Four of the patients were implanted with Apollo Endosurgery's Orbera balloon, while the fifth was implanted with ReShape Medical's Integrated Dual Balloon System. The company also notes that some people - it does not say how many - died while using the device.
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. In the procedures, patients are mildly sedated as a deflated balloon made of silicone is inserted through the throat and into the stomach, after which it's filled with saline to take up space in the stomach.
At least five people have died soon after being fitted with balloons aimed at helping them lose weight, the Food and Drug Administration said Thursday.
Apollo Endo Surgery said there have been more than 220,000 cases of successful Orbera placements across 80 countries. "Patients with questions about this FDA update should contact their physicians directly".
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The FDA warned that someone who has already had gastrointestinal surgery or who is "unwilling or unable to participate in a medically-supervised diet and behavior modification program" should not try either of the devices.
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.
It says it has not received any communications or indications from physicians or hospitals that the deaths were due to ORBERA, adding that the FDA's letter did not indicate the deaths were related to the device. The exact causes in three of the deaths remained unknown. The FDA says it can't confirm the devices are responsible for the deaths.
This is less than 0.01 percent of the more than 277,000 Orbera balloons distributed during that time period, their statement said. The agency recommends that doctors closely monitor patients who are using these devices.
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