In the past two years, the FDA has approved two different types of intragastric balloon systems:
- Fluid-filled intragastric balloon systems, including the ReShape Integrated Dual Balloon System and Orbera Intragastric Balloon System.
- Air-filled intragastric balloon systems, such as the Obalon Balloon System.
On Thursday, February 9th, the FDA sent a letter to healthcare providers, informing them of two different types of adverse events that have recently been reported with the use of fluid-filled intragastric balloons. The two types of adverse events include:
- “The fluid-filled intragastric balloon over-inflating with air or with more fluid (spontaneous hyperinflation) in patients’ stomachs.”
- “The development of acute pancreatitis.”
These adverse events have only been reported with the fluid-filled balloon systems. In its letter, the Agency informs health care providers that it wants to ensure they are “aware of these potential complications that have been observed in patients treated with FDA-approved obesity treatment devices, although the root cause and incidence of these complications is not known.”
Fluid-Filled Intragastric Balloon Systems
In 2015, two intragastric balloon systems were approved by the FDA, the ReShape Integrated Dual Balloon System (manufactured by ReShape Medical Inc.), which uses two balloons, and the Orbera Intragastric Balloon System (manufactured by Apollo Endo-Surgery), which uses one balloon. The devices are both fluid-filled balloon systems, and were developed to be used as weight-loss systems that work by taking up space in a patient’s stomach.
“The balloons are placed into the stomach through the mouth, using a minimally invasive endoscopic procedure, while the patient is under mild sedation. Once in place, the Orbera balloon is filled with saline only, and the ReShape balloons are filled with saline and methylene blue dye. The maximum placement period for both brands is six months.”
Adverse Events
Over-Inflation
The FDA’s letter states that it 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 over-inflation can include some or all of the following:
- Intense abdominal pain
- Swelling of the abdomen (abdominal distension), with or without discomfort
- Difficulty breathing
- Vomiting
The Agency notes that this event may require premature removal of the balloon in order to resolve the patient’s symptoms. Over-inflation of the balloon has been experienced as soon as nine days after implantation, and the FDA states that “at this moment there is not enough information to determine what is causing the balloon to over-inflate.”
Acute Pancreatitis
“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).” Symptoms of acute pancreatitis include severe abdominal and back pain. FDA notes that all of the reported cases of acute pancreatitis have required the device to be prematurely removed, and four of the patients required hospitalization.
Acute pancreatitis has been experienced as soon as three days after implantation. Furthermore, the letter states that the labeling for Orbera and ReShape does not list pancreatitis as a potential complication. Because of this, “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.”
FDA Recommendations
The FDA is recommending 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.”
The Agency is continuing to work with ReShape Medical Inc. and Apollo Endo-Surgery to gain a better understanding of the issues with these fluid-filled intragastric balloons, and states that it is committed to providing additional information on the subject as the investigation continues.
For additional information, view FDA’s full letter.
Do you have a medical device or other FDA-regulated product that you want to ensure is both safe for use as well as compliant with all requirements and regulations? We can help. Contact us today to learn more about our services and how we can help you.
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