The FDA has announced plans to commission a study of the corrosion that occurs in certain models of metal hip implants, saying more data is needed to safeguard patients.
The devices in question —prosthetic hip joints that have modular junctions which provide more options at implantation but pose risks for excess mechanical motion causing fretting and corrosion —are associated with a type of wear that can release toxic metal debris, including cobalt and chromium ions, into the body.
Stryker Orthopaedics, a medical products manufacturing company, manufactures two such devices —the Rejuvenate and the AGB II hip implant systems. Several other models that may be studied are DePuy Orthopaedics’ ASR and Pinnacle Hip Implant systems and Biomet’s M2a Magnum device.
The study, according to the FDA, will examine specific aspects of the wear these devices can experience, which in turn may help predict the side-effects they can have on patients. The study will investigate how the placement of the device, day-to-day use by patients, and the inclusion of different materials in the manufacturing process can cause unwanted wear, fretting and corrosion. It is expected the study will include a sampling of more than 250 devices of various sizes and genders.
Weitz & Luxenberg is at the forefront of the multidistrict litigations associated with these devices. Ellen Relkin serves as the court-appointed chairperson and liaison counsel in the In Re: Stryker Rejuvenate & ABG II Hip Implant Litigation centralized in New Jersey, as well as the co-lead of the In Re: DePuy Orthopaedics, Inc. ASR Hip Implant Litigation in Ohio. Relkin also serves on the Plaintiffs’ Steering Committee in the In Re: Biomet M2a Magnum Hip Implant Products Liability Litigation. Weitz & Luxenberg’s Peter Samberg sits on the plaintiff’s steering committee of the In Re: DePuy Orthopaedics, Inc. Pinnacle Hip Implant Litigation in Dallas.
Relkin said her firm was pleased the FDA is commissioning this study, but believes that the findings will come too late for many patients. “This type of study should have been performed by the manufacturers of these devices on an ongoing basis,” said Relkin. “The data should have been promptly provided to the FDA and the medical community. These companies have a duty to study the safety of their products before marketing them. Instead, they dove straight into marketing and sales, waiting for the FDA to commission this safety study only after thousands of patients have been grievously injured.”
Relkin urged injured patients to call Weitz & Luxenberg to discuss their device’s safety and the possibility of a hip implant lawsuit.