The French Medicines Safety Agency (ANSM) issued a warning on the risks of serious complications with Allurion gastric balloons on Thursday, July 18.
- Allurion brand gastric balloons are medical devices used in patients who are overweight or obese.
- The ANSM is issuing a warning after being informed of several incidents with this gastric balloon reporting serious gastrointestinal complications.
- The agency has asked the manufacturer to inform healthcare professionals about the management of these complications. It also draws patients’ attention to the importance of medical monitoring throughout their treatment.
After learning of several cases of serious complications with Allurion gastric balloons, the drug safety agency (ANSM) is calling on health professionals and their patients to exercise caution in a press release dated July 18, 2024.
Several thousand people have this medical device fitted, which is not covered by Health Insurance, each year in France.
Allurion Gastric Balloon: Intestinal obstructions and gastric perforations noted
“Allurion brand gastric balloons are medical devices used in patients who are overweight or obese. We call for vigilance regarding the use of these gastric balloons following the reporting of several incidents reporting serious gastrointestinal complications.”explains the ANSM in its document.
This medical device aims to promote weight loss by reducing the size of the stomach. It must be ingested under the supervision of a health professional and then filled with liquid. The gastric balloon is normally evacuated through the natural channels after about 16 weeks. According to the American manufacturer, it would allow patients to gain between 10% and 15% of their weight in just over a quarter.
The health agency says it has recorded “several cases of gastrointestinal complications, such as intestinal obstructions, pyloric obstructions, gastric perforations”. “In the last two years, we have had 23 reported cases, which is low, but sometimes with cases that required reinterventions (sic) endoscopic surgery”said Gwenaëlle Even, deputy director of medical devices, cosmetics and in vitro diagnostic devices, at France Info.
To limit these risks, the ANSM has asked the manufacturer Allurion to inform all healthcare professionals of the recommendations regarding the management of patients who develop these complications. It specifies that doctors must, for their part, inform gastric balloon wearers of the risks of gastrointestinal disorders and tell them how to react if they experience them.
Complications: what are the symptoms to look out for?
The ANSM reminds people with the Allurion gastric balloon of the importance of medical monitoring throughout their treatment.Always be able to access an emergency care facility throughout your treatment with this medical device“, adds the French agency.
It is also advisable to consult a doctor quickly if you experience any of these symptoms:
- persistent nausea;
- vomiting;
- constipation ;
- diarrhea ;
- dehydration;
- abdominal pain, cramps or discomfort;
- abdominal distension;
- any unexpected symptoms such as fever, gastrointestinal bleeding.
“Bring your implant card and show it to all the healthcare professionals you see.”adds the health organization.