ArticleObesity surgery2021
Real-World Experience of Intragastric Balloons for Obesity: Insights from the FDA Manufacturer and User Facility Device Experience (MAUDE) Database.
Article in Obesity surgery, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 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
6 citing papers in PubMed.
- Obesity and Pancreatic Diseases: From Inflammation to Oncogenesis and the Impact of Weight Loss Interventions.Nutrients · 2025Review
- Intragastric balloon adverse events: a comprehensive MAUDE database review.Proceedings (Baylor University. Medical Center) · 2025Article
- Patient Complications and Device Issues Associated With FDA-Approved Intragastric Balloons Available in the USA: A Maude Database Study.Obesity surgery · 2024Article
- Lifestyle in Obese Individuals during the COVID-19 Pandemic.Healthcare (Basel, Switzerland) · 2022Article
- Can indocyanine green during laparoscopic sleeve gastrectomy be considered a new intraoperative modality for leak testing?BMC surgery · 2022Article
- Leak after sleeve gastrectomy with positive intraoperative indocyanine green test: Avoidable scenario?International journal of surgery case reports · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Intragastric balloons have been used to bridge the obesity treatment gap. We aim to investigate the number and type of complications associated with intragastric balloons using public-access governmental databanks. We analyzed post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from Jan 2017 through Nov 2020. During the study period, approximately 773 cases with 830 device issues and 1134 patient complications were identified. Most balloon complications were due to leaks (33.4%). The most reported adverse events were vomiting (26.6%), abdominal pain (25.3%), and nausea (15.8%). Findings from the MAUDE database highlight patient and device adverse outcomes that should be addressed to improve clinical success.
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33687626What OpenQuestion holds
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.