The French National Agency for the Safety of Medicines (ANSM) had warned of the risks of the Allurion gastric balloon, and has now withdrawn it from the market in France. “Allurion must immediately withdraw its gastric balloons from the French market in order to protect the health and safety of patients,” declared the ANSM in a press release accompanied by an administrative withdrawal decision.
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 start-up founded in the United States but very active in France, the device must be swallowed in capsule form. It then remains active for four months, before being reabsorbed.
Controversial effectiveness and proven risks
But its use is very controversial. First of all, its effectiveness: in France, the health authorities authorize it but do not recommend it given the doubts about its long-term interest and its high cost, which can reach several thousand euros.
The risks, however, are proven: according to the ANSM, serious side effects have been reported, such as intestinal occlusions or gastric perforations. The agency, which had already published a warning in mid-July, has therefore finally decided to suspend the marketing and use of the balloon, of which several thousand are implanted each year.
Many reports
“This decision follows the increase in the number of reports of adverse effects over the last two years, the lack of monitoring of the insertion of these gastric balloons, the lack of specific training in the management of these complications outside the insertion sites, as well as the advertising of Allurion balloons that does not comply with regulations,” lists the ANSM.
