The federal watchdog said it has received multiple reports of 2 different types of adverse events associated with the balloons, including over-inflation requiring premature removal and the development of acute pancreatitis, also requiring premature device removal.
The balloon devices are designed to be placed in the stomach through the mouth in a minimally invasive endoscopic procedure and then filled with fluid, and stay in the stomach for a period of 6 months.
Apollo’s Orbera intragastric balloon system is composed of a single balloon which is filled with Saline, while ReShape’s integrated dual balloon system uses 2 balloons filled with saline and methylene blue dye.
A 3rd balloon system which uses air to inflate, the Obalon system, was approved last year but the FDA said it has not received adverse event reports associated with the air-inflated system.
The agency said it has received “several dozen” adverse event reports of issues related to balloon over-inflation, most of which involved Apollo’s Orbera system, though the same issue has been reported with the ReShape system.
Symptoms of over-inflation include intense abdominal pain, abdominal dissension with or without discomfort, difficulty breathing or vomiting, and may require the premature removal of the balloon to resolve the issues.
Balloon over-inflation can occur as soon as 9 days after implantation, according to the FDA report, though the cause is unknown.
Both brands were noted in reports of acute pancreatitis, the Agency reported, which developed due to the compression of gastrointestinal structures created by the implanted balloons. All cases reported required premature removal, and 4 of the cases required the patient to be hospitalized.
Symptoms of acute pancreatitis in the presence of a fluid-filled balloon include severe abdominal and back pain, the FDA said. The Agency’s report indicates that acute pancreatitis can occur as soon as 3 days after implantation.
The FDA recommended that healthcare providers be aware of the complications that could be associated with the balloons, and to report any adverse events associated with them.
The federal watchdog said it is working with both companies to better understand the complications associated with the balloons.