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Stomach Filling Balloon is FDA Approved for Weight Loss

The procedure is harmless and will take less than half an hour.

One third of the American population is suffering from obesity, so now a stomach filling balloon is FDA approved for weight loss that might open new ways to trim down the numbers. The Food and Drug Administration released as statement on Tuesday that the “belly balloon” is an approved method for weight loss.

Developed by ReShape Medical, the ReShape Integrated Dual Balloon System (or more simply known as the ReShape Dual Balloon) is a device planted in the patient’s stomach that will give off the impression of “fullness” and help with the unhealthy reflex of overeating, one of the main causes of obesity.

The ReShape Dual Balloon is placed in the stomach through a relatively harmless outpatient procedure, an endoscopy, that is much less invasive than other surgical solutions currently available for weight loss. It will generally last less than 30 minutes while the patient is under mild sedation. After the device is implanted, it’s then filled with nontoxic saline solution.

The study was conducted on 326 people suffering from obesity aged between 22 and 60 years old, all of which had at least one obesity-related condition, such as heart issues or diabetes. The 187 participants who opted for the “balloon belly implant” recorded a 6.8% loss of their body weight after the typical six months of recommended time, while the rest 139 lost only 3.3%.

It has shown promise as a minimally invasive procedure and vast improvement over a similar design created in 1992, which ruptured and caused artery blockage in patients. The company aimed to take that concept and improved on it.

However, while the device has shown decent results in patients, over the next six months after its removal, most of them gained up to two thirds of their weight back. It forces the issue that a matter of nutrition change should also be accompanied with the implant and a permanent modification in the food pallet. Or else it was all for nothing.

The Food and Drug Administration spokesman, Deborah Kotz, has stated that the ReShape Dual Balloon device is meant for obese people who have already tried the traditional diet and exercise regime, but with little results. As well, it will also be meant as a solution to people suffering from obesity who do not qualify for other procedures.

The stomach filling balloon will be soon an available treatment, though the company has not yet disclosed an official price or the medical centers where it will be available.

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