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“The first type of adverse event involves the fluid-filled intragastric balloon over-inflating with air or with more fluid (spontaneous hyperinflation) in patients’ stomachs, resulting in the need for premature device removal. The second type of adverse event is the development of acute pancreatitis, which has also resulted in the need for premature device removal,” the FDA stated in a letter. “The FDA wants to ensure you are aware of these potential complications that have been observed in patients treated with FDA-approved obesity treatment devices, although the root cause and incidence of these complications is not known.”
The FDA did, however, note that no problems have been reported with the Obalon System, which was approved in 2016 and uses only air. If you’re looking into a balloon-based weight-loss solution, make sure to discuss all the pros and cons with your doctor.
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