What is the Obalon Balloon System?

Obalon® Balloon SystemThe Obalon Balloon System is the FIRST and ONLY swallowable, FDA-approved balloon treatment  option for weight loss. The lightweight balloons occupy space in the stomach so people eat less which makes weight loss much easier. The non-surgical treatment lasts 6-months and is coupled with a professionally supervised nutrition and exercise program.  It truly is an exciting remarkable device that really works to help those trying to lose weight.

What is the vision behind the Obalon Balloon System?

We invented the Obalon Balloon System to be a non-surgical device for weight loss that:

  • Is designed for convenient placement
  • Achieves weight loss without severe side effects. Less than 1% of adverse events were
    severe or serious in nature
  • Facilitates progressive weight loss over the entire treatment period when combined with a moderate intensity weight loss and behavior modification program


What makes the Obalon Balloon System unique?


The Obalon Balloon System combines several high level technologies. Four distinct features are:

  1. The balloon film: novel, multi-layer, strong, smooth and durable.
    This enables the balloon to withstand the acid, enzymes and motility forces within the stomach environment. It is also bacteria resistant.
  2. The valve: designed to be used with gas, reliable, leak-free and radiopaque. This enables the balloon to maintain the inflation state during the full 6-month course of treatment. The balloons can always be viewed with digital imaging.
  3.   The capsule and catheter make the Obalon Balloon System the ONLY FDA-approved swallowable weight loss balloon. The capsule contains a fully folded balloon and the catheter is designed to be ejected, not forcefully removed.
  4. The gas makes the Obalon Balloon System the ONLY FDA-approved gas-filled weight loss balloon. Gas makes the balloon lightweight and buoyant. The proprietary nitrogen gas mixture is designed to reliably maintain the balloon inflation state during the full 6-month treatment period.

Who can get the Obalon Balloon System?

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

Obalon® Balloon System

The Obalon® Balloon System FAQs

The Obalon Balloon System helps facilitate weight loss by taking up space in their stomach so people eat less. During treatment people receive professional nutrition and exercise support to help make the lifestyle changes that facilitate weight loss. The Obalon Balloon System provides support to help change eating habits and keep the weight off for the long-term.

What commitment is required?

The Obalon Balloon System can assist with weight loss efforts, but weight loss success is also dependent on people’s readiness to develop new lifestyle skills. The degree of long-term weight loss will depend on their ability to modify their lifestyle and maintain this behavior after the balloons are removed.

What weight loss results can be expected?

In a large clinical study, the Obalon Balloon System was shown to help adults have clinically meaningful weight loss. When used with a diet and exercise program people lost up to 50 pounds. An average of 89.5% of the total weight loss was maintained at 1 year.

How long is the treatment?

The Obalon Balloon treatment is a 6-month treatment. People usually have a second balloon 1 month after the first balloon and a third balloon 2 months after the second balloon. All balloons will be taken out 6 months after the first balloon capsule was swallowed.

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

The Obalon Balloon System is a safe, effective, FDA-approved, non-surgical weight loss system. In the clinical trial, the majority of adverse events were reported as mild and consisted of abdominal pain and nausea which typically resolve within two weeks. (serious side effects were less than 0.3%). You can find this information and a complete list of contraindications, warnings and precautions at www.obalon.com/safety-information.

Will the Obalon Balloon System limit people’s activity?

There is no downtime during placements. People usually resume normal activities immediately after the balloon placement procedure.

How is the Obalon Balloon System placed?

Placement of the Obalon Balloon System typically takes less than 10 minutes and does not require sedation. During the in-office treatment, people swallow a capsule containing a small balloon that is attached to a micro-catheter. Next, the capsule location is confirmed by digital imaging verification, and then the balloon is inflated with the gas. After the inflation is completed, the catheter is detached and removed leaving the inflated balloon in the person’s stomach.

How large is the Obalon Balloon?

A fully inflated single balloon has a volume of 250cc, weighing less than 6 grams, and is about the size of a small orange. Therefore, all 3 balloons have a combined volume of 750cc.

Successful woman on Obalon® Balloon SystemHow many balloons are used during the treatment period?

Typically, three (3) lightweight, buoyant balloons are placed gradually over 3 months to maximize 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.

What happens after people get the Obalon Balloon System?

It is important to follow the techniques learned during the Obalon Balloon treatment.  As people become aware that they are eating less, it is important to adopt a healthy lifestyle by making healthy food choices and making exercise a priority.

What should people expect when using the Obalon Balloon System?

Patients with the balloon in place simply will not want to eat as much food as they normally would.  The balloon mechanically partially obstructs the ability to eat large portions of food and it puts mild pressure on the nerves that make you feel full.  Therefore, the feeling of being hungry is greatly diminished.

What is the recommended follow-up?

People should be seen 1-2 times per month for support and supervised coaching. During these visits, a registered dietician will perform weight measurements, review the person’s food intake and exercise activity and make adjustments as needed to support their weight loss.

How are the balloons removed?

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.

Is the Obalon Balloon System covered by insurance?

The Obalon Ballon System is not covered by insurance. Many practices offer financing options to help people achieve their weight loss goals.

Who cannot get the Obalon Balloon System?

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 anti-arrhythmic medications.
  • Alcoholism or drug addiction.

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.

 

About Dr. Cywes

Dr. CywesDr. Cywes is Board Certified in General Surgery and Pediatric Surgery. He specializes in Pediatric and Adult Bariatric Surgery. He has been doing bariatric surgery for 18 years and has performed around 6000 surgeries. His medical training began in Cape Town, South Africa where he received his medical degree from The University of Cape Town.

In 1989, Dr. Cywes moved to North America and completed a year-long residency in pediatric surgery at Ohio State University’s Columbus Children’s Hospital before moving to Canada where he completed his general surgery residency and specialized in minimally invasive surgery at the University of Toronto. Dr. Cywes also earned a PhD in liver transplant immunology and the effect of glucose metabolism.

After completing his pediatric surgery fellowship at the University of Michigan’s C.S. Mott Children’s Hospital, Dr. Cywes was appointed as an Assistant Professor of Pediatric and Fetal Surgery at Vanderbilt University in Nashville, Tennessee where he did hepatic stem cell research. During this time, Dr. Cywes became increasingly interested in adolescent obesity and the impact of the liver and  metabolic syndrome on young patients. Dr. Cywes’ research led to a comprehensive understanding of the toxicity of chronic excessive carbohydrate consumption as the primary cause of obesity and so-called obesity-related co-morbidities, and he became interested in developing a clinical program to treat obese adolescents using this knowledge. Dr. Cywes relocated to Jacksonville, Florida where he joined the Department of Pediatric Surgery at the Nemours Children’s Clinic and Wolfson Children’s Hospital. This led to a national meeting in Jacksonville where guidelines for adolescent obesity surgery were established.

In 2004, Dr. Cywes established Jacksonville Surgical Associates to continue his work in both adolescent and adult obesity treatment and surgery, and in 2013 opened a practice in West Palm Beach and Jupiter Florida with Tenet Healthcare. He now works with a highly experienced team of professionals from a variety of medical sub-specialties to better care for obese patients. He has developed the practice into a nationally recognized Center of Excellence for obesity surgery. The practice uses a cognitive behavioral therapy approach that addresses carbohydrate addiction, along with bariatric surgery, to help patients manage their obesity long term. Based on his extensive clinical research and observations, Dr. Cywes lectures internationally regarding the physiological impact of carbohydrate consumption as the primary cause of the current Chronic Non-Communicable Disease (CNCDs) epidemic.  He also lectures on the behavioral aspects of carbohydrate addiction as the cause of obesity and obesity-related co-morbidities and the use of substance abuse methodology, rather than a diet and exercise approach, to the effective long term treatment of obesity.

Dr. Cywes is a member of ASMBS (American Society of Metabolic and Bariatric Surgery) and is a member of the ASMBS Childhood Obesity Committee. He has earned a Centers of Excellence designation by the Surgical Review Corporation. Dr. Cywes is a proctor for the LAP-BAND system, training other surgeons to perform the operation. Dr. Cywes was one of the lead surgeons on the first US based FDA trials for the Obalon Balloon system and is experienced in placing and retrieving these devices. His results are enhanced before, during, and after balloon placement because of a robust follow-up program treating obesity using a carbohydrate addiction cognitive behavioral change program that supports the patients throughout their weight loss and maintenance journey. 

Dr. Cywes and his team are active in obesity research, including an Adolescent Bariatric Surgery trial. He has become one of the foremost authorities in the treatment and management of obesity in adolescents. Dr. Cywes’ vast experience in pediatric and general surgery serves him well in using bariatric surgery to treat obesity in both adults and children.

If you want to know more about intragastric balloons and weight loss systems you can go to:

Obalon.com, Orbera.com, www.bariatric-surgery-source.com/gastric-balloon.html

For more information on weight loss systems and treatments please call us at 561 776.9555.