Canada is the latest country whose residents are reporting problems with their metal-on-metal hip implant devices. The problem has become so widespread that in Great Britain, experts are telling physicians to stop using the controversial all-metal devices, said CTV News.
Eric Mets, 52, of Etobicoke, Ontario, received his all-metal hip implant in 2008 and soon began experiencing worsening pain, said CTV News. The device failed and Mets was forced to undergo painful and complex revision surgery to remove and replace the defective joint. Mets suffered a massive hip infection and underwent six surgeries. Mets continues to endure constant pain, is unable to return to work, and may have to undergo more surgeries. “I loved my job. I loved the people I worked with. I loved my quality of life, and it is all for naught now,” he told CTV News.
Steven Aldred underwent two hip implants that both failed in three years. “The pain was unbearable. So basically, I went to see another specialist and their findings were to immediately come in and get this hip out of me,” he told CTV News.
While older generation hip replacement devices constructed of ceramic have a 2.5% failure rate, conservative figures on all-metal devices point to a 6-13% failure rate, noted CTV News.
A Health Canada spokesperson told CTV News that the agency knows of the concerns and has advised orthopedic surgeons in that county about the devices’ potential risks. “Doctors are being asked to monitor patients for symptoms (pain or swelling in the groin, hip or leg, and changes in joint movement) so that appropriate plans can be made promptly for patient care,” Olivia Caron wrote in an email to CTV News, noting that the regulator is “actively monitoring” the situation.
We recently wrote that National law firm, Parker Waichman LLP, just filed a lawsuit on behalf of a New York man who allegedly suffered severe injuries after being implanted with a metal-on-metal Pinnacle Hip Implant device. DePuy Orthopaedics, a unit of Johnson & Johnson, manufactures the Pinnacle device. Both DePuy Orthopaedics, Inc. and Johnson & Johnson are named as defendants in the action.
Among other issues, the lawsuit also states that the U.S. Food & Drug Administration (FDA) has received in excess of 1,300 adverse reports concerning problems linked to or attributed to the DePuy Pinnacle Device and that problems associated with the implant are similar to issues that gave rise to the DePuy’s recall of the ASR Hip Implant device. Like the Pinnacle, the ASR is also prone to early failure, and causes metallosis and cobalt toxicity, which can lead to serious health problems and the need for revision surgery.
In August 2010, DePuy acknowledge the ASR’s high failure rate and issued a global recall of over 93,000 ASR devices.
Meanwhile, the FDA has become involved in the growing metal-on-metal hip implant debacle and is conducting a safety review of metal-on-metal hip implants, including DePuy’s ASR Hip Implant device and the all-metal version of the Pinnacle Hip Replacement. Also, last May, the FDA also directed 21 companies that market all-metal hip replacements, including DePuy, to conduct post-market studies of their products to determine if the devices were shedding dangerous amounts of metallic debris in patients. Most recently, the FDA announced that its Orthopaedic and Rehabilitation Devices Panel will meet June 27-28 to discuss the risks and benefits of all-metal hip systems, as well as potential patient and practitioner recommendations for their use.
Last month, a large study published in The Lancet revealed that there exists a 6.2% likelihood that patients with all-metal hips will require a replacement within five years and, most recently, we wrote that in New Zealand, Australia, and some parts of Europe people were notified about another metal-on-metal hip device recall. The recalled MITCH THR device, also manufactured by DePuy Orthopaedics, has been identified as experiencing early failure rate, specifically within three years following implantation. Stryker Corp distributed the MITCH THR.