Earlier this week, NBC10 Philadelphia aired a story about the life changing complications of a recalled metal-on-metal hip device and the 510(k) process with which it was approved. The report illustrated one man’s hip replacement failure and his painful recovery, as well as the inadequate premarket testing methods for the implant.
Johnson and Johnson’s metal hip device was approved under the 510(k) process, which does not require devices to go through premarket testing on humans before doctors begin implanting them. As a result, patients who had a hip replaced with this device are suffering from metal poisoning after the ball and cup grind together and shed metallic particles into the bloodstream.
Though finding the information is sometimes difficult, patients who require implanted devices must keep up-to-date knowledge of the available products and the level of testing they have gone through. Making an informed decision could save a life.