- FDA on Monday sent an update to healthcare providers describing risks associated with liquid-filled intragastric balloon devices used for weight loss treatment and said a total of 18 deaths worldwide have been tied to the devices since their approvals in 2015. It's the fourth communication from the agency in the past three years addressing potentially life-threatening complications involving Apollo Endosurgery's Orbera and ReShape balloons.
- It follows the company's announcement this month it completed the 258-patient post-approval study for Orbera; a final data summary from the ReShape balloon post-approval study was made available last December, FDA said. There were no deaths reported in either of those studies, but neither "were powered to detect rare events such as death," the agency noted.
- FDA recommends healthcare providers monitor patients closely and make them aware of symptoms of potential complications, which include acute pancreatitis and over-inflation of the balloons, but said the devices remain an appropriate treatment option for some adult patients with obesity.
Five years after approving the weight loss treatments, FDA told healthcare providers it's aware of 10 related deaths occurring outside the U.S., and eight in the U.S. Of those U.S. deaths, five were associated with Orbera and three with ReShape.
The agency said it's received more than 200 adverse event reports worldwide of hyperinflation, or spontaneous filling of the intragastric balloons with additional air or liquid while inside a patient’s stomach.
Over 99% of those reports were received for the Orbera device. The balloon typically must be removed early as a result, the agency said. Orbera is placed in the stomach deflated in an endoscopic procedure through the mouth and then filled with saline until it is about the size of a grapefruit, according to the manufacturer. The patient works on a lifestyle program to meet weight loss goals while the balloon is in place for up to six months, then the device is deflated and removed through another non-surgical procedure.
FDA said it is working with Austin, Texas-based Apollo Endosurgery to determine the cause of the over-inflation problem and evaluate possible mitigation strategies.
In addition, FDA has received nearly 30 adverse event reports of acute pancreatitis, with more than two-thirds of those for the Orbera balloon. Acute pancreatitis could develop due to the balloon and distended stomach exerting pressure that injures the pancreas, according to the agency. The issue has also resulted in the need for premature device removal.
"The FDA will continue to work with the manufacturers of all available intragastric balloons in the U.S. to monitor this potential complication," the agency wrote.
FDA first alerted doctors about the risk of hyperinflation and acute pancreatitis with the Orbera and Reshape devices in February 2017 and followed up with updates in August 2017 and June 2018 about the potential risk of death with the devices. Apollo acquired ReShape Medical in December 2018.
The new communication to healthcare providers includes post-approval study data for the Orbera and ReShape balloons. In the Orbera study, six of 258 patients (2.3%) experienced balloon hyperinflation. No hyperinflation events were reported in the ReShape study. Two of the 159 patients (1.3%) in the ReShape study had acute pancreatitis, while no events were reported in the Orbera study. FDA also noted no balloon hyperinflation or acute pancreatitis was reported in the studies the companies used in their premarket approval applications.
An FDA-approved intragastric balloon made by Obalon Therapeutics that is gas-inflated has resulted in no reports of death, hyperinflation or acute pancreatitis, FDA said. The Obalon balloon was approved in 2016.
FDA said it has worked with the intragastric balloon manufacturers since 2017 to update their labeling to include information about possible risks linked to the devices.