This common weight loss tool may have just killed 5 people

Kristen Gonzales
August 13, 2017

All 5 patients died within 1 month of receiving the weight-loss balloon.

The U.S. Food and Drug Administration (FDA) released a report that since 2016, five people died after using liquid-filled balloon weight loss system meant to treat obesity.

In the treatment, a silicone balloon is inserted via the patient's throat into their stomach, then filled with a saline solution.

The patients all went under the knife earlier this year to get FDA-approved liquid-filled balloons fitted in a bid to lose weight.

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

The FDA has not identified a root cause for the patient deaths and can not "definitively attribute the deaths to the devices or the insertion procedures for these devices", according to an agency notice.

'The FDA's letter to health care providers does not indicate that the patient deaths were related to the Orbera device or the insertion procedures.

"The Agency has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment (one gastric perforation with the Orbera Intragastric Balloon System and one esophageal perforation with the ReShape Integrated Dual Balloon System)", the FDA added. One case involves ReShape Medical Inc's ReShape Integrated Dual Balloon System. It's still unclear whether there's a definitive link between the devices and the deaths.

Apollo Endosurgery Provides Update and Clarity to FDA Letter to Health Care Providers Related to Potential Risks of Intragastric Balloons
FDA updates gastric balloon warning after 5 deaths

Apollo Endosurgery uses one balloon, while ReShape Medical uses two.

More than 180,000 of Apollo Endo-Surgery's Orbera balloons have been placed in patients since the product was approved by the FDA in 2015.

The FDA recommends health providers monitor patients closely for pancreatitis - inflammation of the pancreas - and spontaneous overinflation of the inserted bag.

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

Endoscopic placement of the balloon is temporary and reversible without surgical incisions.

MORE: I Swallowed a Balloon For Weight Loss and Lost 40 Lbs.

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

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Other reports by TheSundaySentinel

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