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MHRA Issues New Metal-On-Metal Hip Implant Alert

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The Medicines and Healthcare products Regulatory Agency (MHRA) just issued a new metal-on-metal hip implant alert.

According to the MHRA, some patients who have been implanted with all-metal hip replacement devices might develop progressive soft tissue reactions linked to the debris released when the devices’ metal components wear on each other. The shedded debris can lead to soft tissue necrosis (death) and can adversely affect surgery results.

The MHRA said it is issuing the updated advice following what it described as “extensive” consultation with its clinical orthopedic experts and that this updated advice updates prior recommendations concerning metal-on-metal resurfacing products with no stem and stemmed total metal-on-metal hip replacements with a femoral head constructed in a less than 36mm diameter. In addition to these two types of devices, the MHRA identified metal-on-metal total hip replacements with a head diameter of 36mm or greater and DePuy ASR hip replacements comprising acetabular cups for hip resurfacing arthroplasty or total hip replacement, ASR surface replacement heads for hip resurfacing arthroplasty, and ASR XL femoral heads for total hip replacement.

Recommendations, based on the device type and symptoms, include ongoing patient follow-up imaging, ion blood level testing, and revision surgery.

NewsInferno pointed out that concerns about all-metal hip implants began in earnest in 2010, when DePuy Orthopaedics issued a worldwide recall of its ASR hip replacement devices following discovery that the devices were failing in about 12 percent of patients within five years of implantation. Soon after, in the U.S., the Food & Drug Administration (FDA) began reviewing the metal-on-metal implants to determine if the hip replacement devices shed dangerous metal ion levels into patients’ surrounding tissue and blood streams.

An FDA advisory panel is scheduled to look into metal-on-metal hip implants during a two-day meeting later this week and last week, the FDA revealed that it had received more than 16,000 adverse event reports related to metal-on-metal hip implants from 2000-2011. Those reports mounted in 2008 and, again, in August 2010 after DePuy Orthopaedics recalled its ASR hip replacement devices.

Last year, adverse event reports totaled 12,137 for the metal-on-metal devices, versus 6,332 linked to other types of hip implants, according to Bloomberg News. Revision surgery was the most reported side effect, comprising over 14,000 reports and was followed by more than 8,000 pain reports, said NewsInferno.

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