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# Swallowable Weight-loss Balloon Approved by FDA
- URL: https://www.fdaweb.com/swallowable-weight-loss-balloon-approved-by-fda/
- Published: 2016-09-12T12:00:00.000Z
- Updated: 2026-09-14T21:31:04.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136784

FDA has approved an Obalon Therapeutics PMA for the Obalon Balloon System, a nonsurgical, reversible device for weight loss. The swallowable intragastric balloon device is indicated for temporary use to facilitate weight loss in adults with obesity who have failed to lose weight through diet and exercise. It is intended to be used in addition to a moderate intensity diet and behavior modification program. All balloons must be removed six months after the first balloon is placed.

The device comprises a balloon folded inside a capsule that is swallowed by the patient, without sedation or anesthesia. Once the balloon reaches the stomach, it is remotely inflated with gas via a micro-catheter that is then removed, leaving the buoyant balloon in the stomach. Over the next three months, two additional balloons are swallowed and inflated. At the end of the six-month treatment period, all three balloons are removed via an outpatient endoscopy under conscious sedation.

Approval was based on data from 387 patients who received either three Obalon balloons or three sham placebo-like devices that looked similar to the balloons, but were filled with sugar. The patients in both groups were given diet counseling of 25 minutes every three weeks. According to the company, 65% of patients who received the balloons experienced “clinically meaningful weight loss of at least 5% of their total body weight, which is twice as many people than in the sham-control group,” the company says.