Americans have a new way to shed excess weight, and it isn’t a GLP-1: It’s a pill with a balloon inside it. This week, the U.S. Food and Drug Administration (FDA) approved the Allurion Gastric Balloon System for adults 22 to 65 years old with obesity.
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The device comes in the form of a swallowable “smart capsule” that gets inflated after it reaches the stomach. Once filled, the balloon essentially decreases the volume of the stomach to help people feel full and satisfied while eating less food.
“This device expands our tool kit in treating obesity,” says Rabindra Watson, MD, the director of the metabolic health program at Cedars-Sinai Medicine in Los Angeles, who has been involved in the product development.
“Even in the era of highly effective GLP-1 medications, there remains a substantial group of patients who either cannot tolerate these drugs, do not wish to take a long-term injectable medication, lose access [to the GLP-1s] because of cost or insurance barriers, or prefer a time-limited intervention,” Dr. Watson says.
How the Allurion Balloon Works
To get the balloon to the stomach, a patient swallows the smart capsule, which is connected to thin tubing that stays outside the body. Once the capsule reaches the stomach, a doctor fills the balloon with saline (salt water) and then pulls out the tubing. The balloon expands to about the size of a grapefruit.
The balloon is made of an organic polyurethane film, and adapts to the shape of the stomach. The materials are engineered to withstand gastric acid, digestive enzymes, and mechanical stress within the stomach.
“The actual administration of the capsule, which is about the size of a fish oil pill, takes about 15 minutes, without endoscopy [a procedure requiring a thin, flexible tube fitted with a light and a camera], surgery, or sedation,” says Shantanu Gaur, MD, the founder and chief executive officer of Allurion. “When the balloon is done filling, the patient gets up and leaves. The whole process is very smooth, convenient, and quick.”
The device remains in the body for about four months. After that, the seal on the balloon breaks down, allowing the saline and the empty balloon to pass out of the body naturally in a bowel movement.
“The fact that the balloon basically disintegrates and takes care of itself is a big advantage,” says Rohit Soans, MD, the medical director of bariatric surgery at Temple University Hospital in Philadelphia. “You don’t have to go back to a doctor’s office and have it pulled out.”
The device is designed for short-term, limited weight loss for adults with a BMI between 30 and 40, a measure of obesity. If patients haven’t achieved their goal weight, they can swallow another capsule two months after the first one passes out of their system.
People using the product must also have had at least one unsuccessful attempt at a weight loss program. This requirement demonstrates that they are dedicated and will understand some of the basic building blocks of weight loss, according to John Morton, MD, MPH, the medical director of bariatric surgery for the Yale New Haven Health System.
“You want to make sure that people are committed to having some sort of lifestyle changes, and that they understand how to deal with volume of food, how to orient themselves to protein instead of carbs, and how important exercise is for weight maintenance,” Dr. Morton says.
To that end, the balloon treatment also comes with six months of nutritional coaching to teach better long-term eating habits.
Gastric Balloon Leads to Weight Loss of Up to 20 Percent
Outside the United States, the Allurion gastric balloon has already been used to treat more than 200,000 adults with obesity. On the basis of data from more than 30 peer-reviewed medical journal publications, Allurion estimates that patients can lose about 14 percent of their body weight in the first four months, and more than 20 percent if they get a second balloon.
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Morton notes that these results are “in the ball park” of those achieved with the popular GLP-1 obesity drugs Wegovy and Zepbound.
What Makes This Gastric Balloon Unique
Stomach balloons for weight loss are not new; some have been on the market for a decade or more.
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Older balloon systems, however, require sedation and endoscopy for placement and removal. The body also doesn’t expel the balloon naturally.
“The big deal with this Allurion balloon is that it doesn’t require any kind of invasive procedure to put in or take it out,” says Rohit Soans, MD, the medical director of bariatric surgery at Temple University Hospital in Philadelphia.
Possible Side Effects
As with any medical intervention, side effects are possible.
In the first few days after placement of the gastric balloon, individuals may experience pressure, nausea, or stomach cramping. Serious complications are uncommon but can include migration (the balloon moving somewhere it’s not supposed to be), obstruction of the intestine, and early deflation.
Watson says that the saline solution is often mixed with a small amount of blue dye, which acts as an early warning system: If the balloon deflates prematurely, patients will notice a change in the color of their urine and can then seek medical attention.
He adds that the device does not block the stomach, interfere with nutrient absorption, embed in tissue, or alter anatomy permanently.
Concerns About Weight Return, Availability, and Cost
In clinical trials, people maintained 95 percent of their weight loss in the first year after the balloon passed through their system.
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But Morton cautions that weight loss through this method or any other is never guaranteed to be permanent.
As far as medical procedures go, bariatric surgery has the highest success rate for keeping pounds off, he says.
Following FDA approval, the Allurion balloon is now immediately available to patients, according to Dr. Gaur. “The bottleneck now will be actually us training physicians on the proper use of the technology, and having places for interested patients to go get the technology,” he says.
Although the price of the product may vary depending on the physician practice, Gaur estimates that the cost is on a par with GLP-1s, at about $400 per month.
Whether insurance will cover the cost of treatment remains an open-ended question.
“The reality is, most of the GLP-1 market right now is not covered by insurance — people are paying out of pocket, so that’s becoming a bit of the status quo here in the United States when it comes to weight loss,” says Gaur.
