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Obesity Balloons Alert: FDA Finds 5 Deaths Within a Month of Placement

Image: Obesity Balloons Alert: FDA Finds 5 Deaths Within a Month of Placement
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By    |   Friday, 11 Aug 2017 08:56 AM

Obesity balloons were being used in five post-surgical deaths that all occurred within a month of the device being implanted, the U.S. Food and Drug Administration said in a safety alert. The exact causes in three of the deaths remained unknown.

The liquid-filled intragastric balloon systems have been used as a treatment for obesity, said the FDA alert issued on Thursday.

In three of the cases the FDA said it does not yet know the root cause or incidence rate of patient death, nor can it "definitively attribute the deaths to the devices or the insertion procedures for these devices."

The FDA said four patients who died used the Orbera Intragastric Balloon System, made by Apollo Endo Surgery, and one used the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc.

The FDA said in one treatment, there was a gastric perforation with the Orbera Intragastric Balloon System. In the other death, there was an esophageal perforation with the ReShape Integrated Dual Balloon System.

"The FDA continues to work with Apollo Endo-Surgery and ReShape Medical Inc. to better understand the issue of unanticipated death, and to monitor the potential complications of acute pancreatitis and spontaneous over-inflation," the agency said.

Apollo Endo-Surgery said, per NBC News, that international sales of gastric balloons were estimated to total about $120 million in 2015, driven by broad use in Brazil, Mexico and Europe, and the death reports came from all around the world, and did not necessarily include U.S. patients.

Gastric balloons are among the varied devices on the market to treat severe obesity. The object of the balloon is to reduce how much a person can eat by filling the stomach with the balloon, NBC News noted.

"FDA continues to recommend that health care providers closely monitor patients treated with these devices for complications and that you report any adverse events related to intragastric balloon systems through MedWatch, the FDA Safety Information and Adverse Event Reporting Program," the FDA said.

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Obesity balloons were being used in five post-surgical deaths that all occurred within a month of the device being implanted, the U.S. Food and Drug Administration said in a safety alert. The exact causes in three of the deaths remained unknown.
obesity, balloons, alert, fda, 5 deaths
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2017-56-11
Friday, 11 Aug 2017 08:56 AM
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