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Liquid-Filled Intragastric Balloons; New Risks Labeling; Deaths


On June 4, 2018, the FDA issued a letter to healthcare providers about the risks of liquid-filled intragastric balloons. In collaboration with the manufacturers, Apollo Endosurgery and ReShape Lifesciences, the FDA has approved new labeling for the Orbera and ReShape balloon systems with more information about possible deaths associated with the use of these devices in the U.S.

 

Intragastric balloon systems are weight-loss systems to treat obesity, which function by taking up space in a patient’s stomach. In 2015, the FDA approved two intragastric balloon systems in the U.S. The ReShape Integrated Dual Balloon System is manufactured by ReShape Medical Inc. and uses two balloons. The Orbera Intragastric Balloon System manufactured by Apollo Endo-Surgery uses one balloon. Both brands are liquid-filled balloon systems and are indicated for use in conjunction with diet and exercise.

 

The FDA recommended healthcare providers instruct patients regarding the symptoms of potentially life-threatening complications such as balloon deflation, gastrointestinal obstruction, ulceration, and gastric and esophageal perforation. Additionally, the FDA recommended healthcare providers monitor patients closely during the entire term of treatment with liquid-filled intragastric balloon systems for potential complications, including acute pancreatitis and spontaneous hyperinflation.

 

Since 2016, the FDA received reports of 12 deaths that occurred in patients with liquid-filled intragastric balloon systems worldwide. Seven of these 12 deaths were patients in the U.S. (four with the Orbera Intragastric Balloon System and three with the ReShape Integrated Dual Balloon System). After the FDA’s August 2017 update, the FDA received reports of five additional deaths that occurred worldwide since 2016. Four of these deaths (three with the Orbera Intragastric Balloon System and one with the ReShape Integrated Dual Balloon System) occurred one day to three and a half weeks after balloon placement following gastric perforation. The fifth death reported, which involved the Orbera Intragastric Balloon System, did not mention a perforation event and the manufacturer is still investigating this death.

 

See the FDA Safety Alert

 

See the FDA Health Care Provider Letter

 

See also Medical Risk Law Report: Gastric Bypass, Sleeve Gastrectomy, Lap Banding and More: Risks of Patient Injury and Provider Malpractice in Weight-Loss Surgery

 

 

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