Pharmaceutical

New study may spell trouble for all-metal hip implants and their makers

When orthopedic device manufacturers conceived all-metal hip implants a decade ago, their intention was to provide patients with a more durable and longer lasting alternative to traditional devices, which incorporate plastic or ceramic components. But according to a new report published Tuesday in the British Medical Journal, that plan appears to have backfired.

According to Reuters, the new report’s findings “could hurt orthopedic companies that make the devices and accelerate lawsuits.”

Instead of less pain and greater mobility, many recipients of all-metal hip devices, including the ASR implants manufactured by DePuy Orthopaedics and recalled last year, experience acute pain and swelling around the implant, decreased mobility, bone fracture, and joint dislocation. Metal debris shed by the implants’ metal-on-metal components has also caused more systemic health problems associated with metal poisoning in some people.

According to Dr. Art Sedrakyan, associate professor of public health at Weill Cornell Medical College in New York City and the study’s lead author, preliminary data indicates that patients with all-metal implants are twice as likely to need revision surgery.

The report, funded by the U.S. Food and Drug Administration (FDA), is based on a comprehensive analysis of all published materials concerning metal-on-metal hip implants, the results of nearly 20 studies encompassing more than 3,000 patients, and data concerning more than 830,000 surgeries pulled from joint registries. The FDA has also asked the companies that make the all-metal devices for further safety studies. In addition to DePuy, those companies include Biomet, Smith & Nephew, and Wright Medical.

Metal-on-metal hip implants are still being used despite growing concerns about their stability and long-term safety, but the number of all-metal hip replacements has fallen sharply since DePuy withdrew its ASR XL Acetabular System and ASR Hip Resurfacing System.

Source:

Reuters