Grim Metal-on-Metal Data from U.K. Registry
BY LAUREN UZDIENSKI, SEPTEMBER 19, 2011
The bad news keeps piling up for DePuy and their ASR metal-on-metal hip, with a new batch of registry data indicating that almost a third of implanted devices failed after just six years. The company is already anticipating more than $1 billion in litigation and other expenses associated with their metal-on-metal portfolio, including medical costs for affected ASR patients, and those costs could continue to climb as the extent of the product failures are realized.
Though there are no metal-on-metal registries in the U.S., the FDA has ordered companies selling metal-on-metal systems to collect post-market data on the devices. This surveillance is the largest post-market effort the FDA has initiated, with the agency requesting data from about 20 companies, including DePuy, Zimmer, Biomet and Wright Medical. It was U.K. registry data that first led regulators to sound the alarm about metal-on-metal. DePuy followed with a voluntary recall of the ASR.
The New York Times noted that prior to the recent drop in sales, which were not limited to the ASR but to all metal-on-metal hips on account of the potential for metal ion shedding and inflammation, about a third of all U.S. hip sales were metal-on-metal. In the U.K., the Birmingham Hip had the lowest failure rate of any of the metal-on-metal systems at five years, though resurfacing has faced its own challenges with product adoption, a steep learning curve and questions about efficacy.
