The Food and Drug Administration (FDA) has approved updated labeling for 2 liquid-filled intragastric balloon systems, Orbera (Apollo Endosurgery) and ReShape (ReShape LifeSciences), to provide additional safety information regarding the risk of acute pancreatitis, spontaneous hyperinflation, and death associated with these weight-loss devices.
Specifically, the new labeling includes updated data on the global rate of occurrence related to these adverse events. With regard to mortality, the global rate of occurrence was found to be <0.01% for Orbera patients (as of March 31 2018) and 0.06% for ReShape patients (as of April 30 2018). In addition, training documents have been revised to provide more guidance on the management of patients experiencing symptoms suggestive of refractory intolerance to these balloon systems.
”These updates provide important enhancements to our existing labeling and support our continued emphasis on patient safety. Physicians should always monitor patients closely during the entire term of treatment, and patients should be thoroughly instructed on signs or symptoms of potentially life-threatening adverse events,” said Christopher Gostout, MD, Chief Medical Officer at Apollo Endosurgery.
In February 2017, the FDA had issued a safety alert warning of potential complications associated with fluid-filled intragastric balloon use after the Agency received multiple reports of adverse events, including spontaneous hyperinflation and acute pancreatitis. Subsequently, in August 2017, several deaths associated with balloon use were reported prompting the Agency to launch an investigation; neither the devices nor the insertion procedures could be directly attributed to the deaths at that time.
“We have been carefully tracking adverse events, including a total of 12 deaths over the past two years, that have been reported in patients with two balloon devices used to treat obesity,” said William Maisel, MD, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “The FDA continues to work with the companies that manufacture these liquid-filled intragastric balloons to better understand the complications associated with these devices, and to ensure the product labeling adequately addresses these risks. 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 their latest press statement, the FDA recommended that clinicians instruct patients on the symptoms of potentially life-threatening complications associated with intragastric balloon devices such as balloon deflation, gastrointestinal obstruction, ulceration, and gastric/esophageal perforation. “In particular, the importance of seeking immediate care in the event of acute development of severe abdominal pain or the presence of blue-green urine,” said Deborah Schmalz, Vice President, Regulatory Affairs, Clinical Research and Compliance for ReShape LifeSciences. Patients should be monitored during the entire term of treatment for potential complications and any adverse events related to these balloon systems should be reported to FDA’s MedWatch.
Orbera and ReShape are both indicated for use in obese adults with body mass index (BMI) of ≥30 and ≤40kg/m2 who have failed weight reduction with diet and exercise alone.
For more information visit FDA.gov.