Unapproved heart procedure being performed on thousands of Afib patients
It’s a dangerous heart surgery experiment being performed on thousands of people a year.
And none of them are being told about it!
If you suffer from atrial fibrillation (Afib), you know you’re at an increased risk for a serious blood clot or stroke. And you may have been told that a medical device called the Lariat — which ties off part of your heart — could save your life.
But a top Ivy League researcher is warning that the Lariat procedure has never been proven safe or effective for heart patients.
It was approved through an FDA loophole that’s putting us all at risk — and that’s already sent some heart patients to their early graves.
And that makes sense. Because the way these surgeries are being done, it feels an awful lot like the wild, wild West.
Lots of people dying — and no law in sight.
You see, for most people with Afib, blood clots start in the left ventricle. So the Lariat actually “lassos” and ties off a pouch in that section of your heart — and is supposed to keep clots from ever reaching your bloodstream.
Now before some surgeon inserts a medical device into your heart, you’d like to believe there’s lots of science proving that it’s safe. Or at least that it works.
And that’s what Dr. Jay Giri from the University of Pennsylvania expected to find when he started studying whether his hospital should start using the Lariat on Afib patients.
Instead, he was shocked to learn that the devices were leaking like an old faucet! Not only were patients dying after getting the Lariat, but some needed to be rushed back to the ER for emergency heart surgery.
And there wasn’t a shred of data proving that the Lariat was preventing strokes!
Even worse, when Dr. Giri checked out SentreHEART’s FDA application for the Lariat, he couldn’t find a single mention of this popular Afib lassoing in the paperwork.
And you can thank the FDA’s ridiculous 510(k) clearance program for that.
You see, it’s practically harder to get approved for a high-interest credit card than it is to get a new medical device rubber stamped through 510(k).
Manufacturers just have to prove that their new product is “substantially similar” to a device that’s already on the market. And bingo — they get to skip years of clinical trials.
And that’s exactly what SentreHEART did.
When the company sent in its 510(k) application to the FDA, it said that the Lariat was a “suture device” (like a bunch of others already on the market). It never breathed a word about heart surgery, strokes or Afib.
But it didn’t take long before the company’s officers and consultants started promoting it “off label” for just those conditions.
Now, thanks to Dr. Giri’s research, the FDA has finally woken up from its long winter’s nap — sort of. The agency has just issued a “Safety Communication” warning of patient deaths and other serious problems when the Lariat is used to treat Afib.
Well, thanks for nothing. This device is still being used that way, and hospitals all over the country are looking for even more heart patients to try it on.
And the FDA isn’t doing a thing to crack down on all the doctors and hospitals that are still promoting Lariat procedures right now.
If your doctor is one of them, it’s time to have a serious talk with him before he ropes you into a surgery that could cost you your life.
Or that makes you a lab rat in an experiment that’s already claimed its share of victims.
Sources:
“Special report: Popular heart surgery carried hidden danger” Sheila Kaplan, November 10, 2015, Stat, statnews.com
