Metal hip implants, the subject of thousands of consumer lawsuits, will have to navigate a longer U.S. review process and should only be offered to patients after safer options are considered, government regulators said.
The proposed tightening of regulations by the Food and Drug Administration would apply to metal-on-metal hip implants, which have a higher danger of causing tissue damage and complications than similar devices made from different material. Makers of all-metal, total-hip replacement products will now have to file approval applications for the strictest level of agency device review, the FDA said today in a statement on its website.
