2024-08-06 14:58:11
The gastric balloon is a non-surgical device designed to help people who are obese or overweight lose weight. IPCO
The decision has been in the works for weeks. Following a warning in July, French health authorities ordered on Tuesday, August 6, that gastric balloons produced by US start-up Allurion be withdrawn from the market immediately. this is for “Protecting patient health and safety”designated the National Agency for the Safety of Medicines (ANSM), which ordered the suspension.
The gastric balloon is a non-surgical device designed to help people who are obese or overweight lose weight. But it can cause serious complications. The principle is close to the gastric band. It involves reducing the space in the stomach that can hold food, but does not require surgery.
Allurion, a US-based startup active in France, develops balloons that are swallowed in capsule form. It then remains active for four months before being reabsorbed. Thousands of copies are implanted every year. But its use is highly controversial. In France, health authorities have approved the practice but do not recommend it due to doubts about its long-term benefits and costs of thousands of euros.
adverse reactions
Medical risks have been demonstrated. Serious side effects, such as intestinal obstruction or stomach perforation, have been reported, according to the ANSM. “This decision follows an increase in the number of reports of adverse reactions over the past two years, a lack of monitoring of the placement of these gastric balloons, and a lack of specialized training in managing these complications outside of the installation site. As well as the non-compliance of Allurion “Balloon Advertising”health authorities continued.
In fact, the Allurion balloon was the subject of an intense business strategy that included promotion to dozens of private clinics and multiple editorial articles in the media.
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