Adverse events appear lower vs. other balloons
Potential risks associated with the Allurion balloon include the potential for early deflation; however, the pooled rate of early balloon deflation observed in the meta-analysis was relatively low at 1.8%.
Other adverse events reported with the Allurion balloon were abdominal pain (37.5%), vomiting (29.6%), diarrhea (15.4%), and small bowel obstruction (0.5%).
The corresponding rates of abdominal pain with the ReShape Duo and Orbera balloons have been reported at 54.5% and 57.5%, respectively, with the effects possibly caused by overinflation, the authors noted.
And rates of vomiting with the ReShape Duo and Orbera balloons have been reported as much higher, at 86.7% and 86.8%, respectively.
Of note, there were no deaths or cases of acute pancreatitis reported in the meta-analysis studies of Allurion.
As reported by this news organization, such concerns have been raised in previous FDA alerts regarding the Orbera and ReShape Duo liquid-filled intragastric balloons.
In the most recent update, issued in April 2020, the FDA described receiving reports of 18 deaths that had occurred worldwide since the approvals of the Orbera and ReShape balloons, including eight in the United States.
Dr. Ramai noted that the concern about the issues is warranted.
“These concerns are valid,” he told this news organization. “Theoretically, since the Allurion balloon is placed for a shorter time span, it is conceivable that there may be less adverse events. However, comparative trials are needed to confirm this.”
Although the balloons show efficacy in patients struggling with weight loss, metabolic syndrome, and fatty liver disease, “the type and duration of intragastric balloons should be tailored to the patient,” Dr. Ramai said.
“Clinicians should thoroughly discuss with their patients the benefits and risks of using an intragastric balloon,” he added. “Furthermore, placement of intragastric balloons should only be attempted by clinicians with expertise in bariatric endoscopy.”
The study received no financial support. Dr. Ramai reported no relevant financial relationships.
A version of this article first appeared on Medscape.com,