwhelming and mounting evidence that these metal on metal devices can break down early and expose patients to dangerous metallic particles, a condition known as metallosis.

FDA Expert Panel Report

The Food and Drug Administration asked its panel of experts to recommend guidelines for monitoring U.S. patients with metal hip replacements.

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 suggests they are more likely to deteriorate, exposing patients to higher levels of cobalt, chromium and other toxic metals.

The FDA has received 17,000 adverse reports of problems with the implants, which sometimes require repeat hip surgery to replace them.

Early Hip Failure linked to Metallosis

The pain and inflammation reported by patients is usually caused by microscopic metal particles or fragments that leach into the joint, causing inflammatory damage the surrounding muscular and connective tissue and bone.

The long-term effects of elevated metal levels in the bloodstream may cause neurological and heart problems.

Scope of the Metal on Metal problem

Over 500,000 Americans have had metal on metal hip replacements, although the exact number is uncertain because the U.S. does not maintain a national registry, unlike the U.K., Australia and other countries.

About 400,000 Americans get a hip replacement each year to relieve arthric pain and restore omotion. Metal hips replacements accounted for about 27 percent of all hip implants in 2010, down from nearly 40 percent in 2008.

Orthopedic surgeons have shying away from the metal on metal implants because of several high-profile recalls, including J&J's recall of 93,000 DePuy ASR metal hips in August 2010. Many experts now expect that J&J Pinnacle, Biomet's Magnum m2a, Smith and Nephew and Wright's Conserve and Profemur will follow suit with their own recalls.

FDA Experts Recommend Testing

According to FDA's experts patients complaining of pain and other hip symptoms should get regular X-rays and blood testing for toxic metal levels, particularly cobalt and chromium. But, panelists pointed out the problems with the accuracy of blood tests and the difficulties of interpreting the results. There are no standard diagnostic kits for sale that test for chromium, cobalt and other metals

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.

Too little too late

But public health advocates say it could take a decade before that information is available. So what to do in the interim while waiting for definitive recommendations?