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FDA: Adverse Events Reported for Intragastric Balloons

The ReShape Integrated Dual Balloon System and the Orbera Intragastric Balloon System are fluid-filled weight loss systems used to surgically treat obesity. Both systems were approved by the FDA in 2015 to be used by patients in conjunction with diet and exercise programs.

Placement of the systems requires patients to undergo a minimally invasive endoscopic procedure, during which the balloons are inserted into the stomach through the mouth. When the systems are positioned properly in the stomach, they are filled with fluid.

Recently, however, the FDA has received multiple reports detailing adverse events associated with these intragastric balloon systems. The two types of events reported are detailed below:

Over-Inflation

Dozens of adverse event reports have been submitted to the FDA regarding over-inflation of fluid-filled balloon systems. Instances of hyperinflation have required device removal as soon as nine days after initial implantation.

Symptoms of over-inflation of an intragastric balloon system include:

  • Abdominal pain
  • Abdominal distension (swelling)
  • Difficulty breathing
  • Vomiting

Neither the ReShape or Orbera systems involved in these incidents currently include labeling that addresses the potential for over-inflation of the balloons once placed in a patient’s stomach. As such, physicians may not be aware that such symptoms can be linked to balloon hyperinflation. If you have experienced or are experiencing similar symptoms and have undergone intragastric balloon system implantation, it is important to seek medical attention and to make your physician aware of the device.

Acute Pancreatitis

The FDA has also received adverse event reports indicating that patients who have received both the ReShape or Orbera systems have developed acute pancreatitis stemming from the compression of gastrointestinal structures by the balloons. In every instance of acute pancreatitis patients have undergone device removal, and in specific instances patients have required hospitalization for the condition.

Symptoms of pancreatitis caused by an intragastric balloon system include:

  • Abdominal pain
  • Back pain

Reports indicate that acute pancreatitis has been identified in patients with intragastric balloon systems as early as three days after implantation. As this condition is not listed on the labeling for the ReShape or Orbera systems, healthcare providers may not know to assess a patient experiencing these symptoms for intragastric balloon-related pancreatitis. This could lead to improper treatment for the condition.

If you have experienced or are experiencing symptoms of acute pancreatitis and have undergone intragastric balloon system implantation, it is important to seek medical attention and to make your physician aware of the device.

FDA and Manufacture Action

The FDA and manufacturers of the ReShape and Orbera intragastric balloon systems are analyzing the adverse events detailed above and to understand the possible causes of the conditions.

To read the full FDA report, click here.