The FDA is investigating after five people have died since 2016 following an anti-obesity procedure involving silicone balloons, the Washington Post reports. The procedure, which is FDA-approved, involves inserting one or two silicone balloons into the stomach through the mouth and filling them with liquid until they are about the size of a grapefruit. The balloons are left in the stomach for up to six months with the idea being they leave less room for food. All five deaths occurred within a month of the procedure, and three of them happened within three days of the procedure. However, the FDA says it hasn't determined if the deaths were, in fact, caused by the silicone balloons or the procedure to insert them.
Four of the deaths are being investigated in connection with the Orbera Intragastic Balloon System by Apollo Endosurgery; the fifth death is in connection to the ReShape Integrated Dual Balloon System by ReShape Medical Inc., CNN reports. "There is no responsibility that we take more seriously than patient safety," ReShape says in a statement. Apollo notes that even with the deaths, its procedure has a fatality rate of less than 0.01%. According to NBC News, Apollo says it reported the deaths to the FDA itself. The FDA is also looking into two additional deaths that could possibly be related to "complications associated with the balloon treatment"—one from each company.