Post-Approval Data Confirm Risks With Intragastric Balloons

Megan Brooks

April 27, 2020

The results of two post-approval studies confirm the potential risk of hyperinflation and acute pancreatitis with the Orbera and ReShape liquid-filled intragastric balloon systems used to treat obesity.

The Orbera Intragastric Balloon System is manufactured by Apollo Endosurgery. The ReShape Integrated Dual Balloon System was previously manufactured by ReShape Medical Inc but was acquired by Apollo Endosurgery in December 2018.

In the Orbera post-approval study, 6 of 258 patients (2.3%) experienced balloon hyperinflation, the US Food and Drug Administration (FDA) said today in a letter to healthcare providers. There were no hyperinflation events detected in the ReShape post-approval study.

Acute pancreatitis was reported in 2 of 159 patients (1.3%) in the ReShape study, with no cases of acute pancreatitis reported in the Orbera study.

No balloon hyperinflation or acute pancreatitis events were reported in the studies the companies submitted to the FDA to gain approval, the agency said.

No deaths were reported in the post-approval studies, though the agency notes that the studies were not powered to detect. However, since Orbera and ReShape were approved in 2015, the FDA has learned of 18 deaths worldwide, including eight patients in the United States (five with Orbera and three with ReShape).

The FDA issued previous letters to healthcare providers concerning issues with these devices in June 2018, August 2017, and February 2017.

As of January 1, 2019, Apollo Endosurgery stopped selling the ReShape Balloon. The Orbera balloon remains available.

"The FDA wants to ensure healthcare professionals are aware of the rates of these potential complications observed in the post-approval studies so they can discuss the risks and benefits of weight loss treatments with patients and monitor patients during treatment," Benjamin Fisher, PhD, director, Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office, FDA's Center for Devices and Radiological Health, said in a statement.

"While these devices remain an appropriate treatment option for some patients with obesity, patients should always discuss with their doctors which treatment option is best for them," said Fisher.

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