FDA must look more closely at epidemic of all-metal hip implant failures
The New York Times reported this month that the Food and Drug Administration has received more than 5,000 reports THIS YEAR of failed metal-on-metal hip implants. At this rate, hip implant failures will be the most significant medical product failure since the Medtronic heart device failures in 2007.
All-metal implants account for about one-third of the estimated 250,000 replacements performed each year, and one of the most problematic devices is Johnson & Johnson's Articular Surface Replacement (ASR) which accounts for about 75% of the complaints examined by the Times. The times found another 1600 complaints involving the Durom cup since 2007, 200 complaints about the all-metal DePuy Pinnacle device and 400 additional related complaints in Pinnacle patients. One of the concerns raised by the complaints relates to metal debris and the dissemination of metallic ions through the patient's body.