The French authorities have requested the emergency withdrawal from the French market of the Allurion anti-obesity gastric balloon, because it can cause serious complications, such as intestinal obstruction.
The anti-obesity gastric balloon can cause certain complications PHOTO: Shuterstock
“We are making the public health decision to suspend the marketing, distribution, use and advertising of gastric balloons. Allurion must immediately withdraw its gastric balloons from the French market to protect the health and safety of patients.” announced the National Agency for the Safety of Medicines (ANSM) in France in a press release.
A gastric balloon is a device that aims to help obese or overweight people lose weight. The principle is similar to that of a gastric ring, reducing the space available for food in the stomach. The difference is that a balloon requires little or no surgery.
According to ANSM, this decision comes as a result “the increase in the number of adverse event reports over the past two years, the lack of monitoring of gastric balloon placement, the lack of specific training in the management of these off-site complications, and the non-regulatory advertising of Allurion gastric balloons.”
The Allurion gastric balloon is indicated for overweight or obese patients whose body mass index (BMI) is greater than or equal to 27.0 kg/m2. Swallowed under the supervision of a healthcare professional, it is then filled with fluid and inflated in the stomach. According to the instructions, it is discharged naturally after about 16 weeks.
“Over the past two years, we have received several reports of gastrointestinal complications such as intestinal obstruction, gastric obstruction and gastric perforation. These complications, mentioned in the package insert of the Allurion gastric balloon, sometimes led to endoscopic or surgical interventions. Due to the urgency of the treatment, the latter is not always carried out in the facility where the medical device is installed, and there is a risk that the nursing staff will not be trained in the management of complications associated with this device”says the National Agency for the Safety of Medicines (ANSM) in France.
In addition, experts claim that the manufacturer does not provide adequate medical monitoring of patients fitted with Allurion gastric balloons, although this would help prevent complications and ensure their management, if necessary.
“To reduce this risk, we have asked the manufacturer Allurion to inform all healthcare professionals about the recommendations regarding the management of patients with serious gastrointestinal complications. We also asked healthcare professionals and patients to report any adverse effects or incidents related to this device. In addition, there are first-line alternatives for the treatment of overweight or obesity“, the French health authorities also sent.
