ArticleProceedings (Baylor University. Medical Center)2025
Intragastric balloon adverse events: a comprehensive MAUDE database review.
Article in Proceedings (Baylor University. Medical Center), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
4 citing papers in PubMed.
- Real-World Evidence for Existing Anti-Obesity Therapies-The Realities of Treatment Adherence, Tolerability, Access and Patient Satisfaction.Diabetes, obesity & metabolism · 2026Review
- Article
- Changes in microbiota associated with the use of intragastric balloons.Scientific reports · 2025Article
- Advances and future directions in endoscopic bariatric therapies.World journal of gastrointestinal endoscopy · 2025Review
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
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/m 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.