The FDA updated its warning on liquid-filled intragastric balloons used to treat obesity after receiving five new reports of patient deaths. 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. It stays in the stomach for up to six months, while the patient also follows a diet and exercises regularly.
In its statement released on August 10, the agency said that all of the five fatalities occurred within a month or less after the placement of the balloon.
Four of the reports to the FDA involve the Orbera Intragastric Balloon System (Apollo Endosurgery), and one report involves the ReShape Integrated Dual Balloon System (ReShape Medical), the FDA said in a safety alert.
All five patient deaths occurred within a month of balloon placement, and three happened just one to three days after the procedure.
The alert from the FDA does not mean that the agency has definitively proven that the balloons caused the deaths, but that they are looking into it.
Apollo Endo-Surgery said in a press conference they are responsible for one death in the USA, one in Great Britain, one in Mexico, and two in Brazil.
An Apollo spokesperson said that the reports were from around the globe and did not necessarily involve patients residing in the United States. "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". Pancreatitis and balloon over-inflation were not listed as potential side effects until February 2017, so doctors might not be aware of the risk. "There is no responsibility that we take more seriously than patient safety", ReShape says in a statement.