Complications related to balloon deployment or removal:

Above and beyond complications due to the upper digestive tract endoscopy (perforation or bleeding, bronchial inhalation as a result of gastric reflux, arrhythmia) or the anaesthetic, other complications are specifically associated with deployment and extraction of the balloon: Damage to the pharynx or oesophagus, Damage to the stomach wall, Perforation of the oesophagus, duodenum, ostium cardiacum or stomach wall if the balloon is in the wrong place when it is inflated.


Mechanical complications caused by the balloon:

The weight of the liquid-filled balloon can act on ulcers in the stomach wall to cause frank perforation, a life-threatening situation that requires emergency surgery. The digestive tract can become obstructed as a result of migration of an insufficiently inflated or partially deflated balloon; obstruction of the gut is possible as is gastric obstruction if the balloon gets lodged in the pyloric antrum: this will sometimes require surgical repair. Such complications are far more likely if the maximum time frame of six months is exceeded. The literature reports a risk of spontaneous hyperinflation due to the generation of gas inside the balloon.Acute pancreatitis is possible if the balloon exerts mechanical pressure on the organ across the stomach wall.

Functional complications (side effects)

Insertion of an intra-gastric balloon is sometimes accompanied in the early days by gastric heaviness, and nausea and vomiting which normally recede in 2 to 7 days.  Symptoms of gastro-esophageal reflux are also possible.  These problems can be corrected by appropriate treatment with drugs (anti-secretory medication, anti-nausea drugs).  Vomiting may persist necessitating premature removal of the balloon.

Metabolic complications

These result from uncontrolled or neglected vomiting which can be the cause of dehydration, metabolic alkalosis, hypocalcaemia, and functional renal failure.  Hypocalcaemia can be responsible for serious cardiac rhythm disorders with a risk to life.


Absence or a refusal of dietary treatment concomitant with the insertion of an intra-gastric balloon compromises the results as far as weight loss is concerned.  Similarly, the risk of regaining weight after the removal of the intra-gastric balloon is even more likely if the obesity is longstanding and serious.

Instructions for use