New York, New York (PRWEB) June 07, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, has filed a lawsuit naming Biomet Orthopedics, LLC, Biomet, Inc., and Biomet, LLC as Defendants on behalf of an Indiana woman who suffered pain and revision surgery, allegedly due to her defective Biomet M2a Magnum metal-on-metal hip implant. The suit was filed on May 17th in the U.S. District Court for the Southern District of Ohio, Eastern Division (Case No. 2:12-cv-00396-JLG-NMK).
According to the complaint, the Plaintiff was implanted with the Biomet M2a Magnum Hip System in November 2005. The complaint alleges that the defective metal-on-metal design caused pain and implant failure, prompting the need for a complex, risky revision surgery in order to remove the device. Given the nature of the revision, the Plaintiff has allegedly been exposed to future complications, such as an increased risk of dislocations. The lawsuit is claiming economic damages including lost wages and medical expenses, severe and permanent injuries, pain, suffering and emotional distress on behalf of the Plaintiff.
The lawsuit alleges that the Biomet hip replacement was not adequately tested before being sold. According to Parker Waichman LLP, the Biomet M2a Magnum and other metal-on-metal hip implants were approved via 510(k), an approval route requiring no formal review under the condition that it is proved “substantially equivalent” to an already approved device. All-metal hip replacements have been linked to numerous side effects, including:
- High failure rate
- Necrosis (tissue death)
- Increased levels of cobalt and chromium ions
- Pain at the implant, sometimes spreading to the groin and back
- Osteolysis (bone loss)
- Fluid collections/solid masses around the hip joint
According to the complaint, Biomet was aware of the adverse events associated with their product, but allegedly continued to promote and defend it for financial gain.
Recent research continues to confirm the dangers associated with metal-on-metal hip replacements. In February, the British Medical Journal warned that metal hip implants may be releasing toxic amounts of metal ions in hundreds of thousands of patients. The following month, the Lancet published a study showing that metal-on-metal hip implants failed at a rate of 6 percent in five years, leading the authors to call an end to their use. Last month, a study in the Journal of Arthroplasty linked corrosion of the head-taper junction in metal-on-metal hip implants to adverse local tissue reaction. [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, the Journal of Bone & Joint Surgery published a study where pseudotumors appeared in 39 percent of all-metal hip recipients. Researchers found that the risk increased dramatically with elevated metal ion levels. (http://www.bjj.boneandjoint.org.uk/content/94-B/6/755.abstract)
The U.S. Food and Drug Administration (FDA) is currently reviewing the safety of metal-on-metal hip implants. The agency’s Orthopaedic and Rehabilitation Devices Panel will meet on June 27th and 28th to discuss the risks and benefits of the devices. (http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241604.htm)
For more information regarding complications that may be associated with Biomet metal-on-metal hip replacements, please view this video produced by Parker Waichman LLP.
Parker Waichman LLP continues to offer free legal consultations to victims of Biomet M2a Magnum Hip System and other 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 Biomet Hip Implant or other metal-on-metal hip implant, please contact their office by visiting the firm's Defective Hip Implants 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: yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney