New York, NY (PRWEB) June 06, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the legal rights of people injured by defective medical devices, is alerting the public to Smith & Nephew’s recall of a metal hip implant liner that is used with the company's R3 Acetabular Hip Implant System. According to a report from Reuters, Smith & Nephew issued the R3 metal liner recall after an analysis of clinical results showed that 1.6 percent of patients with the system needed revision surgery each year, which is above the 1 percent guideline set by Britain's National Institute for Health and Clinical Excellence. Some patients with the all-metal version of the R3 Acetabular System have experienced problems including infections, fractures and dislocations, Reuters said. [reuters.com/article/2012/06/01/us-smithnephew-hip-idUSBRE85010J20120601]
According to Smith & Nephew's recall notice, approximately 7,700 metal-liners have been implanted in patients with the R3 Acetabular System since the component was introduced in 2007 and launched globally in 2009. The majority of these have been used in stemmed total hip replacements.[global.smith-nephew.com/master/40912.htm]
According to Parker Waichman LLP, when the R3 Acetabular Hip device is used with the recalled metal liner, they create a metal-on-metal hip replacement system. The U.S. Food & Drug Administration (FDA) is currently conducting a safety review of metal-on-metal hip implant devices amid concerns that they may shed dangerous amounts of metal debris into surrounding tissue and patients' blood streams. This may lead to an adverse local tissue reaction called metallosis, the formation of pseudotumors and other problems that may result in premature revision of the hip implant. The FDA recently announced that 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]
In February, the British Medical Journal cautioned that all-metal hip implant recipients may have been exposed to dangerously high levels of metallic debris. The following month, the Lancet published a study showing that metal-on-metal implants fail at a rate of 6 percent in five years, as opposed to the 1.7 to 2.3 percent seen in their plastic or ceramic predecessors; the findings prompted the authors to recommend against using the devices altogether. Last month, a study in the Journal of Arthroplasty linked corrosion of the head-taper junction in metal hip replacements to adverse local tissue reaction. [http://www.bmj.com/content/344/bmj.e1410; thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2960353-5/fulltext; arthroplastyjournal.org/article/S0883-5403%2812%2900175-1/abstract]
Most recently, a study in the Journal of Bone & Joint Surgery found that 39 percent of patients with all-metal implants developed pseudotumors. The risk of developing such a side effect increased significantly with elevated levels of metal ions.
Parker Waichman LLP continues to offer free legal consultations to victims of metal-on-metal hip implant injuries. If you or a loved one experienced premature failure of your implant or other health problems associated with a metal-on-metal hip replacement device, please contact their office by visiting the firm's defective hip implant injur y 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 metal-on-metal 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
Gary Falkowitz, Managing Attorney