Allurion Gastric Balloon: Updated safety information due to the risks of gastric outlet obstruction, small bowel obstruction and gastric perforation (DSI/2026/004)

In rare instances, the Allurion Gastric Balloon has not transited through the stomach or bowel as intended, leading to complications such as gastric outlet obstruction, small bowel obstruction and gastric perforation. Prompt medical intervention is essential to manage these complications. Allurion Technologies Inc. have updated documentation with new safety information. Field Safety Notice (FSN-01-2026) provides further details and should be read in conjunction with this Device Safety Information (DSI).

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Clinical Resources
Allurion Gastric Balloon: Updated safety information due to the risks of gastric outlet obstruction, small bowel obstruction and gastric perforation (DSI/2026/004)
clinical-resource/MHRA-DSI-on-the-Allurion-Gastric-Balloon
In rare instances, the Allurion Gastric Balloon has not transited through the stomach or bowel as intended, leading to complications.

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Guidance
Endoscopy
British Society of Gastroenterology and Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland guidance on best practice for upper gastrointestinal endoscopy
clinical-resource/Best-practice-for-upper-GI-endoscopy
National root cause analysis of post-endoscopy upper gastrointestinal (UGI) cancer in England has found wide variations in UGI endoscopy quality.