Adverse events prompt FDA warning about obesity devices

The FDA is working with Apollo and ReShape to learn why acute pancreatitis and overinflation are occurring.

The FDA has issued a warning about two devices used to treat obesity after receiving upward of 40 reports of adverse events. The reports link the ReShape and Orbera balloon systems the FDA approved in 2015 to cases of overinflation and acute pancreatitis that necessitated the removal of the devices.

Both devices consist of balloons put in the stomach via the mouth. Once in position, the balloons are filled with liquid and left for up to six months. The presence of the balloon in the stomach is intended to make people feel full sooner, and, in doing so, cut down the amount of food they eat. Both products were deemed to have tolerable safety profiles in clinical development.

Most of the reports received by the FDA stem from over-inflation of the balloon. This problem, which has affected Apollo Endosurgery’s Orbera system more than ReShape Medical’s balloon, has been reported to the FDA “several dozen” times. When overinflated, the balloons cause abdominal pain, breathing difficulties and vomiting.

More than half of participants in clinical trials of both devices reported experiencing vomiting or abdominal pain. Vomiting was particularly common, with almost 87% of subjects in the ReShape study and 76% of participants in the Orbera trial suffering this side effect. These events weren’t linked by investigators to over-filling, although both companies have acknowledged the potential link between fill volumes and side effects.

The ReShape trial found patients who were 5-foot-4-inches or shorter were less likely to need to have their balloons retrieved early if the fill volume was reduced from 900 cc to 700cc. And Apollo advises healthcare professionals not to increase the fill volume when replacing an Orbera balloon as it “may result in severe nausea, vomiting or ulcer formation.”

Yet, the labeling of the balloons doesn’t address the risk of over-inflation, meaning physicians may be unaware it could be the cause of symptoms experienced by their patients. The FDA is unsure why balloons are over-inflating, and is working with the manufacturers to figure out the problem.

Cases of acute pancreatitis are rare but severe. The FDA said the condition has developed in “several” patients. The devices were removed from all the patients. Four of the patients were hospitalized.

Rare reports of acute pancreatitis in patients treated with other brands of intragastric balloons predate FDA approval of the Apollo and ReShape devices, but the side effect isn’t listed as a potential complication on the label of the either product.