FDA Issues Warning Letter Concerning Stomach Balloons Used to Treat Obesity
After the sudden deaths of five people following the placement of inflated silicone balloons in their stomachs to treat obesity, the Food and Drug Administration sent a letter to health care providers on August 10, 2017, warning of potential risks associated with the intragastric balloons. All five reported deaths happened within one month of the procedure, with three of the five people dying one to three days after the procedure. The agency said two more death reports happened within the same time frame and may be related to complications from the balloon treatment. The agency has not yet determined whether any of the deaths were directly related to either the devices or the insertion procedures.
Potential Risks of Intragastric Balloons
One risk is over-inflation. Overinflation may occur when the intragastric balloon inflates with more fluid or with air after placement in the patient’s stomach. Overinflation symptoms include abdominal swelling, severe abdominal pain, breathing problems, and vomiting. Acute pancreatitis is a separate type of risk, caused when the balloons compress other gastrointestinal structures. Symptoms include back and abdominal pain.
Both types of complications can happen within days of the procedure and may require doctors to remove the devices.
Intragastric Balloon Procedure
The procedure to place the silicone balloons in a mildly sedated patient’s stomach lasts for approximately 30 minutes. One or two balloons are placed inside the stomach through the mouth using an endoscope. The balloons are then inflated with liquid, usually a saline solution. The purpose of the inflated balloon is to leave less room for food, thereby helping the patient to lose weight. The balloon devices stay in the stomach for up to six months.
Intragastric Balloon Manufacturers
The devices at issue are manufactured by two California companies. Four of the deaths involved the Orbera Intragastric Balloon System by Apollo Endosurgery. One involved the ReShape Integrated Dual Balloon System by ReShape Medical.
In response to the FDA letter, Apollo Endosurgery issued a statement saying that the company self-reported the deaths of five patients who received the Orbera intragastric balloon since the FDA approved the device in August 2015. Apollo Endosurgery also said that 21 deaths have been reported in the past 11 years, out of more than 277,000 Orbera balloons distributed during that time period.
FDA Recommendations for Intragastric Balloons
The FDA recommends close monitoring of patients with liquid-filled intragastric balloon systems used to treat obesity for the potential risks of acute pancreatitis and spontaneous over-inflation. Both companies have revised their product labeling to address these risks.