2017-02-14 14:22:48 UTC

FDA Alert: Adverse Events Associated with Fluid-Filled Intragastric Balloons

Feb. 14, 2017

Physicians are encouraged to closely monitor patients treated with these FDA-approved obesity treatment devices.

FDA has received multiple reports of potential complications observed in patients treated with FDA-approved obesity treatment devices. While the root cause and incidence of these complications is not known, physicians need to closely monitor their patients and report adverse events to FDA.

Over-inflation of fluid-filled balloon systems — symptoms included intense abdominal pain, abdominal distension with or without discomfort, difficulty breathing, and/or vomiting, which may present as soon as nine days after implantation. The event may require premature removal of the balloon to resolve the patient’s symptoms.
 
Acute pancreatitis — symptoms included severe abdominal and back pain, which may be present as soon as three days after implantation due to the compression of gastrointestinal structures created by the implanted balloon(s). All of these cases required premature device removal, and four of the patients required hospitalization. 
 
FDA encourages physicians to report any adverse events related to intragastric balloon systems. Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations. Health-care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical devices.

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