Evaluating the safety of intragastric balloon: An analysis of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program.

BACKGROUND: Laparoscopic bariatric surgery (LBS) is effective for severe obesity but is invasive and costly. Intragastric balloons (IGBs) are increasingly popular as an alternative to LBS with modest short-term weight loss. However, IGBs are associated with complications and a comparison of the safety of IGB to LBS is warranted.

OBJECTIVES: The objective of this study was to compare the safety profile of IGB with LBS through analysis of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database.

SETTING: The MBSAQIP collects data from 791 bariatric surgery centers in the United States and Canada.

METHODS: A propensity-matched analysis was performed between IGB and LBS. Multivariable logistic regression analysis was performed to determine if IGBs were independently associated with adverse outcomes.

RESULTS: A total of 145,408 patients were included, of which 144,627 (99.5%) underwent LBS and 781 (0.5%) underwent IGB therapy. With one-to-one propensity score matching, 684 pairs of IGB and LBS patients were selected. Multivariable logistic regression found that IGB (odds ratio 1.97, confidence interval 1.10-3.52, P = .023) was independently predictive of 30-day adverse outcomes. This was due to a significantly higher nonoperative reintervention rate in the IGB cohort (4.2% versus 1.0%, P < .001) from early balloon removal (2.8%).

CONCLUSIONS: In this propensity-matched analysis, IGBs were associated with a higher adverse event rate than LBS, due to a 4-times higher nonoperative reintervention rate. The utility of IGB as a primary weight loss intervention should be reconsidered due to its poor safety profile compared with LBS.