Complications of intragastric balloons

The American Society for Gastrointestinal Endoscopy (ASGE) and the American Society for Metabolic and Bariatric Surgery (ASMBS) have defined acceptable thresholds of safety and efficacy for primary endoscopic bariatric therapies (EBTs). Specifically, a given EBT should have an incidence of serious adverse events ≤5% and should result in ≥25% excessive weight loss (EWL) at 12 months, and this EWL should be ≥15% higher than in a control group. In recent decades, several intragastric balloons (IGBs) have demonstrated safety and efficacy, with broad adoption internationally. The U.S. Food and Drug Administration (FDA) has approved the Orbera Intragastric Balloon System (Apollo Endosurgery, Inc., Austin, TX, USA), the ReShape Integrated Dual Balloon System (ReShape Medical, Inc., San Clemente, CA, USA) and, more recently, the Obalon (Obalon Therapeutics, Inc. Carlsbad, CA, USA). The Spatz Adjustable balloon (Spatz Medical, Great Neck, NY, USA) is currently conducting its US pivotal trial. The Elipse Balloon (Allurion Technologies, Natick, MA, USA) has been proven to be a safe and effective device in European clinical studies and the clinical study for FDA approval is still in process. EBTs are mostly represented by intragastric balloons and the balloons we are addressing in this chapter have either been approved or are in the process of being approved by the FDA. The number of adverse events associated with IGB insertion varies across studies. The most commonly reported symptoms after IGBs placement are accommodative in nature, such as abdominal pain, nausea, and vomiting. These generally tend to last only for few days after balloon insertion and are usually self-limiting. Serious adverse events described after IGB placement include dehydration, gastrointestinal ulceration, dislocation of the balloon causing intestinal obstruction, and perforation especially during balloon insertion or removal.