For decades, Class III medical devices that are implanted in humans, such as hip implants, have been approved by the FDA through the 510(k) process. The 510(k) process is the fast-track approval process, which does not require clinical studies or pre-market testing. This process was never intended for Class III medical devices; however, a loophole in the FDA regulations that was never addressed until recently has allowed thousands of implanted medical devices to be approved without clinical testing.
As a result of this process, hundreds of thousands of metal-on-metal (MoM) hip implants have been sold and implanted in patients without any premarket clinical testing. The changes to the design of these implants have proven to be defective over the years, and as a result, patients with these implants have suffered from cobalt and chromium poisoning and severe tissue and bone damage. Many of these patients have also required a revision surgery to remove the defective device.
