The U.K MHRA warned of increased revision among metal-on-metal hip implant patients who received the Mitch TRH Cup/Heads in combination with uncemented Accolade Femoral Stems
New York, New York (PRWEB) April 04, 2012
Parker Waichman LLP, a national law firm representing victims of defective hip implants and other medical devices, is warning metal-on-metal hip implant patients that U.K. medical regulators have advised that DePuy Orthopaedic's Mitch TRH Cup/Heads are prone to premature failure when used for total hip replacement in combination with Stryker Corp.'s Accolade Femoral Stems. According to the Medicines and Healthcare products Regulatory Agency (MHRA), Mitch TRH Cup/Heads were made by Finsbury Orthopaedics Ltd., which was purchased DePuy Orthopaedics, a unit of Johnson & Johnson, in 2009.
According to an MHRA advisory issued on April 2012, the Mitch TRH system is a metal-on-metal hip replacement system consisting of components that can be used in different combinations to carry out either hip resurfacing arthroplasty or total hip replacement. The MHRA warned of increased revision among metal-on-metal hip implant patients who received the Mitch TRH Cup/Heads in combination with uncemented Accolade Femoral Stems. Data from the England and Wales National Joint Registry indicated that the revision rate for patients with this type of metal-on-metal total hip replacement was 10.7 percent four years after implantation. The MHRA recommended close monitoring of the 271 patients in England and Wales who already received this device combination during total hip replacement surgeries. The warning does not apply to patients who received the Mitch TRH implant during hip resurfacing procedures. [mhra.gov.uk/home/groups/dts-bs/documents/medicaldevicealert/con149604.pdf]
This new warning comes a little more than a month after the MHRA advised that patients with large diameter metal-on-metal hip joints (bearings greater than 36mm) should have annual blood tests and possibly MRI scans for the lifespan of the joint).[mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON143782]
About Metal-on-Metal Hip Implants
Metal-on-metal hip implants have been the subject of growing concerns since the August 2010 worldwide recall of the DePuy Orthopaedics' ASR Hip Resurfacing System and ASR Acetabular System. The recall was issued after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years of receiving it. According to Parker Waichman LLP, since the DePuy ASR hip implant recall, evidence has mounted that such devices can shed potentially dangerous amounts of metal debris into patients' blood streams, leading to serious health risks, including tissue damage, device failure, additional surgeries, disability, and possibly cancer.
In March, a large study published in The Lancet showed that there is a 6.2 percent chance patients with all-metal hips will need a replacement within five years. "Metal-on-metal stemmed articulations give poor implant survival compared with other options and should not be implanted," the study authors wrote. The month prior, a report in the British Medical Journal revealed that metal-on-metal hip implant manufacturers were aware of mounting evidence linking the devices to serious, long-term health consequences, but for years failed to warn the public about these dangers. The report warned that hundreds of thousands of people around the world may have been exposed to dangerously high levels of toxic and potentially cancer-causing metals from failing metal-on-metal hip implants. [thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2960353-5/fulltext; bmj.com/content/344/bmj.e1410]
Last May, the U.S. Food & Drug (FDA) directed 21 companies that market all-metal hip replacements, including DePuy and Stryker, to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metallic debris in patients. Last week, the agency announced its Orthopaedic and Rehabilitation Devices Panel will meet over June 27 and 28 to discuss the risks and benefits of metal-on-metal hip systems, as well as potential patient and practitioner recommendations for their use. [fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241604.htm; fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm297745.htm]
Parker Waichman LLP is already representing scores of plaintiffs in personal injury lawsuits filed against the makers of all-metal hip implants, including DePuy Orthopaedics's recalled ASR Acetabular Hip Implant System, as well as a metal-on-metal version of the DePuy Pinnacle Acetabular Cup System. Lawsuits involving the ASR hip implant have been consolidated in a multidistrict litigation in the U.S. District Court for the Northern District of Ohio (MDL 2197). Meanwhile, DePuy Pinnacle hip implant lawsuits have been consolidated in a multidistrict litigation in U.S. District Court for the Northern District of Texas (MDL 2244).
Parker Waichman LLP continues to offer free legal consultations to victims of metal-on-metal hip implant injuries. If you or a loved experienced premature failure of your implant or other health problems associated with metal-on-metal hip replacement devices, please contact their office by visiting the firm's d efective hip implant page at http://www.yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
For more information regarding defective hip implant lawsuits and Parker Waichman LLP, please visit: http://www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Herbert Waichman, Partner