Obesity Balloons Alert: FDA Finds 5 Deaths Within a Month

Obesity Balloons Alert: FDA Finds 5 Deaths Within a Month

Five people have died after have anti-obesity devices surgically inserted into their stomachs, United States regulators have revealed. The procedure, which is FDA-approved, involves inserting one or two silicone balloons into the stomach through the mouth and filling them with liquid until they are about the size of a grapefruit.

At least three patients died within one to three days following a procedure for a liquid-filled intragastric balloon system.

In each case, the person who received the weight loss balloon died within a month or less of having the balloon placed.

The agency says they don't know the root cause or the incidence rate of death with these devices, nor have they confirmed that the balloon systems definitely caused the deaths.

The agency, however, cautioned that it has yet to determine whether the devices or the way in which they were placed in the stomachs directly caused those deaths. 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.


All five reports indicate that patient deaths occurred within a month or less of balloon placement. One case involves ReShape Medical Inc's ReShape Integrated Dual Balloon System. 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.

According to NBC News, Apollo says it reported the deaths to the FDA itself.

A spokeswoman for Apollo said the reports were from around the world and did not necessarily involve US patients.

"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.

Last year America expended $2.5 billion on commercial weight-loss balloons. 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. Symptoms include intense abdominal pain, swelling of the abdomen, difficulty breathing and vomiting.

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