Great Britain’s medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) is being accused of being “slow in responding” to data about defective metal-on-metal implants.
Patients have suffered “needlessly” due to the agency’s slow response to the implants, , wrote Wales Online, citing the Science and Technology Committee, which also stated that it appears as if the MHRA did not respond quickly enough. The Committee said that problems were reported for several years prior to the eventual and worldwide recall of DePuy ASR metal-on-metal hip implants, which it considered “disappointing.”
Problems were noticed in 2007 by Australian officials; the implants were taken off the Australian Market in December 2009, noted Wales Online. The MHRA issued a product recall in 2010 and a worldwide recall was issued by DePuy August 2010.
The committee’s report on the Regulation of Medical Implants in the EU and UL indicated that, “The European Commission and UK Government must improve the speed with which information from adverse incident reporting abroad is handled and acted upon…. It is disappointing that problems with metal-on-metal hip implants were picked up several years before the worldwide recall and it appears that the MHRA was slow in responding to data emerging from Australia. Because of that delay, many patients have suffered needlessly,” Wales Online reported.
The Altogether Hip Patient Support Group told the Committee that the MHRA did not place patient safety first, said Wales Online. Group members also told the Committee that, “The MHRA seems to be a totally ineffective body working on behalf of the corporations rather than patients.”
Meanwhile, we just wrote that possibly 10,000 or more Britons may have been fitted with a metal-on-metal hip implant in the last decade and now face the serious and life-altering risks posed by these devices. Like thousands more worldwide, people living in England are facing problems caused by their defective hip implants at alarming rates and have begun the process of seeking damages from the companies responsible for manufacturing them. According to a report from The Birmingham Mail, at least one dozen residents of Midland, England, have filed lawsuits against DePuy Orthopaedics over injuries caused by the company’s failed ASR metal-on-metal hip implant.
The 2010 DePuy ASR hip implant sparked a widespread controversy over the safety of metal-on-metal hip implants. A high rate of early failures suffered by recipients of the ASR device gave rise to thousands of reports of complications suffered by people fitted with that and an array of other all-metal implants. At least 100 people—likely more—have filed lawsuits against DePuy, a division of medical giant Johnson & Johnson, seeking compensation for the many injuries these implants have been known to cause.
Metal-on-metal hip implants were designed, or at least marketed, to last as long as 20 years, and were meant reduce the need for revision surgeries and give recipients a better chance at regaining full mobility. For many recipients of the DePuy ASR hip implant and many others, it only took months or just a couple years for complications to arise. Popping, squeaking, and other noises emanated from the site of the implant; patient suffered serious pain and inflammation; and some recipients experienced complete deice failure, necessitating early revision or full replacement surgery to remove a defective implant.
The devices also pose risks for metal poisoning because, as the metal components of the implant wear, small metallic particles are dispersed throughout the body and into the bloodstream. Recipients have suffered the effects of high levels of cobalt and chromium, which causes organ and tissue damage and the potential growth of small tumors throughout the body.
Revision and replacement surgeries are costly and painful and those forced to endure these procedures are not always guaranteed they’ll regain full mobility. Early failure rates with the DePuy ASR hip implant may be as high as 13 percent; up to 100,000 of those devices may have been used worldwide. In the U.S., hundreds of people nationwide have joined lawsuits against the makers of all-metal hip implants. A first trial has been scheduled for early 2013 that could lay the groundwork for future injury claims.