How does the Obalon Balloon System work?
The Obalon Balloon System helps with weight loss by filling the stomach so you eat less.
Who can get the Obalon Balloon?
You are a candidate for the Obalon Balloon if you have a body mass index (BMI) from 30 to 40 kg/m2 and are 22 years or older. You must be willing to follow a 12-month program. The program begins with the placement of the Obalon Balloons in your stomach for up to six months. The program includes a healthy diet and exercise program during the time that you have the balloons and for six months after the balloons are removed.
What weight loss results should I expect?
The Obalon Balloon System was shown to help patients lose weight. In a clinical study patients with the Obalon balloon system and diet and exercise lost approximately twice as much weight than those who did diet and exercise alone. The Obalon Balloon System was also shown to help change your eating habits and keep weight loss long-term.
How long is the treatment?
The Obalon Balloon System consists of 3 lightweight balloons that are placed in the stomach over a 6-month treatment period. Rather than introducing one large balloon, the Obalon Balloon System is designed to minimize discomfort by introducing 3 small balloons over time.
How is the Obalon Balloon System placed?
Placement of the Obalon Balloon System is a straightforward procedure that typically takes less than ten minutes. The balloon technology utilizes a capsule that contains the balloon inside. The capsule is attached to a tiny tube that allows inflation. You drink a cup of water and swallow the capsule with the tube attached, just like you would swallow a normal capsule. Once the capsule reaches your stomach, it opens up and releases the balloon. Your physician confirms the balloon placement using an x-ray and then uses a device to inflate the balloon with gas. After the balloon is inflated, your physician releases the tube from the balloon and pulls the tube out of your mouth, leaving the balloon free-floating in your stomach. You do not need any sedation for this procedure and you are free to go home right after the balloon is inflated. Additional balloons are placed in the exact same way.
How is the Obalon Balloon System removed?
At the end of the 6-month treatment period, all three balloons are removed via outpatient endoscopy under conscious sedation.
How many balloons are used during the treatment period?
Three (3) Obalon Balloons should be placed in the stomach within the 6-month treatment period to benefit from use of the weight loss system. The system is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first balloon is placed.
How large is the Obalon Balloon System?
A fully inflated single balloon has a volume of 250cc, weighing less than 6 grams and about the size of a small orange. Based on your weight loss progress, you may need 3 balloons placed in your stomach over the 6-month period. The total amount of volume with 3 balloons is 750cc.
What should I expect when using the Obalon Balloon System?
Your physician will work closely with you to help you develop healthier eating habits, such as making the right food choices and limiting yourself to appropriate portion sizes. After the initial balloon placement, you should expect that you won’t be able to eat the same quantity of food you previously consumed at one sitting. This helps your ability to control your eating habits.
How do I know I’m ready for the Obalon Balloon System?
The Obalon Balloon System is indicated for patients with a body mass index, or BMI, of 30-40 kg/m2. The Obalon Balloon System can assist your efforts, but your weight loss success is also dependent on your readiness to develop new lifestyle skills. The degree of long-term weight loss will depend on your ability to modify your behavior during the 6-month therapy period and to maintain this behavior. It is important that you discuss your willingness to accept this commitment with your physician before getting the Obalon Balloon System.
What are the side effects of this treatment?
During the first couple of days that the balloon is put in, you will likely have abdominal (belly) cramping/pain and nausea, and may also have vomiting, bloating and diarrhea. Not all of these may happen, but they are all common and should be expected. Sometimes these symptoms may be severe and your doctor can provide medicine and advice to help. Make sure that you take your medications as the doctor has told you.
Patients typically resume normal activities immediately after the procedure.
What should I do after I get the Obalon Balloon System?
It is important that you listen to the instructions provided by your physician. As you become aware that you are eating less, it is important to adopt a healthy lifestyle by making healthy food choices and making exercise a priority.
Will the Obalon Balloon System limit my activity?
The Obalon Balloon System is a lightweight balloon that is non-surgical and reversible. Patients usually resume normal activities immediately post procedure. See safety information section and patient labeling for more information.
Who should I talk to about the Obalon Balloon System?
Ask your doctor. The Obalon Balloon System can be administered only by a physician.
The Obalon gastric balloon should not be used if you have any of the following limitations/conditions:
• Anatomical abnormalities of the upper gastrointestinal (GI) tract
• Functional disorders of the upper GI tract
• Inflammatory and other pathophysiological conditions of the GI tract
• Chronic or acute use of medications known to affect integrity of the GI tract and/or weight
• Prior GI tract surgeries, excluding uncomplicated appendectomies
• Untreated hypothyroidism or untreated Cushing’s disease or syndrome
• Severe, unstable/uncontrolled medical conditions of major organ systems
• Alcohol and/or illicit drug abuse
• Undergoing chronic steroid or immunosuppressive therapy
• Pregnant, or breastfeeding, or intention of becoming pregnant during the study
• Type 1 diabetes mellitus
• Must not undertake scuba diving or travel in an unpressurized airplane cabin
• Allergies to products/foods of porcine origin
• Untreated H. pylori infection