FDA has issued a letter warning health care providers about gastric balloon filled with water (Orbera balloon system, and Reshape Balloon systems) about potential adverse events linked to
- Spontaneous hyperinflation syndrome : patients present with intense abdominal pain, abdominal dissension, difficulty breathing and vomiting
- Acute pancreatitis : patients present with severe abdominal pain which can radiate in to the back.
Labelling on these devices do not address spontaneous hyperinflation or acute pancreatitis, health care providers may be unaware that symptoms could be related to these complications.
Patients should be aware of the fact that these balloons are only a temporary means of achieving weight loss, and once the balloon is removed they will tend to gain it back unless they have made significant lifestyle modifications.
Dr. Adi Malhotra