Gastric balloons linked to 12 deaths
US health authorities are warning doctors about the possible risk of death in patients who have liquid-filled intragastric balloons designed to promote weight loss.
Twelve patients worldwide have died since 2016, according to the US Food and Drug Administration (FDA).
The FDA has now issued a safety alert with the following recommendations for healthcare providers:
- Instruct patients regarding symptoms of potentially life-threatening complications, such as balloon deflation, gastrointestinal obstruction, ulceration, and gastric and oesophageal perforation.
- Monitor patients closely during the entire term of treatment with liquid-filled intragastric balloon systems for potential complications, including acute pancreatitis and spontaneous hyperinflation.
The 12 fatalities follow the death of a morbidly obese Australian woman who died in 2015 from