The FDA alerted healthcare providers June 4 about five more deaths of patients using two brands of fluid-filled intragastric balloon systems to treat obesity.
Here are five things to know:
1. Since 2016, 12 patient deaths have been reported worldwide from the use of the Orbera Intragastric Balloon System and the ReShape Integrated Dual Balloon System. Two patient deaths were confirmed in February 2017; five were confirmed in August 2017; and five more were confirmed June 4.
2. The FDA issued warning letters to healthcare providers concerning issues with the devices in February 2017 and last August.
3. The weight-loss system, which was approved by the FDA in 2015, works by taking up space in a patient's stomach. The balloons are placed into patients' stomachs via a micro-catheter and are then inflated. The balloons remain in the stomach for six months to help facilitate weight loss before being removed during an outpatient endoscopy.
4. Four of the five new deaths are linked to the Obera Intragastric Balloon, and one is related to the Reshape Integrated Dual Balloon System. In four of the cases, the death was preceded by a gastric perforation, or hole in the stomach wall, that appeared about a month after the balloon had been inserted. The fifth death is still under investigation.
5. "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," the agency said.