(NEW YORK) — At least five people have died from 2016 to present day after using gastric balloon systems to treat obesity, according to the Food and Drug Administration.
“All five reports indicate that patient deaths occurred within a month or less of balloon placement,” the FDA said in a statement, adding officials do not know if it was the devices or the surgical procedures that led to the deaths.
Four of the deaths were attributed to people using the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery. One death involved the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc, according to the FDA.
“In three reports, death occurred as soon as one to three days after balloon placement,” the FDA said.
The updated safety alert comes after the FDA issued a letter to health care providers in February, recommending “close monitoring of patients with liquid-filled intragastric balloon systems used to treat obesity for the potential risks of acute pancreatitis and spontaneous over-inflation.”
The FDA said officials still recommend health care providers to “closely monitor patients treated with these devices for complications,” and report any issues related to the balloon systems to the FDA’s MedWatch.
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