The FIRST and ONLY
swallowable, GAS-FILLED,
FDA-approved balloon system
for weight loss.

The Obalon Balloon System is a swallowable intragastric balloon system indicated for temporary use to facilitate weight loss in adults with obesity (BMI of 30 – 40 kg/m2) who have failed to lose weight through diet and exercise. The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first balloon is placed.

Swallowing the Obalon® Balloon

obalon-animation-pill

1. You will swallow a capsule.

obalon-animation-inflation

2. Once in the stomach, the balloon is inflated with gas.

obalon-animation-3balloons

3. Over the course of 6 months, you will receive 2 additional Balloons for a total of 3.

What happens after Balloons are put into your stomach

Talk with your doctor before the procedure to learn about any dietary rules.

Your doctor will take the Obalon Balloon out of your stomach during a short outpatient procedure. First, you will be made comfortable with a medication in your vein that causes conscious sedation (light anesthesia). Then your doctor will use a tube that can bend and has a camera on the end to view the balloons. The doctor will puncture the balloons one by one to deflate them. Once your doctor deflates the balloons, they are taken out of your stomach (Fig. 3). Taking all three balloons out of your stomach typically takes less than 20 minutes.

obalon-animation-deflated

Figure 3. Deflated Obalon Balloon Removal

U.S. PIVOTAL TRIAL

clinical-trial

Double Blinded, randomized sham-controlled trial


Rigorous, level one
study design

387-patients

387
Patients


Randomized 1:1

location

15
Sites


Bariatric surgeons
and gastroenterologists

Please talk with your doctor to find out more about your condition and whether Obalon is right for you.

You may also call Obalon Customer Service: 1.844.362.2566

IMPORTANT SAFETY INFORMATION
The Obalon Balloon System is intended for adults with a body mass index (BMI) of 30 to 40 kg/m2 willing to follow a diet and exercise program. All Obalon balloons must be removed in 6 months. Patients with prior weight loss surgeries are not eligible. The most common side effects reported were mild abdominal pain and nausea which typically resolved within two weeks. You must take daily acid-blocking medicine prescribed by your doctor. For full Important Safety Information click on Safety Information and Patient Labeling.