The US Food and Drug Administration (FDA) on Thursday sent a letter to health care providers noting the receipt of dozens of reports for two different types of adverse events linked to fluid-filled intragastric balloons used to treat obesity.
“The first type of adverse event involves the fluid-filled intragastric balloon over-inflating with air or with more fluid (spontaneous hyperinflation) in patients’ stomachs, resulting in the need for premature device removal. The second type of adverse event is the development of acute pancreatitis, which has also resulted in the need for premature device removal,” FDA explained.
The agency said it has received “several dozen adverse event reports” regarding balloon over-inflation of fluid-filled systems, most of which involved the Apollo Endo-surgery’s Orbera Balloon System, though also with the ReShape Medical’s ReShape Balloon System.
“A separate set of reports involving both brands of fluid-filled balloons (Orbera and ReShape) indicate that acute pancreatitis developed in several patients due to the compression of gastrointestinal structures created by the implanted balloon(s),” FDA says. “All of these cases required premature device removal, and four of the patients required hospitalization.”
Intragastric balloons are weight-loss systems intended to treat obesity by taking up space in a patient’s stomach.
In 2015, FDA approved two intragastric balloon systems: ReShape’s ReShape Integrated Dual Balloon System, which uses two balloons, and Apollo’s Orbera Intragastric Balloon System, which uses one balloon. Both brands are fluid-filled balloon systems, and are indicated for use in conjunction with diet and exercise, FDA says.
“The balloons are placed into the stomach through the mouth, using a minimally invasive endoscopic procedure, while the patient is under mild sedation. Once in place, the Orbera balloon is filled with saline only, and the ReShape balloons are filled with saline and methylene blue dye. The maximum placement period for both brands is six months,” FDA explains.
In 2016, FDA also approved the Obalon Balloon System, which consists of up to three balloons delivered to the stomach inside a swallowable capsule. The capsule is attached to a thin inflation catheter used to inflate the balloons with air. To date, the concerns addressed in this letter to physicians have only been observed with the use of fluid-filled intragastric balloons and have not been reported for the Obalon Balloon System, FDA notes.
FDA recommends that health providers recognize patients with implanted fluid-filled intragastric balloons “may develop balloon-related symptoms or other abnormalities following balloon placement, and throughout the duration of their treatment. Consider spontaneous over-inflation and/or pancreatitis in the differential diagnosis of patients presenting with the symptoms noted in this communication. If abnormalities are found, perform any confirmatory diagnostic studies. If the device is removed, follow the manufacturer’s instructions for device returns or evaluations.”
FDA also asks doctors to report any adverse events related to intragastric balloon systems.
The FDA alerts health care providers about potential risks with fluid-filled intragastric balloons