If weight loss with weekly self-injected drugs doesn’t sound appealing to you—such as Ozempic, Wegovy, and Zepbound—a new option may soon be available.
According to Allurion Technologies, the Massachusetts company that manufactures it, it is the “first and only gastric balloon in the world that can be swallowed to lose weight, without the need for surgery, endoscopy or anesthesia.”
(The FDA approves a new weight loss drug that in clinical trials helped people lose up to 62 pounds in 16 months)
Currently, three other gastric balloons are approved by the Food and Drug Administration (FDA), but require sedation and endoscopy for implantation or removal, explains Shelby Sullivan, obesity medicine specialist and director of the gastroenterology program. metabolic and bariatric from the University of Colorado.
Sullivan is leading a clinical trial, sponsored by Allurion Technologies, designed to support FDA approval of the balloon. The company says it expects to have the results by the end of 2024 and will then begin the process of submitting its application to the FDA.
What is the Allurion ball and why is it attractive to some?
The Allurion gastric balloon is a capsule-shaped balloon that is swallowed. The doctor fills it with saline to take up space in the stomach and make the patient feel full. After four months, the balloon deflates and the organism comes out when defecating.
Although it is not yet approved in the United States, It is already used in more than 70 countriesincluding Canada, Mexico and Europe.
Patients can lose 10% to 15% of their body weight with the use of the balloon, according to Allurion. In comparison, drugs like Wegovy and Zepbound help you lose between 15% and 20%, according to their respective manufacturers, Novo Nordisk and Eli Lilly.
The balloon is an alternative for people with obesity who do not want to undergo bariatric surgery or take weight-loss medications, either because of cost or fear of permanent body changes, Sullivan says.
“Many people don’t like taking medications, they don’t want to ingest them,” he explains. “Patients see (the balloon) as help they are receiving, but it is not medication they have to take forever.”
How is it ingested?
The patient ingests the capsule, which contains the balloon and a connected catheter, in the doctor’s office.
According to the company, more than 99% of patients can swallow it, but if someone is having trouble, Sullivan says they can use a medical instrument to quickly insert it into the stomach.
(The weight loss drug Wegovy reduces the risk of heart attack by 20%, according to a clinical study carried out by the pharmaceutical company)
The fluid is then connected to the end of the catheter coming out of the patient’s mouth and the balloon is filled with about 18 fluid ounces of saline, Sullivan says.
When x-rays confirm that the balloon is fully dilated, the catheter is removed and “the patient continues with his normal life,” he explains.
The outpatient visit lasts about 15 minutes, according to Allurion.
After four months, the balloon opens, releases the liquid, deflates and leaves the body in the form of feces.
What are the side effects?
These include nausea, vomiting and abdominal pain as the stomach gets used to having the balloon there, Sullivan says. These symptoms usually disappear within three to seven days.
(Will your health insurance pay for weight loss drugs like Ozempic and Wegovy?)
Patients are initially placed on a liquid diet, then transitioned to a diet of purees and soft foods, and begin eating normally after 7 to 14 days, he adds.
Another side effect is thickening of the stomach wall due to the weight of the balloon, which returns to normal about a month after removal, explains Sullivan.
What is the long-term effectiveness?
According to Sullivan, the balloon acts in two ways: it takes up space in the stomach, so the patient feels fuller for longer. It also delays gastric emptying, so food stays in the stomach longer, increasing the feeling of satiety.
But some experts are skeptical about whether this will lead to lasting weight loss.
The concept of ingestible, procedure-free technology is “amazing,” but gastric balloons in general have very limited usefulness, says Dr. Shauna Levy, an obesity specialist and medical director of the Tulane Weight Loss and Bariatric Center in New Orleans.
“For a long-term weight loss solution, I don’t think balls are the answer,” says Levy.
(Myths and realities of Ozempic, the diabetes drug that doctors consider “revolutionary” for weight loss)
“Obesity is hormonally driven, and these are balloons that take up space. They allow you to feel full more quickly, but they don’t target hormones… Understanding the physiology of obesity seems to guarantee that the weight will come back” when the balloon is gone, says Levy.
Long-term results will be a very important consideration, because the ball is deployed in such a short time, says William Yancy, medical director of the Duke Lifestyle and Weight Management Center in Durham, North Carolina.
However, other options are still needed to help obese people lose weight, because not all patients tolerate weight-loss drugs or simply cannot afford them, he adds.
“The balloon actually shares one attribute with these medications: feeling full sooner,” explains Yancy.
The fact that no procedure is necessary to place or remove the ball “is an advance that makes it accessible and probably more affordable,” he adds.
“The problems with this method will continue to be related to tolerance and long-term efficacy; We will have to see when it is used more widely,” says Yancy.
(The popularity of a weight loss medicine leaves diabetics without their treatment)
According to Allurion, only between 1 and 3% of people who use the balloon do not tolerate it and have to remove it early by endoscopy and, on average, people maintain 96% of their weight loss one year after pass the ball. The ball comes accompanied by a “behavior change program” that includes nutritional counseling to create healthier habits.
There is also no limit to the number of times the balloon treatment can be repeated, according to the company.
Sullivan says that, in his experience, when the balloon is removed, patients do not feel hungrier than when they had it on, possibly because it can permanently alter the stomach’s production of ghrelin, the so-called “hunger hormone.”
But Levy cautions that there is no long-term data on the balls’ potential for weight loss. Bariatric surgery is the longest-lasting option, and weight-loss drugs will also have better long-term results than balloons, as long as people continue taking the drugs, he adds.
Gastric balloons are often a “gateway procedure” to bariatric surgery, Levy says, but he worries that a balloon could cause scarring in the stomach that could make future surgery difficult.
(A new drug helped patients with type 2 diabetes lose 15% of their weight)
Allurion says the balloon is made from a thin, soft polyurethane film designed not to damage the lining of the stomach. According to data from the 130,000 patients treated by the company, there has never been a case of stomach scarring that would make future bariatric surgery difficult.
What is the price of the Allurion ball?
Costs vary, but patients typically pay between $3,000 and $4,000 for treatment with the Allurion balloon, the company says.
In comparison, Wegovy’s monthly supply price is $1,349, and Zepbound costs about $1,059.
