FDA Issues Alert About Fluid-Filled Balloons to Treat Obesity

So far, the adverse events have been reported for the 2 fluid-filled designs, not for an air-filed design later approved.

The FDA has alerted healthcare providers about reports of adverse events from the fluid-filled balloons approved over the past 2 years to treat obesity.

The FDA’s February 9, 2016, notice reports 2 types of events:

  • The balloons overinflate with air or more fluid, requiring early removal.
  • Patients develop acute pancreatitis, although how this occurs is unknown.

In 2015, the FDA approved 2 fluid-filled balloon systems, the ReShape integrated dual balloon system, and the Orbera balloon system. ReShape uses 2 balloons, while Orbera uses 1 balloon. Both systems place the balloons into the stomach through the mouth, using an endoscopic procedure.

In 2016, the FDA has also approved the Obalon system, which uses a swallowable capsule to place up to 3 balloons. The capsule is attached to a catheter used to fill the balloons with air. So far, the FDA, reports, the adverse events reported have not affected this balloon system.

The FDA reminds providers to report any adverse reactions through its MedWatch system, which can be found here.