FDA warns of overinflation, acute pancreatitis with certain intragastric balloons for weight loss
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The FDA on Monday issued a Letter to Health Care Providers detailing risks for hyperinflation and acute pancreatitis observed in post-approval studies for two liquid-filled intragastric balloons indicated for weight loss, both approved in 2015 and manufactured by Apollo Endosurgery.
In the studies, 2.3% (6 of 258) of participants using the Orbera balloon system experienced hyperinflation of the balloon with events occurring from within a week of a placement to 23 weeks; 1.3% (2 of 159) of participants using the ReShape balloon system experienced acute pancreatitis — one participant at 3 days and the other at 2 weeks after placement. Participants who experienced the adverse events had symptoms of nausea, vomiting and abdominal pain; the devices were removed early for these participants. No instances of hyperinflation were observed with the ReShape system, and no cases of acute pancreatitis were observed with the Orbera system, according to the letter.
Apollo Endosurgery discontinued selling and distributing the ReShape device January 2019 after acquiring it in December 2018, according to the letter.
“As a condition of device premarket approval, the FDA requires the manufacturers of gastric balloon devices used for weight loss to conduct studies assessing the devices’ performance after they are approved, known as post-approval studies. This is one important way the FDA continues to assess the safety and effectiveness of these medical devices,” Benjamin Fisher, PhD, director of the Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office in the FDA’s Center for Devices and Radiological Health, said in a press release from the FDA.
In addition to the findings in the post-approval studies, more than 200 reports of hyperinflation worldwide have been reported to the FDA, and more than 99% of reports were for Orbera with the rest for ReShape, according to the letter. The FDA said it is working with the company to discover the cause of hyperinflation and develop mitigation strategies. Nearly 30 cases of acute pancreatitis have been reported to the FDA, and more than two-thirds of reports were for Orbera with the rest for ReShape. The FDA said it is monitoring the complication.
The FDA has also received reports of 18 deaths worldwide with the devices; eight occurred in the United States — five with Orbera and three with ReShape, according to the letter.
“The FDA wants to ensure health care 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,” Fisher said in the press release. “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.”
In contrast to liquid-filled intragastric balloons, Obalon balloon devices (Obalon Therapeutics) filled with gas have not had cases of hyperinflation, acute pancreatitis or death reported to the FDA, according to the letter. – by Jill Rollet
Disclosure: Fisher reports he is director of the Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office in the FDA’s Center for Devices and Radiological Health.