The balloon is made by Reshape Medical, a non-surgical weight loss company based in Southern California. The firm says the balloon can be safely inserted into the stomach using an endoscope, at which point it is filled with a saline (saltwater) solution. Patients, who will be sedated during this process, can expect the procedure to last well under an hour.
This isn’t the first time such a device has been approved by the FDA. The government regulatory body approved a similar balloon more than two decades ago, but the approval was withdrawn when the device threatened to rupture and block patients’ arteries.
But Deborah Kotz, an FDA spokesperson, says Reshape Medical’s balloon is much safer. “The new device aims to address the design failings of the earlier device,” said Kotz.
There’s no denying the need for devices that effectively promote weight loss. It’s currently estimated that about one in three American adults are obese, meaning they have a body mass index (BMI) of 30 or higher.
It’s worth noting that Reshape Medical’s stomach balloon is designed for people with a BMI between 30 and 40 and have one or more medical condition preventing them from following a more traditional diet and exercise routine.
It’s not yet clear how much it will cost to have the balloon insertion procedure performed. Reshape Medical says the price will likely vary by region.
