The U.S. Food and Drug Administration (FDA) has approved the Allurion Gastric Balloon System, a temporary device intended to support short-term, limited weight loss in adults living with obesity. Unlike some other gastric balloon options, it doesn’t require surgery, endoscopy, or anesthesia to place or remove. Instead, a person swallows a capsule that contains the device, which is then filled with fluid once it is in the stomach. After around four months, you pass the balloon.

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The approval adds another potential treatment option for people living with obesity and considering weight loss support, alongside approaches such as lifestyle changes, medications (including GLP-1 drugs), and bariatric surgery.

What Is the Allurion Gastric Balloon?

Allurion’s system uses a capsule that is attached to a catheter and contains a deflated balloon. The capsule is swallowed, then the balloon is filled in the stomach under a healthcare provider’s supervision. The balloon takes up space in the stomach, which may help some people feel full sooner. The device is designed to be put in place without requiring surgery, endoscopy, or anesthesia.

The device is indicated for adults aged 22 to 65 with a body mass index (BMI) of 30 to 40 who have had at least one unsuccessful attempt at a weight loss program. It’s intended to be used alongside a moderate-intensity lifestyle modification program, including changes in eating patterns, activity, and habits.

The balloon is not permanent. After approximately four months, the device’s release valve opens, and the balloon passes out of the body naturally. Another capsule can be swallowed two months after the first balloon passes.

What Did the Studies Show?

The approval was based on the outcome of a U.S. study called Audacity that enrolled 550 people at 17 U.S. sites. Participants were randomly assigned to either two cycles of the Allurion Balloon or a control group that received moderate-intensity lifestyle therapy.

Among the results from the study:

• 58 percent of participants in the balloon group lost more than 5 percent of their total body weight at 48 weeks, meeting one of the study’s main goals.
• The people in the balloon group lost more weight than the people in the control group at 48 weeks.

What About Side Effects and Safety?

Temporary gastric balloons can cause side effects, and some complications may be serious. According to Cleveland Clinic, side effects of intragastric balloons may include:

• Temporary abdominal pain
• Temporary sore throat
• Nausea
• Indigestion
• Acid reflux
• Constipation

Rare but serious complications of gastric balloons may include:

• Ongoing gastrointestinal symptoms
• Hyperinflation (when a balloon overfills)
• Deflation (when the balloon breaks or deflates and moves from the stomach to the intestines, potentially becoming stuck)
• Acute pancreatitis (inflammation of the pancreas)
• Stomach ulcers

Why This Matters for People Living With Obesity

For some people, weight loss can be difficult even with sustained changes in eating patterns, activity, and daily habits. Others may not be able to take certain medications, may not get the results they hoped for, or may not feel ready for a surgical option.

A temporary device like the Allurion balloon may be of interest to people who:

• Want a nonsurgical approach
• Have tried at least one weight loss program without success
• Are looking for an option designed to be used with structured lifestyle support
• Want to understand how device-based approaches compare with other treatments

If you’re living with obesity and aren’t seeing the results you want from your current treatment plan, consider asking your healthcare provider about alternatives, including their respective benefits and potential risks.

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On MyObesityTeam, people share their experiences with obesity, get advice, and find support from others who understand.

Have you tried a gastric balloon to help with weight loss? Let others know in the comments below.