DAKOTA DUNES, S.D. | A silicon balloon designed to help those struggling with diet and exercise shed excess pounds is now available in Siouxland.
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."
Rizk placed ORBERA in a Siouxland patient for the first time about seven weeks ago. Since then, he said the patient has lost more than 20 pounds. He said the balloon, which isn't covered by health insurance, must be paired with a dietary coaching program to ensure success.
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, which is less invasive than the other weight loss procedures, will appeal to patients with a BMI between 30 and 40 who don't qualify for weight loss surgery.
You have free articles remaining.
"If someone has diabetes or high blood pressure and their BMI is 32 and we can get them with this tool to lose 40 pounds, that would really dramatically improve their health," Rizk said.
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, who said patients can return home about two hours later.
He said ORBERA, which he likens to a breast implant, takes up space in the stomach, causing the patient to feel full after consuming a smaller amount of food.
"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 how it was inserted.
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 a small amount of weight back, 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," Rizk said. "For a specific patient it can be really good, but as the BMI gets higher, that balloon may not be appropriate."