The decision had been in the works for several weeks. After a warning in July, the French health authorities demanded the immediate withdrawal from the market of the gastric balloon created by the American start-up Allurion on Tuesday, August 6. And this in order to “protect the health and safety of patients”specifies the National Agency for the Safety of Medicines (ANSM), which ordered the suspension.
A gastric balloon is a non-surgical device that aims to help obese or overweight people lose weight. But it can cause serious complications. The principle is similar to the gastric band. It consists of reducing the space available for food in the stomach, but without resorting to surgery.
The balloon developed by Allurion, a start-up founded in the United States, very active in France, is swallowed in the form of a capsule. It then remains active for four months, before being reabsorbed. Several thousand copies are implanted each year. But its use is very controversial. In France, the health authorities authorize it but do not recommend it in view of doubts about its long-term interest and its high cost, which can reach several thousand euros.
Side effects
The medical risks are proven. Serious side effects have been reported, such as intestinal obstructions or gastric perforations, according to the ANSM. “This decision follows the increase in the number of reports of adverse effects over the last two years, the lack of monitoring of gastric balloon implantations, the lack of specific training in the management of these complications outside the implantation sites, as well as the advertising of Allurion balloons that does not comply with regulations.”continues the health authority.
The Allurion ball is, in fact, the subject of an intense commercial strategy which involves promotion to dozens of private clinics and multiple advertorial articles in the press.