At least five people have died after receiving gastric balloons to help them lose weight, the Food and Drug Administration said Thursday.
It’s unclear whether the balloons or the surgery to implant them could have caused the deaths, but the FDA issued an alert to doctors to monitor patients who have the devices, according to NBC News. The balloons are intended to treat severe obesity by reducing how much a person can eat by filling the stomach, closing off part of the stomach or surgically reducing stomach volume.
Two different balloon devices have been involved in reports of the deaths, which came as quickly as a day after surgery: one made by Apollo Endo-Surgery, the other by ReShape.
Apollo said the company has sold 180,000 of Orbera balloon devices worldwide.