Hip Replacement Warning Issued For A Certain Combination Of Hip Replacement Parts
On April 2, 2012, the U.K.’s Medicines and Healthcare products Regulatory Agency (“MHRA”) issued a hip replacement warning on a particular combination of metal-on-metal hip replacement parts, according to Bloomberg News. The MHRA announced that surgeons should closely monitor patients with a combination of Mitch TRH cup/head manufactured by a subsidiary of Johnson & Johnson, Finsbury Orthopaedics, and Accolade femoral stems made by Stryker. The hip replacement warning advised surgeons to stop using these metal-on-metal hip replacement parts together due to “unacceptably high” rates of revision surgeries required for patients with this particular combination in implants. According to the MHRA patient registry, after four years, 10.7 percent of patient with this combination of hip replacement parts needed to undergo a second operation.
Upcoming FDA Meeting Will Review Safety Of Hip Replacement Parts
Metal hips have been the subject of widespread criticism and media attention since the August 2010 DePuy ASR hip implant recall. As Bloomberg News reported, researchers found that metal hip replacement parts have high failure rates and put patients at an increased risk for metallosis. The U.S. Food and Drug Administration (“FDA”) announced on March 29, 2012 that an advisory panel will convene on June 27-28 to conduct an expert review of metal hip replacement parts to address these concerns. The panel will gather a team of scientists, researchers, patients and medical providers to discuss whether the FDA needs to impose a new set of testing standards and review requirements for medical devices before they can be sold in the United States. According to Reuters, the meeting will focus on the “failure rates, metal ion testing, imaging methods, patient risk factors, follow-up surgery and complications associated with metal-on-metal hip replacement and resurfacing systems.”
Latest Hip Replacement Warning Follows Prior Studies On The Safety Of Hip Replacement Parts
The MHRA hip replacement warning comes after a series of studies analyzing the safety issues of hip implants with metal-on-metal hip replacement parts. In March 2012, The Lancet British medical journal concluded that hip implants made of metal hip replacement parts have higher failure rate than any other type of artificial hip implant and should be banned. Earlier this year, the MHRA issued a hip replacement warning that advised patients to undergo annual testing for as long as they had a metal-on-metal device, in order to monitor for signs of metallosis, tissue damage and other complications. The MHRA recommended the following:
- Patients with hip replacement parts should be tested annually for signs of high blood metal ion levels, which could indicate that they are suffering from metallosis, or metal blood poisoning.
- Patients with blood metal ion level of greater than 7 parts per billion should get a second blood test three month later to monitor potential soft damage tissue.
- Patients with high levels of metal ions detected are advised to undergo an ultrasound or MRI to look for potential damage.
Contact A Hip Replacement Parts Lawyer Today
If you have experienced problems with defective hip replacement parts, consider filing a hip replacement lawsuit to seek compensation for your injuries. You may be entitled to compensation for your lost wages, medical expenses, and pain and suffering. Contact a Bernstein Liebhard LLP lawyer today to learn about your legal rights and options. The lawyers at our firm have recovered over $3 billion on behalf of our clients, and will provide you with personal attention to guide you through the complex litigation process.