Orbera is a balloon-based weight loss system that fills up your stomach to trick your body into thinking it’s full. Here’s our Orbera review.
What is Orbera?
Orbera is a medical product classified as an intragastric balloon system, which just means that it goes inside your stomach.
The balloon fills up inside your stomach to occupy space. By occupying space in your stomach, Orbera makes it easy to eat less while still feeling full. When you eat less, you lose weight.
Although the balloon goes inside your body, Orbera is officially classified as a non-surgical weight loss system. The balloon promises to help anyone kickstart to weight loss system – especially if they have previously been unsuccessful with traditional dieting, exercise, or supplement-based diet programs.
How Does Orbera Work?
Orbera is classified as a non-surgical weight loss treatment because you only have to undergo a small procedure to start the Orbera program.
The balloon is installed through a minimally-invasive endoscopic procedure. Typically, patients are only under mild sedation while the balloon is inserted. The balloon is attached to a small tube.
The balloon is inserted in its deflated form. Then, once the balloon is in place in the stomach, the doctor performing the procedure will fill the balloon with saline solution.
Depending on the size of your stomach and your health goals, the balloon will be filled with either 400 or 700 cc of saline solution.
As the saline solution fills the balloon, Orbera expands into a spherical shape, occupying a significant portion of your stomach.
You now physically have a large sphere in your stomach taking up a lot of space. You can now eat smaller amounts of food while still feeling full.
After undergoing the Orbera procedure, your medical provider will typically leave it in place for about 6 months, after which the balloon will be deflated and removed.
The entire installation process takes less than 30 minutes from beginning to end. Patients can typically resume their normal activity immediately after the procedure, as recovery times are short and side effects are minimal.
The FDA Approves the Use of Orbera in 2015
Orbera has been around for 20 years. So why are Americans just hearing about this treatment now?
The reason is that the FDA only recently approved the use of Orbera for weight loss surgery in August, 2015.
On August 5, 2015, the FDA officially approved the use of Orbera as a product ready to be marketed to consumers across America. In their official statement, the FDA said that “the device is used in obese adult patients who have a Body Mass Index (BMI) of 30 to 40kg/m2 who have been unable to lose weight through diet and exercise.”
Orbera is also significant for American consumers because it’s the first intragastric balloon system approved for use in America. Previously, Americans who wished to undergo Orbera treatment or similar balloon-based treatments would travel to Mexico or Canada to have the procedure performed.
Prior to 2015, Orbera was an approved weight loss treatment in other parts of the world – including Australia, Canada, Mexico, India, and other countries around the world. In fact, the balloon-based weight loss treatment has been used for over 20 years in countries all over the world.
Scientific Evidence for Orbera
In order to receive FDA approval, Orbera had to demonstrate its legitimate weight loss results on a large group of people. After the results of that study were published and analyzed by the FDA, the organization approved the treatment.
Here are some key points from that study:
— The study lasted for one full year and involved 255 patients
— During the study period, 125 patients received the Orbera device and took part in a “12-month behavior modification program” while 130 patients participated in the 12-month behavior modification program without receiving the device
— The patients who received the Orbera device had the device removed after 6 months, while the study continued to follow these patients for 6 months afterwards
— Patients who used the Orbera device lost 21.8 pounds on average, or 10.2% of their body weight, after the device had been in place for just six months
— Patients who used the Orbera device received a checkup 3 months after the device was removed, and these patients were observed to have maintained an average weight loss of 19.4 pounds
— Meanwhile, the patients who never received the device (but still participated in the weight loss program) also lost weight, but they only lost an average of 7.0 pounds or 3.3% of their body weight
Orbera Side Effects and Safety Concerns
As you can imagine, placing an inflated balloon inside your body isn’t something for everybody.
Although the FDA has approved the use of Orbera has a generally safe weight loss procedure, there are still some safety concerns and side effects related to the device.
First and most importantly, Orbera is not a recommended treatment for all patients who want to lose weight. The FDA advises that patients with the following symptoms and conditions should not use Orbera:
— You already have an intragastric balloon within your body
— You have had prior gastrointestinal or bariatric surgeries
— You have any inflammatory disease in your gastrointestinal tract
— You have (or have the potential to develop) upper gastrointestinal bleeding conditions
— You have a large hiatal hernia
— You have a structural abnormality in the esophagus or pharynx that would block the insertion of Orbera
— You have serious esophageal motility disorders
— You have a gastric mass
— You have or have had severe clotting or bleeding disorders, including coagulopathy
— You have liver failure (also known as hepatic insufficiency) or cirrhosis
— You are known to have or suspected to have an allergy to the materials used in Orbera
— You have any other medical condition that would not permit elective endoscopy
— You suffer from a serious prior or present psychiatric illness
— You suffer from alcoholism or a drug addiction
— You are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of time the Orbera device is in your body
— You are unable or unwilling to participate in a medically supervised diet and behavior modification program with routine medical follow-up
— You are receiving aspirin, anti-inflammatory agents, blood thinners, or other gastric irritants
— You are pregnant or breastfeeding
As long as you don’t meet any of that long list of conditions, you’re safe to use the Orbera device in the eyes of the FDA. Obviously, talk to your doctor about Orbera because he or she will know your unique characteristics better than anyone.
It’s also important to note that the FDA approved the use of Orbera only when installed by skilled physicians in a supervised medical setting and is also removed within 6 months.
The FDA also claims that the device will have the best effects on those who have a BMI over 27 or those who are at least 27 pounds overweight.
The device is also recommended to be used by those who have struggled to lose weight through traditional diet or exercise. It shouldn’t be the first weight loss system you try.
What to Expect After your Orbera Procedure
After your Orbera procedure, you’ll need to follow the specific directions from your health care provider to ensure you stay safe and healthy.
First, you can expect some mild gastric discomfort, nausea, and vomiting for the first 3 to 5 days. This is a normal and expected part of Orbera, as your body is adjusting to the foreign object inside your body. Doctors may choose to prescribe medications to help you manage these symptoms.
During the first 3 days, you’ll also be forbidden from eating anything but liquids. Doctors will tell you to drink lots of water during these first 3 days. Other recommended items include soups, broths, milk, juices, and gelatins.
Certain types of foods and beverages are forbidden during the first 3 days: you can’t eat any solid foods, fatty foods, chocolate, or ice cream, for example. You’ll also be forbidden from drinking carbonated beverages and coffee.
Once the 3 day transition period is over, it’s recommended that you slowly re-introduce solid foods to your diet, starting by eating things like soups and fruit purees. The adjustment period will vary according to your body’s unique characteristics.
Orbera isn’t just a weight loss device: it’s an entire weight loss system. That’s why 2 weeks after the device is installed, your doctor will recommend that you start a specific exercise program to maximize the effects of Orbera.
How Much Weight Can You Expect to Lose?
Orbera and other intragastric balloon surgeries typically come with specialized diet and exercise advice. You’re not just paying for the procedure and the device: you’re paying for the complete weight loss system.
With that in mind, following a healthy diet and exercise routine while using Orbera is expected to lead to 30 to 40 pounds of weight loss for obese individuals during the first 6 months.
By continuing to follow the recommended diet and exercise systems from your doctor, you can continue to keep that weight off after the device is removed. However, if you fall back to your old eating habits, then you’re unlikely to keep the weight off.
Orbera Removal Process
The Orbera removal process is similar to the initial Orbera insertion.
24 hours before the removal, you’ll need to stop eating solid foods. 12 hours before the removal, you stop drinking liquids.
You’re sedated for the removal procedure. To start, the doctor will “suck out” the saline solution from the Orbera device before removing the deflated balloon.
You’re kept under observation for 20 to 30 minutes to ensure there are no complications, and then you’re done!
Typically, doctors recommend that you have someone pick you up after this procedure.
It’s important to note that the safety of Orbera has only ever been studied for a 6 month period, during which it has proven to be very safe. However, leaving the balloon in for longer than 6 months can be dangerous. As one doctor on RealSelf.com explained,
“No. You can not keep the balloon in longer than 6 months. The ballon has only been studied for 6 months. The danger of leaving it longer is that it can lose its fluid and then migrate into your intestines and cause an obstruction requiring emergency surgery or even death. It is very safe during the 6 month period.”
Who Makes Orbera?
Orbera is made by a company named Apollo Endosurgery, Inc. That company is a medical equipment maker based in Austin, Texas and describes itself as “a world leader in minimally invasive endoscopic surgical products for gastrointestinal procedures.”
Other systems made by the company include gastrointestinal products like the OverStitch endoscopic suturing system and the LAP-BAND gastric banding system.
To date, over 220,000 people in 80 countries around the world have used Orbera for weight loss. Since Orbera was approved for use in August 2015, it’s unclear how many Americans have undergone the procedure.
How to Get Orbera
Orbera is now available at clinics across America and around the world. Sometimes, finding Orbera in your area is as easy as Googling “Orbera [your city]” or [your state].
In other cases, you can contact the makers of Orbera directly using this online form or by calling 1-855-MYORBERA directly, in which case you can get in touch with an Orbera provider in your area.
Here’s another important question people want to know before undergoing Orbera: how much does Orbera cost?
Typically, Orbera costs between $5,500 and $8,000 USD at clinics across America (and a similar amount in local currencies around the world).
The RealSelf.com page for Orbera does not yet have enough reviews to determine its “Worth It” rating, but stay tuned to this page to see what future customers have to say about the procedure.