PHOENIX - A new capsule could help people lose 20 to 30 pounds in a few months without surgery. But, Americans have to leave the country to get it.
WEIGHT LOSS BALLOON YOU CAN SWALLOW
Obalon, which has been described as one of the biggest advancements in obesity treatment, is the world's first gastric balloon that you can swallow. It's targeted at individuals who are overweight, but do not qualify for traditional weight loss surgery.
During a five-minute procedure that does not require anesthesia or medication, the patient swallows a vitamin-sized capsule attached to a thin tube, according to the company’s website.
Then, 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 a patient can eat and suppresses the appetite.
After about a month, the company says the patient's body starts to adapt to the balloon, and its appetite-suppressing effects start to diminish. Then, the patient swallows another capsule to maintain the effects of treatment. A patient can use two-to-three balloons over the course of 12-week treatment.
At the end of treatment, an endoscopic procedure is performed to deflate and remove the balloon through the patient’s mouth. During that process, patients have to be sedated while the balloon is punctured and removed.
The total treatment time is approximately three months. In that time, the company says patients can lose more than 50 percent of their excess weight.
Even though Obalon is manufactured in San Diego, patients have to either go to Mexico or Europe to get it.
In the U.S., the drug received Investigational Device Exemption from the Food and Drug Administration (FDA), according to the manufacturer . That means it’s likely on the road to get premarket approval (PMA) by the FDA.
The FDA would not confirm that Obalon is in the approval process, saying “We cannot confirm the existence of or comment on any current/pending product applications.”
ONE PATIENT’S JOURNEY SOUTH OF THE BORDER
Ora Verduzco found Obalon when she was searching YouTube, she said.
"It's almost like having a nutritionist in your pocket every single day," Verduzco said. She said she had dieted unsuccessfully for the last couple of years and always gained the weight back.
Verduzco, from San Diego, decided to go south of the border to get the procedure. She found Dr. Ariel Ortiz at the Obesity Control Center in Tijuana. It costs between $3,000 and $4,000 for the procedure there. He said he receives hundreds of requests for the device 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.
After they get the balloons implanted inside of them, Ortiz's patients work with a nutritionist on their eating and exercise plan. It’s all monitored by a smart phone app.
But, there’s a catch: If a patient still chooses to overeat, they will get sick.
CRITICS AND COMPLICATIONS
Critics say the device could rupture or cause blockage. In the company’s safety information, there are warnings about injury to the stomach lining and “spontaneous balloon deflation and resulting passing through the intestines.” That, they say, could result in bowel obstruction, which can be deadly.
The ABC15 Investigators talked to Dr. David Podkameni, a bariatric surgeon at Banner Gateway Medical Center.
He says the balloon rupturing and causing a blockage are the same kinds of complications that happened when balloons like this were first on the market in the 1980s.
“So, essentially, it was pulled off the market,” Podkameni said.
But Dr. Ortiz claims the "worst case scenario" for patients who use Obalon isn’t all that bad.
“What we would most fear is that the balloon deflates in the stomach, then it would pass through and into the toilet,” he said.
Podkameni said the balloons that are being manufactured today are better, but the root problem is the same.
“It’s similar to yo-yo dieting,” he said. “Probably you’re going to lose a little more weight and you can prolong that effect of the weight loss, but it’s probably bound to happen again that you’re going to end up regaining the weight.”
He said balloons could help as a bridge for an obese patient who wanted to get a metabolic surgery like gastric bypass or a sleeve gastrectomy.
But, for patients looking to lose weight long term using just a balloon device, he doesn’t think it’s the healthiest option.
“You are not addressing the root issue, which his changing behavior, changing metabolism,” Podkameni said.
The ABC15 Investigators found three clinical trials on Obalon. Two were conducted at Dr. Ortiz’s Obesity Control Center in Tijuana and another took place in France.
Podkameni said there are clinical trials going on in South America, Brazil, Europe and Asia and he expects balloons like these will have a role in the United States in the future – keeping in mind, he said, “it needs to be followed
up by a program.”
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.
The San Diego-based company that makes the capsule did not respond to requests for comment.