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FDA Issues Safety Alert About Swallowing Weight Loss Balloons

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UPDATE (Aug. 16, 2017) Scary! The FDA has issued a safety alert after five people have died after swallowing saline-filled balloons as part of an increasingly popular weight-loss procedure.

According to the report, all five deaths occurred less than a month after the initial balloons were ingested. In three reports, death occurred as soon as one to three days after balloon placement. The FDA is still investigating which part of the process turned fatal.

Four of the deaths were attributed to two manufacturers: the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one report involves the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc.

The balloon treatment, which entails patients ingesting saline-filled balloons to help them feel fuller so they eventually lose weight, had seen early success in clinical trials, with patients losing twice as much weight as diet and exercise alone.

Still, even before this news of associated deaths, the balloon procedure was not without controversy; earlier this year, the FDA issued a warning earlier this year about over-inflating balloons posing a risk for pancreatitis.

In the wake of these deaths, the FDA is recommending that health care providers closely monitor patients treated with these devices for complications. Any adverse events related to intragastric balloon systems should be promptly reported through MedWatch.

ORIGINAL (Aug. 9, 2017) The concept is certainly not for the skittish: People are now swallowing balloons — three over a three-month period — to facilitate weight loss and/or prevent obesity. It’s called Obalon, and it’s the first swallowable intragastric balloon system of its kind, marketed as a nonsurgical, FDA-approved reversible way to lose weight.

And apparently, it’s working for the brave patients trying it.

Balloons for weight loss: How it works

According to the company, overweight adults swallow a capsule, which is then remotely filled with air via a micro-catheter. No sedation is required, and each treatment takes about 10 minutes. The capsule (the balloon) is inflated by a gastroenterologist to about the size of an orange, and weighs approximately the same as a penny.

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Over the course of three months, a total of three balloons is placed in the patient’s stomach. According to ABC7NY.com, the balloons’ purpose is to help keep the patient feeling full so that they eat less and are able to shed stubborn pounds. After six months, all three balloons are removed via an outpatient endoscopy under light conscious sedation. Side effects, including stomach pain or nausea, have been reported as mild and typically clear up within two weeks.

“I’d like to think of these balloons as being used in the earliest phases of obesity to prevent people from getting to a point where perhaps the balloon is not enough,” said Dr. Starpoli, a gastroenterologist who is working with patients trying Obalon.

Does it work?

Results thus far are encouraging: In clinical trials, patients lost twice as much weight as diet and exercise alone. Nearly 90 percent of participants maintained their weight loss after the one-year mark (and we all know how difficult that can be to achieve, right?). Patients reportedly lose about 7 percent of their body weight on average when combined with diet and exercise.

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Like most things in life, the procedure isn’t cheap: Obalon has a price tag of about $8,000, which does include nutritional and behavioral counseling and an endoscopy to remove the balloons at the 6-month mark.

We’re also still a little unsure about the idea of swallowing balloons — which frankly sounds a bit too much like a party trick gone wrong. What do you think — would you try it?

h/t: ABC7NY.com

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