Majority of Implanted Medical Devices Never Safety Tested

Monday, April 02, 2012
Millions of medical implants have been sold in the U.S. without ever being tested, according to Consumer Reports.
The magazine says among the untested are artificial joints, heart defibrillators and surgical mesh that’s been surgically implanted in human bodies.
Most of the devices have never been subject to independent assessment because the Food and Drug Administration (FDA) only requires manufacturers to file some paperwork and pay a fee in order to receive approval for marketing.
“Often, the only safety ‘testing’ that occurs is in the bodies of unsuspecting patients,” writes Consumer Reports.
Medical device manufacturers have taken advantage of a loophole in the law that the FDA has chosen not to fill. The first law requiring the testing of medical devices took effect in 1976. However, if a manufacturer could prove that a new device was “substantially equivalent” to a device already being sold, the testing was waved. Since then, the FDA has been unusually liberal in giving exemptions. For example, transvaginal meshes (used to treat pelvic and bladder prolapses) were given an automatic go-ahead because they were supposedly similar to mesh used to repair abdominal hernias even though they are used in a different part of the body and, unlike the hernia meshes, are inserted during open surgery.
Even when a new device does require testing, the FDA charges the manufacturers only $220,050, a drop in the bucket compared to potential profits, not to mention the $1,840,000 the FDA charges to review drug applications.
-David Wallechinsky, Noel Brinkerhoff
To Learn More:

Former FDA Scientists and Doctors Sue FDA over Secret Surveillance (by David Wallechinsky and Noel Brinkerhoff, AllGov) 


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