FDA Announces Deadline for Metal-on-Metal Hip Replacement Applications
In February 2016, the FDA issued a final order that requires medical device companies to submit premarket approval (PMA) applications by May 18th for two types of metal-on-metal hip replacement devices, including one with a cemented pelvic component and another with an uncemented pelvic component. In a statement released on its website, the FDA indicated that applications should include all information pertaining to the risks of the device, the product’s effectiveness, and full reports from investigations about the safety and effectiveness of the device. In some metal-on-metal hip implants, the devices may release metal particles into the bloodstream and bone and soft tissue damage that surround the implant and joint. Gradually, the erosion can lead to serious problems such as device failure or the need for revision surgery.