The Food and Drug Administration recently rejected a proposed rule change that sought to ensure the safety of all medical devices. As reported in DrugWatch the proposal would have eliminated the loophole that allows certain medical devices, like hip implants, from undergoing clinical trials. The mandate for more testing of devices before their mass use would catch potentially defective products before they are capable of injuring patients.
The chaos surrounding the DePuy hip implant recall was the impetus for the proposal. As blog readers are aware, over 93,000 implants were recalled at the end of August this year after the metal-on-metal hip implant system was discovered to fail at a much higher rate than usual. The malfunction caused metallic particles to enter the patient’s body, leading to bone and tissue problems. The defect requires a painful and risky revision surgery. As a result, anyone who has had a hip implant with the DePuy ASR XL Acetabular System and ASR Hip Resurfacing Systems may have a legal claim against the company for the problem with the medical device.
However, had the proposed rule been in place, the clinical trials would likely have caught the problem with the DePuy implants before thousands of patients suffered.