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British Regulators Say Some Metal-On-Metal Hip Implants Need Lifetime Monitoring

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British regulators are calling for lifetime monitoring for patients who received some metal-on-metal hip implants. Testing includes monitoring of exposure to toxic metals. Britain’s medical regulator made the announcement, said The Chicago Tribune, calling for patients who received large-head implants—a head diameter larger than 36 millimeters—saying that they should receive blood tests for metal ions and undergo magnetic resonance imaging scans (MRIs) if they have increased metal levels or are exhibiting adverse symptoms, said the Medicines and Healthcare Products Regulatory Agency (MHRA). The new clinical guidelines to doctors follow increasing reports about patients worldwide suffering from swelling, tissue damage, and significant failure rates in metal-on-metal artificial hip devices, noted The Chicago Tribune. According to the MHRA, some 49,000 of 65,000 patients who were implanted with an all-metal hip are in a high-risk category. In Britain, revision surgery is recommended for patients whose MRI scans or blood tests are abnormal, said The Chicago Tribune. Recommendations are called for the life of the device, updating April 2010, guidance which called for monitoring for the first five years after surgery. The revised guidance does not impact all-metal hip resurfacing systems with no “stem sticking into the bone,” said The Chicago Tribune, which said the Smith & Nephew’s Birmingham Hip Resurfacing joint is such a system. Zimmer, Stryker, Corin, Biomet, Implacast, Wright Medical, Joint Replacement Instrumentation, and Finsbury/MatOrtho make metal-on-metal implants, said the

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MHRA. Metal-on-metal hip implants also include the notorious DePuy Orthopaedics’ ASR Hip Resurfacing System and the DePuy ASR Acetabular System, which were recalled in 2010 over unusually high early failure rates.. Last year, the U.S. Food & Drug Administration (FDA) directed 21 firms that market all-metal hip devices to conduct post-market studies of those devices to learn if those devices are shedding dangerous amounts of metallic debris in patients bodies.

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