from Consumer Reports
1:57 PM CDT, March 29, 2012
You may think, if a doctor prescribes a medical treatment, it's been thoroughly tested. For one type of treatment, however, you would be dead wrong. A Consumer Reports' investigation found medical devices -- like defibrillators, joint replacements, and even surgical mesh used to treat hundreds of thousands of women -- may not be clinically tested at all.
Dr. Stephen Tower is an orthopedic surgeon. When the arthritis in his hip became too hard to bear, he opted for a metal-on-metal hip. The new hip, however, caused him so much pain, exhaustion, and depression that he had it removed.
The tissues around the hip had been destroyed, and metal debris was spreading down his thigh. Tower says normal friction in the artificial joint caused cobalt, a toxic metal, to be released into his body, leading to serious tissue, heart, brain, and thyroid problems.
Consumer Reports says this particular type of hip, called the ASR XL, was made of chrome cobalt metal, but it was never clinically tested before the Food and Drug Administration cleared it to be sold. Because of high failure rates and complications like Tower experienced, it’s now off the market.
While metal-on-metal hips have been widely criticized, a Consumer Reports’ investigation found there are other dangerous devices that are being implanted.
Hundreds of thousands of women have had mesh slings inserted to support internal organs as they age, such as the uterus and bladder. Again, those products were never clinically tested before being marketed for that use.
The FDA’s own database shows thousands of complaints about the mesh, including debilitating infections. Yet it’s still on the market and not even classified as high-risk.
Consumer Reports believes the FDA should require rigorous testing for implantable devices, just as it does for prescription drugs.
Consumer Reports also urges creating a national registry to keep track of implanted medical devices and to be able to alert patients if there is a problem. Currently there is no such tracking in the U.S., and it’s estimated only a fraction of device problems actually do get reported.
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