The FDA alerts health care providers about potential risks with fluid-filled intragastric balloons
The FDA released a Dear Health Care Provider Letter alerting health care providers about potential risks with fluid-filled intragastric balloons. The FDA has recently received multiple reports for two different types of adverse events associated with fluid-filled intragastric balloons used to treat obesity. We recommend that you closely monitor patients with these devices for these adverse events, and to submit reports to help us better understand any complications from the use of these obesity treatment devices.
The FDA released a Dear Health Care Provider Letter alerting health care providers about potential risks with fluid-filled intragastric balloons. The FDA has recently received multiple reports for two different types of adverse events associated with fluid-filled intragastric balloons used to treat obesity. We recommend that you closely monitor patients with these devices for these adverse events, and to submit reports to help us better understand any complications from the use of these obesity treatment devices.
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 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.
For more information, including background and recommendations, please review the Dear Health Care Provider letter - http://www.fda.gov/
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La información en esta página es para el público en general, y para profesionales y educadores de salud. Esta información puede ser distribuida y publicada sin previa autorización. En Español
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