Mounting concerns over metal-on-metal hip implants led the Food and Drug Administration to plan a two-day expert review in the summer that may lead to stricter new standards for the medical device approval process.
The panel - which is set for June 27-28 - will gather input from researchers, scientists, patients, and medical practitioners to help regulators decide if new testing standards and review requirements are needed before metal-on-metal hip replacements can be sold in the U.S., according to Reuters.
The FDA’s announcement comes after a May 2001 order from the agency requiring makers of metal-on-metal hip replacements to collect more safety information on the implants.
The upcoming review will examine metal ion testing, failure rates, patient risk factors, imaging methods, follow-up surgery and complications linked to metal-on-metal hip replacement and resurfacing systems.
If you or a loved one has been harmed by a metal-on-metal hip replacement or another unsafe medical device, contact Sokolove Law for a free legal consultation. A product liability lawyer may be able to help you.