Posted in Defective Medical Devices on March 30, 2012
A recent investigation by Consumer Reports indicates that medical devices such as artificial hip implants are often not tested thoroughly enough to protect consumers. The Consumer Reports investigation suggests that metal-on-metal hip implants were rushed to the marketplace without adequate safety testing to ensure that implant recipients would not be harmed.
Metal-on-metal hip implants made by manufacturers such as DePuy Orthopaedics have injured thousands of patients in California and across the country. Through the process of daily wear these hip implants can deposit metal debris into a patient’s body.
In addition to causing pain and inflammation, the metal debris can kill the tissue surrounding the hip implant and seep into the bloodstream. Medical science is currently uncertain as to the extent and nature of the injuries which metal debris in the bloodstream can cause. Large scale clinical tests prior to placing the hips on the market would likely have identified these design defects before the metal hip implants were made available to the public and might have prevented massive metal-on-metal hip implant injuries.
In the Consumer Reports investigation, one doctor cited a “consistent pattern” of failure for medical devices, which he documented in a study showing that faulty medical devices killed 2,800 people in 2006.
“I think people make the assumption that when their doctor implants a device, whether it be an artificial joint or a pacemaker, that it’s undergone very rigorous testing,” the doctor said. “That assumption isn’t always true.”
Medical devices often go untested because regulatory loopholes allow manufacturers to bypass safety testing by claiming that their new devices are similar to others that have been previously approved. This means that patients such as one 56-year-old hip implant recipient have to deal with severe pain and reconstructive surgeries because of faulty medical devices that weren’t tested.
“I’m finding out now that these things that they put into me weren’t even tested, and they’re in my body,” the patient said. “It’s really quite upsetting.”
Source: CBS, “Report: Medical implants rarely tested,” Elaine Quijano, Mar. 28, 2012