Update June 4, 2018:
The Food and Drug Administration is releasing another warning to health care providers about a popular weight loss device. According to a statement issued by the FDA, five more deaths have been reported in patients with two liquid-filled intragastric balloon systems used to treat obesity, totaling 12 deaths attributed to the device since 2016.
“We have been carefully tracking adverse events, including a total of 12 deaths over the past two years, that have been reported in patients with two balloon devices used to treat obesity,” said William Maisel in a statement, M.D., director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “The FDA continues to work with the companies that manufacture these liquid-filled intragastric balloons to better understand the complications associated with these devices, and to ensure the product labeling adequately addresses these risks. While these devices remain an appropriate treatment option for some patients with obesity, patients should always discuss with their doctors which treatment option is best for them.”
We will continue to update as more information is released regarding this device.
Update August 22, 2017 with a response from Apollo Endosurgery:
Apollo Endosurgery, makers of the Orbera Intragastric Balloon System, reached out to us to reiterate that the FDA was not able to definitely attribute any of the patient deaths to the Orbera device or the insertion procedure. According to a company spokesperson, “While the cause of death has not been provided or determined in all cases, Apollo has not received any communication or indication from the attending physicians or hospitals that the deaths have been due to the device.”
Original Article August 13, 2017:
The U.S. Food and Drug
Administration issued an update warning health providers that since 2016 five
people died after getting intragastric balloon systems, a procedure to treat obesity.
During the insertion process, patients are sedated as a deflated weight-loss balloon made of silicone is delivered through the throat into the stomach. It’s then filled with saline in order to fill up the stomach. It’s meant to remain in the stomach for many months.
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the five cases involved Orbera Intragastric Balloon System, which is manufactured by Apollo Endosurgery. The one other report involves ReShape
Integrated Dual Balloon System, manufactured by ReShape Medical Inc.
the FDA isn’t able to attribute these deaths to the devices or the
insertion, all the patients died within a month or less of doing the procedure.
Three of the people died one to three days after.
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continues to work with Apollo Endo-Surgery and ReShape Medical Inc. to better
understand the issue of unanticipated death and to monitor the potential
complications of acute pancreatitis and spontaneous over-inflation,” the FDA wrote in its report.
So while they can’t say 100 percent that
the balloons caused the deaths, the FDA will continue to look into it until
it better understands what happened. Until then, it recommends that doctors
keep a close eye on patients using these devices.