Intragastric balloon adverse events: a comprehensive MAUDE database review.

Abstract

Background: Endoscopic bariatric interventions are viable alternatives to traditional weight loss surgeries for patients with a body mass index between 30 and 40 kg/m². While studies have explored the impact of intragastric balloons on obesity and weight reduction, comprehensive data on real-world device-related complications and failures are limited. This study aimed to investigate mechanical failures leading to patient adverse events reported to the US Food and Drug Administration.

Methods: A retrospective analysis using the Manufacturer and User Facility Device Experience (MAUDE) database examined device-related events and patient outcomes associated with various intragastric balloons from July 2017 to October 2023. Data analysis was performed using SPSS software to assess the reported events and their associations with specific types of intragastric balloons.

Results: Our review included 1393 cases, revealing 1758 device malfunctions and 1760 patient complications. Deflation problems (25.31%) and balloon leakage or rupture (21.90%) were the most common device-related complications. Patient complications were primarily linked to the Orbera balloon, with implant failure (24.30%), abdominal pain (21.92%), and vomiting (21.26%) as leading adverse events.

Conclusion: Our findings highlight the need for continuous surveillance, rigorous monitoring, and enhanced safety protocols for intragastric balloons.