FDA Announces Modernization of System that Approved Metal-on-Metal Hip Replacements
In November 2018, the FDA announced regulatory changes to modernize the way medical devices are tested and approved. The plan intends to ensure that companies use new technology for device designs that meet modern safety and performance criteria, replacing the FDA’s former 510(k) medical device approval standards that Congress legalized 42 years ago.
Metal-on-metal hip replacements were approved for use under the FDA’s 510(k) medical device approval standards, which allowed orthopedic companies like Zimmer Biomet and Johnson & Johnson to use designs from the 1970s. Many hip implant patients now face serious health risks due to metal poisoning and device fracture, sometimes necessitating painful and more complicated revision surgery.
If you or a loved one has experienced complications after receiving a metal-on-metal hip implant, please contact us by calling us at 877-790-3588 for a confidential evaluation of your potential claim.