The Food and Drug Administration (FDA) reported that at least five patients have died soon after being fitted with anti-obesity gastric balloons.

“All five reports indicate that patient deaths occurred within a month or less of balloon placement. In three reports, death occurred as soon as one to three days after balloon placement. At this time, we do not know the root cause or incidence rate of patient death, nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices. The Agency has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment,” an FDA statement said.

The FDA-approved, liquid-filled balloons were designed to induce weight loss by surgically inserting them into the stomach, thus coaxing the body into feeling fuller and prompting lower food intake among users.

Four of the patients used Apollo Endo Surgery’s Orbera balloon. The saline-filled device was approved in 2015 and was touted to help obese patients shed more than three times the weight lost through diet and exercise. According to the company, there have been more than 220,000 cases of successful implants across 80 countries.

On the other hand, the fifth patient was found to have used ReShape Medical Inc.’s ReShape Integrated Dual Balloon System. The device, approved in June 15, was inserted into a patient’s stomach through the mouth in order to avoid surgical scarring. 

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