FDA Approves a Balloon That Patients Swallow to Lose Weight
Dr Weeks’ Comment: this is a vastly superior and much safer treatment option than gastric surgery or banding. This has been approved in Europe for over a decade and it’s been embarrassing as an American doctor that it was not available in America until now. This is a very sensible option for weight loss as, once inflated, it gives the patient a sense of being full so the patient eats less and eats slower.
by Kristen Monaco, Senior Staff Writer, MedPage Today
February 24, 2026 • 2 min read
The FDA granted premarket approval to a gastric balloon system for short-term weight loss alongside lifestyle intervention, developer Allurion announced on Monday.
The drug-free system is indicated for adults 22 to 65 years with obesity who had an unsuccessful attempt at weight loss with a prior program. By taking up room in the stomach, the device helps patients feel fuller and eat less.
It features a “smart capsule” ingested during a 15-minute office visit without the need for surgery, endoscopy, or anesthesia. Once inside the stomach, the physician fills the balloon with fluid. It then remains in the stomach for roughly 4 months until a release valve opens and the balloon is passed naturally. A new smart capsule can be ingested 2 months after the previous one passes.
In the AUDACITY trial of 550 participants, 58% of those randomized to two cycles of treatment with Allurion’s balloon lost more than 5% of their total body weight by week 48, achieving a 3.77% greater reduction in total body weight loss compared with a control group.
The device can be used as a standalone or as a complementary tool to existing therapies, such as GLP-1 receptor agonists, according to investigator Shelby Sullivan, MD, of the Geisel School of Medicine at Dartmouth College in Hanover, New Hampshire.
“It has a finite time in the body, is repeatable when necessary, and it does not require patients to take long-term medications for weight loss,” Sullivan said in a statement.
In AUDACITY, serious adverse events (AEs) occurred in 3.1% of balloon participants. This was the lowest rate reported in a pivotal FDA trial for a liquid-filled intragastric balloon indicated for weight loss, said Allurion.
Other intragastric balloon systems, including Orbera and ReShape, have been approved for weight loss but require removal with an outpatient procedure. They have also been linked to serious outcomes like spontaneous hyperinflation, acute pancreatitis, and deaths.
In a real-world study of patients who used Allurion’s balloon outside the U.S., AEs included nausea, vomiting, and abdominal pain, with serious AEs including small intestine obstruction, pancreatitis, or gastric outlet obstruction.