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FDA Issues Warning About Balloon Obesity Treatments
Some devices are over-inflating, and some have been linked to pancreas inflammation, agency says

By Robert Preidt

MONDAY, Feb. 13, 2017 (HealthDay News) -- Fluid-filled balloons placed in the stomach to treat obesity have been linked to serious complications, the U.S. Food and Drug Administration reports.

The balloons treat obesity by taking up space in a patient's stomach, and are used in conjunction with diet and exercise. Two types of fluid-filled balloon systems -- the ReShape Integrated Dual Balloon System and the Orbera Intragastric Balloon System -- were approved by the FDA in 2015.

But in a recent warning sent to health care providers, the FDA said it has received multiple reports of complications associated with the two balloon systems.

One type of problem involved the balloons over-inflating with air or with more fluid in patients' stomachs. This led to the premature removal of the balloons.

The second type of problem is development of acute pancreatitis. This complication also led to the removal of the balloons. This may occur due to compression of digestive system structures, the FDA said.

The FDA letter recommends that health care providers "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 agency said it is working with the manufacturers to better understand the problems caused by the fluid-filled balloon systems. The FDA said it will provide more information as the investigation continues.

No problems have been reported with another type of balloon system used to treat obesity -- the Obalon system -- which uses only air, the FDA said.

More information

The U.S. National Heart, Lung, and Blood Institute has more on obesity treatment.

SOURCE: U.S. Food and Drug Administration, news release, Feb. 9, 2017

Copyright © 2017 HealthDay. All rights reserved. URL:http://consumer.healthday.com/Article.asp?AID=719616

Resources from HONselect: HONselect is the HON's medical search engine. It retrieves scientific articles, images, conferences and web sites on the selected subject.
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The list of medical terms above are retrieved automatically from the article.

Disclaimer: The text presented on this page is not a substitute for professional medical advice. It is for your information only and may not represent your true individual medical situation. Do not hesitate to consult your healthcare provider if you have any questions or concerns. Do not use this information to diagnose or treat a health problem or disease without consulting a qualified healthcare professional.
Be advised that HealthDay articles are derived from various sources and may not reflect your own country regulations. The Health On the Net Foundation does not endorse opinions, products, or services that may appear in HealthDay articles.


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