An intragastric balloon is a nonsurgical and temporary weight loss device. A smooth, soft saline-filled balloon (about the size of a grapefruit) is placed in your stomach. Once in place, the intragastric balloon will partially fill the stomach, so you may consume smaller portions of food and still feel full. Along with professional health and wellness advice, the balloon will allow you to adopt good healthy eating habits and change your lifestyle.
Here’s how Orbera works
The Orbera intragastric balloon is placed via the mouth into the stomach, helping you adjust to smaller portion sizes to promote weight loss. The balloon is removed after six months, while lifestyle changes help maintain your progress.
Who’s a good fit for Orbera?
Orbera is for those who need a little help gaining traction in their weight loss journey. It's an option for people with a BMI of 30 to 40 who have failed to achieve and maintain weight loss with a supervised weight-control program.
Frequently asked questions about Orbera
You’ve got questions. We’ve got answers.
To qualify for Orbera, you must be an adult, have a body mass index (BMI) of 30 to 40 kg/m2, and be willing to participate in a medically supervised program.
It is important to understand that the balloon is a tool to aid weight loss and must be used in conjunction with diet, exercise, and a behavior modification program. The amount of weight you lose and maintain will depend on how closely you follow your diet and adopt long-term lifestyle changes. In a study, patients lost 3.1 times the weight of those who were on a diet and exercise program alone.2 Typically, patients lose 10-13% total body weight with the Orbera intragastric balloon at 6 months.2,3,4
Orbera has been reviewed in over 250 published global clinical papers, and a balloon leak or deflation happens in fewer than 1 in 200 patients over the course of six months. However, if the balloon should spontaneously deflate, you may no longer feel full after eating. If you suspect this may be the case, notify your doctor immediately. A simple abdominal X-ray can determine if the balloon has deflated. If it has, your doctor will arrange to remove the deflated balloon.
The balloon should be removed at the stated time. Leaving the balloon in your stomach for a longer period increases certain risks, most notably deflation of the balloon. If the balloon does deflate, there is a risk of it causing an obstruction in your stomach or intestines. This happens rarely, but you should schedule your balloon removal soon after your balloon is placed, so that there is no delay.
In a clinical study, patients on average maintained about 75% of their weight loss six months after the Orbera intragastric balloon was removed.2
It is very likely the presence of the balloon in the stomach will cause nausea or vomiting after placement. In some patients, it may last one to two weeks. Your doctor may prescribe medication to help minimize these potential effects. You must maintain regular contact with your doctor while Orbera is in your stomach. Nausea and vomiting are common when Orbera is first placed. These symptoms typically improve in the first few weeks as you adjust to Orbera. If you begin to feel intense stomach or back pain, either steady or cyclic, contact your doctor immediately. These may be signs of a major problem with your stomach and could lead to death. After you have adjusted to Orbera, contact your doctor and seek immediate medical care if you once again begin to have nausea, vomiting, stomach or back pain, swelling of the upper stomach with or without discomfort, difficulty breathing or gastroesophageal reflux.
In approximately 1 in 300 patients, the balloon can get bigger while it’s in your stomach. If you think the balloon is getting larger, contact your doctor. An X-ray can be performed to confirm whether this has happened. If it has, the balloon should be removed. Talk with your doctor to fully understand all risks and benefits of using this device.
The Orbera intragastric balloon is constructed of a very smooth and soft silicone material to minimalize the risk of irritating the stomach wall. You will also be prescribed medicines that will reduce the acidity in your stomach and help protect your stomach wall. Patients with prior stomach surgery are not eligible for the procedure because of a higher risk of the balloon causing perforation in the stomach. Some patients without prior stomach surgery have also had stomach perforations, but this is typically following extended periods of side effects. Patients should be advised to immediately contact their physician if they are experiencing severe pain and nausea. The balloon may need to be removed.
The balloon should be removed at the stated time. Leaving the balloon in your stomach for a longer period increases certain risks, most notably deflation of the balloon. If the balloon does deflate, there is a risk of it causing an obstruction in your stomach or intestines. This happens rarely, but you should schedule your balloon removal soon after your balloon is placed, so that there is no delay.
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Common side effects include nausea, vomiting and abdominal pain. Speak to your physician about these and other more serious side effects that may occur. For full safety information, visit IFU-BSCI.com or call 888‑272‑1001.
1. Calculations performed by Boston Scientific. Data on file.
2. OrberaTM Intragastric Balloon System U.S. FDA Pivotal Study. n = 137 Orbera, n = 136 control, p<0.001. Most of the patients from the US FDA Pivotal study were female and Caucasian. Because of this, data from this study may not accurately represent the same effectiveness and safety profiles in Hispanic, African American, or other ethnic populations.
3. Kumar N, et al. The Influence of the Orbera Intragastric Balloon Filling Volumes on Weight Loss, Tolerability, and Adverse Events: a Systematic Review and Meta-Analysis. 2017.
4. Moore et al. Safety and effectiveness of an intragastric balloon as an adjunct to weight reduction in a post-marketing clinical setting. 2020.
Important OrberaTM Intragastric Balloon System ("ORBERA") Safety Information:
Talk with your doctor to fully understand all the risks and benefits of using this device. Ask your doctor if this device is right for you.
Indications for Use:
ORBERA is for temporary use in weight loss therapy. It is intended for obese adult patients with a Body Mass Index (BMI) of ≥30 and ≤40 kg/m2. It is for those who have failed to achieve and maintain weight loss with a supervised weight-control program.
The maximum placement time for ORBERA is 6 months.
To receive ORBERA, you must be willing to follow a 12-month program. The program begins with the use of ORBERA. You must follow a healthy diet and exercise program for these first six months. After six months, ORBERA is removed. Then, you follow six more months of a healthy diet and exercise program without ORBERA.
Contraindications:
Your doctor will ask you about your medical history and will also perform a physical exam to determine if ORBERA is right for you. At the time of your procedure, the doctor may identify internal issues that prevent you from receiving ORBERA. For example, stomach ulcers or inflammation in the stomach may impact device placement.
You must not receive ORBERA if: you currently have another intragastric balloon implanted; you have had prior surgery involving your food pipe, stomach and/or small intestine or bariatric surgery; you know or suspect you may have an allergic reaction to the materials of ORBERA; you have poor general health or history and/or symptoms of several kidney, liver, heart and/or lung diseases; you have a serious or uncontrolled psychiatric illness or disorder; you have alcoholism or drug addiction; you are unable or unwilling to take prescribed medicine to lower stomach acid for the duration of the device implant; you are unwilling to participate in an established medically supervised diet and behavior modification program, with routine medical follow-up; you take aspirin, anti-inflammatory agents, blood thinners, or other medicines that irritate the stomach that a doctor does not regularly follow up on.; or you are pregnant or breast-feeding.
Warnings:
Do not use ORBERA for more than six months. Prolonged placement may increase the risk of ORBERA deflating. A deflated ORBERA can cause blockage in the stomach or intestines, requiring surgery.
If you don’t feel full, experience increased hunger, and/or weight gain, contact your doctor as this may be a sign of deflation.
You must maintain regular contact with your doctor while ORBERA is in your stomach. Nausea and vomiting are common when ORBERA is first placed. These symptoms typically improve in the first few weeks as you adjust to ORBERA. If you begin to feel intense stomach or back pain, either steady or cyclic, contact your doctor immediately. These may be signs of a major problem with your stomach and could lead to death. After you have adjusted to ORBERA, contact your doctor and seek immediate medical care if you once again begin to have nausea, vomiting, stomach or back pain, swelling of the upper stomach with or without discomfort, difficulty breathing or gastroesophageal reflux. If you become pregnant at any time while ORBERA is in your stomach, contact your doctor. ORBERA should be removed as soon as it is safely possible.
Potential Risks:
Inhaling material into the lungs/difficulty breathing; bleeding; lack or loss of fluids leading to loss of normal body functions; bloating of stomach; heartburn/reflux, nausea, vomiting; infection; swelling and redness in the tissue; blockage, hole or tear in the digestive tract; uncomfortable feeling or pain; unintended expansion of ORBERA after placement in the stomach; injury or damage to the tissue; death
MRI Safety Information:
ORBERA is Magnetic Resonance Imaging (MRI) safe. The implant can safely be scanned with MRI.