New York, New York (PRWEB) June 05, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the victims of defective medical devices, is alerting the public to a new study which indicates that patients who have received large-diameter metal-on-metal hip implants in total hip replacement surgery may face a significant risk of developing pseudotumors. The study, conducted by researchers at Isala Klinieken hospital in The Netherlands, found that hip replacement recipients who received metal-on-metal devices with large-diameter femoral heads had a four times increased risk of developing a pseudotumor if they presented with elevated serum metal ion levels. [ncbi.nlm.nih.gov/pubmed/22628588]
The prospective cohort study followed 119 patients who underwent 120 metal-on-metal total hip replacements with large-diameter femoral heads between January 2005 and November 2007. Out of 108 patients (109 hips) eligible for evaluation by CT scan at a mean follow-up of 3.6 years, 42 patients (39%) were diagnosed with a pseudotumor. The hips of 13 patients (12%) were revised to a polyethylene acetabular component with small diameter metal head, the study authors reported.
Pseudotumors seen in metal-on-metal hip replacement patients are an immunological delayed hypersensitivity response to metal particles, the study authors wrote. Patients who develop this complication require revision surgery to remove and replace their metal-on-metal hip device. According to the report, symptoms of a pseudotumor in a metal-on-metal hip implant patient depend on its size and location, and may include:
- unexplained pain in the region of the hip
- clicking or subluxation
- a swelling of the upper leg
- lump in the inguinal region
- dislocation of the hip joint
- nerve palsy
The study authors advised that based on their findings, patients with large-diameter metal-on-metal hip implants should be closely monitored for the potential development of pseudotumors.
Metal-on-metal hip implants have been the subject of growing concerns since the August 2010 worldwide recall of the DePuy ASR Hip Resurfacing System and the DePuy 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. [depuy.com/asr-hip-replacement-recall]
The U.S. Food & Drug Administration (FDA) is currently conducting a safety review of metal-on-metal hip implants. The agency 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 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]
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 injury 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