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Intragastric balloon adverse events: a comprehensive MAUDE database review
Islam Mohamed1, Jagadish Koyi2, Husam Abu Suilik3
1Department of Gastroenterology and Hepatology, University of Missouri, Columbia, Missouri, USA.
Proceedings (Baylor University. Medical Center)
|December 23, 2024
Summary
Intragastric balloons for weight loss can fail, with deflation and rupture being common issues. Patient complications like implant failure, pain, and vomiting require ongoing safety monitoring for these endoscopic bariatric devices.
Area of Science:
- Bariatric Endoscopy
- Medical Device Safety
- Obesity Management
Background:
- Endoscopic bariatric interventions offer an alternative to traditional surgery for patients with a BMI of 30-40 kg/m².
- Limited real-world data exists on device-related complications and failures of intragastric balloons.
- This study addresses the gap by investigating mechanical failures and adverse events reported to the US Food and Drug Administration.
Purpose of the Study:
- To analyze device-related mechanical failures of intragastric balloons.
- To identify common complications and adverse events in patients using these devices.
- To assess the safety profile of various intragastric balloons based on real-world data.
Main Methods:
- Retrospective analysis of the Manufacturer and User Facility Device Experience (MAUDE) database.
- Inclusion of device-related events and patient outcomes for intragastric balloons from July 2017 to October 2023.
- Statistical analysis using SPSS to evaluate reported events and balloon type associations.
Main Results:
- A total of 1393 cases were reviewed, identifying 1758 device malfunctions and 1760 patient complications.
- The most frequent device malfunctions were deflation problems (25.31%) and balloon leakage or rupture (21.90%).
- The Orbera balloon was associated with the highest patient complications, including implant failure (24.30%), abdominal pain (21.92%), and vomiting (21.26%).
Conclusions:
- Findings underscore the necessity for continuous surveillance of intragastric balloon safety.
- Rigorous monitoring and enhanced safety protocols are crucial for managing device-related risks.
- Real-world data analysis is vital for improving patient outcomes in endoscopic bariatric interventions.
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