NPR

Lax Oversight, Lack Of Clinical Trials Mean Some Medical Devices More Likely To Injure Than Cure

In 2015, the FDA received 16,000 reports of deaths associated with medical devices; one analysis estimated that only 1 percent of device-related deaths are reported to the FDA.
Robert Cummins, CEO and chairman of Cyberonics, holds a vagus nerve stimulator at the companies headquarters in Houston, Tuesday, July 20, 2004. (David J. Phillip/AP)

About 1 in 10 Americans will have some kind of medical device implanted over their lifetime — artificial hips, pace makers, stents, cataract lenses. Drugs must undergo two clinical trials before hitting the market, but fewer than half a percent of high-risk medical devices have undergone that standard. In 2015, the Food and Drug Administration received 16,000 reports of deaths associated with medical devices; one analysis estimated that only 1 percent of device-related deaths are reported to the FDA.

Here & Now‘s Robin Young discusses with investigative reporter Jeanne Lenzer (@JeanneLenzer1), author of the new book “The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It.”

Book Excerpt: ‘The Danger Within Us’

By Jeanne Lenzer

When I was studying to be a physician associate (PA) at Duke University, I was taught to diagnose and treat common and not-so-common illnesses. As a practicing PA, I wrote prescriptions, performed minor surgical procedures, and made referrals to specialists. I thought that if I stayed on top of new developments in medicine, and was caring and conscientious enough, I could help people. I wouldn’t harm

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