Medical devices often riskier and less regulated than drugs

Is there a ticking time bomb inside of you?

Halloween may be over a month away, but if you’re looking for a good horror flick, I’ve got one for you: a Netflix film called The Bleeding Edge.

Nope, it’s not another Psycho, Saw, or Nightmare on Elm Street that makes it hard to sleep… although this picture may indeed keep you up at night!

It’s all about medical devices — an industry that’s even bigger than the drugs that come out of Pharma Land.

Devices cover the waterfront from tongue depressors to that shiny new knee – and they add up to a $300 billion a year cash cow, all supposedly “regulated” by the FDA.

But with that kind of payday, you can guess who has the upper hand here. The scary stories told in The Bleeding Edge aren’t just about devices that don’t work, but also ones that are so inherently dangerous that they can destroy lives in the blink of an eye.

For women who were sold on having Essure, Bayer’s birth control device, inserted into their fallopian tubes during a quick outpatient procedure, an untold number of hysterectomies have been done just to get the device out (sometimes in numerous pieces). Plus that, Essure users have suffered splitting headaches, disabling pain, vomiting, fainting, and heavy bleeding.

And along with that, this “permanent sterilization” device doesn’t always work like it’s supposed to. There have been around 800 unintended pregnancies… only those babies were miscarried and never made it into the world alive.

Compared to devices, the review the agency gives drugs seems stunningly robust!

Actually, for the most part, the FDA doesn’t even bother reviewing new devices at all.

And it’s all fine and dandy, covered by a loophole in the law – called 510(k) — that’s as big as the Grand Canyon.

The 510(k) provision allows device manufacturers to put anything on the market as long as it’s considered to be “substantially equivalent” to another device that is (or was) used.

And wait until you hear this! It doesn’t even matter if that prior device was recalled because it was deemed too dangerous to use. The new one will still be given to go-ahead!

Former FDA Commissioner Dr. David Kessler calls it a “system that doesn’t work.”

I’d certainly say so!

Other dangerous devices include stents, thousands of which are inserted every year for no good reason at all, and one particularly gruesome device called the Watchman, which is supposedly designed to prevent a-fib patients from getting a blood clot.

If anyone at the FDA had been paying attention, the Watchman would have never been allowed on the market. One prominent cardiologist who did take a good long look at it says that not only won’t it protect you against a stroke, but it could trigger one!

This “foreign body in the heart,” however, is still being heavily advertised to doctors as a way for their patients to ditch blood thinners.

If you or someone you love will be having any kind of device inserted, you need to start doing your own research. You can find out quite a bit online from studies, other patients, and — believe it or not — even the FDA.

And if you need any more incentive to take matters into your own hands, just give The Bleeding Edge a watch!

I’ll be telling you more about this unbelievable situation and how to protect yourself tomorrow morning, so be sure to keep an eye on your inbox!

“New documentary film is scathing indictment of FDA’s regulation of medical devices” Dan Munro, August 4, 2018, Forbes, forbes.com