Are intra-gastric adjustable balloon system safe? A case series

Abstract

There is a need to study our experience with a larger population of patients who have had this device inserted. Its safety needs to be questioned and its design may need to be addressed.

Elipse™, a Procedureless Gastric Balloon for Weight Loss: a Proof-of-Concept Pilot Study

“…The radiopaque catheter (black arrowhead) is seen entering the stomach. The radiopaque marker inside Elipse™ (white arrowhead) is also visible reports demonstrate that balloons are more likely to spontaneously empty, migrate into the intestines, and occasionally cause an obstruction when patients do not return to have the balloon removed [8][9][10]. While filling balloons with methylene blue-stained liquid is intended to alert the patient that the balloon has opened, it is not a fail-safe technique [13].…”

“…Second, all require some type of anesthesia or sedation [7]. Third, patients who fail to return and have the balloon removed risk spontaneous balloon deflation, migration into the intestines, and small bowel obstruction [8][9][10].…”

Spatz 3 Adjustable Intragastric Balloon: Long-Term Safety Concerns

“…Of interest, the patients were on continuous proton pump inhibitors and no gastro-toxic drugs intake was noted prior to the perforative complications. As stated by the authors, the Spatz 3 ABS, with its new upgraded design with a soft catheter instead of the rigid catheter and metal chain is supposed to avoid the reported incidents of perforation or requirement for surgery secondary to catheter impaction or dislodgement [2][3][4]. Nevertheless, we believe that the sequential placement of two BIB balloons may prove to be safer on the long term, although not costefficient relative to the placement of a single Spatz balloon with upward adjustment when needed.…”

The Effect of Gastric Balloons on Weight Loss

“…There is a balloon called the 'Spatz' which is supposed to last for one year. However, a study found that all the adverse events that occurred during Spatz balloon therapy occurred after six months of operation [13]. This implies that the Spatz is safe for before six months of insertion, but becomes dangerous after six months.…”