British Report Finds Metal-on-Metal Hip Implants Failing FasterSep 16, 2011 | Parker Waichman LLP
A new report from the United Kingdom finds that premature failures of DePuy Orthopaedic’s ASR hip implant, as well as other metal-on-metal hip implants, are increasing. The report focuses on U.K recipients of all-metal hip implants, but according to The New York Times, its findings do not bode well for U.S. hip implant recipients, as some 500,000 are estimated to have received all-metal devices In fact, about 40,000 of the 90,000 ASR hip implants sold worldwide prior to its August 2010 recall were used in this country.
The report draws data from National Joint Registry for England and Wales. According to a statement issued from the registry, while all of the non-metal prostheses types reported a less than 1 percent increase in revision rates, the metal-on-metal group climbed 4.11 percent. The registry also found that women were experiencing the highest rates of metal-on-metal hip implant failure. At five years, revision rates for a 60-69-year old female were 7.34 percent for traditional hip replacement with metal-on-metal devices. Meanwhile, the same statistics for men with all-metal devices came in 5.48 percent the report said.
DePuy's ASR hip implant, which was recalled last year because of an unexpectedly high number of early failures, was associated with the highest rate of early failure. According to The New York Times, the British Registry is following 2,100 ASR patients who received the implant in traditional hip replacement surgery, which is how the devices were used in the U.S. The registry found that 29 percent of those who received the implant six years ago experienced failure, while 17 percent who received the ASR five years ago had failures. A hip implant should last for 15 years.
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 U.S. Food & Drug Administration (FDA) asked DePuy 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.
In August, the Times reported that since January, the FDA received around 5,000 adverse event reports related to all-metal hip replacements, more than it received in the previous four years combined.