What is the Obalon Balloon System?
In 2021, the Obalon Balloon System was purchased by ReShape LifeSciences. Since that time, Obalon Balloon System production has been halted. Due to this delay in production, we are currently unable to offer Obalon Balloon System placements. This page will be updated when additional information is available from ReShape LifeSciences.
The Obalon Balloon System consists of three, multilayer balloons, each folded within a hard gelatin capsule. The balloons are placed in the stomach at an outpatient office visit, without endoscopy or sedation. Each balloon (in capsule) is swallowed like a pill and then confirmed to be within the stomach using the Obalon Navigation System. Approximately 2 to 3 weeks after the first balloon placed, a second balloon will be placed, and then again 2 to 3 weeks later the third and final balloon placement will be completed.
The FDA has approved the Obalon Balloon System for patients with a BMI between 30-40, who are at least 22 years old. The Obalon Balloon System is a temporary procedure and placement of the balloons should not exceed 6 months.
Expected weight loss is about 10-30lbs. An average of 89% of the total weight lost with the Obalon Balloon System at 6 months was maintained at 1 year.1
Please take note, this procedure is so new that health insurance does not cover the procedure cost, so it is offered as cash pay only.
Obalon Balloon System Recovery Time
Because the placement procedures are completed at in-office appointments, there is no recovery time. The Obalon Balloon System is removed endoscopically at a 3-hour, outpatient visit. The removal procedure itself last just 30-minutes. Most patients are able to return to work one day after removal.
Reported Complications2
- Bleeding Gastric Ulcer – 0.3%
Frequent Side Effects2
- Abdominal Pain
- Nausea
- Vomiting
** Please note – There are many possible complications to the Obalon Balloon System and Upper Endoscopy. Your surgeon will review these potential risks prior to your procedure.**
2 ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2014 Sep 10 – . Identifier NCT02235870, Obalon Balloon System Pivotal IDE (SMART) Trial (SMART); 2018 Mar 8 [cited 2019 Mar 27]; [about 6 screens]. Available from: https://clinicaltrials.gov/ct2/show/results/NCT02235870
