FDA Expert Panel to Assess Metal HipsMar 30th, 2012 | By Jane Akre | Category: FDA News
The FDA has scheduled a two-day expert panel review of metal-on-metal hips as concerns mount about patient injuries. The June 27-28 gathering (location yet to be announced) will include researchers, patients, doctors and scientists to decide whether or not the agency needs to do a better job protecting patients in light of the high complication rate.
According to the FDA, about 270,000 hip replacement surgeries are performed every year in the U.S., which is about 40 percent of all joint replacements. But metal-on-metal hip replacements, either a total replacement or a resurfacing device, have been failing prematurely, at least where such things are tracked.
The national Joint Registry of England and Wales found six percent of patients needed to replace or repair the metal hips after five years. Compare that to 1.7 to 2.3 percent of patients with a plastic or ceramic hip. The U.S. does not track medical device outcomes in patients so the complication rate is not really understood.
The advisory panel will consider failure rates as well as the toxic condition of metallosis found in some patients, metal ion testing, patient risk factors, follow-up surgery and complications associated with metal-on-metal hip replacement and resurfacing systems.
Howard Sadwin, 65, was profiled in MDND (here) after he suffered crippling injuries from his Smith & Nephew metal-on-metal resurfacing artificial hip, intended for the younger, more active hip replacement recipient.
On February 28, 2012, the BBC and British Medical Journal (BBC/BMJ) issued a joint investigation into patient complications from metal-on-metal hip implants. Researchers have known for at least a decade that metal debris was excreted in the blood of some patients and that hundreds of thousands worldwide may be at risk for the complications which can include toxic levels of cobalt and chromium ions that can seep into tissues and organs and destroy muscle and bone, leaving some patients with a long-term disability.
The BBC/BMJ (here) looked at hips made by the largest companies including J&J of New Brunswick, New Jersey; Warsaw, Indiana-based Zimmer Holdings Inc.; and Smith & Nephew Plc of London.
In 2008, Zimmer, based in Warsaw, Indiana, announced it was suspending the marketing and distribution of the Durom Cup after early failure rates led to crippling injuries in patients and removal surgeries became necessary.
In 2010, Johnson & Johnson issued a voluntary recall of its ASR metal hip system after it received a non-approval letter from the FDA due to metal poisoning data it received.
FDA will look at metal on metal hips