2024-08-06 13:00:02
In early July, the Medicines Safety Agency issued a plea for patients wearing these gastric balloons to be vigilant.
Published on 08/06/2024 3:00 pm
Reading time: 1 minute National Agency for the Safety of Medicines and Healthcare Products (ANSM) in Saint-Denis (93). (Humbert/BSIP)
The National Drug Safety Administration announced the suspension on Tuesday, August 6thMarketing, distribution, use and advertising of Allurion Gastric Balloon“And appeal to American society”Withdraw the product from the French market without further delay”. Every year, thousands of French people are fitted with gastric balloons from the American brand Allurion.
A gastric balloon is a device designed to help obese or overweight people lose weight. The principle is similar to a ring, reducing the space in the stomach that can hold food, but a balloon requires little or no surgery. The balloon developed by US startup Allurion must be swallowed in capsule form and then remains active for four months before being absorbed. French health authorities do not recommend the use of the Allurion gastric balloon and therefore it will not be reimbursed.
this ANSM decision “The number of adverse reaction reports has increased in the past two years”. In fact, several incidents reported serious complications, e.g. “Intestinal obstruction, gastric obstruction or gastric perforation“If potential adverse effects are mentioned in the manufacturer’s instructions, endoscopic or surgical intervention may be required in some cases. ANSM also regrets”Lack of monitoring of the installation of these gastric balloons, lack of specific training on management of complications outside the installation site and non-compliant advertising”.
ANSM had called on doctors in mid-July to be vigilant about the use of these gastric balloons. She lamented the lack of medical monitoring services from US manufacturer Allurion and asked that its products be withdrawn from the French market. The National Drug Safety Administration also called for measures to prevent potential risks to patients’ health.
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