The Obalon Balloon System is the FIRST and ONLY swallowable, FDA-approved balloon system for weight loss. The non-surgical treatment should consist of 3 lightweight balloons, placed gradually over 3 months. The balloons occupy space in your stomach so you eat less, making weight loss easier. You should expect the Obalon System to be accompanied by a professionally-supervised diet and exercise program. The Obalon Balloon System is a 6-month treatment.
The Obalon Balloon System helps facilitate weight loss by taking up space in your stomach so you eat less. During treatment you should receive professional nutrition and exercise support to help you make the lifestyle changes that facilitate weight loss. The Obalon Balloon System supports you to help change your eating habits and keep the weight off for the long-term.
The Obalon Balloon System can assist with your weight loss efforts, but your weight loss success is also dependent on your readiness to develop new lifestyle skills. The degree of long-term weight loss will depend on your ability to modify your lifestyle and maintain this behavior after the balloons are removed. It is important that you discuss your willingness to accept this commitment with your physician before undergoing the Obalon Balloon System.
The average cost, including 3 balloons, nutritional support and balloon removal, typically ranges from $6,000 to $9,000. Individual pricing may vary based on the physicians within your geography. Many physicians offer financing options to help patients achieve their weight loss goals.
You are a candidate for the Obalon Balloon System if you have a body mass index (BMI) from 30 to 40 kg/m<sup>2</sup> and are 22 years or older. The program begins with the placement of the Obalon Balloons in your stomach for up to six months. The program should be accompanied with a healthy diet and exercise program during the time you have the balloons and is recommended for six months after the balloons are removed.
In a large clinical study, the Obalon Balloon System was shown to help adults experience clinically meaningful weight loss. When combined with a diet and exercise program people lost twice as much weight as than with diet and exercise alone. An average of 89% of the total weight lost at 6 months was maintained at 1 year.
The Obalon Balloon treatment is a 6-month treatment. After the first balloon your doctor will usually have you swallow a second balloon capsule 1 month after the first balloon and a third balloon capsule 2 months after the second balloon. All balloons will be taken out 6 months after the first balloon capsule is swallowed.
Placement of the Obalon Balloon System typically takes less than 10 minutes per balloon and does not require sedation. In your physician's office, you swallow a capsule containing a small balloon and then your physician inflates the balloon. In the clinical study after placement, most patients returned to normal activities with no downtime.
At the end of the 6-month treatment period, all three balloons are removed by a brief, approximately 15 minute, outpatient endoscopic procedure which is performed under light, conscious sedation.
Three (3) lightweight, buoyant balloons are intended to be placed gradually over 3 months to maximize patient tolerability and facilitate progressive weight loss throughout the 6-month treatment period. Optimal weight loss is achieved with 3 balloons. Those treated with 3 balloons lost more than 4x as much weight as those treated with 2 balloons. All balloons must be removed 6 months after the first balloon is placed.
A fully inflated single balloon has a volume of 250cc, weighing approximately 3 grams (less than a penny) and about the size of a small orange. Therefore, all 3 balloons have a combined volume of 750cc.
Your physician will work closely with you to help develop healthy eating and exercise habits, such as making the right food choices and limiting yourself to appropriate portion sizes. Because the balloons take up space in your stomach, you won’t be able to eat the same quantity of food you previously consumed.
The Obalon Balloon System is a safe and effective, FDA-approved, non-surgical weight loss system. In our clinical trial, the majority of adverse events were reported as mild and consisted of abdominal pain and nausea. Serious side effects were less than 0.3%. Your physician will discuss more details on the potential side effects and you can find full Important Safety Information including a complete list of adverse events reported in the clinical trial in the Safety Information section.
Patients usually resume normal activities immediately after the balloon placement procedure. You cannot take any stomach irritating medicines like non-steroidal anti-inflammatory drugs (NSAIDs) or Aspirin while the balloons are in your stomach. Some examples of NSAIDs are Motrin or Advil. You cannot have the balloons placed if you plan to live in a place at an altitude more than 4000 feet higher or 2500 feet lower than where your doctor places your balloons. See the Safety Information section and Patient Labeling for contraindicated activities with the Obalon Balloon System.
It is important that you listen to the instructions provided by your physician and their staff who are available to assist you in your weight loss efforts. They will develop a follow-up schedule to further support your weight loss routine. As you become aware that you are eating less, it is important to adopt a healthy lifestyle by making healthy food choices and making exercise a priority.
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You are NOT a candidate for Obalon if:
- You have any problems with swallowing, any or prior surgeries that would make it difficult to swallow the Obalon balloon capsule.
- You take prescription aspirin, anti-inflammatory agents (such as Advil or Motrin), anticoagulants (blood thinner) or other gastric irritants daily. Taking these drugs on a daily basis increases the possibility of gastric irritations and ulcers when you have the balloons in your stomach.
- You have had prior surgeries or condition that may have led to a narrowing or blockage of your gastrointestinal (GI) tract. If 1 or more of the balloons deflates and passes into your intestines, it will cause a blockage also known as an obstruction and must be surgically removed. This bowel obstruction can lead to serious injury and even death.
- You have ever had weight loss surgery such as a gastric sleeve or lap-band. This does not include the other stomach balloons. Failure to follow this warning may result in damage to your stomach or intestines that may require surgery to repair.
- You have an untreated Helicobacter pylori infection. Having this infection increases the possibility of gastric irritations and ulcers.
- You are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant. Not taking these medications increases the possibility of gastric irritations and ulcers.
- You have been diagnosed including but not limited to bulimia, binge eating disorder, compulsive overeating disorder, or your daily diet includes very high calorie liquids. The balloons may not help you lose weight if you have these eating disorders or these habits.
- You have a history of structural or functional disorders of the stomach including, gastroparesis (stomach emptying disorder), gastric ulcer, chronic gastritis (stomach irritation), gastric varices (veins in your stomach that bleed), large hiatal hernia (> 2 cm), cancer or any other disorder of the stomach. If you have one of these disorders you may not be able to swallow the Obalon Balloon capsule, or the balloon may not inflate properly or you will have increased risk of gastric irritations and ulcers.
- You require the use of anti-platelet drugs or other agents affecting the normal clotting of blood. Use of these drugs may cause you to bleed more during the removal process of the balloons.
- You have a history of irritable bowel syndrome, Crohn’s disease, or other diseases of your bowel system. If 1 or more of the balloons deflates and passes into your intestines, it will cause a blockage also known as an obstruction and must be surgically removed. This bowel obstruction can lead to serious injury and even death.
- You are taking medications on specified hourly intervals that may be affected by changes in gastric emptying, such as anti-seizure or anti-arrhythmic medications. Placement of the balloons in your stomach may further affect gastric emptying and motility.
- You have untreated or unstable alcohol or illicit drug addiction.
- You are pregnant or nursing.
Please review the list of CONTRAINDICATIONS, WARNINGS and PRECAUTIONS here.