In a report, the U.S. Food and Drug Administration (FDA) is warning health care providers about the liquid-filled balloon weight loss system created to fight obesity, announcing that since 2016, there have been five people dead after using it.
The procedure involves a liquid-filled balloon placed in the stomach to make the patient feel more full and eat less.
The FDA said the deaths occurred from some time in 2016 to the present and have issued the warning as a precautionary measure, as the regulatory body has yet to directly link the intragastric balloons to the cause of death. What are the potential side effects of intragastric balloons? The balloon is inserted via an endoscope down the esophagus to the stomach.
The FDA said in one treatment, there was a gastric perforation with the Orbera Intragastric Balloon System. These balloons are meant to stay inside the body for six months before deflating and eventually exiting the body the old-fashioned way.
The FDA also warned that several patients developed acute pancreatitis (pancreas inflammation) because the fluid-filled balloons compressed their internal organs.
In a press release, Apollo Endo-Surgery said it self-reported one death each in the US, Great Britain and Mexico and two in Brazil. The exact causes in three of the deaths remained unknown.
They said that from January 2006 to March 2017, 21 patients using the Orbera device died.
In an August 10 letter to health care providers, the FDA says all five reports indicate that the deaths occurred within a month or less of balloon placement.
In a statement emailed to CNN, ReShape Medical said, "There is no responsibility that we take more seriously than patient safety". In the other death, there was an esophageal perforation with the ReShape Integrated Dual Balloon System.
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