Life-threatening visceral complications after intragastric balloon insertion: Is the device, the patient or the doctor to blame?

Background and aim Intragastric balloon placement is established as a safe, relatively low-cost and well-tolerated minimally invasive procedure for weight loss, giving encouraging results under the strict prerequisite that the obese patient will enroll in a medically supervised weight loss program. This retrospective study reviews already published cases of severe visceral complications for the purpose of assigning responsibility to the device, the patient, or the doctor. Methods We reviewed PubMed and Scopus archived publications describing intragastric balloon (BIB/Orbera)-related severe visceral complications, i.e. perforations and obstructions. Results Twenty-two cases of gastric perforation, two cases of esophageal perforation and 10 cases of bowel obstruction were found. For the gastric perforation the endoscopist was responsible in nine cases, the patient in four, and the balloon itself in nine. For the two cases of esophageal perforation, the endoscopists were responsible, while for the 12 cases of bowel obstruction, the patient was responsible for seven and the device for the other five cases. Conclusion BIB/Orbera balloon insertion remains a safe procedure, with a minimum of complications related to hollow viscera. Mandatory education and accreditation of physicians dealing with bariatric endoscopy and strict supervision of the obese individuals, while living with the balloon, will eliminate such complications.