ANSM urgently recalls all Allurion gastric balloons from the French market to protect the health and safety of patients

L’agence nationale de sécurité du médicament et des produits de santé rappelle les ballons gastriques Allurion (image d’illustration). MAXPPP – Luc Nobout

The ANSM – the French National Agency for the Safety of Medicines and Health Products – has recalled all Allurion gastric balloons. The marketing, distribution and use are suspended and the company must immediately withdraw all its gastric balloons from the market.

Patients who are overweight or even obese, i.e. when their BMI – body mass index – is greater than or equal to 27.0 kg/m2, may “ingest”under the supervision of a healthcare professional” a gastric balloon, which will be filled with liquid to inflate in the stomach. It will be evacuated approximately 16 weeks later by natural means.

The French National Agency for the Safety of Medicines and Health Products made this decision after numerous reports of adverse effects, a lack of follow-up, a lack of specific training and advertising that did not comply with regulations.

Gastrointestinal complications

The ANSM reports that “intestinal obstructions, gastric obstructions, gastric perforations”, have been reported to them, sometimes leading to endoscopic or surgical interventions. Even though these complications are noted in the leaflet, patients sometimes had their surgery done in different establishments than the one where the procedure was performed, so the staff may not have been trained for these procedures.

Allurion has not planned any follow-up after the balloon has been placed, which would allow for the prevention of complications, and if any arise, for the ability to react. The ad was also deemed “not objective”as to the risks of adverse effects and the contraindications associated with it”.

What to do if you have a gastric balloon ?

The implant card identifies the device and its manufacturer. There may be a QR code, which will provide information to leave with the doctor in the event of adverse effects. If the card is lost, you must contact the healthcare facility or healthcare professional who performed the installation to find out which model of balloon was installed.

Without any adverse effects, the balloon will be evacuated approximately 16 weeks after installation. If there are any adverse effects “persistent nausea, vomiting, constipation, diarrhea, dehydration, pain, cramps or abdominal discomfort, abdominal distension, any unexpected symptoms such as fever, gastrointestinal bleeding”, you should contact the doctor who performed the implant as soon as possible.

ANSM asks balloon wearers to report any adverse effects.

In case of emergency, call 15 and show the implant card to healthcare professionals.