Is 'Balloon Pill' a Weight-Loss Miracle Cure or Short-Term Fix?

Controversial capsule device Obalon is not yet approved in the United States.

May 15, 2014, 12:14 PM

May 15, 2014— -- At 330 pounds, Kimmy G. says she is never full.

The Orange, Calif., resident, who asked that her full name not be used, said she has tried nearly every diet and weight-loss regime and nothing seems to help her shed the pounds.

Kimmy, 48, was a successful plus-size model a few years ago and even appeared in the 2006 comedy film “Phat Girlz.” She wants to get back to her modeling weight.

“I still was heavy. I still was thick, but I felt better and I could move around better,” she said.

Another California woman, Daisy Markley, a physician and mother of three from Valencia, Calif., faced similar weight loss issues. At 5-foot-4 and 152 pounds, Markley gained 10 pounds after she got married, and 20 pounds after she had her first child – 18 years ago.

Both women had recently heard about a new capsule nicknamed the “balloon pill” that might help in the weight-loss fight. A magic bullet, so to speak, that claims the kind of weight-loss results that so far only invasive surgery has produced, and is not just for the severely overweight.

The “balloon pill” is a controversial device called Obalon. The pill is attached to a catheter that allows doctors to inflate the balloon once the capsule is swallowed. It enters the stomach and quickly and doctors use nitrogen gas to inflate it into a small balloon, making the patient feel full immediately. It stays there for 30 days at a time, until it is removed by a doctor via endoscopy. Over the course of a 90-day treatment, two more balloons can be added.

The pill comes with strict guidelines. Patients can’t eat solid foods for the first three days and need to work out 90 minutes a day. Once patients start eating food, they won’t be able to eat more than a small meal per day.

Kimmy’s goal is to lose 60 pounds. Gastric-bypass and lap-band surgeries were not the right options for her, she said.

“I feel like cutting your stomach is not really the issue, you know, the issue is right here,” Kimmy added, pointing to her mouth.

But the problem for Kimmy is that the pill is unavailable in the United States because it has not been approved by the U.S. Food and Drug Administration. It is available at a weight-loss clinic in Tijuana, Mexico.

Dr. Ariel Ortiz, a surgeon who was born and raised in Tijuana, provides the Obalon pill – Obalon paid him to help research the capsule. Every day, Ortiz travels to his clinic, The Obesity Control Center in Tijuana, from his home in San Diego.

At his clinic in Mexico, Dr. Ortiz offers numerous plastic surgery procedures that cost a fraction of the price compared to United States prices.

His cheap prices draw thousands of Americans to Mexico in search of cut-rate medical care. Ortiz said 70 percent of his patients at his clinic are American and his staff has fielded more than 100 calls from patients wanting to know more about the “balloon pill,” most of which are American as well.

The balloon pill, Ortiz said, is another option for those trying to lose weight.

“We’re going to call it an alternative for some, especially those who are afraid of surgery or don’t fully qualify for surgery,” he said. “It’s going to be, definitely, a first step for those extremely overweight and have, let’s say, a very high-risk for surgery. I don’t want to take that risk.”

So far, the results have been impressive. According to Dr. Ortiz, patients have lost 30 pounds in 12 weeks.

Obalon is so new that there is no consensus yet in the U.S. medical community about it, but plenty of intrigue.

Dr. David Katz, who teaches weight management at Yale-Griffin Prevention Research Center in Derby, Connecticut, said that while bariatric surgery should be a last resort, his concern about Obalon is the user’s ability to maintain the weight loss after the balloon comes out.

“The stomach is a hormone-producing organ, and bariatric surgery actually influences the production of a hormone called ghrelin, and that’s part of the effect of the surgery,” he said.

“Does the balloon do that? Will it rival the effects of surgery? Because the effects of the surgery, for the most part, are permanent, and if you have a balloon put in your stomach to make you eat less and you lose weight, are you then dependent on that balloon for the rest of your life?”

Ortiz said patients come to him not only for the Obalon capsule, but for other treatments that are approved in the United States, but cheaper in Mexico, such as plastic and gastric-bypass surgeries. The balloon pill costs about $4,000, a fraction of what a gastric bypass surgery costs, and is much less invasive.

“We use exactly the same equipment, exactly the same instruments, exactly the same standards that are used in the United States without the overhead costs of operating in the United States with all that red tape,” Ortiz said.

The pill is supposed to be removed after three months. In the first 30 days, Kimmy and Daisy Markley said they saw results in the first 30 days: Markley lost 10 pounds and Kimmy lost 22 pounds.

Both women are halfway to hitting their goals, but the true test will be when the balloons come out in two months and whether they can keep the weight off.

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