An article in the New York Times today indicates that the number of adverse
event reports regarding metal-on-metal implants is continuing to grow.
According to the article, the FDA has received more than 5,000 reports
since January 2011 regarding the widely used hip implant devices. This
is more than the agency had received about metal-on-metal hip implants
in the previous four years combined.
The significant increase in reports to the FDA is attributed to the Johnson
& Johnson recall of it's DePuy ASR hip implants last year, news
reports regarding recent lawsuits filed regarding these devices and the
FDAs mandate that the device makers conduct studies on the dangers associated
with the devices.
The metal-on-metal hip implants appear to be failing sooner than expected.
The devices were marketed to last around 15 years, but many are failing
much earlier than that. Further, the newly discovered risk of these devices
comes from tissue damaged caused from metallic debris shed in the patient's
body when the metal components rub together.
The FDA is expected to comment on and/or approve the study plans of the
device makers in November of this year.