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Debate Rages Over Treatment Of Metal-On-Metal Hip Patients

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Although it is fairly well established that metal-on-metal hip implants are not all they were originally promised to be, the debate continues on how to treat patients implanted with these devices. Among the headline-making devices are DePuy Orthopaedics’ two ASR hip implant devices and and an all-metal version of its Pinnacle hip replacement system.

Research studies just presented at the annual American Academy of Orthopedic Surgeons confirm some contractions. For instance, British researchers discussed how serum chromium or cobalt ion levels of 7 parts per billion (ppb) or less should be sufficient to initiate a conversation for immediate revision surgery. Yet, said MedPage Today, an American study presented at the same meeting revealed no correlation between ion levels and tissue damage in those patients who underwent revision surgery to remove metal-on-metal devices.

Another presentation discussed a review that revealed that loosening of the device socket was the most prevalent cause for revision surgery, which led study authors to conclude that “it seems appropriate to recommend early revision rather than observation” for these patients. A different presentation in that very session concluded that symptoms were not strongly related to tissue damage, following their study, which revealed significant soft tissue and bone damage in patients who exhibited no systems, but sought revision surgery for other reasons, said MedPage Today.

Removal of all metal implants did help to quickly decline ion in serum and whole blood; however, patients continued to test with high levels for years following revision surgery, said experts at the meeting, according to MedPage Today.

Renowned researcher, Joshua Jacobs, MD, of Rush University in Chicago, pointed out that no one element should be the determining factor but that, “If a patient is symptomatic, they have a high-risk device, they have high metal ion levels, and maybe on x-ray … they show bone loss or on an MRI scan some soft tissue swelling, a so-called pseudotumor, that’s someone where I think you’d want to consider revision,” wrote MedPage Today.

Regardless on treatment debates, the products have proven to be inferior. For instance, in August 2010, DePuy issued a worldwide recall for both models of the hip implant—the ASR Hip Resurfacing System and the ASR Acetabular System—following release of data by the National Joint Registry of England and Wales in which it revealed that 1 out of every 8 patients (12%-13%) implanted with these devices needed revision surgery within five years.

An all-metal version of DePuy’s Pinnacle hip implant system has been named in over 900 product liability lawsuits. Claims allege severe pain, implant dislocation, early hip replacement failure, the need for additional revision surgery, and that the Pinnacle’s metal-on-metal version is similar in design to the recalled ASR hip implant. Claimants have called for a recall of the metal-on-metal DePuy Pinnacle. Since issuing the ASR recalls, DePuy and Johnson & Johnson have been named in over 5,000 product liability lawsuits filed on behalf of people who allegedly suffered early failures of their implants.

Last May, the FDA directed all makers of all-metal hip implants, including DePuy, to conduct post-market studies of their hip devices to determine if these devices shed dangerous amounts of metal debris in patients’ bodies.

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