In un bulletin published on July 18, 2024, the National Agency for the Safety of Medicines and Health Products (ANSM) alerted on the risks of complications due to certain gastric balloonsand called on health professionals and patients to be vigilant. This warning concerns Allurion brand gastric balloonsmedical devices used in patients in situations overweight or obesitynot reimbursed by Social Security.
The placement of an Allurion gastric balloon is always supervised by a doctor and consists of the ingestion of a capsule connected to a catheter. After an X-ray check by the doctor that the balloon is properly in place in the stomach, the healthcare professional fills the balloon with liquid via the catheter, then the latter is removed by traction to release the balloon into the stomach, explains the website of the Lyon Center for Digestive Surgery. The gastric balloon thus makes it possible to fill part of the stomach and create a feeling of satietywhich promotes weight loss in overweight or obese people. After about 16 weeks, the balloon deflates and is evacuated through the natural channels.
Allurion gastric balloon: ANSM has recorded several cases of gastrointestinal complications
The ANSM alert follows the declaration of “several cases of gastrointestinal complicationsas intestinal obstructionspyloric obstructions, gastric perforations“which may have led to endoscopic or surgical intervention,” the agency reports in its press release. It also recalls that “that due to the urgency of the care, the latter is not always carried out within the establishment in which the medical device is fitted, creating a risk that the personnel involved are not trained in the management of complications associated with this device”.
The ANSM adds that the use of gastric balloons is not mentioned in obesity recommendations of the High Authority of Health (HAS) in the care pathway of overweight or obese people. Furthermore, “It appears that aesthetic medicine centers offer this medical device”, the agency says, before recalling that these gastric balloons must be placed by “a physician or healthcare professional under the supervision of a physician, trained in the placement of the Allurion gastric balloon, in a center equipped with X-ray equipment and having access to an endoscopy service and to a recognized endoscopist in case intervention is necessary to puncture or remove the device”.
What are the ANSM recommendations regarding Allurion gastric balloons?
Faced with these risks, the ANSM announced that it had contacted the manufacturer Allurion to ask it to inform healthcare professionals of the recommendations concerning the management of patients in the event of serious gastrointestinal complications due to gastric balloons.
On the side of health professionals, the National Agency for the Safety of Medicines and Health Products reminds them that they are required to inform patients of the risks of gastrointestinal complications and symptoms that should prompt them to consult a doctor without delay. They should also inform patients the need for monitoring throughout the duration of treatment with the gastric balloon.
Gastrointestinal Complications: Signs to Look for in Patients With an Allurion Gastric Balloon Device
In its press release, the ANSM also shares its recommendations for patients wearing an Allurion gastric balloon device. They must always be able to access an emergency care facility during their treatment with this device, and to present their implant card to any healthcare professional. Patients are also encouraged to Consult a doctor immediately if any of these symptoms appear. :
- persistent nausea;
- vomiting;
- constipation ;
- diarrhea ;
- dehydration ;
- abdominal pain, cramps or discomfort;
- distension abdominale ;
- any unexpected symptoms such as fever, gastrointestinal bleeding.
For the moment, The agency maintains surveillance of these devices but does not exclude taking additional measures if necessary, in order to ensure patient safety. Patients and healthcare professionals are therefore invited to report any adverse effects or incidents related to this device as part of this monitoring.
Sources :
- Allurion gastric balloons: recommendations to limit the occurrence of serious complications – ANSM – July 18, 2024
- Gastric balloon – Lyon Center for Digestive Surgery