Five People Die After Using Weight Loss Balloons for Obesity

Bryan Strickland
August 13, 2017

The U.S. Food and Drug Administration (FDA) released a report that since 2016, five people died after using liquid-filled balloon weight loss system meant to treat obesity.

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.

Four deaths occurred among patients implanted with the Apollo Endo Surgery's Orbera Intragastric Balloon System, and one involved ReShape Medical's ReShape Integrated Dual Balloon System. Four of them, named Orbera Intragastric Balloon Systems, were manufactured by Apollo Endo Surgery, while the other one, named ReShape Integrated Dual Balloon System, was fabricated by ReShape Medical Inc.

In each case, the person who received the weight loss balloon died within a month or less of having the balloon placed. They also confirmed this was the cause of the five deaths. "Patients must be monitored closely during the entire term of treatment to detect the development of possible complications and each patient should be instructed to contact his or her physician immediately upon the onset of any unexpected symptoms". Since the February letter, both ReShape and Apollo have changed their devices' labeling to address these risks.

A typical stomach has a gastric volume of 900 ml, and the inflated balloon occupies a volume around 700 ml.

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Now there are three FDA approved balloons in the USA. The company confirmed that only 21 devices from 277,000 distributed all over the world had been linked to deaths between January 1, 2006, and March 31, 2017. This can be done in an outpatient setting under sedation.

The Orbera balloon, approved in August 2015, is filled with saline and inserted in an obese patient's stomach to help them with portion control. Less intake of food will result in weight loss. After a maximum of six months, the balloon device is removed. The use of the balloon is complemented with counseling and nutritional support or advice.

The (intra) gastric balloon for weight loss differs from the Sengstaken-Blakemore balloon used to stop esophageal and gastric bleeding.

"Each patient must be appropriately evaluated prior to the decision to place the balloon, especially the potential risks of anesthesia and an endoscopic procedure", Gostout said in the statement.

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