Can this balloon help you lose weight?

Some doctors call it a revolutionary device

SAN DIEGO - A new capsule could help people lose 20 to 30 pounds in a few months without surgery but Americans must leave the country to get it.

Obalon, which has been described as the biggest advancement in obesity treatment, is the world's first gastric balloon that you can swallow. It's targeted to individuals who are overweight but do not qualify for traditional weight loss surgery.

The patient swallows the vitamin-sized capsule during a five-minute procedure that does not require anesthesia or medication and the balloon deploys to about the size of an apple inside the stomach, creating a sensation of fullness. The expanded balloon restricts the amount of food the patient can eat, also suppressing his or her appetite. 
After about a month, the patient's body starts to adapt to the balloon, and its appetite-suppressing effects start to diminish. The patient then swallows another capsule to maintain the effects of treatment. Two to three balloons may be used over the course of treatment. At the end of treatment, an endoscopic procedure is performed to deflate and remove the balloon. 
Total treatment time is approximately three months; in that time, patients can lose more than 50 percent of their excess weight.
Although the company is based in San Diego, hopeful patients must either go to Mexico or Europe to get it. The drug received Investigational Device Exemption from the Food and Drug Administration.
One San Diegan discovered the drug while searching YouTube.
"It's almost like having a nutritionist in your pocket every single day," said Ora Verduzco, who said she dieted unsuccessfully for the last couple of years.
Dr. Ariel Ortiz administers Obalon at the Obesity Control Center in Tijuana where it costs between $3,000 and $4,000. He said he receives hundreds of requests for the drug each week.
"What we are looking at is very similar weight loss to gastric surgery but instead of a year and a half we are obtaining results in three to four months," Ortiz said.
Ortiz's patients then work with a nutritionist on their eating and exercise plan that is monitored by a smart phone app. If a patient still chooses to overeat, they will get sick.
Critics say the device could rupture or cause blockage. But Ortiz claims the "worst case scenario" is that the " balloon deflates in the stomach, then it would pass through and into the toilet."
Verduzco said the balloon is just one part of her fight to get fit.
"The rest is really you and the commitment you make to following the correct diet," she said.
In addition to Mexico, Obalon also is available in the United Kingdom, and the company said it's about to train doctors on the procedure in the Middle East in mid-March.

Mark Mahmood is the vice president of marketing for Obalon.

“Obesity is a global epidemic,” Mahmood said. “There is such a large, unmet need.”

Mahmood said Obalon’s leaders have more than 20 years experience in medical technology and identified the need to give overweight and obese patients more options in ways to drop pounds.

“It’s a novel technology that really helps patients address their weight and obesity,” Mahmood said. But, “it should in no way replace diet and exercise” and should be used in conjunction with better eating habits and behavior modification, he said.

The company would not comment on the timing of the pending pivotal clinical trial with the FDA, now that the company has completed a small feasibility study. But Mahmood said his company believes they can help suffering patients.

“Hopefully one day, we’ll be in the U.S.,” he said.

(*Editor's note: This story was updated on March 11 when the company responded to comment.)

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