FDA To Launch Study on Metal-on-Metal Hip Implant Ball-Head/Stem-Taper Junction Corrosion
Written By: Rheingold, Giuffra, Ruffo & Plotkin LLP
By Thamanna Husain
Our hip implant revision injury litigation lawyers have noticed some stem and ball corrosion cases. Early focus was on the ball and cup, but the FDA stated that a new project would help to "investigate the potential link between volumetric wear and corrosion of conical head/stem taper junctions in explanted totalhip replacements and clinical outcomes."
In the last decade, Metal-on-Metal hip implants have been the center of safety concerns and are known as one of the largest medical device scandals. As the name suggests, a metal (usually cobalt and chromium) attaches a leg to a metal socket. These medical devices have been linked to a number of adverse reactions, and now federal regulators have announced a planned study regarding the devices potential connection to corrosion. Metal-on-metal hip devices were approved under the FDA's fast-tracked 510(k) approval process and were designed to provide increased durability and longevity. However, the device has done nothing but put the lives of patients at risk. The hip devices have been a growing concern for patients as they are left with severe, long-term injuries.
After a number of consumer complaints, the FDA is finally taking action to establish how efficient or hazardous MoM implants can be. The planned study will examine 250 explanted MoM hip replacements and use the American Society for Testing and Materials (ASTM) procedure for corrosion testing to investigate them. The FDA is currently seeking private sector contractors to help it design and fully conduct the study.
At Rheingold, Giuffra, Ruffo & Plotkin LLP, we have handled thousands of medical device product liability litigations and are deeply involved in the MoM implant litigations. If you have a hip implant that has been recalled or needed revision soon after it was implanted, contact an experienced lawyer at Rheingold, Giuffra, Ruffo & Plotkin LLP for a free consultation.