When the Obalon Balloon System was first FDA approved in September of 2016, its inventors knew it was going up against two existing gastric balloon systems – the ReShape and the Orbera. While one might hear “gastric balloon” and think all of these are the same, there are key differences that separate Obalon from the pack.
While one might hear “gastric balloon” and think all of these are the same, there are key differences that separate Obalon from the pack
Basic Info: ReShape and Orbera
The Reshape and Orbera gastric balloon systems were approved by the FDA in 2015. The ReShape balloon has a dumbbell shape that connects two balloons. These connected balloons are placed in a single session. Like the Obalon Balloon, the ReShape stays in place for six months. It is filled with saline solution.
The Orbera is similar, but it is a single balloon that is also placed in a single session. This balloon is also filled with saline, and it is designed to stay in the stomach for six months.
Both the ReShape and the Orbera are placed into the patient’s stomach using an endoscope, which is a tube-like, lighted instrument. The placement takes a few minutes.
How Is the Obalon Balloon Different?
Sedation-Free Balloon Placement
One major difference between the Obalon Balloon and the ReShape and Orbera balloons is the method of balloon placement. The Orbera and the ReShape require use of an endoscope. While this method of placement may sound relatively simple, it usually requires the patient to be sedated.
While this is still not as much of an inconvenience as surgery is, sedation for an endoscopy can be disruptive, as the patient will usually need someone to drive him or her back home after the procedure. Finding someone to do this can be a challenge if the patient lives alone and/or has a schedule that is different from that of most friends and neighbors. And while sedation wears off somewhat quickly, it makes it difficult for the patient to go back to work afterwards.
By contrast, the Obalon Balloon system does not require sedation for balloon placement. For the patient, getting the balloon to the stomach is (LINK) as simple as swallowing a pill. Then, the patient’s doctor fills the capsule with gas while monitoring the balloon on an x-ray to ensure that it is placed properly. This procedure is repeated two more times over the balloon placement period.
Balloon removal for the Obalon Balloon system requires a light sedation, which allows the patient to be conscious during the procedure. In this procedure, all balloons are removed at once, and the entire procedure takes about 15 minutes.
Gradual Adjustment Period
All gastric balloons have one thing in common: they take up space in the stomach, which requires the patient to adjust food intake accordingly. However, the Obalon Balloon system is different from both the Orbera and ReShape systems in that three balloons are placed gradually. With the Orbera and ReShape, patients have a single large balloon (or dual balloon) placed at once.
Obalon Balloon system is different from both the Orbera and ReShape systems in that three balloons are placed gradually rather than all at once
Some patients have noted that, in the beginning of the treatment, they could feel the balloon within the stomach, and that that feeling took some getting used to.
Each individual Obalon Balloon is smaller than the Orbera and ReShape balloons. This means that, if patients can feel the presence of the first Obalon Balloon initially, that the Orbera and ReShape systems involve a more significant adjustment period.
Since adjusting to a gastric balloon may involve discomfort and acid reflux, the gradual adjustment period that Obalon offers can make a significant difference in the general well-being of weight loss patients. Weight loss is a major undertaking on its own, so minimizing discomfort for patients is important.
While the ReShape and Orbera balloons have been FDA approved along with the Obalon Balloon Diet and system, there are some possible risks associated with ReShape and Orbera. In early 2017, the FDA warned that adverse events had been associated with fluid-filled gastric balloons.
These balloons have been associated with spontaneous overinflation, when the balloons independently fill with more fluid or air. This causes them to have to be removed early. Another risk that has been observed with fluid-filled balloons is the development of acute pancreatitis. This also causes balloons to be removed prematurely.
The FDA noted that, because the Obalon Balloon system is gas-inflated and not fluid-inflated, these adverse events had not been associated with it. The FDA asked physicians to take special care when overseeing patients who are being treated with the Orbera or ReShape, but they did not express these concerns to physicians treating patients with the Obalon Balloon. Thus, the Obalon system appears to be a safer choice with less risk of needed premature removal.
While the Obalon, Orbera, and ReShape all operate using similar principles, the Obalon Balloon System has some clear advantages.
The sedation-free placement, the gradual adjustment period given to patients, and the lowered risk of premature removal makes Obalon a great choice for those who are serious about their weight loss.
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