Q: I have had problems controlling my weight most of my life. I’ve considered those surgeries where they reduce the size of your stomach, but I’m too chicken. The other day I heard something on the radio about a pill you swallow that expands in your stomach. I guess while it’s in there it makes your stomach feel full so you don’t eat so much. I kept waiting to hear the story again, but I never did so I’m hoping you might know about this and can give me more information.
H.M., of Collinsville
A. In just the past few months, a virtual bouquet of gastric balloons has exploded in the area of weight management, and research has shown claims of effectiveness to be anything but filled with hot air.
They all work basically the same way: A small balloon is placed in the stomach, where it is blown up with gas or liquid. Because part of the stomach’s space is now taken up by this inflated balloon, there is less room for food, which means you feel full even after eating much less. The balloon remains for several months until it is removed, after which it is hoped patients now will be smart enough to avoid packing on the lost pounds again. In tests, these balloons were shown to help people lose up to half of their excess weight and keep two-thirds of it from coming back for at least six months.
But there’s a difference in how these balloons are inserted and removed, which is why the story you apparently heard made headlines across the country last week. When it comes to ease of use and patient comfort, the new Elipse gastric balloon made by Allurion Technologies of Wellesley, Mass., may be the best one yet. Unfortunately, you’ll have to wait a while longer to find out. While early studies are promising, it may be at least two or three years before the Food and Drug Administration approves its use in the United States. In the meantime, though, you can judge its reported advantages for yourself:
Just this year, the FDA did approve two similar devices: the Orbera Intragastric Balloon from Apollo Endosurgery of Austin, Texas, and the ReShape Integrated Dual Balloon System from ReShape Medical in San Clemente, Calif. Both are placed in the stomach and filled with a sterile saline solution. In Orbera’s case, it’s a single balloon that is left for six months before being taken out. As the name indicates, the ReShape Dual system places not one, but two balloons that take up even more space in the stomach. The company says it improves safety and better conforms to the shape of your tummy.
But here’s the big difference: Both the Orbera and ReShape systems involve a minor 30-minute surgical procedure (known as endoscopy) that requires patients to be sedated while the devices are inserted through the mouth, down the throat and into the stomach, where they are inflated. Then, when the devices are removed, patients must go through the same procedure, again under sedation, to deflate and remove the balloons.
As Allurion notes, the two endoscopy procedures raise the cost of the procedure substantially while the sedation may add a slight degree of risk. Moreover, if patients don’t return to have the devices removed, they could deflate on their own and perhaps produce a dangerous blockage as they pass through the intestine. In testing, there was a tiny chance (1 percent to 2 percent) of Orbera and ReShape patients experiencing esophageal injury and aspiration pneumonia when the devices were removed through the mouth.
Allurion’s Elipse eliminates at least some of these drawbacks. In this device, the balloon is contained in a small capsule that is attached to a thin tube or catheter. Fully awake, the patient swallows this pill, which, still attached to the catheter, makes its way to the stomach. Once in the stomach, the capsule dissolves, and the catheter is used to fill the balloon with about 19 ounces of liquid — or about the size of a small grapefruit. After the catheter is removed, the filled balloon remains in the stomach for four months. Then, a valve opens automatically to release the liquid and deflate the balloon, which then passes out of the body naturally. No surgical procedures or sedating drugs are needed.
On Nov. 5 Allurion released findings from a small study at Obesity Week, a joint annual meeting of the Obesity Society and the American Society for Metabolic & Bariatric Surgery. In the study, 34 overweight and obese patients lost an average of 22 pounds after four months, which was roughly 37 percent of their excess weight, according to Dr. Ram Chuttani, a study co-author and chief of interventional gastroenterology at Beth Israel Medical Center in Boston. He also said he found improvements in patients’ triglyceride levels and hemoglobin A1C levels, a key measurement of metabolic function.
“Our findings demonstrate that Elipse provides individuals and their caregivers with a safe, effective and non-invasive weight loss intervention that does not require surgery, endoscopy or anesthesia,” Chuttani said. “Because patients get used to feeling full so much quicker with the device, they learn portion control and get used to eating less. We anticipate that the improved eating habits patients develop will mean that a significant amount of the weight will stay off, even when the balloon is no longer in place.”
He also noted that in addition to making the patient feel fuller with less food intake, the device also appears to slow the process by which the stomach empties and alters hormones that control hunger and appetite, both of which adds to its effectiveness.
The Elipse also improves on another recent device — the Obalon balloon from Obalon Therapeutics in Carlsbad, Calif., which also lacks FDA approval. Like the Elipse, the Obalon also involves swallowing a capsule into the stomach, where the balloon is inflated with gas. However, the Obalon must be removed through an endoscopic procedure.
Allurion expects that, once approved, its device will be attractive as a weight-loss aid to people with a body mass index of 27 or higher. That number is midway between the definition of overweight (25) and obese (30), so the balloon may help the overweight stop and reverse their march toward obesity. In any case, it appears demand for these balloons will be increasing. On Thursday, the Centers for Disease Control and Prevention said the U.S. obesity rate had climbed from 32 percent to 38 percent in the past decade, although some experts said the study was not representative of the population as a whole.
For more information and videos on the balloons, see reshapeready.com (ReShape), www.orbera.com (Orbera) and allurion.com (Elipse). Remember, too, that balloons can cause stomach upset and vomiting, at least until patients become accustomed to them. A ReShape study found about a third of patients complained of ulcers forming.
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