New York, New York (PRWEB) September 17, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, has filed a lawsuit on behalf of a California man who alleges that his Biomet 38mm-M2a metal-on-metal hip replacement system is defective and caused pain and injuries, such as elevated cobalt levels, as well as the possible need for revision surgery. The suit was filed on Sept. 13, 2013 in the U.S. District Court for the Northern District of Indiana, South Bend Division (Case No. 3:13-cv-951) and is one of many cases pending in the multidistrict litigation (MDL) entitled In re: Biomet M2a Magnum Hip Implants Products Liability Litigation (MDL No. 3:12-md-2391). Biomet, Inc. and Biomet Orthopedics, LLC have been named as Defendants.
According to the Complaint, the Plaintiff was implanted in his right hip with the 38mm-M2a ball and socket with a Bi-Metric Porous Stem. The lawsuit alleges that by the time he underwent this implant surgery, the Defendants were already aware of over 100 adverse event reports linked to the device, yet they failed to disclose this information to the Plaintiff. Instead, the suit alleges, the Defendants misrepresented the implant as safe and efficacious.
The lawsuit alleges that, as a result of the Biomet 38mm-M2a system’s defective design, the Plaintiff’s hip replacement system failed shortly after it was implanted, resulting in severe pain. On Sept. 21, 2011, the Plaintiff was found to have elevated cobalt levels. Because of this, there is a strong potential that he will need to undergo a complex, risky revision surgery to remove and replace the device, according to the Complaint. The suit alleges that revision surgeries are generally more complex than initial implantation because there is typically less bone to work with when the original device is removed from the body. Revision surgeries usually take longer to complete than the original hip surgery and have a higher rate of complications.
The Biomet 38mm-M2a metal-on-metal hip replacement system is a type of metal-on-metal hip implant. Metal-on-metal hip devices have been recalled worldwide, as the U.S. Food and Drug Administration (FDA) noted in a recall update. The regulator has put the metal-on-metal class of medical devices under increased scrutiny following reports of high failure rates and the release of elevated concentrations of metallic debris into the bloodstream. On January 17, 2013, the FDA released new guidelines for patients who were implanted with all-metal devices. The agency also advised that regular physical examinations, diagnostic imaging, and metal ion testing be conducted in symptomatic patients.
Additionally, new data from Canada suggests that people implanted with metal-on-metal hips are likelier to have to undergo revision surgery within five years of implantation with the all-metal device, according to a July 18 CBC News report. According to the Canadian Institutes for Health Information study, people who have received metal-on-metal implants face a 5.9 percent increased likelihood of having to undergo device replacement within five years of original implantation; this, in comparison to a 2.7 percent rate among people who received metal-on-plastic implants. The all-metal implant design did not work as expected, CBC News reported. In fact, under the body’s weight during daily activity—such as walking—the implant’s metal parts rub against each other. This rubbing causes metal particles to shed into the person’s surrounding tissue and bloodstream, causing bone and tissue damage due to metallosis (metal poisoning), as well as pseudotumors and the need for early revision surgery to remove and replace the hip with implantation of another device.
Parker Waichman LLP continues to offer free legal consultations to victims of injuries allegedly caused by metal-on-metal hip implants. If you or a loved one experienced premature failure of your implant or other health problems associated with a metal-on-metal hip implant, please contact their office by visiting the firm's Defective Hip Implant page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney
1+ (800) LAW-INFO
1+ (800) 529-4636