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Inside the Medical Device Racket

March 6, 2018 in Blogs

By Martha Rosenberg, AlterNet

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Millions of Americans have under-regulated and overhyped devices in their bodies.

Imagine a TV ad for a hip replacement device. Over scenes of the puppies and sunsets, a voiceover warns, “Hip replacements may cause tissue death, the destruction of muscles, bones and ligaments, nerve damage, mental changes, thyroid disorder, vision and hearing problems and heart failure.” Such ads may soon be part of primetime viewing, not just because the device industry is starting to advertise but because medical device side effects are as scary as, if not worse than, drug side effects.

According to a chilling new book by Jeanne Lenzer, The Danger Within Us: America's Untested, Unregulated Medical Device Industry and One Man's Battle to Survive It, an estimated 6.7 million Americans a year––almost 70 million in a decade––are implanted with artificial knees, hips and shoulders, spinal hardware, pacemakers, stents, other cardiac devices and more that are woefully under-regulated and under-tested. The widespread public assumption that if a medical device is on the market, the FDA has found it safe and effective is just not so, writes Lenzer, an award-winning investigative health reporter: “The agency requires clinical testing for only a fraction of high-risk devices.”

Unlike with drugs, which are labeled, dated and tracked, there is no way to know how many people have devices implanted in their bodies, nor how many people have been injured or died: the technology is lacking. “Walmart tracks every single head of lettuce it buys and sells and can determine how many heads of lettuce are on its shelves at any given moment, yet no one––not the FDA, not Brookings, not anyone––can say how many people are dying because of implanted devices,” writes Lenzer. “It is a black hole.”

Yet despite the lax regulation and testing, the device industry …read more


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