The U.S. Food and Drug Administration (FDA) has approved the Allurion Gastric Balloon, the first swallowable, non-surgical device for weight loss, the Massachusetts-based company announced Monday, Feb. 23. The approval marks a significant development for adults with obesity seeking alternatives to medication or bariatric surgery.
The Allurion system allows patients to lose an average of 14% of their body weight, with the potential for greater results through repeat balloon cycles, the company says. It is designed for adults aged 22 to 65 with a body mass index (BMI) between 30 and 40.
“Allurion is now available for patients in the United States,” said Dr. Shantanu Gaur, founder and CEO of Allurion Technologies, in an interview with TODAY.com. “We are currently training doctors across the country to begin utilizing this technology.”
The device is already in use in more than 70 countries, including Canada, Mexico, and European nations.
How the Swallowable Balloon Works
The Allurion balloon comes in capsule form, which patients swallow at a healthcare facility. A catheter attached to the capsule allows doctors to fill the balloon with saline, expanding it in the stomach to create a feeling of fullness. After approximately four months, the balloon deflates and exits the body naturally through bowel movements. A second balloon can be administered two months later if desired.
Unlike other FDA-approved gastric balloons, which require sedation and endoscopy for placement or removal, the Allurion balloon is fully non-invasive. According to Dr. Shelby Sullivan, who led the clinical trial supporting FDA approval, more than 99% of patients can swallow the capsule without difficulty.
“The outpatient procedure takes roughly 15 minutes,” Sullivan said. After four months, the balloon opens, releases its fluid, deflates, and passes naturally, enabling patients to continue their weight-loss journey without surgery.
Weight-Loss Potential and Comparisons
The balloon system offers an average weight loss of 14%, with the potential for over 20% loss for patients completing two cycles. This compares to medications like Wegovy and Zepbound, which can help patients lose 15-20% of body weight.
For patients reluctant to undergo surgery or take long-term medications, the balloon provides a temporary, non-permanent weight-loss option. “Patients see it as a way to get help without committing to lifelong medication,” Sullivan explained. Allurion estimates that around 20 million Americans have already tried and discontinued GLP-1 medications.
Side Effects and Dietary Guidance
Common side effects include nausea, vomiting, and abdominal discomfort, typically resolving within the first week. Patients start on a liquid diet, transition to pureed and soft foods, and resume regular eating within 7–14 days. The stomach may thicken slightly while accommodating the balloon but returns to normal roughly a month after removal.
The balloon promotes weight loss by both occupying stomach space and slowing gastric emptying, prolonging the feeling of fullness.
Expert Perspectives
Some obesity specialists caution that gastric balloons offer short-term results and may not address the hormonal drivers of obesity. Dr. Shauna Levy, medical director of the Tulane Bariatric and Weight Loss Center, noted, “They allow patients to feel full more quickly, but once the balloon is gone, the weight often returns.”
Nevertheless, Dr. William Yancy of Duke Lifestyle and Weight Management Center highlighted the device’s accessibility and affordability advantages compared with long-term medication or surgery.
Only 1–3% of patients are unable to tolerate the balloon, requiring early removal via endoscopy. According to Allurion, patients sustain an average of 96% of their weight loss one year after the balloon passes. The program also includes nutritional coaching and behavioral support.
Cost and Availability
The Allurion program typically costs between $3,000 and $4,000, offering a potentially lower-cost alternative to monthly GLP-1 medications, which can exceed $1,000 per month.
With its FDA approval, the Allurion Gastric Balloon presents a new option for adults seeking non-surgical, non-medication approaches to weight loss, expanding the toolkit available for addressing obesity in the United States.
