Meet with your doctor to discuss weight loss goals and develop a comprehensive program with your care team. Begin planning the diet you will be following after the procedure, as well as how to begin forming better habits moving forward.
How it works
The Orbera® gastric balloon is inserted through the mouth, with no incisions. Afterward, you have less room in your stomach, but more room to succeed with your weight loss goals. Watch for more.
What to expect
Orbera® helps healthier eating habits become second nature. You’ll learn to listen to your body and feel full with less food. So, the weight loss can begin immediately. The habit-building can continue far beyond.
In the first few days after placement, your body should adjust to the balloon. You might feel sick for a few days as you get accustomed to the balloon. Your doctor may prescribe medication to help proactively manage these symptoms. If you experience severe pain, nausea, or vomiting (particularly if you were already acclimating to the balloon), contact your doctor without delay. There could be a problem with your balloon that needs attention.
The adjustments to your eating habits and your continued efforts to stay active will greatly influence your results.
The balloon helps train your body to feel full on smaller portions. The goal of this period is to continue to build strong habits and prepare your mind and body to keep the weight off after the balloon is removed. Continue to work with your care team to optimize your daily nutrition, diet, and exercise routine.
At six months, the balloon is removed. Now, you’ve retrained your body to know what full really feels like. Plus, you’ve been weaving more nutritional meals into your diet. All of this new behavior opens the door for not only keeping weight off but working toward more fitness goals.
Clinical evidence
3.1x
More weight loss than diet and exercise alone.¹
400,000
Devices distributed worldwide in over 80 countries.2
FDA
Orbera® is FDA-approved.
1 Orbera® US FDA Pivotal Study.
2 Data on file.
"I had tried so many other things…I wanted to change, but I just needed something else."
Amanda lost 51 Lbs.
*Results are from individual customer testimonials and your results may vary.
"I accomplished my goal in doing what I wanted to do"
Charlotte lost 43 Lbs.
*Results are from individual customer testimonials and your results may vary.
FAQs
Learning about Orbera®
All procedures have risk. Patients should talk with their doctor and understand all risks before having any procedure.
A gastric 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 gastric 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.
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. On average, patients lost 3.1x the weight of those who were on a diet and exercise program alone.1 In the US clinical study patients lost an average of 21.8 lbs.
¹ Orbera® US FDA Pivotal Study.
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.
Published clinical studies2 for Orbera® have shown that, provided you keep to the prescribed diet and exercise regime, you can maintain weight loss through dieting after removal.
2. Data on file.
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. Patients will need to immediately contact their doctor for any severe or unusual symptoms, such as severe pain or vomiting.
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.
The Orbera® 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.
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 Orbera.com/isi, talk with your doctor, or call Apollo Customer Support at 855-700-0780.
Important Orbera® Intragastric Balloon System Safety Information:
- The Orbera® Intragastric Balloon is made to help you lose weight. From the time that your balloon is placed and for six months after it is removed, you need to follow a healthy diet and exercise program to lose weight. You may not lose weight if you do not follow the program. Your doctor’s clinical team, including dieticians, nutritionists and/or exercise trainers, should help you on your weight loss journey.
- The Orbera® Intragastric Balloon is for adults who are suffering from obesity and have not been able to lose weight and keep it off. To receive an Orbera® balloon, you must be willing to follow a 12-month program. The program begins with the use of the balloon and a healthy diet and exercise program for six months. That is followed by six more months of a healthy diet and exercise program without the balloon in your stomach.
- Your doctor will ask you about your medical history and will also perform a physical examination to determine your eligibility for the device. Additionally, at the time of placement, the doctor may identify internal factors, such as stomach irritation or ulcers, which may prevent you from receiving Orbera®.
- You must not receive Orbera® if you are pregnant, a woman planning to become pregnant within six months’ time, or breast-feeding.
- You must maintain regular contact with your doctor while the balloon is in your stomach. Nausea and vomiting are common when the balloon is placed. Patients typically adjust to the balloon in the first few weeks, then these symptoms improve. If you adjust to the balloon, but then you begin to feel significant stomach pain, contact your doctor immediately as this may be signs of a significant problem with your stomach and could lead to death.
- Do not use Orbera® for more than six months. Prolonged balloon placement may increase the risk of the balloon deflating. A deflated balloon can cause a blockage in the stomach or intestines, requiring surgery. While it has not yet been reported, it is possible for an unaddressed blockage to cause death.
- Call your doctor if you have any concerns about your health or well-being at any time during the six-month placement of the balloon.
- For full safety information please visit Orbera.com/isi to download the Patient Information Booklet, talk with your doctor, or call Apollo Customer Support at 855-700-0780.
CAUTION: Rx only.