Obalon is the first FDA-approved, swallowable, non-surgical gastric balloon in the United States. This unique gastric balloon comes in the form of a “pill” that is attached to a small catheter. It can be placed in your physician’s office, without any anesthesia, and placement can be confirmed with an Xray machine. Once proper placement is confirmed, the balloon is inflated with gas to 250cc. Unlike the other FDA-approved gastric balloons in the United States, no anesthetic or downtime is required for placement.
One balloon is placed initially, followed by 2 more insertions (every 4 weeks) for a total of 3 balloons and 750cc. Obalon differs from Orbera and ReShape in several ways:
- no anesthesia is required for insertion of the Obalon balloons
- no downtime is required after insertion
- the sequential placement of balloons results in much better patient tolerance (i.e. less nausea & vomiting)
- fewer Obalons need to be removed early due to balloon intolerance
- the Obalon balloon is filled with gas, not saline
Similarites include:
- similar total balloon volume (in between Orbera [600cc] and ReShape [750-900cc]
- similar physiologic function of balloon(s), occupying space in the stomach to reduce hunger and help the patient get full on smaller portions
- similar requirements for success-patient must make meaningful changes in diet/exercise habits and be compliant with all follow-up visits
- similar in-stomach balloon duration of 6 months
- similar balloon removal process requiring sedatation and endoscopy
Results submitted to the FDA from Obalon’s SMART trial showed an excellent safety profile with no early balloon removals or balloon deflations and weight loss that was around double that of the placebo group. As with any gastric balloon system, the patient must make a serious commitment to healthy eating, exercise, and attending all post-procedure nutrition visits to maximize success.