FDA Metal-on-Metal Hip Replacement Safety Meeting Enters Day TwoJun 28, 2012 | Parker Waichman LLP
A panel of advisors for the U.S. Food & Drug Administration (FDA) is preparing to make recommendations regarding the safety of metal-on-metal hip implants. The panel is in its second day of deliberations, and is expected to vote on specific recommendations later today.
According to a report from The Wall Street Journal, the FDA has asked the panel of outside experts to recommend whether additional warnings and other information is needed for metal hip systems. They have also been asked to make recommendations about which patients would benefit the most from metal-on-metal hip implants, as well as patients who should not receive the devices. They will not, however, address additional regulations for the devices.
Metal-on-metal hip devices have been implanted in an estimated 500,000 Americans, largely due to the belief that they would last longer than those made from other materials. As we've reported previously, concerns about all-metal hip implants started to mount in 2010, when DePuy Orthopaedics issued a recall of its ASR hip devices after it was found that they were failing in about 12 percent of patients within just five years of implantation. The FDA began studying all-metal hip implants shortly after the DePuy ASR hip implant recall to determine if the devices are shedding dangerous levels of metal ions into patients’ surrounding tissue and blood streams.
Last week, the FDA revealed that it had received 16,800 negative event reports involving metal hips between 2000 and 2011. Of those, more than 14,000 involved revision surgeries, in which a defective implant was removed.
According to The Wall Street Journal, yesterday the panelists appeared to be struggling with the scope of their forthcoming regulations.
"I don't believe the failure mechanism of these devices is the same," said Edward Cheng, a panelist from the University of Minnesota Medical School and Cancer Center.
Among other things, they mulled the idea that some types of metal-on-metal hip implants are more prone to failure than others.
"Could it be the size of the (femoral) head when we are attributing all the problems to metal?" said Raj Rao, a panel member from the orthopedic surgery department of the Medical College of Wisconsin.