|A metal-on-metal total resurfacing hip implant--courtesy of the FDA|
The FDA is proposing reforms that would require metal-on-metal hip implant makers to go through the PMA process for their already-on-the-market devices, and the agency wants to hear from the industry on the proposal.
The agency is taking comments and critiques through April 18, asking the industry to submit feedback through Regulations.gov.
The proposed guidance, once it takes effect, would give devicemakers 90 days to submit data demonstrating the safety and effectiveness of their all-metal hips, and, if they refuse or fail to convince the FDA, their devices will be banned from sale.
None of the metal-on-metal devices on the market have gone through the rigorous PMA process because of a loophole in the FDA's rulemaking: When the agency expanded its approval process to include PMA reviews in 1976, hip replacements were already on the market, so subsequent devices have only needed the less-strenuous 501(k) clearance to make their way to the market.
There is, of course, another factor driving the FDA's proposal: The mountain of evidence suggesting all-metal hips are more failure-prone and dangerous than implants made from other materials. Over the summer, an agency panel examined worldwide data on the implants and found no compelling reason to use metal devices over those made of plastic or ceramic, and the U.K.'s MHRA has come to a similar conclusion and urged doctors to avoid the devices.