FDA updates gastric balloon warning after 5 deaths

Obesity

Five Die While Using Obesity Devices, FDA Says

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. The company also notes that some people - it does not say how many - died while using the device.

The Orbera balloon, approved in August 2015, is filled with saline and inserted in an obese patient's stomach to help them with portion control.

Four of the deaths occurred after patients used the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one took place after a patient used the ReShape Integrated Dual Balloon System, which is made by ReShape Medical Inc. The balloon is created to stay in place for several months to help the patient lose weight.

Apollo said in a press release that the deaths of the patients using their weight-loss balloon were not necessarily caused by their products.

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

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Today's FDA warning follows another alert in February 2017, after dozens of patients suffered life-threatening side effects when their balloon spontaneously over-inflated with air or fluid.

'While the cause of death has not been provided or determined in all cases, Apollo has not received any communication or indication from the attending physicians or hospitals that the deaths have been due to the Orbera device'. "Patients with questions about this FDA update should contact their physicians directly".

They said that from January 2006 to March 2017, 21 patients using the Orbera device died.

"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.

The FDA recommends health providers monitor patients closely for pancreatitis - inflammation of the pancreas - and spontaneous overinflation of the inserted bag. The FDA says it can't confirm the devices are responsible for the deaths.

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