Medical devices are far more common than you might imagine. One American in ten has an implanted defibrillator, pacemaker, artificial hip or knee joint, surgical mesh or other device. How rigorously are such devices tested before they can be used?
You would imagine that the Food and Drug Administration would be even more careful in its oversight of devices than it is with drugs. However, that would be a false assumption. The FDA does not require the same level of testing for medical devices.
Scandals about joint replacements, surgical mesh and birth control devices such as the Essure have not captured public concern. That’s largely because patients are told that the latest and greatest equipment is better and safer. Unfortunately, we often lack the research data to support that claim.
Learn how the FDA has stumbled on its approval of devices that we wear or carry within our bodies. What should we know about the danger within us?
Jeanne Lenzer is an award-winning medical investigative journalist and former Knight Science Journalism fellow. She is a longtime contributor to the The BMJ (formerly, the British Medical Journal), and her articles, reviews and commentary have appeared in the New York Times, Smithsonian, the Atlantic, The New Republic, Discover, Slate, Mother Jones and many other outlets. She is the author of The Danger Within Us: America's Untested, Unregulated Medical Device Industry and One Man's Battle to Survive It.
The photograph of Ms. Lenzer is by A. M. La Hanko.
Diana Zuckerman, PhD, is President of the National Center for Health Research.