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Obesity-treatment stomach balloons linked to 5 deaths

FDA Reports on Five Deaths from Obesity-Treatment Stomach Balloons

August 11, 2017
The U.S. Food and Drug Administration (FDA) has reported that, in the last year, five people have died from complications with fluid-filled balloons that are used in the treatment of obesity.

The balloons associated with the deaths were the Orbera Intragastric Balloon System, manufactured by Apollo Endosurgery; and the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical. All patients died within a month of the balloons’ insertions.

In February, the FDA issued a warning that obesity-treatment balloons could overinflate and potentially contribute to cases of pancreatitis. The agency said that it has not yet been definitively able to link the deaths to the balloons.

The balloons in the ReShape system are filled with saline and a blue dye; the balloons in the Apollo system contain only saline. The devices are meant to left in place for up to six months.

If you’ve undergone an operation to receive a gastric balloon for the treatment of obesity, and have suffered from shortness of breath, vomiting, and/or abdominal pain, call your doctor immediately.

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