FDA reveals five dead after anti-obesity balloon surgery

Molly Cranna for TIME

The balloon is created to remain in place for several months.

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

It's still unclear whether there's a definitive link between the devices and the deaths.

The process involves placing one or two uninflated balloons using an endoscope that goes through a patient's mouth into the stomach.

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 US patients.

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The FDA also warned that several patients developed acute pancreatitis (pancreas inflammation) because the fluid-filled balloons compressed their internal organs. These balloons are meant to stay inside the body for six months before deflating and eventually exiting the body the old-fashioned way. Four reports involve Apollo-Endo Surgery's Orbera Intragarstric Balloon System, and one report involves ReShape Medical Inc.'s ReShape Integrated Dual Balloon System.

Apollo's CEO Todd Newton said numerous patients who use the device as a weight-loss tool have other obesity-related health problems.

According to Apollo Endo-Surgery, there has been one additional death of a person who received its device. It states that of more than 277,000 devices distributed, there have been 21 reported deaths from January 1, 2006, through March 31, 2017.

In three of the reports, the patients died within three days of device placement, while in the other two, the patients died within one month of the procedure, the FDA said. The exact causes in three of the deaths remained unknown.

In a statement emailed to CNN, ReShape Medical said, "There is no responsibility that we take more seriously than patient safety". The other is a dual balloon system made by ReShape. "Patients with questions about this FDA update should contact their physicians directly".