This month, the New York Times online and print editions both ran a piece on the surprisingly unregulated medical device industry. Although now under the purview of the Food and Drug Administration, devices only became their responsibility in 1976. Bogged down with prescription drug approvals, the government organization made the decision to allow all previously marketed medical devices to continue to be sold under something called a 510(k) provision. A secondary provision called a PMA Supplement (Premarket Approval) gives companies the ability to pay a fee for an ‘FDA review’ of a new product that promises to be similar to a company’s previously marketed device. By calling it a supplement and not a new product, they are able to bypass already lax rules for medical devices. Again, no studies or testing required. It seems unbelievable that devices implanted in hips, hearts, knees, eyes, uteri, and just about every other part of the body are able to exist with such minimal supervision and regulation. Unfortunately it’s the truth.
Perhaps it is worth noting that there are devices that have indeed saved lives. Many heart attack patients are enjoying healthy lives thanks to stent placements. Millions of those who struggled to walk and move around are now freely mobile due to hip, knee, and other joint replacements. But what about those devices that haven’t lived up to their intended purpose?
Doctors and Patients Left in the Dark About Known Complications