Comparative effectiveness and safety of swallowable versus endoscopically inserted intragastric balloons

Intragastric balloons (IGBs) are a minimally invasive therapy for weight management; however, real-world comparative evidence for swallowable gastric balloons (SGBs) versus endoscopically inserted balloons (EIBs) remains limited. Retrospective cohort study of 187 consecutive patients treated with swallowable gastric balloon (SGB; n = 120) or endoscopically inserted balloon (EIB; n = 67) from November 2023 to October 2025. Safety outcomes were analyzed in all treated patients ( n = 187). Weight-loss outcomes were analyzed as a complete-case complete-course analysis among patients who completed the planned balloon course and had post-treatment weight available (EIB n = 53, SGB n = 75; overall n = 128). Primary outcomes were percent total weight loss (%TWL), percent excess weight loss (%EWL), and BMI reduction; secondary outcomes included early removal and adverse events. In the complete-course complete-case cohort ( n = 128), weight loss was similar between groups: mean %TWL 5.64%±7.71% (EIB) versus 5.86%±7.45% (SGB; p = 0.8705) and mean %EWL 21.99%±31.75% (EIB) versus 18.94%±27.86% (SGB; p = 0.5661). In the full treated cohort ( n = 187), overall complications occurred in 54/187 (28.9%) and early removal in 51/187 (27.3%), numerically more frequently with SGB (37/120 [30.8%]) than EIB (14/67 [20.9%]; p = 0.1719). Severe dehydration occurred more often with SGB (13/120 [10.8%] vs. 1/67 [1.5%]; OR 8.02, 95% CI 1.03–62.73; p = 0.0202). Exploratory subgroup analyses suggested lower odds of early removal among patients aged ≥ 50 years, but estimates were imprecise. In this retrospective real-world cohort, no statistically significant difference in weight-loss outcomes was observed between SGB and EIB in the complete-course complete-case analysis. However, the high early-removal rate, differing intended treatment durations, and non-randomized treatment allocation limit comparative interpretation. Adverse events—particularly severe dehydration with SGB—highlight the importance of careful patient selection, standardized peri-procedural care, and structured follow-up.