FDA Reports That 5 People Have Died After Weight Loss Balloon Treatments

Five Die While Using Obesity Devices, FDA Says

The balloon is created to stay in place for several months to help the patient lose weight. Four of the deaths occurred after patients used the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one took place after a patient used the ReShape Integrated Dual Balloon System, which is made by ReShape Medical Inc.

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.

Back in February, the FDA issued a similar warning to keep an eye on complications from these procedures including the balloons spontaneously overinflating, which can fill the patient's stomach with fluid, or acute pancreatitis.

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If you're looking to get a "weight-loss balloon" put into your stomach to curtail your weight gain, you may want to think again.

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But three of the five patients died within three days of their supposedly low-risk operation.

Most of the adverse events involve Obera, which uses saline to fill a single stomach balloon, as opposed to the ReShape system that uses 2 balloons filled with saline and a blue due.

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The FDA said the deaths occurred from 2016 to present.

The ReShape balloon, approved by the FDA in June 2015, is inserted into a patient's stomach via their mouth to prevent surgical scarring.

In an August 10 letter to health care providers, the FDA says all five reports indicate that the deaths occurred within a month or less of balloon placement. The exact causes in three of the deaths remained unknown.

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Apollo's CEO Todd Newton said numerous patients who use the device as a weight-loss tool have other obesity-related health problems. The FDA letter is an important reminder to the physician community that obesity is a serious disease and many obese patients are affected by one or more co-morbid conditions due to their obesity.

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