FDA issues warning relating to ReShape and Obera balloon systems that are associated with overinflation and acute pancreatitis.-ReShape Medical and Apollo Endo-Surgery.

The FDA has recently received multiple reports for two different types of adverse events associated with fluid-filled intragastric balloons used to treat obesity.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 approved two intragastric balloon systems in the U.S. The ReShape Integrated Dual Balloon System is manufactured by ReShape Medical Inc., and uses two balloons. The Orbera Intragastric Balloon System manufactured by Apollo Endo-Surgery uses one balloon. Both brands are fluid-filled balloon systems, and are indicated for use in conjunction with diet and exercise.The FDA has received several dozen adverse event reports regarding balloon over-inflation of fluid-filled systems. Most have involved the Orbera Balloon System although this type of event has also been reported with the ReShape Balloon System. Symptoms of balloon over-inflation included intense abdominal pain, swelling of the abdomen (abdominal distension) with or without discomfort, difficulty breathing, and/or vomiting. The event may require premature removal of the balloon to resolve the patient�s symptoms.

A separate set of reports involving both brands of fluid-filled balloons (Orbera and ReShape) indicate that acute pancreatitis developed in several patients 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. Symptoms of acute pancreatitis in the presence of a fluid-filled intragastric balloon system included severe abdominal and back pain.The FDA recommends that health care providers: �Recognize that patients with implanted fluid-filled intragastric balloons may develop balloon-related symptoms or other abnormalities following balloon placement, and throughout the duration of their treatment. Consider spontaneous over-inflation and/or pancreatitis in the differential diagnosis of patients presenting with the symptoms noted in this communication. If abnormalities are found, perform any confirmatory diagnostic studies. If the device is removed, follow the manufacturer�s instructions for device returns or evaluations. �Report any adverse events related to intragastric balloon systems that come to your attention. 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 the FDA identify and better understand the risks associated with medical devices.

The FDA continues to work with ReShape Medical Inc. and Apollo Endo-Surgery to better understand these issues of acute pancreatitis and over-inflation in patients with fluid-filled intragastric balloons.