WASHINGTON — Medical devices implanted in the human body, from pins and artificial joints to heart defibrillators and surgical mesh, don’t require any medical testing, a Consumer Reports investigation has uncovered.
The new information may come as a shock to millions of Americans who rely on implanted devices for mobility and survival. Manufacturers of such devices are required to do no more than file paperwork with the Food and Drug Administration and pay a fee of about $4,000. Unbeknownst to patients, says Consumer Reports, “testing” only occurs in their bodies.
The lax requirements are a side effect from 1976, when the FDA first started regulating medical implants, says Nancy Metcalf, a health insurance expert for Consumer Reports. Devices that were around, in one form or another, prior to 1976 were grandfathered into the testing requirements, creating a loophole that allowed manufacturers to claim a new device is just a variation of an older one.
“A device could be brought to market in 2008 or 2009 that’s almost completely different,” Metcalf tells WTOP. “It’s almost like one of those games of telephone.”
Metcalf says there have been a number of legislative attempts to change the testing requirements and the FDA claims it is looking into it.
Consumer Reports also is calling for changes in how patients are notified of device recalls. The organization says there is a a direct correlation between the devices that lack testing and high recall numbers.
The full Consumer Reports investigation can be found at Kristi and WTOP on Twitter. (Copyright 2012 by WTOP. All Rights Reserved.)