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Balloon alert

FDA issues alert for fluid-filled intragastric balloons

Agency issue warning over balloons over-inflating with air or with more fluid (spontaneous hyperinflation) and and the development of acute pancreatitis

The FDA has issued an alert to healthcare providers about potential adverse events linked to fluid-filled intragastric balloons for the treatment of obesity. The devices affected are the ReShape Integrated Dual Balloon System (manufactured by ReShape Medical) and the Orbera Intragastric Balloon System (manufactured by Apollo Endo-Surgery).

The FDA has recently received multiple reports of two different types of adverse events associated with fluid-filled intragastric balloons:

  • 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 recommends that providers closely monitor patients with these devices for these adverse events, and to submit reports to help the Agency to better understand any complications from the use of these obesity treatment devices.

The Agency 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. The reports indicate that balloon over-inflation can occur as soon as nine days after implantation.

As the current labelling for fluid-filled intragastric balloons does not address the issue of spontaneous over-inflation, health care providers, including ER professionals, may not be aware that the symptoms could potentially be related to an over-inflated balloon. The Agency added that “At this moment there is not enough information to determine what is causing the balloon to over-inflate.”

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 reports indicated that pancreatitis can occur as soon as three days after implantation. Pancreatitis is not listed as a potential complication in the labelling information for the Orbera or for the ReShape balloon systems.

Therefore, health care providers, including ER professionals, may be unaware that acute pancreatitis could develop following balloon placement. This could lead to unsuitable or delayed treatment for pancreatitis in patients with balloons who may have acute abdominal pain.

The FDA recommends that health care providers:

  • Recognise 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 added that it will continue to work with ReShape Medical and Apollo Endo-Surgery to better understand these issues of acute pancreatitis and over-inflation in patients with fluid-filled intragastric balloons.

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