New York, NY (PRWEB) May 10, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the legal rights of people injured by defective medical devices, reports that Health Canada, the agency charged with regulating medical products in Canada, has released new recommendations for follow-up and diagnosis of patients with metal-on-metal hip replacement devices. According to a Health Canada statement released in April, the new guidance was prompted by an increase in awareness of pain, implant loosening, and significant soft tissue reactions thought to be the result of increased levels cobalt and chromium ions shed in the surrounding joint tissue of some metal-on-metal hip implant recipients.
According to Health Canada, a survey conducted by the United Kingdom’s National Joint Registry revealed approximately 14.2% of revised metal-on-metal hip implants exhibited soft tissue reactions. Such soft tissue reactions can range from fluid collection to more extensive necrotic and “pseudotumor” reactions and can necessitate device revision. The Health Canada statement identified the following factors for increased risk of soft tissue reactions:
- Female patients
- Patients with components not aligned optimally
- Patients with increased activity levels
- Patients who are severely overweight
- Patients with bilateral implants
In a patient with a malfunctioning metal-on-metal hip implant, Health Canada said the following symptoms may be present:
- Pain in the groin, hip or leg
- Swelling at or near the hip joint
- A limp or change in walking ability or limited range of motion
Health Canada has advised that patients 3 months post-op with any of these symptoms undergo a thorough clinical evaluation, including imaging tests with MRIs, MRAs or ultrasound. The agency said healthcare practitioners should also consider whole blood or serum tests for cobalt and chromium metal ion levels.
According to Parker Waichman LLP, metal-on-metal hip replacements have been the subject of increasing concerns since DePuy Orthopaedics, a division of Johnson & Johnson, recalled its ASR hip implants in August 2010. Just this past 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, prompting the study authors to call for an end to their use. The month prior, a report in the British Medical Journal 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]
The U.S. Food & Drug Administration (FDA) is currently conducting a safety review of metal-on-metal hip replacement devices, and last May directed 21 companies that market such implants to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metallic debris in patients. The agency’s Orthopaedic and Rehabilitation Devices Panel will meet on June 27 and 28 to discuss the risks and benefits of metal-on-metal hip systems, and make potential patient and practitioner recommendations for their use. [fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241604.htm]
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