By Pat Anson, PNN Editor
The U.S. Food and Drug Administration said today it would take steps to modernize and improve its oversight of medical devices in the wake of a scathing new report that found faulty devices were responsible for over 83,000 deaths and 1.7 million injuries worldwide in the last decade.
The “Implant Files” project, a year-long joint investigation by the International Consortium of Investigative Journalists (ICIJ) and over 50 media partners, found that the FDA approved many devices with little clinical testing and rarely pulled them off the market when problems arose.
Spinal cord stimulators have some of the worst safety records among the 4,000 devices tracked by the FDA, the ICIJ found. Stimulators are implanted near the spine and send electric currents to block pain signals from reaching the brain. The devices are often touted as safer alternatives to opioid pain medication and about 60,000 are now implanted annually.
But a review of FDA data found over 500 deaths and 80,000 injuries involving stimulators since 2008. Patients reported being shocked or burned by the devices and many had them removed.
Jim Taft’s doctor told him a spinal cord stimulator would cloak the chronic pain in his severely injured right arm and make him “good as new.” But a wire in the device broke and after an operation to repair it, Taft said it shocked him so many times he had trouble sleeping and fell down a flight of stairs. The stimulator was removed within a year of being implanted and Taft is now bedridden.
“This is my death sentence,” Taft said from his bed. “I’ll die here.”
Outdated FDA Review Process
Artificial hips, pain pumps, spinal disc replacements and hundreds of other devices were also found to be faulty, raising concern about the level of scrutiny they received before going on the market.
“In contrast to drugs, many surgical innovations are introduced without clinical trial data or centrally held evidence,” Professor Derek Alderson, president of the Royal College of Surgeon, told The Guardian. “This is a risk to patient safety and public confidence.”
FDA commissioner Scott Gottlieb, MD, said his agency would modernize its “outdated” 40-year old review process for medical devices.
“The new technology that we’re seeing holds tremendous public health promise for patients. But with the advances also come new complexities that can make the review of safety and effectiveness more challenging,” Gottlieb said in a statement.
“Advances in material science, digital health, 3D printing and other technologies continue to drive an unparalleled period of invention in medical devices. It’s vital that the FDA’s regulatory approach continue to evolve and modernize to safely and efficiently advance these opportunities. Not only must we keep pace with this complexity and innovation, but we must also stay ahead of the new and evolving risks that sometimes accompany this progress.”
Gottlieb said about 20% of medical devices are based on technology that is more than 10 years old. He said the FDA would consider releasing a list of those devices in order to stimulate the use of newer technologies.
“To be clear, we don’t believe devices that rely on old predicates are unsafe, or that older devices need to be removed from the market. However, we believe that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device,” Gottlieb said.
Do you have a medical device and want to check its safety record? The ICIJ has a database of over 70,000 recalls, safety alerts and safety notices in 11 countries. You can search by the device name or manufacturer by clicking here.