March 31, 2012

Medical implants rarely tested for safety

Consumer Reports - Tens of millions of Americans live with medical devices implanted in their bodies—artificial joints, heart defibrillators, surgical mesh. And it’s a safe bet that most of them assume that someone, somewhere, tested the devices for safety and effectiveness.
But that is rarely the case. For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and pay the Food and Drug Administration a user fee of roughly $4,000 to start selling a product that can rack up many millions of dollars in revenue. Often, the only safety “testing” that occurs is in the bodies of unsuspecting patients—including two of the three people whose stories are told in this report.

1 comment:

Anonymous said...

A friend who is a nurse and had testicular cancer found that out when he was offered a prosthetic testicles for his empty scrotum. My friend did research and discovered many men end up having the prosthetic removed because of infection or allergic reaction. My friend decided to just live without, because he's had enough surgery down there and didn't want to risk more.