Medical device maker, Stryker, has settled four of the numerous lawsuits it faces over its recalled Rejuvenate metal-on-metal hip implants.
The first phase of mediation, under Judge Brian Martinotti of the New Jersey Superior Court for Bergen County, involves ten cases. Four cases have been settled for undisclosed terms; three more are scheduled for mediation in January, and one case has been withdrawn from mediation.
Stryker announced the recall of its Rejuvenate and ABG II devices in July 2012, saying that “fretting and/or corrosion at or about the modular-neck junction” may lead to pain, swelling, and adverse reactions in surrounding tissue, according to MassDevice.com.
All-metal hip replacement devices have been recalled worldwide and are under scrutiny by health regulators after thousands of lawsuits were filed alleging patient injuries and complications caused by the hips’ flawed design. Lawsuits allege the implant recipients have suffered dislocations, pain and inflammation, bone and tissue damage, and buildup of excess metals in the blood, caused by the friction of the hip’s metal parts during normal movement. Many recipients have needed revision surgery to remove and replace a failed implant, MassDevice.com reports.
The Canadian Institute for Health Information (CIHC) reported earlier this year that people with certain metal-on-metal hip devices have a 5.9 percent chance of requiring revision surgery within the first five years of implantation, compared with a 2.7 percent chance for patients receiving the most common type of metal-on-plastic implant, according to CBC News.
In January 2013, U.S. Food and Drug Administration (FDA) issued a Safety Communication discussing the health risks of metal-on-metal hip devices. The communication included new guidelines for those who have all-metal hips. The FDA advises symptomatic patients to undergo physical exams, diagnostic imaging, and blood metal ion testing. The agency is also considering changes to the clearance process for implantable medical devices, requiring clinical testing for every device. Under the current 510(k) process, a device can be cleared for release to market if it is shown to be comparable to a previously approved device, which critics say is not a sufficient level of testing.