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

Abstract

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.

A rare case of gastric perforation by a 5-year-old Intra-gastric Balloon in situ: Case report and review of literature

“…Intragastric balloon (IGB) placement has been endorsed as a minimally invasive procedure in the armamentarium of a bariatric endoscopist, including gastroenterologists and surgeons, and has generally been accepted as safe and efficient [ 1 ] in the care of obese patients. It has been extensively used around the world for at least 20 years [ 3 ], due to its ease of insertion and its simplicity and reversibility.…”

“…Intra-gastric Balloon Insertion (IGB) has widely been used as a minimally invasive procedure for the treatment of overweight or obese individuals. It is considered a preferred method by many due to its safety, tolerability and relatively low cost [ 1 ], bridging the gap between the conventional methods and bariatric surgery [ 2 , 3 ].…”

Gastric space-occupying devices for management of obesity and metabolic disease

“…One should expect nausea and vomiting, especially during the first 2 weeks À the adaptation period [59]. On the other hand, serious adverse events rate is relatively low and entail mainly gastric and esophageal perforations, and bowel obstruction [62]. A single anecdotal report has also described acute pancreatitis due to balloon hyperinflation.…”

Hidden dangers and updated labels on gastric balloons

“…19 A dozen cases have revealed bowel obstruction as a possible AE of IGB. 19 Serious AEs such as esophageal, gastric, and intestinal perforation have also been reported, although less frequently. 19 Early AEs with the Orbera system include abdominal pain, nausea, early explantation, migration, and gastrointestinal perforation.…”

“…19 Serious AEs such as esophageal, gastric, and intestinal perforation have also been reported, although less frequently. 19 Early AEs with the Orbera system include abdominal pain, nausea, early explantation, migration, and gastrointestinal perforation. 14 Notably, IGBs have been identified as an important cause of gastric outlet obstruction with resultant perforation if early retrieval is not implemented affecting up to 0.8% of patients in certain populations.…”