Five people have died after have anti-obesity devices surgically inserted into their stomachs, US regulators have revealed.
The patients all went under the knife earlier this year to get FDA-approved liquid-filled balloons fitted in a bid to lose weight.
But three of the five patients died within three days of their supposedly low-risk operation. The other two died within a month.
The FDA said it is not clear whether the deaths were caused by the devices - which were approved in 2015 - or the surgical process.
However, the agency has issued a warning to doctors treating patients with similar devices to monitor them closely.
Since 2016 five people who have had balloons inserted into their stomachs to treat obesity have died. The FDA does not know if the deaths were caused by the devices themselves or the insertion surgeries (file photo)
Four of the patients were using the Orbera Intragastric Balloon System, made by Apollo Endo Surgery. The fifth was using the ReShape Integrated Dual Balloon System, made my ReShape Medical Inc.
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.
Apollo Endo Surgery said there have been more than 220,000 cases of successful Orbera placements across 80 countries.
The company said the product can help overweight people lose more than three times the weight that diet and exercise alone can.
The ReShape balloon, approved by the FDA in June 2015, is inserted into a patient's stomach via their mouth to prevent surgical scarring.