Introduction: The Orbera System® intragastric balloon is an endoscopically placedshort termdevice that facilitates weight loss. The device, which was formerly known as the Bioenteric Intragastric Balloon® (BIB), is extensively used in numerous foreign countries, but is presently not FDA approved for placement in the US. There have been a number of reported cases of Orberaremovals in the US. Among these reports are instances of significant life threatening complications including aspiration and esophageal injury.
Methods and Procedures: Between November 2008 and June 2009 the author endoscopically removed 15 Orberas without incident. These cases are reviewed along with recommendations to maximize the safety of balloon removal.
Results: Of the 15 removals, 13 were removed electively, under propofol anesthesia, at a free standing outpatient GI center. Two were removed in the operating room after general anesthesia and endotracheal intubation. The presence of the Orbera leads to delayed gastric emptying. This places patients at increase risk of aspiration at the time of Orbera removal. To combat this, the last 10 removals were accomplished after a “pre-balloon removal diet”. The diet consisted of no vegetables for one week, clear liquids for three days, and nothing per mouth after midnight prior to the procedure. This approach led to no particulate material in the stomach in 7 of 10. The remaining 3 had a small amount of solid food that was manually manipulated through the pylorus prior to balloon removal. If significant particulate material is found the proper strategy would be to stop and delay Orbera removal after a longer period of restricted oral intake.
All balloons were initially punctured by an aspiration needle that is specifically designed for this purpose. The needle allows for threading of a sheath deep into the balloon to fully deflate the balloon. This is critically important as any residual fluid will pool at the trailing edge of the extracted balloon making the diameter of the balloon too large to safely pass through the esophagus. After the balloon is fully deflated it is grasped for extraction. Again there are grasping instruments specifically designed for this purpose. These were used for the first 2 removals. The design of these instruments potentially exposes the esophagus to the sharp edges of the instrument mandating very careful withdrawal of the balloon under direct vision timed with the peristalsis of the esophagus. A safer option is to grasp the fully deflated balloon with a large snare. This is technically more challenging as the circular shape of the deflated balloon and the stiffness of the material conspire to resist ensnarement. Removal with the snare was possible in 12 of 13 removals.
Conclusion: Endoscopic intragastric balloon removal can be accomplished in a straightforward and safe way if proper attention is paid to avoiding common pitfalls.
Program Number: P370