DAKOTA DUNES, S.D. -- A silicon balloon, which is less invasive than other weight loss procedures, made its debut at Midlands Clinic in 2016.
ORBERA, an intragastric balloon, has been used for weight loss worldwide for years, but the device, which has been placed more than 220,000 times in patients' stomachs, didn't gain U.S. Food and Drug Administration approval until August 2015.
William Rizk, a bariatric surgeon who is offering the device at Midlands Clinic along with his colleague Keith Vollstedt, said a previous gastric balloon was an option in Siouxland 20 years ago, but he said that particular model had a much higher complication rate than that of ORBERA.
"This new balloon is made of different material and instead of being filled with air it's filled with saline. It tends not to leak or deflate like the old ones did," he said.
"I think we kind of gave it a try 20 years ago and it didn't work so well, so we kind of shelved it."
Laparoscopic sleeve gastrectomy is the most popular weight loss surgery in the United States, topping laparoscopic gastric bypass, which is the most effective and most invasive, and laparoscopic gastric banding, which has declined in popularity, according to Rizk.
He said ORBERA will appeal to patients with a BMI between 30 and 40 who don't qualify for weight loss surgery. The balloon, which Rizk likens to a breast implant, takes up space in the stomach, causing the patient to feel full after consuming a smaller amount of food. ORBERA, which isn't covered by health insurance, must be paired with a dietary coaching program to ensure success.
You have free articles remaining.
ORBERA is inserted with a scope through the esophagus into the stomach while the patient is sedated. Then the balloon is inflated with 600 milliliters of saline to about the size of a grapefruit. The procedure takes about 15 minutes, according to Rizk. Patients can return home about two hours later.
"When you start losing weight the first few pounds come off rather quickly. When you place the balloon, the first week is kind of an adaptation phase," he said.
"There can be some symptoms of nausea in the first week, which really limits how much people can eat. Maintaining hydration is really important."
The balloon stays in place for six months, then Rizk said it's punctured and retrieved in a procedure similar to the one used during insertion.
The FDA trial that assessed the safety and effectiveness of ORBERA showed patients with the device who participated in diet and exercise lost 3.1 times more weight than people who just tried to lose weight with diet and exercise alone.
A year later, Rizk said trial participants who had the balloon gained back a small amount of weight, but maintained the majority of their weight loss and still managed to lose more weight than participants who relied on diet and exercise alone.
"It's another kind of weapon in our arsenal or tool in our toolbox," he said. "For a specific patient it can be really good, but as the BMI gets higher, that balloon may not be appropriate."