On Thursday, the FDA is expected to announce a proposal that could stop manufacturers from selling all-metal hip implants. The law would require these manufacturers to produce clinical data to prove that these devices are safe and effective in order to continue selling them.
In the US, an estimated 500,000 patients have received an all-metal hip replacement and many of these devices are failing at high rates - much earlier than the traditional hip replacement that has both plastic and metal components. Because of the failure of the all-metal hip, patients have had to undergo costly and painful revision surgeries. Additionally, as a result of the movement of the metal joints, tiny particles of metallic debris have been released into the bodies of some patients.
FDA officials say that this proposal will most likely take a year to be put into effect. Once finalized, manufacturers will have 90 days to submit the clinical data supporting the safety of their device.
The product liability attorneys at Arias, Ozzello & Gignac are currently investigating claims against Johnson & Johnson and other all-metal hip manufacturers for increased failure rates. If you or someone you know has experienced complications from your metal-on-metal hip replacement, contact our attorneys today for a free consultation. You may be entitled to compensation for your damages.