The ANSM has suspended the marketing of Allurion gastric balloons, non-surgical devices designed to help obese people lose weight.
- The ANSM issued a warning on the use of Allurion gastric balloons last July.
- The agency has just suspended its marketing in France “in order to protect the health and safety of patients”.
- This decision was taken, among other things, due to the increase in the number of reports of adverse effects over the past two years.
Following a warning about the risks of serious complications with Allurion gastric balloons issued last July, the French National Agency for the Safety of Medicines and Health Products (ANSM) has decided to suspend its marketing in France. “in order to protect the health and safety of patients.”
This decision by the health police, announced on August 6, 2024asks the American company to immediately withdraw its gastric balloons from the French market.
Allurion gastric balloon: suspended after several serious complications
The ANSM demands that the marketing, distribution, use and advertising of Allurion gastric balloons be suspended. “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.”the organization explains in its press release.
The device, which is intended for people with a BMI of 27 or more who want to lose weight, is ingested by the patient. It is then filled with liquid to expand in the stomach, which then reduces the space for food. It is normally evacuated through the natural tract after about 16 weeks.
However, several cases of gastrointestinal complications such as intestinal obstructions, gastric obstructions, gastric perforations in patients with the device have been reported to the ANSM over the last two years.
Some patients had to undergo endoscopic or surgical intervention. Although these side effects are known and listed in the instructions, these urgent operations were not always carried out in the establishment in which the medical device had been fitted. This leads to “a risk of lack of training in the management of complications associated with this device for healthcare personnel”specifies the ANSM. The advertising in favor of the Allurion balloon was also judged “not objective, particularly with regard to the risks of adverse effects and the contraindications associated with it”.
What to do if you have an Allurion gastric balloon?
To find out if you have an Allurion gastric balloon, you must refer to the implant card given to you by the doctor after the installation. It contains the elements allowing you to identify the device and its manufacturer as well as a QR code. “referring to information available to the physician regarding patient management in the event of an adverse effect”. In the event of loss, it is possible to contact the healthcare establishment or healthcare professional who carried out the procedure.
If you are a wearer of the Allurion device and have no adverse effects, the ANSM wants to be reassuring: “the balloon will evacuate through the natural channels, approximately 16 weeks after its installation.”
In case of adverse effects (persistent nausea, vomiting, constipation, diarrhea, dehydration, pain, cramps or abdominal discomfort, abdominal distension, any unexpected symptoms such as fever, gastrointestinal bleeding): consult the doctor who fitted the device without delay.
“In case of emergency, consult a doctor as soon as possible or call 15. Show your implant card to the healthcare professionals treating you.”recalls the ANSM.
