New drugs must undergo clinical trials before receiving FDA approval, however if a medical implant resembles a product already on the market, testing may not be required. This is what happened with the Articular Surface Replacement, a hip replacement device made by DePuy Orthopaedics.
Many patients who received the implant have developed pain. Upon replacement, physicians have located masses of dead tissue in the patient's thighs. Other patients claim high levels of cobalt ions in their blood, leading to fears of poisoning. According to a recent lawsuit, as the result of the DePuy hips, "many suffer severe pain, inflammation, death to surrounding tissue and bone, a partial or complete lack of mobility and the need for surgery to remove and replace the device, leading to a potentially increased risk of complications."