Some really bad ideas not only don’t go away — they multiply!
Such is the case with the weight-loss scheme called a “gastric balloon.” And it’s exactly what it sounds like — a balloon inflated in your belly.
The idea, of course, is that if your stomach is filled up with one, two, or even three of these balloon bags, you won’t eat as much, and you will lose weight!
What could possibly go wrong with that?
Well, as it turns out, plenty.
Currently, the FDA has approved three different brands of gastric balloons. After the first one, called the ReShape Integrated Dual Balloon System, got the okay in 2015, two others quickly followed.
Now, there’s a fourth waiting in the wings for the FDA to get on the market, called The Elipse Balloon. You swallow the device, which is folded like a tiny parachute in the form of a pill that is attached to a long, thin tube. Once it hits your stomach, the doctor fills it with water to inflate it. The tube comes back up, and the Elipse bounces around in your stomach for four months.
After that time, the company says it deflates, and your body moves it right out of your system. What fun!
While Elipse isn’t sold yet in the U.S., two others that are have already become the subject of an FDA-required “Dear Doctor” letter — a warning that the device makers were recently required to send out to physicians via email or snail mail.
And hopefully those letters didn’t land in the spam folder or the “circular file” — because they’re supposed to be alerting doctors about “multiple reports” of two serious side effects with ReShape balloons and another type called the Orbera.
Turns out that these devices can spontaneously over-inflate, causing “intense abdominal pain” and swelling, difficulty breathing and vomiting.
Along with that, the balloons can injure the pancreas, causing acute pancreatitis, something that can lead to serious complications. The FDA says that if someone with one of these things in their stomach shows up at the ER, doctors probably won’t even realize what’s causing the problem.
None of these side effects, however, should come as any big surprise.
Thirty years before all these new inflatable devices hit the market, another balloon-in-the-stomach weight-loss idea was approved by the FDA — and failed tragically.
That product was called the Garren-Edwards Gastric Bubble, and it only lasted a year on the market before the company was required to send out its own “Dear Doctor” letter warning that the bubble didn’t always stay inflated and that when it collapsed, it could cause a life-threatening intestinal blockage. The first year it was in use, at least one patient died because of that.
But this certainly isn’t the only ill-conceived weight-loss plan to which the FDA has given a green light.
Last year we told you about the AspireAssist, a way to drop some pounds by throwing up on demand though a system of tubes, ports and valves.
It’s basically nothing more than FDA-approved bulimia, or, as one late-night comedian called it, “abdominal vomiting.”
Look, I know losing weight can be frustrating and seemingly impossible at times. But do you really want to risk suffering side effects such as vomiting, agonizing abdominal pain, an intestinal obstruction or acute pancreatitis, and still have to eat like a bird (if, in fact, you can eat at all)?
And while patients in the trial for the up-and-coming Elipse Balloon did drop some weight, they were also put on a calorie- and carb-restricted diet. And after the device was removed, they were instructed to eat Mediterranean-style, with lots of veggies and not too much protein or carbs.
So perhaps a healthier and safer idea to shed some pounds would be to move directly to the healthier diet — skipping the balloon-in-your-stomach part entirely!