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Home E-Weekly February 28, 2017

FDA Warns About Safety of Weight-Loss Balloons

Published: February 27, 2017

WEIGHT-LOSS ISSUES The FDA approved the ReShape Dual Balloon System in 2015.

Intragastric balloons designed to help overweight individuals shed excess pounds have been linked to spontaneous hyperinflation and acute pancreatitis, according to the FDA, which is recommending that healthcare providers closely monitor implanted patients.

The FDA's warning impacts use of the ReShape Integrated Dual Balloon System made by Reshape Medical and the Orbera Intragastric Balloon System made by Apollo Endo-Surgery. Most of the reported adverse events have been linked to the Orbera system, according to the FDA.

The systems, which the FDA approved in 2015, are inserted into the stomach through the mouth during endoscopic surgery. Once inserted, the dual balloons of the ReShape are filled with saline and methylene blue dye, while the single balloon of the Orbera system is filled with saline only. Both systems are designed take up space in the stomach and have been approved as temporary weight-loss solutions that should be removed within 6 months of implantation, according to the FDA.

Over-inflation can occur within 9 days of implantation when the balloons spontaneously fill with air or more fluid. The exact cause of the spontaneous malfunction is currently unknown, says the FDA, which adds over-inflation of the devices can cause abdominal pain, abdominal distention, difficulty breathing and vomiting. The balloon systems can also compress gastrointestinal structures and cause acute pancreatitis within 3 days of implantation, says the FDA. Those dangers are not listed on the labeling of both systems, so healthcare providers might not be aware that the devices are the cause of the associated symptoms.

Healthcare providers should closely monitor patients who received the implanted systems and remove the devices if they are found to be the cause of the adverse reactions, says the FDA. Providers should also submit reports of related problems to MedWatch, the FDA's Safety and Information and Adverse Event Reporting program. Questions about the safety warning can be directed to the FDA via email or by calling 800-638-2041.

Daniel Cook

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