Urgent: FDA issues heart-attack warning on new stent device

The FDA has just issued a warning about a type of stent, one that it approved less than a year ago.

You may still hear it being pitched as the greatest invention ever — a device that will dissolve in a few years after being inserted into a blocked artery during an angioplasty procedure.

But unfortunately, this magic disappearing stent trick is coming with some big extra risks, ones that your doctor may not even know about.

Affairs of the heart

Almost a year-and-a-half ago we warned eAlert readers about the Absorb stent. Now, the FDA is finally getting around to warning about it, too. The agency has just put out a letter on its website for doctors, saying that this device appears to be causing increased numbers of heart attacks and “other major cardiac events.”

Plus that bad news for anyone who’s had one of these devices inserted inside of them, Absorb can also raise the risk of a deadly kind of blood clot.

Unlike traditional metal stents that stay in place, Absorb is supposed to slowly disappear after being absorbed by your body over a period of three years.

Dr. E. Magnus Ohman, of the Duke Clinical Research Institute, calls the situation a “fascinating” look at how these types of heart procedures can take “two steps forward and then usually one back.”

Seriously Dr. Ohman? This isn’t a board game we’re playing here. What’s really “fascinating” is how the FDA went ahead and approved Absorb to begin with, because none of these new warnings should come as any kind of surprise.

After the Absorb three-year trial data was released last year, the device was called “worrisome,” and “disappointing.” One report went so far as to say that the studies on Absorb revealed “every one” of the stent’s “theoretical benefits to be untrue.”

And as we told you even before that, despite looking at Absorb up, down and all around, the clinical trial didn’t produce any benefit for the device. Yet, the FDA still rushed it onto the market.

Now, it would be bad enough if this was some unusual mistake or oversight on the part of the FDA. But the system that allows medical devices to be used, called the 510(k) clearance program, is about as ridiculous as it gets.

All a device manufacturer has to do is simply prove that a new product is “substantially similar” to one already on the market. It’s probably one of the most lax, and absurd regulations ever put into action.

And that “clearance program” covers things that are put inside our bodies. If they don’t work right, or are dangerous, we can’t exactly just pop them out now, can we?

So, if your doctor is talking about implanting any type of device inside of you, from a knee replacement to a stent, obviously you can’t just take for granted that all will be well. It’s time to start asking some important questions.

What exactly is it? What have the clinical trials revealed, and have there been any warning signs that it might be dangerous?

Those are the kinds of questions that the FDA should be asking, but apparently isn’t.

And if your cardiologist should ever mention the Absorb stent, a good response would be exactly what Dr. Ohman said when he heard about the FDA’s warning:

“Whoa.”

“FDA probing Absorb stent” Nicole Lou, March 18, 2017, Medpage Today, medpagetoday.com