Experts reveal new heart devices may be ticking time bombs

If you think the FDA approves drugs in a careless, haphazard way, that’s nothing compared to how new devices get on the market.

Now, experts are taking a good, hard look at some recent approvals for devices used in heart patients, and uncovering some shocking facts.

And if you, or someone you love, will be receiving a stent, undergoing a valve repair, or anything else having to do with medical devices and the heart, there are some very important things you need to know right now.

Approve now, ask questions later

An expert in cardiology summed up the approval of six new heart devices with these two words: “shaky ground.”

Taking a closer look, it turns out the FDA gave them the green light despite misleading, confusing and “negative findings” during clinical trials.

But the truth is, now the real trials are being conducted, with millions of unsuspecting heart patients being used as guinea pigs.

These new devices include the Absorb stent and another called the Watchman.

Absorb is being pitched as if it’s the greatest thing since sliced bread. Its purpose is to do what all stents do: prop open a weak artery and keep the blood flowing. Absorb also is supposed to slowly disappear.

This vanishing stent, however, was approved by the FDA even though its clinical trial couldn’t find any benefit for the device. But even worse, those trials revealed that Absorb might raise your risk of a deadly side effect called “stent thrombosis,” a blood clot that’s almost always fatal.

The Watchman was approved by the FDA last year against the advice of its own panel of experts, and “with little or no data” proving that it really works.

Watchman looks like the top of a tiny parachute, and is sent up through a leg vein and inserted into the heart, where its job is to catch blood clots.

And while doctors and hospitals are promoting it nonstop, even the FDA admits that studies done by the manufacturer show that the blood-thinner warfarin works better than the Watchman at preventing strokes!

Plus that, your risk of “serious bleeding” is actually higher during the first months after receiving Watchman than if you took warfarin.

Yet, that device, and many, many more are given the green light by the FDA despite failed trials and dangerous findings.

Medical devices are approved through the FDA’s absurd 510(k) clearance program. All a manufacturer has to prove is that their new product is “substantially similar” to a device that’s already on the market. That’s it!

Why, it’s harder to get approved for a triple-digit interest credit card!

And all the while patients, and plenty of doctors, are blissfully unaware of what’s going on.

For those who follow the FDA carefully, however, it should come as no surprise. One expert, who just wrote a scathing review at the mainstream site MedPage Today, calls these device approvals a “big problem” for the FDA that’s going to get the agency into “hot water.”

But unfortunately, it’s the patient who ends up getting burned.

If your cardiologist has been talking about any procedure to put a new device inside you, it’s time to start asking some questions and doing some research. Why, we spend more time finding out about a car before we buy it than something that’s put inside our body!

Find out all you can about when the device was approved, how long it has been used and if it has really been proven to be safe, rather than simply rushed into use so some company can start raking in the big bucks.

“CardioBrief: Cardiac devices could become a big problem for FDA” Larry Husten, November 7, 2016, Medpage Today, medpagetoday.com