Clinical safety and effectiveness of a swallowable gas-filled intragastric balloon system for weight loss: consecutively treated patients in the initial year of US commercialization

Background: Obesity is the most common chronic disease in the United States today. Additional therapies are needed to improve obesity treatment. Objective: A swallowable, gas-filled intragastric balloon system was approved for the treatment of obesity by Food and Drug Administration in September 2016 and commercialization started January 2017. A registry was made available to physicians to capture evidence of safety and effectiveness with use. Setting: United States private clinics, surgery centers, and hospitals. Methods: This study is a retrospective analysis of a prospective registry of patients with body mass index (BMI) >= 25 kg/m(2) that initiated therapy in the first year. Data on demographics, procedural timing, weight loss, adverse events, and device deficiencies were captured. Results: The final analysis comprised 1343 patients across 108 treating physicians (mean age 45.7 +/- 10.8 yr, 78.6% female, baseline BMI of 35.4 +/- 5.4 kg/m(2)). Nonserious and serious adverse events were reported in 14.2% and.15% of patients, respectively. There were 7 balloon deflations, none caused obstruction. Weight loss in the indicated use (BMI 30-40 kg/m(2)) was 9.7 +/- 6.1 kg and 10.0 +/- 6.1% total body weight loss (TBWL). Weight loss in other BMI categories was 8.2 +/- 5.6 kg or 10.3 +/- 7.0% total body weight loss for BMI 25 to 29.9 kg/m(2) and 11.6 +/- 7.8 kg or percent total body weight loss 9.3 +/- 6.0 for BMI >40 kg/m(2). Conclusions: This swallowable gas-filled intragastric balloon system is safe and effective at inducing weight loss and offers physicians another tool for patients whose obesity has been resistant to noninvasive treatments. (C) 2019 Published by Elsevier Inc. on behalf of American Society for Bariatric Surgery.