FDA-Cleared Is Not the Same as FDA-Approved in This Last Week Tonight with John Oliver Clip

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FDA-Cleared Is <i>Not</i> the Same as FDA-Approved in This <i>Last Week Tonight with John Oliver</i> Clip

This week’s Last Week Tonight with John Oliver takes aim at a topic that is always fun and never gross at all: medical devices. As Oliver explains, these can range from eye contacts to hip replacements. Basically, if it goes in your body, it’s a medical device. And one would think these devices have met the highest standards an American good can, right? The Food and Drug Administration would never let doctors implant products in human bodies without proper human testing. Well …

Medical manufacturers have a loophole that allows products to move into public use without actual human trials. This workaround—known as the 510(K) plan—states that a device can hit the market as long as it is “substantially similar” to a product that has come before it. Intended to prevent stifled innovation within companies, it has become what Oliver describes as “a high-stakes game of telephone.” A device is close enough to its most recent predecessor, but following its family tree leads to decades of minimal testing. A ball-and-joint replacement with a fatal new flaw reaches patients before anyone is even aware.

Even more confusingly, these products that receive a mark stating they are “FDA cleared.” That sounds convincing enough—even doctors are sometimes fooled, Oliver notes. But “cleared” does not mean “approved,” a label meaning said medical device has been strenuously tested.

In a running joke, Oliver promises to provide a trigger warning before all intense medical images—look away now when the word “opossum” flashes on screen. He, of course, neglects to do so, leaving viewers with shots of muscle tissue like “black cheese” and fluid build-up more befitting of an oil change at your local Jiffy Lube.

All of this leads to the revelation that many of those with faulty devices only discover the problem through the most unbelievable sources, not medical professionals. You know those late-night litigation ads, the ones urging you or your loved ones to reach out if they’ve experienced medical malpractice? That’s the level of reliable information we’re talking here. Or even Facebook, a place which, as Jane Krakowski says in a cameo, “The only thing you you should ever learn from Facebook is which of your friends has the ugliest baby.”

Spoiler alert: It’s Greg’s.

Watch the clip below.

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