The FDA has announced that they have received several reports of adverse events in patients using the Orbera and ReShape gastric balloons since their approval in the US 18 months ago.
Gastric balloons are a non-surgical short-term weight loss device, implanted through the mouth and filled with saline to occupy a portion of the stomach’s volume.
The two safety concerns reported by the FDA are over-inflation and acute pancreatitis. Over-inflation, an issue that is not currently addressed on the product’s labeling, has been reported to cause abdominal pain and swelling, difficulty breathing, and vomiting, and may require removal of the device. Acute pancreatitis, also reported following implantation of these two gastric balloons, is caused by compression of the gastrointestinal system when the balloon is implanted. Further research is required to determine what is needed to rectify these issues.
According to GlobalData research, the gastric balloon segment of the bariatric surgery devices market is expected to increase in the coming years. Since approval in 2015, the market in the US has grown rapidly and already holds a 6% market share in the US, but the growth of this market may be jeopardised if safety concerns continue to arise with saline-filled gastric balloons.