INTRODUCING THE OBALON BALLOON SYSTEM


Many people have tried and failed a diet plan. You may be concerned about your health and self-conscious of your appearance, which can keep you from doing what you love. Now you have a treatment option to aid in your weight loss journey.

The Obalon Balloon System is FDA-approved and non-surgical. The 3-balloon system helps facilitate weight loss by taking up space in your stomach so you eat less.  During treatment you will receive professional diet and exercise support to help you make the appropriate lifestyle changes. The Obalon Balloon System is designed to help jump-start long-term weight loss.  Three lightweight, buoyant balloons are placed gradually over 3 months to maximize patient tolerability and facilitate progressive weight loss throughout the 6-month treatment period. When combined with diet and exercise, studies show that 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.

 

WHAT TO EXPECT FROM THE OBALON BALLOON SYSTEM

 

 

 

 

Insertion procedure
• Each balloon placement is done in your physician’s office, typically taking less than 10 minutes, with no downtime.

• Swallowable capsule contains the balloon and allows for placement without the need for sedation.

• Thin, flexible micro-catheter facilitates balloon inflation and is gently removed after each placement, leaving the inflated balloon behind.

• Two additional balloons will be placed gradually over 3 months to maximize patient tolerability and facilitate  progressive weight loss

• Lightweight, buoyant balloons, residing in the top of the stomach, are designed for patient comfort

• All balloons must be removed 6 months after the first balloon is placed.

Removal procedure
All 3 balloons are removed by a brief, approximately 15-minute outpatient endoscopic procedure, which is performed under sedation.

 

POSITIVE RESULTS AFTER 6 MONTHS
In a large clinical study, the Obalon Balloon System was shown to help adults experience clinically meaningful weight loss. Patients lost twice as much weight as diet and exercise alone. Six months after the balloons were  removed, 89% of the weight lost was kept off, when combined with diet and exercise.
AM I A CANDIDATE?
You are a candidate for the Obalon Balloon System if you have a body mass index (BMI) from 30 to 40 kg/m2 and are 22 years or older. The program begins with the placement of the Obalon balloons in your stomach for up to 6 months. The program includes a healthy diet and exercise plan. Talk to Dr. Simoni to see if Obalon is right for you.
Your weight loss success is dependent on your readiness to develop new lifestyle skills.

 

See Dr. Oz’s video

 

FREQUENTLY ASKED QUESTIONS
How large is the Obalon Balloon System? 
A fully inflated single balloon is about the size of a small orange and weighs approximately 3 grams (about a penny).

How many balloons are used during the treatment period?
Three 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. All balloons must be removed 6 months after the first balloon is placed.

What are the potential side effects of the Obalon Balloon System?
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 a complete list of adverse events reported in the clinical trial on our website, www.obalon.com, in the safety information section.

Will placement of the balloons limit my activity?
Patients usually resume normal activities with no downtime after the balloon placement procedure.

AM I A CANDIDATE?
You are a candidate for the Obalon Balloon System if you have a body mass index (BMI) from 30 to 40 kg/m2 and are 22 years or older. The program begins with the placement of the Obalon balloons in your stomach for up to 6 months. The program includes a healthy diet and exercise plan. Talk to Dr. Simoni to see if Obalon is right for you.
Your weight loss success is dependent on your readiness to develop new lifestyle skills.

 

 

 

DOCTORS AND PATIENTS PRAISE THE OBALON BALLOON SYSTEM

 

IMPORTANT INFORMATION YOU SHOULD KNOW

What are the differences between Obalon and other balloons?

The major difference between Obalon and the other two systems (ReShape and Orbera) is that Obalon is gas filled, while the other two are fluid filled.  However, the table below gives you more details:

You are not a candidate for the Obalon Balloon System if:
• You have any problems with swallowing, or have had any 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 conditions 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 allergies to products/foods of porcine origin. You might experience an allergic reaction to the capsule.
• You have been diagnosed with (including but not limited to) bulimia, binge eating disorder, or 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.

Dr. Simoni will discuss this and other important information with you to see if you are a candidate for the Obalon Balloon System.

For full Important Safety Information including Patient Labeling, go to www.obalon.com/safety-information.

The Obalon Balloon System is intended for adults with a body mass index (BMI) of 30 to 40 kg/m2 willing to follow a diet and exercise program. All Obalon balloons must be removed in 6 months. Patients with prior weight loss surgeries are not eligible. The most common side effects reported were mild abdominal pain and nausea, which typically resolved within 2 weeks. You must take daily acid-blocking medicine prescribed by Dr. Simoni.

 

 

Reach out to us today to see how we can help you

Advanced Gastroenterology, Inc.

Phone: (805) 719-0244

Fax: (805) 777-1730

555 Marin Street, Ste. 270

Thousand Oaks, CA 91360

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