The U.S. Food and Drug Administration revealed on Thursday that at least five people have died after they were fitted with liquid-filled intragastric balloon created to help people lose weight. 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. Both systems can be placed in the stomach for up to 6 months to help obese people lose weight.
The FDA said four patients who died used the Orbera Intragastric Balloon System, made by Apollo Endo Surgery, and one used the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc.
In all five cases, death occurred within a month or less of the procedure to place the balloon. In three cases, the person died within one to three days of treatment.
The agency says they don't know the root cause or the incidence rate of death with these devices, nor have they confirmed that the balloon systems definitely caused the deaths.More news: Russian Recon Plane Flies Over DC & Trump Golf Course
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"The Agency has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment (one gastric perforation with the Orbera Intragastric Balloon System and one esophageal perforation with the ReShape Integrated Dual Balloon System)", the FDA added. "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". The company confirmed that only 21 devices from 277,000 distributed all over the world had been linked to deaths between January 1, 2006, and March 31, 2017.
The (intra) gastric balloon for weight loss differs from the Sengstaken-Blakemore balloon used to stop esophageal and gastric bleeding.
A spokeswoman for Apollo said the reports were from around the world and did not necessarily involve USA patients.
In a statement to CNN, ReShape Medical said: "There is no responsibility that we take more seriously than patient safety".