The gastric balloon from the start-up Allurion, which promises to help people lose weight without requiring surgery, can cause serious complications, the French National Agency for the Safety of Medicines (ANSM) warned on Thursday, July 18. “We are calling for vigilance regarding the use of these gastric balloons following the reporting of several incidents reporting serious gastrointestinal complications,” it said. in a press release.
A gastric balloon is a device that aims to help obese or overweight people lose weight. The principle is similar to a ring, by 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 reabsorbed. It is the only gastric balloon that works this way and it is the most used in France, according to details from the ANSM to AFP.
But its interest is far from unanimous. In France, the health authorities authorize it, but they do not recommend it in view of doubts about its long-term interest 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.
Lack of information
Added to these considerations is the question of risks. According to the ANSM, serious side effects have been reported, such as intestinal occlusions or gastric perforations. Around twenty reports have been recorded since 2016, the agency told AFP. These risks are certainly reported in the balloon’s instructions, but the drug 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 any serious problems.
The ANSM, which points out that the procedure must absolutely be supervised by a doctor, therefore asks Allurion “to inform all health professionals of the recommendations concerning the management of patients in the event of serious gastrointestinal complications.”