Post-approval study results on the risk of hyperinflation, acute pancreatitis, and death associated with the use of liquid-filled intragastric balloons have been made available by the Food and Drug Administration (FDA).
The FDA required the post-approval studies to allow for continued monitoring of efficacy and safety of both the Orbera (Apollo Endosurgery, Inc) and ReShape (ReShape LifeSciences) intragastric balloons as a condition of approval. In 2017 and 2018, safety communications were issued by the agency about the potential risks associated with these liquid-inflated devices used for the treatment of obesity in adult patients.
The study results showed that 2.3% (6/258) of patients experienced balloon hyperinflation with Orbera; the onset of symptoms (ie, nausea, vomiting, abdominal pain) ranged from within 1 week of placement to 23 weeks after placement. Hyperinflation events were not reported with the ReShape balloon in the post-approval study. In total, 200 cases of hyperinflation have been reported worldwide since 2015, with over 99% of these reports related to Orbera.
As for pancreatitis risk, there were no events reported with Orbera, while 2 out of 159 patients who received ReShape were diagnosed with acute pancreatitis. Worldwide, there have been around 30 adverse event reports related to acute pancreatitis, with over two-thirds associated with Orbera use.
The post-approval studies also showed that there were no deaths reported with either Orbera or ReShape. Since approval, there have been a total of 18 deaths worldwide, including 8 deaths in the US (5 with Orbera and 3 with ReShape). The deaths occurred following gastric perforation (n=3), esophageal perforation (n=1), and following complications from pulmonary embolism after balloon placement (n=2). In 2 cases, it could not be determined what the exact cause of death was.
Based on the findings of these post-approval studies, the FDA is recommending the following:
- Study results should be considered when discussing the risks and benefits of liquid-filled balloon placement with patients.
- The product labeling should be carefully followed as it includes additional information on possible risks associated with these devices.
- Patients should be instructed about the symptoms of potentially life-threatening complications (ie, balloon deflation, gastrointestinal obstruction, ulceration, and gastric and esophageal perforation).
- Patients should be monitored for the entire duration of treatment for potential complications, including acute pancreatitis and hyperinflation.
- Adverse events should be reported to the FDA’s MedWatch program.
To date, the FDA has not received any reports of death, hyperinflation or acute pancreatitis associated with the Obalon Balloon System, a swallowable, gas-inflated intragastric balloon system approved in 2016.
In a Letter to Healthcare Providers, the agency noted that it would continue to monitor post-approval data for all intragastric balloon devices and would continue to work with manufacturers to incorporate findings into the product labeling.
For more information visit fda.gov.