Hip implants have helped renew the life and vitality of millions of Americans. But in the last decade, a new type of all-metal hip implant emerged on the market, offering patients better durability than the standard metal-on-plastic hip implant designs. Metal-on-metal hip implant designs, so called because the ball and cup of the device are both metallic, were a rising star in the orthopedic device industry. In fact, metal-on-metal implants accounted for about one third of the estimated 250,000 hip replacements made in the U.S. each year. But that trend nearly ground to a halt by the August 2010 recall of two DePuy ASR (Articular Surface Replacement) devices, and the growing attention the media is giving to the problem.
Last night, NBC Nightly News aired a report about the growing metal-on-metal hip device problem. The report features a woman who received a metal-on-metal hip implant that failed after 5 years, leaving her with pain in her right hip and a 102-degree fever every night – a problem she said was “much more painful than what sent me to have my hips done in the first place.”
Her story is not uncommon. It represents the experiences that thousands of other all-metal hip implant recipients have already endured, and recent analyses of medical data from the U.S. and the U.K. show that many more thousands could be at risk.
The U.S. does not have a national joint registry to track orthopedic prostheses, but according to one estimate, about 500,000 Americans have received all-metal hip implants. Combine that number with recent studies confirming all-metal hip replacement devices are failing at increasingly greater rates, and it’s easy to see that U.S. is facing one of the biggest medical device failures ever.
According to NBC, the FDA received nearly 11,000 complaints about all-metal hip implants just last year. A recent New York Times analysis found the FDA received more complaints about metal-on-metal hip devices in the first six months of this year than the previous four years combined.
In England, researchers discovered that the all-metal hip devices were failing prematurely at three times the rate of hip implants made of metal and plastic components. Many orthopedic surgeons are seeing their caseload of all-metal hip implant complaints growing heavier.
So far, the majority of all-metal device failures involve DePuy’s ASR implants, but nobody yet knows why those implants are failing at much faster rates than similar all-metal devices made by other companies. The FDA has ordered all 21 manufacturers of metal-on-metal hip implants to study the problem.