Perforations, intestinal obstructions… Allurion gastric balloons can cause serious complications, warns the ANSM

C’est le ballon gastrique le plus utilisé en France. Pixabay – peakSTOCK

Les ballons gastriques de la start-up Allurion peuvent causer de graves complications, alerte l’agence du médicament ce 18 juillet 2024.

The gastric balloon from the start-up Allurion, which promises to help lose weight without requiring surgery, can cause serious complications, the drug agency warned on Thursday.

"We call for vigilance regarding the use of these gastric balloons following the reporting of several incidents reporting serious gastrointestinal complications&quot ;, declared the National Medicines Safety Agency (ANSM) in a press release.

Similar to gastric band

A gastric balloon is a device that aims to help obese or overweight people lose weight. The principle is similar to a ring, reducing the space available for food in the stomach, with the difference that a balloon requires little or no surgery.

In the case of the balloon developed by Allurion, a startup founded in the United States but very active in France, the device must be swallowed in capsule form, then it remains active for four months before being absorbed.

Most used in France

This is the only gastric balloon that works in this way and it is the most used in France, according to details from the ANSM to the AFP.< /p>

But its interest is far from unanimous. In France, the health authorities authorize it, but they do not recommend it given the doubts about its long-term benefit and its high cost, which can reach several thousand euros.

It is therefore not reimbursed, which does not prevent several dozen private clinics from offering the implantation of this balloon.

Around twenty reports since 2016

Added to these considerations is the question of risks. According to the ANSM, serious side effects have been reported, such as intestinal obstructions or gastric perforations.

Around twenty reports have been recorded since 2016, the agency told AFP.

These risks are certainly indicated in the balloon instructions but the medicines agency regrets a lack of information for patients and, even, for professionals who supervise the implantation of this device.

This is, in fact, often offered in establishments, primarily simple aesthetic medicine centers which are unable to urgently treat possible serious problems.

L’ANSM, which recalls that the procedure must absolutely be supervised by a doctor, therefore asks Allurion "to inform it’ set of health professionals recommendations concerning the management of patients in the event of serious gastrointestinal complications."