The ORBERA™ Intragastric Balloon is made to help you lose weight. ORBERA™ is a balloon made of soft, smooth silicone rubber. The empty balloon is passed through your mouth, down your esophagus, and into your stomach. Once in place, it is filled with saline. It then becomes about the size of a grapefruit. The filled ORBERA™ floats in your stomach and takes up space.

From the beginning and six months after ORBERA™ is removed, you will follow a healthy diet and exercise program. You may not lose weight if you do not follow the program.

Losing weight and keeping it off is not easy. A group of doctors, physiologists, and nutritionists will help you through your journey. They will help you make and keep changes in your eating and exercise habits.

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Risks Related to Endoscopic Procedures and Sedation

After you have been given a sedative medication, ORBERA™ will be placed and removed by your doctor using an endoscope that goes down your throat and into your stomach. Endoscopy is very safe, but there are small risks. The most common risks of endoscopy include bleeding, infection, and tearing of the esophagus or stomach. These problems only occurred in about 3–5 of every 10,000 endoscopies.

Risks related to sedation during endoscopic procedures are rare, occurring in less than 1 in every 10,000 people. The most common side effects of sedative medications are a temporary slowing of your pulse or breathing rate, which can be improved by the doctor giving you extra oxygen or medication to reverse the effect of the sedative.

Patients with heart, lung, kidney, liver, or other chronic diseases are at higher risk for side effects from medications. in order to reduce the chance of having a side effect during the orbera™ procedures, you should follow your doctor’s instructions on how to prepare for endoscopy, such as not eating and stopping certain medications.

Benefits of ORBERA™

The benefits of ORBERA™ were tested in a clinical study in the United States. The study looked at people with BMI between 30 and 40. People in the study received ORBERA™ along with diet and exercise. They were compared with people who only used diet and exercise. The people who only used diet and exercise are called the Control group. Both groups had regular doctor visits during the study.
The benefits of ORBERA™ were tested in a clinical study in the United States. The study looked at people with BMI between 30 and 40. People in the study received ORBERA™ along with diet and exercise. They were compared with people who only used diet and exercise. The people who only used diet and exercise are called the Control group. Both groups had regular doctor visits during the study.
Six (6) months after ORBERA™ was removed (at 12 months), patients in the ORBERA™ group weighed an average of 16.2 pounds less than when they got the ORBERA™ balloon. Weight loss for the control group at 6 months and 9 months was 7.1 and 6.3 lbs, respectively.

On the day of placement:

  • DO NOT drive, use machinery or power tools, or make important decisions for 24 hours. You will have had sedation and your judgment will be affected without you knowing it. You may have accidents and make mistakes.
  • DO call your doctor if you have pain or redness at the area on your arm where the needle was placed for your IV fluids. If you don’t you could get a clot or swelling in the vein of your arm which may cause pain.
  • DO call if you don’t urinate (pee) for 12 hours after going home from the clinic. This may mean that you are not getting enough fluids.
  • ORBERA™ will stay in your stomach for 6 months (180 days). During this time and for 6 months after the balloon is removed, your doctor and nutritionist will help you change your eating and exercise habits.