The ORBERA intragastric balloon is a newly FDA-approved treatment option that enhances weight loss and helps address obesity. The Orbera balloon is a soft silicone, expandable intragastric device developed by the company Apollo Endosurgery, Inc. that is temporarily placed inside the stomach, without the need for an invasive surgical method. The major difference between this treatment and other more aggressive ones also meant to decrease hunger and limit food intake is that it is temporary and does not require surgery involving incisions or general anesthetic.
What the ORBERA Intragastric Balloon Treatment Involves
The ORBERA gastric intragastric balloon system is inserted while deflated into the stomach through the mouth using a minimally invasive endoscopic procedure. The patient is sedated during the procedure and after the device is placed, the physician will fill the balloon with a saline solution through a self-sealing valve, expanding it to create a spherical shape inside the stomach. The treatment is customized to a patient’s specific medical needs and the balloon can be filled with 400 to 700 cc of saline solution.
When in place, the ORBERA intragastric balloon can remain in the stomach for up to six months, according to a physician’s recommendations. The temporary treatment is recommended for adult patients with a Body Mass Index (BMI) between 30 and 40, and who already tried but failed to lose weight with diet and exercise. The balloon does not directly provoke weight loss, but it increases the feeling of satiety (i.e. “feeling full”), and it can be removed at any time during the six month period when the physician feels it is appropriate.
Following the ORBERA Intragastric Balloon Placement
During the time that the ORBERA intragastric balloon is in the patient’s stomach, a physician will continue monitoring the pateint’s reaction to the device. After being discharged from the hospital, the patient will gradually initiate a diet, starting with liquids and transitioning to solid food, which involves a healthy dietary regimen designed by a dietitian. To ensure the success of the procedure, regular exercise is also recommended. Weight loss is achieved through behavioral alterations, which involves the entire ORBERA Managed Weight Loss Program in addition to the functioning of the device itself.
Patients can lose an average of 1kg per week, or a total of 10 to 15 kgs, depending on each patient’s characteristics and motivation. The weight loss is usually more significant during the first three months with the device, after which it will work more as support to manage weight loss, as well as healthy eating and exercise habits. Following the six months (or before if the physician deems it appropriate) the balloon is removed through a simple endoscopic procedure similar to the one conducted to place the device.
ORBERA Intragastric Balloon As An Option To Lose Weight
Losing weight may not be easy to do alone and there are currently a series of medically supervised weight loss programs to help patients achieve their goals, including diet and exercise, pre-packed meals, pharmacotherapy and surgery. There are both advantages and disadvantages associated with the ORBERA intragastric balloon as an alternative to surgery. Despite the fact that not requiring surgery may offer an attractive benefit to patients, it is a temporary treatment and may not be tolerated by all patients.
ORBERA was approved by the U.S. Food and Drug Administration (FDA) in August, 2015 and the pivotal studies presented by the company demonstrated significantly better results in weight loss accomplished by the group who received the balloon compared with a study group that only participated in a behavior modification program. At 6 months, the patients with ORBERA had a mean total body weight loss of 10.54%, compared to 4.71% for the control group — results that were maintained at 12 months, when the balloon had already been removed. However, the superiority of ORBERA in comparison to surgery was not studied.