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

5 Die After Being Fitted With Balloons for Obesity FDA Says

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.

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. The balloon is created to stay in place for several months to help the patient lose weight. In three reports, death occurred as soon as one to three days after balloon placement.

In its statement released on August 10, the agency said that all of the five fatalities occurred within a month or less after the placement of the balloon.

"At this time, we do not know the root cause or incidence per rate of patient death", the FDA said, adding that it is working with the companies that manufacture the devices. Four reports involve 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. One case involves ReShape Medical Inc's ReShape Integrated Dual Balloon System.

The FDA's adverse report system is very broad and is not created to immediately prove a device or drug caused a complication.

Apollo Endo-Surgery said, per NBC News, that global 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.

All five reports indicate that patient deaths occurred within a month or less of balloon placement.

Christopher Gostout, Apollo Endosurgery's chief medical officer, said the FDA letter is a reminder of the complications that could happen to obese patients.

The FDA update comes six months after the agency issued a letter recommending that healthcare providers keep an eye out for two types of adverse events in patients who have been implanted with Apollo and ReShape's devices. Pancreatitis and balloon over-inflation were not listed as potential side effects until February 2017, so doctors might not be aware of the risk.

In a statement to CNN, ReShape Medical said: "There is no responsibility that we take more seriously than patient safety".

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