On the heels of the controversy over metal-on-metal hip implants in the U.K., the FDA is starting a two-day session on the devices' safety on Wednesday, weighing whether to subject the implants to stricter premarket review requirements. The agency will gather experts to examine data on implant safety from around the world, looking to identify which devices and which patients are most at risk, The Associated Press reports.
Once again, the FDA is playing catch-up, circling back to examine a generation of devices that were meant to be safer and more effective than their forbears but may in fact be more dangerous, the AP notes. Doctors have favored metal-on-metal hip implants over ceramic or plastic ones over the past decade, according to the AP, but patients have reported pain, swelling and full-scale device failure in the ensuing years.
In the U.K., one doctors group recommended physicians cease implanting metal-on-metal implants entirely, citing a study of 400,000 patients that found subjects with all-metal techs were about three times more likely to need their joints fixed or replaced than other patients. Further fanning the flames was Johnson & Johnson's ($JNJ) DePuy ASR metal hip implant, recalled in 2010 due to galling failure rates.
For its part, the FDA has thus far only asked devicemakers to study whether all-metal implants present risks of blood contamination in patients, responding to reports of complications with metal debris from devices affecting other organs. Now, by bringing together much of the available data on hip implant safety from around the globe, the agency expects to eventually be able to make an informed decision about how to move forward, William Maisel, the FDA's chief scientist for medical devices, told the AP.
- read the FDA's release
- here's the agency's page on implant safety
- check out the AP story