The U.S. Food and Drug Administration has some questions about the safety of metal-on-metal artificial hips.
According to news reports, the FDA is requiring all producers of artificial, metal-on-metal hips to study the implants. The unusual request will likely affect patients who have received a metal-on-metal hip implant.
The FDA said it wants information on the devices safety as a product, and is not necessarily inquiring about a single manufacturer.
“Under the order, producers of “metal-on-metal” hips will have to conduct studies of patients who received the device to determine, among other things, whether the implants are shedding high levels of metallic debris. Some patients have encountered that problem, including soft tissue damage that has disabled them,” according to news reports .
The metal-on-metal devices also have an early failure rate compared to its counterparts, a statistic the companies are also being asked to research.
Nearly 20 manufactures, including DePuy division of Johnson & Johnson, Zimmer, Stryker, Biomet and Wright Medical, will be affected by the order. The producers will have approximately a month to propose a plan with the FDA, which will likely include collecting information from patients who received the device and taking their blood samples.
As a Charleston DePuy hip recall attorney , I urge every patient who received an ASR hip implant, whether it has physically failed or not, to seek legal advice to ensure their civil rights and liberties are protected. If you have been injured by a DePuy hip and think you would qualify to be part of the multidistrict litigation, contact a DePuy hip implant attorney in Charleston .