Obesity Balloons Alert: FDA Finds 5 Deaths Within a Month

Toni Houston
August 13, 2017

Used to treat obesity, the balloon is inserted into the stomach and filled with liquid to partially fill the stomach so that patients will achieve fullness eating less food.

In an alert issued Thursday, the FDA said four reports involved the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one report involves the ReShape Integrated Dual Balloon System, manufactured 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.

The FDA said the deaths occurred from 2016 to present. The other is a dual balloon system made by ReShape.

The FDA said in one treatment, there was a gastric perforation with the Orbera Intragastric Balloon System.

Five people have died unexpectedly shortly after being treated with a weight loss balloon devices. The balloon is created to remain in place for several months. The use of the balloon is complemented with counseling and nutritional support or advice.


Apollo Endo Surgery said there have been more than 220,000 cases of successful Orbera placements across 80 countries.

"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 Endosurgery also said that 21 deaths have been reported in the last 11 years, from January 2006 to last March, out of more than 277,000 Orbera balloons distributed during that time period.

Endoscopic placement of the balloon is temporary and reversible without surgical incisions. The FDA recommended in February to monitor individuals who have implanted the gastric system to avoid any complication, like acute pancreatitis and spontaneous over-inflation. 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.

Shares sold off nearly 26% yesterday after the FDA published a letter warning healthcare providers of the risks of liquid-filled intragastric balloons.

The products and procedures are approved by the FDA.

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