Five Die While Using Obesity Devices, FDA Says

Aurora Colorado. John Moore

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 company also notes that some people - it does not say how many - died while using the device.

One of the devices is a balloon that can be placed in the stomach and filled with saline water, the Orbera balloon made by Apollo Endo-Surgery.

Four of the reports to the FDA involve the Orbera Intragastric Balloon System (Apollo Endosurgery), and one report involves the ReShape Integrated Dual Balloon System (ReShape Medical), the FDA said in a safety alert. The balloon is created to remain in place for several months.

Two additional deaths since 2016 were related to potential complications - one stomach perforation due to Orbera, and one esophageal perforation with the ReShape weight-loss balloon.

However, the agency has issued a warning to doctors treating patients with similar devices to monitor them closely.

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Apollo Endo-Surgery said, per NBC News, that worldwide 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 USA patients. The exact causes in three of the deaths remained unknown.

The ReShape balloon, approved by the FDA in June 2015, is inserted into a patient's stomach via their mouth to prevent surgical scarring. Three patients died 1 to 3 days afterward.

It says it has not received any communications or indications from physicians or hospitals that the deaths were due to ORBERA, adding that the FDA's letter did not indicate the deaths were related to the device.

"Serious adverse events observed in global product experience with Orbera and from literature reviews, but not seen in the US clinical study include: ulcerations/erosions, balloon deflation/migration, esophageal perforation, cardiac complications/cardiac arrest, and death", it says on its website.

Apollo's CEO Todd Newton said numerous patients who use the device as a weight-loss tool have other obesity-related health problems.

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