Canadians Detail Metal-on-Metal Hip Implant WoesApr 24, 2012 | Parker Waichman LLP
Concern over the safety of metal-on-metal hip implants is growing in Canada as legal action against the makers of these devices intensifies in the U.S.
According to a CTV.com (Canadian Television) report, Health Canada has responded to the influx of research and reports of complications suffered by Canadians by notifying orthopaedic surgeons working in the country about the possible adverse results suffered by recipients of these all-metal hip implants.
Metal-on-metal hip implants is a relatively new technology and is attempting to replace previous models of artificial joints which use combinations of metal, ceramic, and plastic components. In just a short time being available for use worldwide however, the future of these implants is as clouded as their future was once considered bright.
Thousands of people fitted with new metal-on-metal hip implants have suffered complications soon after getting off the surgeon’s table. Most often, pain and inflammation at the site of the implant are the beginning of a long, painful, and arduous journey on the defective devices that eventually just leads to several revision surgeries and an eventual replacement of the defective implant. This has led to increased medical costs for recipients and leaves them at risk of permanently losing full mobility in the future after believing the implant would restore some normalcy in their lives.
Depending on the study, all-metal hip implants like the recalled DePuy Orthopaedics ASR hip implant and its other entry into this market, the currently failing Pinnacle model fail early in as many as 13 percent of recipients. Older, more trusted models of hip implants typically fail early for about 3 percent of recipients.
And while concerns over the devices are only just being noted in Canada, the woes of these devices and the torture it has caused recipients worldwide and in the U.S. has prompted Congressional leaders to order the makers of these devices to submit full safety reviews of the devices to defend their place on the market in the future.
The failed ASR and struggling Pinnacle implants were approved by the U.S. Food and Drug Administration through the agency’s fast-track approval system, which only requires makers to prove their new device has a similar design as a previously approved product. Less stringent safety data is required for these approvals and device makers like DePuy, a division of Johnson & Johnson, use this system as a loophole to get new devices to the market without having to complete expensive and time-consuming pre-market safety trials.
Those trials likely would have caught the numerous problems an all-metal hip implant poses to a recipient. In addition to the pain and inflammation reported from recipients, newer research has noted a rise in deposits of toxic metals found in the bloodstream, surrounding tissue and muscles of people who depend on these implants. As the metal components from the implant rub together through normal wear-and-tear, they shed small metal particles into the body. Recipients of all-metal implants suffering from metal poisoning caused by the devices face a risk of organ and tissue damage and possible organ failure if the problem goes unchecked. Patients who’ve received these devices should be having the metallic ion levels in their blood tested annually to see if this issue is becoming a problem for recipients.