medical

Investigation of dangerous medical device implants reveals most have never been tested for safety

Wednesday, April 04, 2012 by: Jonathan Benson, staff writer
Tags: medical devices, safety testing, investigation

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(NaturalNews) Did you know that the vast majority of medical devices on the market today have received approval from the U.S. Food and Drug Administration (FDA) without ever having been properly safety tested? A thorough investigation by Consumer Reports has revealed that the medical device approval process is a pay-for-play sham that is putting millions of people at risk of serious injury or death.

Confirming two earlier studies that were published in the Journal of the American Medical Association (JAMA) and the American Journal of Therapeutics (AJT) back in 2010 (http://www.naturalnews.com/028276_FDA_medical_devices.html), the Consumer Reports findings expose the FDA's complete lack of oversight of the medical device industry. Rather than require that medical device manufacturers prove the safety of medical devices prior to their approval, the FDA instead extorts user fees in exchange for the agency's seal of approval.

"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," says Consumer Reports. "Often, the only safety 'testing' that occurs is in the bodies of unsuspecting patients."

In 1998, the FDA ruled that medical device distributors were no longer required to report adverse events, including death, to the agency, which means there is no way to know just how many people are being injured or killed by medical devices (http://www.fda.gov). And if that is not bad enough, the FDA is now trying to work with Congress to enact new laws that would make it even easier for medical device manufacturers to get their products to market without having to first prove their safety.

"Because so many medical devices are not being held to a higher safety standard, people are dying who wouldn't otherwise die and who don't have to die," Diana Zuckerman, president of the National Research Center for Women & Families, is quoted as saying by USA Today. "People are being harmed who don't have to be harmed" (http://yourlife.usatoday.com).

When also considering the fact that the U.S. Supreme Court ruled back in 2008 that medical device manufacturers could not be sued for injury or death caused by their FDA-approved products (http://www.naturalnews.com/022713.html), it becomes disturbingly obvious that using medical devices or getting them implanted into your body is like playing Russian Roulette with your health.

Be sure to read the entire Consumer Reports piece on medical devices here:
http://www.consumerreports.org

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