The MHRA has issued updated safety advice for the Allurion Gastric Balloon after rare instances in which the device did not move through the stomach or bowel as intended.
The regulator says reported complications include gastric outlet obstruction, small-bowel obstruction and gastric perforation. Prompt medical assessment is important because these events can become serious.
Healthcare professionals should explain warning signs, review symptomatic patients early and ensure each recipient receives a completed patient information card. Devices involved in an adverse event or that do not perform as intended should be retained for evaluation and reported.
Patients are advised to seek immediate medical attention for severe or persistent abdominal pain, vomiting, nausea, abdominal swelling or breathing difficulty, and to carry the information card when receiving care. This report reflects the regulator's guidance and is not a substitute for individual medical advice.
