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Long-Term Health Concerns Continue to Mount for Metal-on-Metal Hip Implants

Feb 8, 2012 | Parker Waichman LLP

The news just keeps getting worse for recipients of metal-on-metal hip replacement devices, including those with DePuy Orthopaedics' recalled ASR Hip Resurfacing System and ASR Acetabular System, as well people implanted with an all-metal version of the company's Pinnacle Hip Implant system. Mounting evidence continues to indicate that patients with metal-on-metal hip implants face not only a high threat of early failures, but the risk of sustaining long-term health problems, even if they have defective devices removed.

"This is a serious problem in the USA," said Mathias Bostrom, an orthopedic surgeon at the Hospital for Special Surgery in New York City. "Some implants have a worse record than others, but almost all the metal-on-metal implants have issues."

According to a report in USA Today, Bostrom was attending the American Academy of Orthopaedic Surgeons in San Francisco, where the issues surrounding metal-on-metal hip implants is a hot topic of discussion.

The research discussed at the conference linking metal-on-metal hip implants to serious health problems includes:

  • A study out of the Netherlands which found that 202 of 614 (32%) metal-hip implant recipients had suffered adverse reactions in soft tissue.
  • An English study which 24% of metal-on-metal hip implant patients who had revision surgery after a metal-on-metal implant had "worsening symptoms." A third of those had revision, and disease progression "was confirmed in all cases of re-revision," the authors wrote.
  • An orthopedic surgeon from the Hospital for Special Surgery reported that a study he participated in found that 98% of the cups and 93% of the balls showed "moderate to severe scratching" in 46 retrieved metal-on-metal implants.

Concerns have been growing for some time that metal-on-metal hip implants could pose long-term health risks.  Last year, the U.S. Food & Drug Administration (FDA) directed 21 makers of all-metal hip implants, to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metallic debris in patients.  This shedding of metal debris could cause tissue damage, premature device failure, the need for revision surgery, and even long-term health problems, including heart and nervous system damage.

Problems with all-metal hip implants have also led to a growing number of lawsuits against the makers of such devices.  At last count, DePuy had been named in more than 3,500 U.S. lawsuits over the recalled ASR devices.  At least 900 complaints have been filed against the all-metal version of its Pinnacle hip replacement device, with plaintiffs claiming it is similar in design to the ASR implants and should have been recalled as well.



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