A Study Examining the Orbera365 Intragastric Balloon Safety and Effects on Weight Loss

INTRODUCTION: The Orbera365 is a new balloon that can stay in the stomach for up to 12 months. The aim of this study is to investigate the safety and effect of Orbera365. METHOD: Prospective study on our initial experience with a consecutive group of patients who underwent the insertion of Orbera365 in the period between September 2019 and August 2020. The patients were followed up to assess, pain, nausea, and vomiting after procedure, weight loss, and the complication rate. RESULTS: A total of 97 patients underwent Orbera365 placement. Mean weight and BMI before the procedure were 93.8 ± 15.2 kg and 35.2 ± 4.4 kg/m(2), respectively, which dropped to 80.6 ± 13.1 kg and 29.8 ± 4.0 kg/m(2) by 8.2 months and were 82.4 ± 16.1 and 30.4 ± 4.6 at the last day of follow-up of 12.9 months. Fourteen patients did not tolerate the balloon, and had to have it removed, six of them in the first week, and eight within the first 8 months of insertion. Other than intolerance, two patients had balloon rupture, three patients had leakage at time of insertion requiring balloon replacement, two patient had pancreatitis, one patient had spontaneous balloon hyperinflation, and one patient had balloon deflation and vomited the balloon. At day of last follow-up, total body weight loss % (TBWL%) was 16.2 ± 10.1 and %EWL was 54.6 ± 38.3. CONCLUSION: Orbera365 is safe and effective for weight loss. GRAPHICAL ABSTRACT: [Image: see text] SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11695-021-05729-8.