Complaints Associated with DePuy ASR Hip Implant, Other All-Metal Devices, MountAug 24, 2011 | Parker Waichman LLP
The U.S. Food & Drug Administration (FDA) has recorded a big spike in complaints related to all-metal hip implants. According to a report from The New York Times, some experts now fear all-metal hip implants could become one of the biggest and most costly medical implant problems in recent history.
According to The New York Times' analysis, the FDA has received around 5,000 adverse event reports related to all-metal hip replacements, more than it received in the previous four years combined. The device with the most complaints, not surprisingly, is DePuy Orthopaedics' recalled ASR hip implant. That one device was responsible for 75 percent of the reports made to the FDA since January. Between 2007 and this June, the DePuy ASR hip implant was the subject of 7,500 complaints to the FDA.
Other hip implants were also named in the complaints. During the same period, about 1,600 complaints related to the Durom Cup were filed with the agency. The all-metal version of DePuy's Pinnacle implant was the subject of 200 complaints, while another 400 noted metal-related problems in Pinnacle devices. It's not clear how many of those were associated with all-metal devices, as the Pinnacle is sold in several versions, the Times said.
Complaints involved cases were an all-metal device had failed within just a few years of implantation, despite the fact that they're designed to last 15 years or so. In most cases, patients had undergone, or were preparing to undergo, revision surgery.
According to the Times, all-metal hip implants were once very popular, with nearly one-third of the estimated 250,000 replacements performed each year. According to one estimate, some 500,000 patients have received an all-metal replacement hip. But since concerns about their safety have grown, they've fallen out of favor, and now are used in about only 5 percent of all hip implant surgeries.
It is believed all-metal hip implants can shed dangerous amounts of cobalt and chromium through wear, leading to tissue damage, premature device failure, the need for revision surgery, and even long-term health problems. In May, the FDA asked DePuy Orthopaedics and 20 other manufacturers of metal-on-metal hip implants to conduct safety studies aimed at determining how often they fail prematurely, and if these devices are shedding dangerous amounts of metallic debris in patients. However, it will likely be years before those studies are completed.