Millions of people with implanted medical devices—artificial joints, heart stents, defibrillators, gastric bands, insulin pumps, and others—believe the device has been tested for safety. In many cases, this belief is wrong.
Because of the way the device approval process works, manufacturers often need only file paperwork and pay a fee to the U.S. Food and Drug Administration (FDA) to start selling a product, Newsmax Health reports. Through the FDA’s 510(k) approval process, a manufacturer simply has to demonstrate that the device is “substantially equivalent” to a product already being sold. The agency is considering a revised process that would require clinical testing for all implantable devices.
Neurosurgeon Russell Blaylock told Newsmax Health that, as a “general rule,” patients should consider implantable devices “[o]nly if there’s no other choice.” Dr. Blaylock is especially concerned about the metals contained in many devices. “There’s a considerable amount of literature on cobalt and nickel absorption producing significant neurological effects as well many other effects such as auto-immune disorders and immune dysfunction.” Metal-on-metal hip implants, introduced to be a more durable alternative to older models, have been a particular problem, and manufacturers now face thousands of lawsuits over illnesses, injuries, and device failures. The metal-on-metal hips came to market mostly without clinical testing, based on their similarity to previous models.
Infection is always a possibility with an implanted medical device, according to Newsmax Health. Dr. Blaylock says many “complex and deadly” surgical infections are due to implanted medical devices. And when a device fails, as many lawsuits allege metal-on-metal hips frequently have, the recipient may need complex and risky surgery to remove and replace the device.
Dr. Blaylock urges patients to thoroughly research treatment alternatives before having any device implanted. The FDA’s website (FDA.gov) has the latest information about implanted medical devices, safety warnings, complaints, and recalls. The agency recently instituted a new labeling system for medical devices to make it easier to track device performance and identify a device in case of recall.
The FDA encourages patients to report problems and complications with implanted medical devices through the MedWatch safety program: www.fda.gov/MedWatch/report.htm.