The Food and Drug Administration (FDA) is alerting doctors that it has received several dozen adverse event reports with fluid-filled intragastric balloons used to aid in weight loss of obese patients. Doctors are being advised to closely monitor patients with these devices for adverse events and submit reports to the agency so that investigators can better understand any complications associated with the use of obesity treatment devices.
The first type of adverse event involves the fluid-filled gastric balloon over-inflating with air or with more fluid, a condition known as spontaneous hyperinflation, while in the patient’s stomach, leading to the premature removal of the device. The other adverse event is the development of a painful inflammation of the pancreas called acute pancreatitis, which has also resulted in the need for the device to be removed.
Intragastric balloon systems work by taking up space in the stomach, enabling the patient to eat less. In 2015, the FDA approved two intragastric balloon systems – the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc., which involves the use of two balloons; and the Orbera Intragastric Balloon System, made by Apollo Endo-Surgery, which uses one balloon. Both are fluid-filled balloon systems and both are intended to be used in conjunction with diet and exercise.
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 balloons are intended to be kept in place for no more than six months.
In 2016, the FDA approved a third fluid-filled intragastric balloon, the Obalon Balloon System, which uses up to three balloons that are inserted into the stomach through a swallowable capsule. The capsule is attached to a thin inflation catheter used to inflate the balloons with air. To date, the over-filling and acute pancreatitis events associated with the balloon devices have not been seen in the Obalon device, though it may be too early to tell.
Reports of over-inflation of the fluid-filled balloons have occurred as soon as nine days after implantation. The agency said there is currently not enough information to determine the cause of over inflation. Signs and symptoms of balloon over-inflation include intense abdominal pain, swelling of the abdomen with or without discomfort, difficulty breathing, and/or vomiting.
Cases of acute pancreatitis in patients with the intragastric balloons were caused by the compression of gastrointestinal structures created by the implanted balloon or balloons. In all cases, premature device removal was necessary, and four of the patients required hospitalization. Symptoms of acute pancreatitis in patients with fluid-filled intragastric balloons included severe abdominal and back pain. Cases of pancreatitis can occur as soon as three days after implantation.
Over-inflation and pancreatitis are not yet listed on the product’s safety label, thus ER doctors may not be aware that the symptoms a patient is experiencing may be related to the fuild-filled intragastric balloons.
Doctors are being advised to monitor patients for these symptoms. Patients are also being advised to be aware of the symptoms of over-inflation or pancreatitis and to seek medical attention promptly if symptoms occur. Any adverse events related to these devices should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.