Potential Risks with Intragastric Balloons

Potential Risks with Liquid-filled Intragastric Balloons

April 27, 2020

The FDA is providing an update on the potential risks of over-inflation (spontaneous hyperinflation), acute pancreatitis, and deaths in patients with Orbera and ReShape liquid-filled intragastric balloons used for weight loss in adult patients with obesity.

The FDA first communicated on the potential risk of hyperinflation and acute pancreatitis with liquid-filled intragastric balloons in February 2017. Since then, the FDA provided updates in August 2017 and June 2018 about the potential risk of  death with liquid-filled intragastric balloons, and in December 2019 announced the availability of the final data summary for the Reshape balloon post-approval study (PAS).


  • Instruct patients about the symptoms of potentially life-threatening complications such as balloon deflation, gastrointestinal obstruction, ulceration, and gastric and esophageal perforation and advise them when to seek medical attention.
  • Monitor patients closely during the entire duration of treatment with liquid-filled intragastric balloon systems for potential complications, including acute pancreatitis, spontaneous hyperinflation, and other potentially life-threatening complications.
  • Report any adverse events related to intragastric balloon systems

Find more articles about minimal invasive surgery here.

Leave a Reply

Your email address will not be published. Required fields are marked *

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

The reCAPTCHA verification period has expired. Please reload the page.

Back to top

Treba vam savet?

Tu sam da vam pomognem

Ukoliko imate pitanja ili želite da zakažete pregled možete da pozovete 064 500-4-300 ili danam pošaljete poruku ispod