Can you really lose weight by just swallowing a pill? Yes, but not in America just yet.
Obalon, a new diet pill marketed as a “nonsurgical, fully reversible weight-loss option,” promises grand weight-loss results for overweight and obese patients by simply swallowing the pill. According to its San Diego, Calif.-based maker, Obalon Therapeutics, the capsule helps users feel full so they eat less, with reports of some users dropping up to 20 pounds in just three months.
An “easily swallowable capsule,” Obalon comprises a deflated balloon attached to a long, thin tube. Once it's swallowed, the gastric balloon inflates with gas and the tube is quickly removed, all in 15 minutes, with no anesthesia. From there, the 250cc balloon, about the size of an apple, stays inflated at the top of the stomach to make its user feel full sooner. The Obalon maker says up to three balloons, rather than one large one which could be uncomfortable, could be added over a 12-week treatment program to help “consume less food at each sitting.” The balloons do not affect regular activity and are removed in a short endoscopic procedure at the end of the treatment period.
Obalon, billed as “the biggest advancement in obesity treatment,” is intended for people with a body mass index (BMI) of 27 or higher. According to the National Heart, Lung and Blood Institute, overweight is considered a BMI of 25 to 29.9 and obese is defined as 30 or above.
European and Mexican clinical studies showed the Obalon balloon yielded a loss of “8.2 percent of their total body weight and 48.9 percent of excess body weight over a 12-week treatment period,” or about 20 pounds.
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Side effects included pressure, cramping, or discomfort in the abdominal region as “the body gets used to the balloon,” as well as nausea and vomiting “during the first few days of placement.”
According to ABC News, Dr. Aurora Pryor, the chairwoman of the Emerging Technologies Committee for the ASMBS, said the biggest risk of the Obalon seems to be unintentional deflation of the device.
Spire Healthcare said the total fixed price for one balloon is £1,995, or $3,310, £2,995 ($4,969) for two balloons and £3,995 ($6,628) for three.
The non-FDA approved pill is available only for experimental use in the United States and not administered by any American doctors at this time. This Obalon website reminds users “is not intended for a U.S. audience. This website describes our product, which has not been approved or cleared for marketing by the U.S. Food and Drug Administration. Our product is not available for sale in the United States.”
However, it can be purchased in Austria, Belgium, Germany, Italy, Luxembourg, the Netherlands and Spain, and someday, the maker hopes, in the States.
“It’s a novel technology that really helps patients address their weight and obesity,” Mark Mahmood, the vice president of marketing for Obalon, told ABC. He would not disclose details about pending FDA clinical trials but said it completed a “small feasibility study.”
“Hopefully one day, we’ll be in the U.S.,” he said.