DePuy Orthopaedics/Johnson & Johnson ASR Hip Implant Defect
DePuy, a division of Johnson & Johnson, warned doctors about the ASR implant in a March 6, 2010 letter. Apparently, the device has a higher than expected failure rate in some patients. The ASR was failing in many patients just a few years after implant, causing expensive and painful replacement operations.
This action was taken over two years after reports that the ASR was failing. Although the ASR is not widely used in the U.S., it has been implanted in thousands of patients worldwide.
The March 6 letter stated that the ASR has a higher-than-expected failure rate when used in traditional hip replacement on certain type of patients, with the risk being highest for patients of smaller stature - generally meaning women, and patients with weak bones.
When a report asked why the company was just now issuing the advisory, DePuy issued a statement that "this is new and important information surgeons who continue to use ASR should have to inform their clinical decision making." The ASR is only one of many hip models sold by DePuy, and is in a category called metal-on-metal implants. These implants can generate metallic debris as they wear, causing inflammation in some patients, damage of muscles and other soft tissues and subsequent operations to replace the device soon after implant. Most artificial hips should last 15 years or more.
It is interesting that this announcement comes at a time when the company was phasing out the product anyway, rather than when the reports of failure began pouring in. But hey, what else is new? No surprises here when it comes to Big Pharma.
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