Medical Device Risks
Written by Faith Anderson on April 25, 2013
Medical Devices Approved Without Being Tested
In recent years, a number of high-risk medical devices have been approved for use by consumers in the United States under the agency’s controversial “fast-track” 501(k) approval process. This process allows medical device manufacturers to obtain approval for their devices by proving that the product design is “substantially equivalent” to a device already on the market. In many cases, however, the new devices are are nothing like the products they are supposed to be “substantially equivalent” to, and some even use new components and techniques, which makes them inherently different from the originally-approved device.
Injuries Caused by Defective Medical Devices
According to post-marketing reports submitted to the FDA, thousands of consumers throughout the United States are suffering serious and debilitating injuries and side effects from medical device implants that were never thoroughly tested or evaluated by the FDA, claims the Consumer Union letter. In light of this disturbing trend, consumer advocates are calling for the FDA to reclassify all high-risk implantable medical devices and require that they go through clinical trials under the PMA approval process, in order to prove that they are effective and safe for consumer use.
Recalled DePuy ASR Hip Implant
The metal-on-metal hip implant that has drawn the most scrutiny in recent years is Johnson & Johnson’s DePuy ASR hip implant, which was recalled in August 2010, after post-marketing data indicated that about one in every eight implants were failing within five years. According to allegations raised in the thousands of DePuy hip implant lawsuits filed since, Johnson & Johnson’s DePuy Orthopaedics subsidiary failed to conduct adequate research into the safety of the all-metal hip implant, or warn consumers about the risk of side effects resulting from metal debris being released into the body.
Potentially Dangerous Surgical Mesh Devices
Another potentially defective medical device, vaginal surgical mesh, has been associated with painful and severe complications in women who had the devices implanted as treatment for pelvic organ prolapse (POP) or stress urinary incontinence (SUI). “Other high risk implanted medical devices like surgical mesh should also be put into the PMA approval track, requiring more clinical information,” the letter says. “Patients suffering from harm due to surgical mesh implants have reported debilitating side effects from punctured organs to autoimmune disorders. Many have undergone multiple surgeries to remove the mesh, which has broken apart and traveled to other parts of the body.”