These devices made it easy to lose weight.
A decision by the health police has suspended the marketing, distribution, use and advertising of Allurion© gastric balloons. This initiative was taken following an increase in the number of reports of adverse effects in recent years. A gastric balloon is placed without surgery in the stomach to occupy part of it and allow weight loss through satiety. Food intake is reduced, which helps reduce excess weight. The Allurion© gastric balloon was indicated for patients who were overweight or obese when their body mass index (BMI) was greater than or equal to 27kg/m². Swallowed in front of a healthcare professional, it was evacuated naturally after approximately 16 weeks. However, the company must “immediately withdraw its gastric balloons from the French market in order to protect the health and safety of patients”according to a communicated from Ansm.
“Over the past two years, we have been reported several cases of gastrointestinal complications such as intestinal obstructions, gastric obstructions, gastric perforations.”communicates the Ansm. These complications are mentioned in the gastric balloon instructions, but they have sometimes led to endoscopic or surgical intervention. They are a medical emergency and several risks are associated with them. Their management, for example, is not always carried out within the establishment in which the medical device was fitted, so there is a possibility of a lack of training for healthcare staff in the management of these specific complications. In addition, medical monitoring of patients with gastric balloons is not provided by the manufacturer, although it would prevent potential complications and simplify their management if necessary.
How do I know if I am affected? In the event that an Allurion© gastric balloon has been fitted to you, if you have no adverse effects, it will pass naturally approximately 16 weeks after its fitting. According to the Ansm, here are the symptoms that may indicate a potential complication, or even the possibility of endoscopic or surgical intervention:
- Persistent nausea
- Vomiting
- Constipation
- Diarrhea
- Dehydration
- Pains
- Abdominal cramps or discomfort
- Abdominal distension
- Any unexpected symptoms, such as fever, gastrointestinal bleeding
If you do not know which gastric balloon you were given, please note that the healthcare professional gave you an implant card after the insertion, which contains information to identify the device and its manufacturer. If this card is no longer available, simply contact the healthcare facility or healthcare professional who performed the insertion.