This common weight loss tool may have just killed 5 people

Molly Cranna for TIME

All five patients died within a month or less of balloon placement.

The FDA is investigating after five people have died since 2016 following an anti-obesity procedure involving silicone balloons, the Washington Post reports.

One of the devices is a balloon that can be placed in the stomach and filled with saline water, the Orbera balloon made by Apollo Endo-Surgery.

The balloons are put inside patients' stomachs and inflated to help people feel full and eat less. In three cases, the person died one to three days afterward.

The FDA said on Thursday that doctors should stay alerted when placing this expensive balloon system and to monitor the patient really close.

"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 FDA wrote.

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All deaths happened within a month of the procedure, the FDA said in a letter earlier this week to health-care providers.

Apollo Endo Surgery said there have been more than 220,000 cases of successful Orbera placements across 80 countries.

Four of the reported deaths involved the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one other death involved the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc., the FDA said in a press release. "Patients must be monitored closely during the entire term of treatment to detect the development of possible complications and each patient should be instructed to contact his or her physician immediately upon the onset of any unexpected symptoms".

An Apollo spokesperson said that the reports were from around the globe and did not necessarily involve patients residing in the United States. The company confirmed that only 21 devices from 277,000 distributed all over the world had been linked to deaths between January 1, 2006, and March 31, 2017.

Two additional deaths since 2016 were related to potential complications - one stomach perforation due to Orbera, and one esophageal perforation with the ReShape weight-loss balloon. 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.

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