DePuy, J&J Aware of 40 Percent Failure Rate on its ill-fated ASR Metal-on-Metal Hip ImplantJan 24, 2013
The widespread problems that doomed the DePuy Orthopaedics ASR hip implant may only be the beginning.
New information released in court documents this week, according to a New York Times report, suggest that DePuy, and its parent company Johnson & Johnson, withheld evidence showing that the failed metal-on-metal hip implant was bound to fail in just five years or less for an unthinkable 40 percent of its recipients.
That figure trumps even the highest previous independent estimate at the early-failure rate of the first metal-on-metal hip implant to removed from the U.S. and worldwide markets after thousands had reported myriad complications caused by the devices.
The ASR hip implant recall was issued in August 2010 and sparked a global controversy centered around the viability of metal-on-metal hip implants and the process that got it and other similar devices to surgeons and into patients before any pre-market clinical testing had been conducted to determine if it was safe and/or effective. Tens of thousands of people in the U.S., and that many more worldwide had already received the ASR hip implant during a total hip replacement surgery before the recall. Hundreds of thousands more received some other form of metal-on-metal hip implant and today many people worry their hip implant may be the next to fail … and for good reason.
After just five years, the DePuy and Johnson & Johnson research found, an unheard of 40 percent of the ASR hip implant recipients were likely to experience some form of complication that could be classified as a device failure and result in them either undergoing a revision or replacement surgery long before they were told they’d have to endure such a procedure by choosing the metal-on-metal hip implant. In addition, in the years after that five-year mark, thousands more recipients of the ASR hip implant could expect to experience those same problems.
Severe and persistent pain, inflammation, and swelling around the site of the implant are just some of the early problems caused by a defective metal-on-metal hip implant. The dubious hallmark of these devices however, is the risk of metal poisoning, metallosis, caused by the wearing of the two component parts of the hip implant against each other. As the hip implant is used more, it sheds tiny metallic particles into a recipient’s bloodstream and through surrounding tissue and organs, causing serious harm, including the risk of organ failure, from the accumulation of the toxic metals cobalt and chromium.
The information regarding DePuy and Johnson & Johnson’s knowledge of the extremely high 40-percent early failure rate comes from an internal analysis conducted by the companies in 2011, following the recall. This and thousands of other documents will likely become public knowledge in the coming weeks as the first of what could be thousands of trials involving recipients of this specific metal-on-metal hip implant begins in a California court this week.