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Orthopedic and Dental Industry News Complete Archive »

Metal-on-Metal Hip Complaints Surging: NYT Analysis BY SANDER DUNCAN, AUGUST 23, 2011

The FDA received more complaints about metal-on-metal hip implants this year to date than in the preceding four years combined, according to a New York Times analysis of FDA data. Since January, the study found, the agency has received over 5,000 reports related to the much-maligned devices. The “vast majority” of these reports reflect patients who have had an all-metal device removed within “a few years” despite the typical 15 year lifespan typical of hip implants.

DePuy’s ASR implant, recalled last year, comprised about 75% of the complaints in the Times analysis. The review found 7,500 complaints regarding the ASR, almost 5,000 of which were filed since January. Zimmer’s Durom cup accounted for roughly 1,600 FDA complaints since 2007, while Wright Medical and Biomet were among the remaining reports. The Times speculates that the ASR and Durom report volume likely stems from an acceleration in lawsuits filed against their manufacturers.

These complaints are supported by recently published failure rates. In May, prompted by these alarming figures, the FDA ordered all manufacturers of metal-on-metal hip implants to conduct post-market studies of the devices. But planning these studies may prove difficult for some companies in the absence of a standard FDA protocol, which researchers estimate is at least a year off. Patient recruiting poses a potentially larger obstacle because of limited patient registries. To solve the latter problem, Biomet proposed launching a study of 400 patients with existing implants that would leverage several other studies already under way. The FDA will decide on the proposed studies’ adequacy by November of this year.

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