What is it?The ORBERA® Intragastric Balloon System is a weight-loss system that uses a gastric balloon that occupies space in the stomach. The balloon is placed into the stomach through the mouth, using a minimally invasive endoscopic procedure, while the patient is under mild sedation. Once in place, the balloon is filled with salt water (saline) so that it expands into a spherical shape. The balloon can be filled with different amounts of saline (from 400 to 700 cc) to best match the patient’s body structure.
How does it work?
The ORBERA Intragastric Balloon System takes up space in the stomach to help patients lose weight. The system is temporary and should be removed after 6 months.
When is it used?
The device is used in obese adult patients who have a Body Mass Index (BMI) of 30-40 kg/m2 who have been unable to lose weight through diet and exercise. It is intended to be used while a patient participates in a diet and exercise plan supervised by a health care provider.
What will it accomplish?
During the clinical study, the group of people who used the ORBERA Intragastric Balloon lost more weight than those who did not. The study included a total of 255 patients who were followed for one-year. During that period, 125 patients received the device and had it in place for six months. After the device was removed, they were followed for an additional six months. 130 patients participated in a 12-month behavior modification program and did not receive the device.
Patients with ORBERA lost an average of 21.8 pounds (10.2% of their body weight) after the device had been in place for six months. Three months after the device was removed (9 months after device placement), patients who received the device maintained an average of 19.4 pounds weight loss. The 130 patients who participated in the behavior modification program but did not receive the device lost an average of 7.0 pounds (3.3% of their body weight).
Your Weight Loss Journey with the ORBERA Intragastric Balloon
The first consultation with your doctor will involve discussions about:
Your medical history
Your previous attempts at losing weight
Your personal goals
Your commitment to the program
How comfortable you feel about the whole process which is an important part of the journey.
Once you have decided to go ahead with ORBERA® Managed Weight Loss Program, your doctor will schedule a date for your procedure, and once you begin you’ll be meeting with your professional support team and learning the principles that will become the basis of your success.
You will be lightly sedated while the deflated intragastric balloon is inserted into your stomach through your mouth. Immediately following the placement of the intragastric balloon, it is filled with sterile saline. Soon after this you will regain complete awareness. You will remain in the clinic for observation usually for a minimum of 2 hours or until the doctor discharges you into the custody of the person who will take you home. This is generally an uncomplicated process. Nevertheless, over the first few days after the procedure you may experience gastric discomfort, nausea and vomiting as the digestive system adjusts to the presence of the intragastric balloon. As with any medical procedure, you need to remain alert to any possible complications. You doctor will advise you what to look out for. Some important things to organize beforehand are:
Arrange to have someone with you when you return home from clinic
No solid foods or liquids 12 hours prior to the procedure
Stock your kitchen with the necessary post-procedure foods and liquids as instructed by your dietician
Plan for at least 48-72 hours of inactivity after the procedure.
Recovery and Liquid-Only Diet
In the first few days following the procedure you may feel uncomfortable as the stomach gets used to the presence of the intragastric balloon.
Predictable side effects most patients experience include nausea, vomiting and gastric discomfort over the first week. These symptoms can be managed by the medications provided by your doctor. These conditions are normal and should be expected.
Your doctor will provide strict instructions for your hydration regimen during this period. It is critical that you drink plenty of water during the first few days and avoid eating any solid foods.
You’ll be restricted to a liquid diet for the first three days, which might include:
Thin soups or broths
The following foods will need to be avoided:
Moving to Solid Foods
After a few days on a liquid diet you’ll be ready to begin the transition to solid foods. You will start with semi-solids and gradually move to fully solid foods.
How quickly you make this transition will depend on your progress and how well your body is tolerating the liquids. It’s important to make the transition slowly and not try to rush the adjustment process.
Patients can start exercising under the advice from their doctor and support team, as soon as they feel well enough. This is usually about two weeks after their procedure.
Important things to remember for exercising:
Don’t engage in any physical activity for the first 24-48 hours
Drink cold liquids in small amounts, beginning with a teaspoon, and slowly increase the amount of the liquid as you are able. If liquid is taken in large amounts there is a higher risk of nausea and vomiting.
Your clinic will be on call for the first 24 hours or provide you with an emergency contact to handle any reactions or distress you may encounter
The Six Months of the Orbera Managed Weight Loss Program
During the six month period that the ORBERA® intragastric balloon is in place you will meet regularly with your team to monitor your progress and receive education and training. These important educational aspects of the program involve the nutrition and lifestyle changes that you must follow in order to achieve long-term success. Your regular meetings with the support team will continue for six months after the intragastric balloon is removed.
Removal of the Orbera Intragastric Balloon
Removal of the intragastric balloon takes around 20-30 minutes, similar to when it was inserted. During the removal procedure, you will be sedated and your doctor will remove the sterile salt water from the intragastric balloon before removing the deflated balloon from your stomach. It’s very important that you continue seeing your support team on a regular basis during this final six months of the program as this will set the foundations for the future.
You’ll need to prepare for removal of the ORBERA® intragastric balloon with:
No solid food 24 hours prior to the procedure
No liquids 12 hours prior to the procedure
Arrange to have assistance when you return home from the clinic
How is the gastric balloon inserted?
The ORBERATM Intragastric Balloon is a non-surgical procedure done under mild sedation. The thin and deflated Orbera balloon is placed into the stomach (through your mouth) and is then filled with saline solution until the balloon is approximately the size of a grapefruit. The procedure takes approximately 20 minutes. Once the balloon is in place, the 12-month coaching program begins.
Who is a candidate for the Gastric Balloon?
The ORBERATM Intragastric Balloon System is a weight loss aid for adults suffering from obesity.
Have a body mass index (BMI) of 30 to 40.
Have tried other weight loss programs, such as following supervised diet, exercise, and behavior modification programs, but who were unable to lose weight and keep it off.
How is the balloon removed after six months?
At six months, the balloon is removed in the same way it was placed. Through a nonsurgical procedure done under a mild sedative, it is deflated and then removed. After the removal of the balloon, the supervised weight loss program continues for an additional 6 months.
Is this a new procedure?
The FDA just approved it in the U.S. in August 2015; however, over 200,000 procedures have been performed throughout the world in over 80 countries. The procedure is being performed by a limited number of surgeons chosen and we are proud to be of one of those initial surgeons.