Risks of The Gastric Balloon

Alert for Fluid-Filled Intragastric Balloons by the FDA

The FDA has issued an alert to healthcare providers about potential adverse events linked to fluid-filled intragastric balloons for the treatment of obesity.

The FDA has recently received multiple reports of two different types of adverse events associated with fluid-filled intragastric balloons:

  • The first type of adverse event involves over inflating with fluid (spontaneous hyperinflation) in patients’ stomachs, resulting in the need of premature device removal.
  • The second type of adverse event is the development of acute pancreatitis, which has also resulted in premature removal.

The FDA recommends that providers closely monitor patients with these devices for the above adverse events.

Symptoms to look for in balloon over-inflation include:

  • Intense abdominal pain
  • Swelling of the abdomen (with or without discomfort)
  • Difficulty breathing
  • Vomiting

The reports indicate that balloon over-inflation can occur as soon as nine days after implantation and as yet there isn’t enough information to determine what is causing the balloon to over-inflate.

Acute pancreatitis develop in patients’ due to the compression of gastrointestinal structures created by the inflated balloon.

Symptoms to look for with acute pancreatitis are:

  • Severe abdominal pain
  • Back pain

The reports indicate that acute pancreatitis can occur as soon as three days after implantation.

It is important that healthcare providers are aware of these adverse events to be able to identify the symptoms and treat the patient as soon as possible by removing the device.

The FDA is working closely with the manufacturers of the intragastric balloon to better understand these issues of acute pancreatitis and over-inflation in patients with fluid-filled intragastric balloons.