At the beginning of July, the Medicines Safety Agency issued a call for vigilance for patients who wear these gastric balloons.
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The National Agency for the Safety of Medicines announced on Tuesday, August 6, that it was suspending “the marketing, distribution, use and advertising of Allurion gastric balloons” and calls on American society to “proceed without delay to withdraw the products from the French market”. Every year, several thousand French people have a gastric balloon from the American brand Allurion fitted.
The 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, except that a balloon requires little or no surgery. The balloon developed by the American start-up Allurion must be swallowed in capsule form, it then remains active for four months before being reabsorbed. The Allurion gastric balloon is not recommended by the French health authorities and is therefore not reimbursed.
The ANSM decision “follows the increase in the number of reports of adverse effects over the last two years”. Several incidents have in fact reported serious complications, such as “intestinal obstructions, gastric obstructions or gastric perforations“. Although the potential adverse effects are clearly mentioned in the manufacturer’s instructions, endoscopic or surgical interventions have been necessary in certain cases. The ANSM also deplores “the lack of monitoring of the placement of these gastric balloons, the lack of specific training in the management of complications outside the placement sites and advertising that does not comply with regulations“.
The ANSM had already called on doctors in mid-July to be vigilant regarding the use of these gastric balloons. It deplores a lack of medical monitoring offered by the American manufacturer Allurion and calls for the withdrawal of its products from the French market. The National Agency for the Safety of Medicines is also calling for measures to be put in place to stop the potential risk to patients’ health.
