The FIRST and ONLY
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
1. You will swallow a capsule.
2. Once in the stomach, the balloon is inflated with gas.
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.
Figure 3. Deflated Obalon Balloon Removal
U.S. PIVOTAL TRIAL
Double Blinded, randomized sham-controlled trial
Rigorous, level one