“Always be able to access an emergency facility,” warns the ANSM.
“We call for vigilance.” In a press release dated July 18, 2024, the National Agency for Medicines (ANSM) warns about gastric balloons used in overweight or obese patients to lose weight. “serious gastrointestinal complications” have been reported. What are they?
The gastric balloons in the ANSM’s sights come in the form of a capsule to be swallowed that contains a balloon connected to a thin tube. The insertion and removal do not require surgery, endoscopy or anesthesia. Once the capsule is in the patient’s stomach, the doctor uses the catheter (thin tube) to fill the balloon with water. This balloon fills the stomach, the person is satisfied more quickly and for longer so they eat less and lose weight. According to the instructions, it is evacuated through the natural channels after about 16 weeks. The capsule must be ingested under the supervision of a doctor or a health professional accompanied by a doctor but “in practice, it appears that aesthetic medicine centers offer this medical device” reports the health agency.
Serious complications such as intestinal obstruction, pyloric obstruction and gastric perforation have been reported to the ANSM in patients and have sometimes led to endoscopic or surgical intervention. In such complications, management is “urgent” the authority emphasizes that it is not always carried out within the establishment in which the medical device was installed “which creates a risk that the personnel involved will not be trained in managing the complications associated with this device”In order to reduce this risk, the drug agency has asked the manufacturers of the gastric balloons concerned, namely the company Allurion, to inform healthcare professionals of the recommendations concerning the management of patients in the event of serious gastrointestinal complications.
People currently using an Allurion gastric balloon are advised to be vigilant: “Always be able to access an emergency care facility throughout your treatment with this medical device” informs the ANSM. You should consult a doctor “without delay” if one of these symptoms appears or reappears:
- Persistent nausea;
- Vomiting;
- Constipation ;
- Diarrhea ;
- Dehydration;
- Abdominal pain, cramps or discomfort;
- Abdominal distension;
- Any unexpected symptoms such as fever, gastrointestinal bleeding.
L’ANSM will maintain monitoring of Allurion brand gastric balloons and will be able to “take additional measures if necessary to ensure patient safety.”