The FDA asked Johnson & Johnson (NYSE:JNJ) and a score of other medical device makers for data on metal levels in the blood of patients implanted with metal-on-metal hip implants.
The federal watchdog agency sent letters May 6 to J&J — already embroiled in more than 1,000 lawsuits over its DePuy ASR metal-on-metal implant — and other hip implant makers including Biomet Inc., Stryker Corp. (NYSE:SYK) and Zimmer Holdings Inc. (NYSE:ZMH), asking them run post-market studies of their hip replacements.
The FDA "is aware of the public health questions regarding the safety of metal-on-metal total hip replacement systems," spokeswoman Karen Riley told Bloomberg News in an email. "There is not enough scientific data to specify the concentration of metal ions in a patient’s body necessary to produce adverse systemic effects."
Last August, J&J’s DePuy Orthopaedics arm recalled the ASR implant, which had by then been implanted in 93,000 patients. The recall was prompted by new data from the National Joint Registry of England and Wales showing “a five-year revision rate of approximately 12 percent for the ASR Hip Resurfacing System and approximately 13 percent for the ASR XL Acetabular System,” according to a DePuy press release announcing the recall. Thousands of lawsuits quickly followed.
The company "is seeking further clarification from the FDA and considering how to best meet the agency’s requirements," DePuy spokeswoman Lorie Gawreluk told Bloomberg. Zimmer spokesman Garry Clark wrote in an e-mail to Bloomberg that his company was "working to understand the scope of the agency’s request." Stryker, which doesn’t make metal-on-metal implants, declined to comment.
