Obalon

The Davtyan Difference

Obalon Gastric Balloon for Weight Loss is currently used with great success at Davtyan Medical Weight Loss And Wellness. At Davtyan Medical Weight Loss And Wellness, we have been able to achieve weight loss far exceeding the national average for the Obalon Gastric Balloon. We achieve these excellent results because we truly understand your pain and frustrations in the struggle against obesity and share in your dreams. We are as committed to your success as you are.

Many people who struggle with extra weight have tried to lose the weight with dieting and exercise alone, but have been unable to achieve long term results. Thankfully there is THE OBALON GASTRIC BALLOON SYSTEM — a new non-surgical weight loss procedure that is FDA-approved.

For people who are worried about their health and don’t look or feel their best, at Davtyan Medical Weight Loss And Wellness we offer the Obalon gastric balloon system as a great option to help you succeed on your weight loss journey.

Obalon Gastric Balloon for Weight Loss The Obalon treatment procedure is made up of three lightweight, gas filled balloons that take up space in your stomach, making you feel full faster so that you end up eating less and losing weight. These balloons are placed one at a time over the course of several weeks. This allows patients to adapt and tolerate them with less side effects, leading to progressive weight loss and a better patient experience. After 6 months from the first balloon placement, the balloons are removed endoscopically under general anesthesia.

During the balloon treatment, Dr. Davtyan and his staff will support you by providing a professional diet and exercise support recommendations which will help you adopt new, healthier habits. The Obalon system essentially jump starts you on your weight loss journey, helping you lose 30-50lbs in the 6-month treatment period, while teaching you the skills you’ll need to keep the weight off for a very long time.

HOW OBALON WORKS

Insertion

The balloons are places one at a time, without sedation, in our state of the art facility. The process only takes about 15 minutes per balloon and doesn’t require any downtime
Once you swallow the capsule that contains the balloon, a thin, flexible micocatheter that is attached is used to inflate the balloon inside your stomach. The catheter is then removed once the balloon is properly inflated
The next two balloons are placed at regular intervals over the next several weeks based on your comfort level
Because the balloons are lightweight, they comfortably float at the top of your stomach
After 6 months from the first balloon placement, all three balloons are removed

Removal

All 3 balloons are removed by Dr. Davtyan during a brief outpatient endoscopic procedure, which is performed under general anesthesia for your safety.

GREAT RESULTS IN ONLY 6 MONTHS

Obalon is clinically proven to help adults achieve weight loss. Compared to just diet and exercise alone, patients who completed the Obalon program lost twice as much weight and 89% of them kept the weight off six months after the removal of the balloons when they continued with diet and exercise.

Once the Obalon balloons are placed in your stomach they stay there for no longer than six months. A healthy diet and exercise plan must be included as well. This procedure is for those who are ready to commit to developing new habits and living a healthier lifestyle. It is important that you understand this commitment before undergoing this procedure.

Obalon Gastric Balloon Surgery Before and After
*Your results may vary

The Obalon Balloon System in Spanish

Will the Obalon Balloon System limit my activity?

After the balloon is placed, patients are usually able to go back to their normal routine immediately. It’s important to note that you must avoid any medicines that may irritate your stomach such as non-steroidal anti-inflammatory drugs (NSAIDs), or Asprin during the time when the balloons are in your stomach. Another potential limitation is if you plan to move to a place which is more than 4000 feet higher or 2500 feet lower in altitude than where Dr. Davtyan placed your balloons. Please review the Safety Information and Patient Labeling sections to see which other activities are not allowed while you have the Obalon balloons placed.

What are the potential side effects of the Obalon Balloon System?

While the Obalon Balloon system has been FDA approved and proved to be safe and effective, as with any procedure, there is always the potential for complications. In the clinical trial that Obalon conducted, the complications reported were mild, mostly abdominal pain and nausea. Serious side effects only occurred in less than 0.3% of patients. Dr. Davtyan will discuss more details on the potential side effects at the complimentary consultation.

Safety Information

INDICATIONS FOR USE

The Obalon Balloon System (the “System”) is a swallowable intragastric balloon system indicated for temporary use to facilitate weight loss in adults with obesity (BMI of 30 – 40 kg/m2) who have failed to lose weight through diet and exercise. The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first balloon is placed.

CONTRAINDICATIONS

The following contraindications apply to the Obalon Gastric Balloon System:

Anatomical abnormalities or functional disorders that may inhibit swallowing or passage through any portion of the entire Gastrointestinal (GI) Tract.
Prior surgeries that may have resulted in intestinal adhesions, narrowing of any portion of the digestive tract or any other condition that may inhibit passage through any portion of the GI tract.
Persons whom have undergone any bariatric surgery procedure.
Inflammatory and other pathophysiological conditions of the GI tract.
Chronic or acute use of medications known to be gastric irritants or to otherwise alter function or integrity of any portion of the GI tract, including but not limited to NSAIDs and aspirin.
Untreated Helicobacter pylori infection.
Patients who are unable or unwilling to take prescribed proton pump inhibitor medication for the duration of the device implant.
Allergies to products/foods of porcine origin.
Patients diagnosed with bulimia, binge eating, compulsive overeating, high liquid calorie intake habits or similar eating related psychological disorders.
Patients with known history of structural or functional disorders of the stomach including, gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (> 2 cm), cancer or any other disorder of the stomach.
Patients requiring the use of anti-platelet drugs or other agents affecting the normal clotting of blood.
Pregnant or lactating women, or women with an intention to become pregnant.
Known history of duodenal ulcer, intestinal diverticula (diverticulitis), intestinal varices, intestinal stricture/stenosis, small bowel obstruction, or any other obstructive disorder of the gastrointestinal tract.
Known history of irritable bowel syndrome, radiation enteritis, or other inflammatory bowel disease, such as Crohn’s disease.
Patients taking medications on specified hourly intervals that may be affected by changes in gastric emptying, such as anti-seizure or antiarrhythmic
medications.
Alcoholism or drug addiction.

For full safety and instructions for use, visit www.obalon.com/safety-information

PRECAUTIONS

The Obalon Balloon System procedure should only be conducted by physicians specifically trained to perform the Obalon Balloon System procedure.
Prior to usage of the Obalon Gastric Balloon System, patients should have previously attempted to lose weight unsuccessfully using a medically supervised or non-medically supervised diet.
Patients using medications known to affect weight or who are undergoing chronic steroid immunosuppressive therapy should not use the treatment.
Patients should be advised not to undertake scuba diving or travel in an unpressurized airplane cabin as these activities might cause the balloons to deflate.
The safety and effectiveness of the Obalon Balloon System has not been established in patients with:
- Type 1 diabetes.
- Type 2 diabetes requiring insulin or other hypoglycemic oral agents.
- Uncontrolled hypothyroidism or Cushing’s disease or syndrome.
- Severe, unstable/uncontrolled medical conditions of major organ systems.
- Patients with known cardiovascular disease such as recent acute coronary syndrome or clinically unstable ischaemic cardiac disease including evolving or ongoing myocardial infarction, typical angina at rest, recent coronary intervention, recent deterioration of ECG, laboratory or clinical findings.
- Poorly controlled hypertension (≥160 mm Hg Systolic and ≥100 mm Hg Diastolic).
- End stage renal disease or requiring hemodialysis within the past 6 months.

PATIENT LABELING SAFETY INFORMATION

INDICATIONS FOR USE

You are a candidate for the Obalon Balloon if you have a body mass index (BMI) from 30 to 40 kg/m2 and are 22 years or older. You must be willing to follow a 12-month program. The program begins with the placement of the Obalon Balloons in your stomach for up to six months. The program includes a healthy diet and exercise program during the time that you have the balloons and for six months after the balloons are removed.

CONTRAINDICATIONS

- 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 allergies to products/foods of porcine origin. You might experience an allergic reaction to the capsule.
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 antiarrhythmic 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.
Speak to your doctor for information on other conditions that may prevent you from having the Obalon System. Additional reasons why you should not get the Obalon Balloon (contraindications) may not be known until the time of your medical history and physical with your doctor.

Things you must do to avoid serious harm (Warnings and Precautions)

WARNING: RETURN at 6 months to have the Obalon Balloons taken out. If you wait until after 6 months, 1 or more of the balloons may deflate and move from your stomach into your intestines and may cause a blockage also known as an obstruction and must be surgically taken out. This
bowel obstruction can lead to serious injury and even death.
WARNING: CALL your doctor immediately if you start experiencing a new stomach pain that is different from the stomach pains that you felt when the balloon was put in, or if the pain does not go away. If you do not, one or more of the balloons may have deflated and moved from your stomach into your intestines and cause a blockage also known as an obstruction and must be surgically taken out. This bowel obstruction can lead to serious injury and even death.
WARNING: CALL your doctor immediately if you have a sudden loss of feeling of stomach fullness. If you do not, one or more of the balloons may have deflated and moved from your stomach into your intestines and cause a blockage that must be surgically taken out.
WARNING: TAKE daily acid-blocking medicine prescribed by your doctor (examples: Prilosec, Nexium) while the Balloon(s) are in your stomach. If you do not take this medicine daily, there is a higher risk of developing a stomach ulcer or small hole in your stomach.
WARNING: DO NOT 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. Please read the warnings on any medicines that you might take to see if they can hurt your stomach. You might get ulcers or bleeding if you take these kinds of medications while the balloons are in your stomach.
WARNING: DO NOT have the balloons placed if you plan to live in a place that is at an altitude more than 4000 feet higher or 2500 feet lower than where your doctor places your balloons. Based on laboratory testing, changing where you live might cause the balloon to deflate. If the balloons deflate you may need to have an endoscopy to have them removed early from your stomach. If one or more of the deflated balloons moves from your stomach into your intestines and cause a blockage also known as an obstruction, they must be surgically taken out. This bowel obstruction can lead to serious injury and even death.
WARNING: DO NOT have the balloons placed if you plan on embarking on air travel in non- commercial aircraft. Based on laboratory testing, this type of travel might cause the balloon to deflate. If the balloons deflate you may need to have an endoscopy to have them removed early from your stomach. If one or more of the deflated balloons moves from your stomach into your intestines and cause a blockage also known as an obstruction, they must be surgically taken out. This bowel obstruction can lead to serious injury and even death. There are no restrictions for commercial airplane travel.
WARNING: DO NOT SCUBA dive while you have balloons in your stomach. SCUBA diving might cause the balloons to deflate. If the balloons deflate you may need to have an endoscopy to have them removed early from your stomach. If one or more of the deflated balloons moves from your stomach into your intestines and cause a blockage also known as an obstruction, they must be surgically taken out. This bowel obstruction can lead to serious injury and even death.
WARNING: DO NOT bite the tubing that inflates the balloon. This might cause the balloon not to inflate. If the balloon does not inflate completely, you will require an endoscopy to have them taken out of your stomach early.

IMPORTANT INFORMATION YOU SHOULD KNOW

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.

Your doctor 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.

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