Gastric Ballooning for Moderate Weight Loss

The ORBERA™ Managed Weight Loss System is unlike anything you have ever experienced. It’s not a diet. It’s not surgery. It’s not a pill. It’s a novel and proven system to unlock the “you,” you’ve always known you can be. We know you’re finally ready to achieve and enjoy the weight results you’ve dreamed of. We’re here to help you.

What is ORBERA™

The ORBERA™ Managed Weight Loss System is a safe* and effective, non-surgical program for weight loss – with proven results.

This weight loss journey is made up of three important parts and begins with a medically placed device, the ORBERA™ System intragastric (inside the stomach) balloon, which is inserted temporarily into your stomach to encourage portion control. In conjunction with education and training to build a personalized habit changing action plan and a support team of experts to join you on your journey, the ORBERA™ System provides a kick-start to healthy, sustained weight loss.

The ORBERA™ System has already become a clinically accepted treatment for weight loss in Europe and South America and is being introduced to Canada and Australia.

ORBERA™ System Intragastric (inside the stomach) Balloon:

The ORBERA™ System device is a soft, silicone balloon that is inserted into the stomach and filled with sterile water. With the balloon you will have a feeling of satiety, or lack of hunger. The balloon will be removed after six months. With the help of the ORBERA™ System, you can more easily adopt the lifestyle changes needed to lose weight.

Support Team Of Experts:

Experienced weight-loss professionals that may include physicians, nutritionists, psychologists and exercise therapists will consult with you and design a program to help successfully reach and maintain your weight-loss goals. Your team will be there every step of the way with encouragement and support. Your support team of experts may include the following:

• Physician
• Dietitian
• Exercise therapist
• Psychologist
• Other specialists

Education And Training:

During the regularly scheduled meetings with your team, you will learn the principles needed to manage your weight and promote long-term health. Some of these include nutrition, exercise, eating behaviours, and psychological issues related to food. While learning, you will be motivated by your success and turn these principles into habits that will serve you the rest of your life.

How does the ORBERA™ System work?

The ORBERA™ System consists of a soft, expandable intragastric (inside the stomach) balloon that is temporarily inserted into the stomach to create a feeling of early and prolonged fullness after meals – a foundation for weight loss. The device itself is a soft silicone intragastric balloon that is inserted (without surgery) in a deflated state into the stomach and then inflated with sterile water through a self-sealing valve once it enters the stomach. The intragastric balloon will remain in place for a maximum of 6-months.

The intragastric balloon provides a 6-month kick-start to healthy weight loss and is an ideal solution if you are looking to lose 20-40lbs but are fearful of surgery, fed up with diets, pills and other weight loss programs that didn’t work.

The ORBERA™ System is a life changing, three pillared approach to achieving – and sustaining – your weight loss goals, once and for all.

During those 6 months (and beyond) you will work together on a customized plan with your support team of weight loss experts, to overcome the challenges of retraining your appetite, adopting new nutritional habits, and establishing a reasonable exercise routine to help you succeed and stay motivated.

The ORBERA™ System has already become a clinically accepted treatment for weight loss in Europe and South America and is being introduced to Canada and Australia.

Explaining the procedure

The balloon is inserted in a deflated state by an endoscopic procedure. Once inside the stomach the balloon is immediately filled with sterile water through a small filling tube. The balloon has a self-sealing valve and once it is filled the catheter is gently removed. Once it has been filled, the balloon will be too large to leave the stomach.

Placement procedure times can vary between 20 to 30 minutes.

Immediately after the placement you will regain complete awareness but will remain in the clinic for observation for a period of 1 – 2 hours. After this the physician will discharge you into the custody of the person who will take you home.

Side effects such as nausea, vomiting, bloating, diarrhea and cramping will be experienced during the first few days as your stomach gets used to the presence of the balloon. These side effects can often be managed by medication prescribed by your physician.

How much weight loss can be expected?

The amount any patient will lose depends entirely on how well they adapt to the ORBERA™ System, alter their eating behaviour, and adopt an exercise regimen. A good aim is to try and average a loss of 2lbs per week, and studies have shown that with the ORBERA™ System, patients can lose 20-40lbs in six months.

Experience has shown that 70-80% of a patient's weight loss typically occurs during the first three months of treatment4. After that time, the presence of the intragastric balloon plays a supportive role in helping patients to maintain their new nutrition and exercise habits.

Clinical Support for the ORBERA™ System

The health risks of being overweight, in terms of cardiovascular disease, Type 2 diabetes, musculoskeletal disorders and some cancers are well known.

“…Recent evidence from a large prospective, 10 year follow-up of over 500,000 middle aged men and women showed a two-three fold greater risk of mortality in obese than non obese individuals, and a 20-40% increased risk of death in overweight subjects – confirming the dangers of excess body weight at all levels.”

As part of a supervised diet and lifestyle modification program, ORBERA™ System is a useful tool in helping patients with a qualifying BMI and previous poor record of dietary success to achieve significant weight loss over the six months that the device and support program are in place.

The ORBERA™ System, used in conjunction with a managed weight loss program, including a supervised diet and lifestyle modification, is designed to increase the possibility of sustaining weight loss. The ORBERA ™ System is indicated for a maximum placement duration of six months.

FACT: ORBERA™ System experts from Italy, Brazil, Spain and Canada conducted a survey, in person or over the phone, with 186 current (40%) and post-removal (60%) patients. Eighty-seven percent of patients were satisfied to very satisfied with the intragastric balloon and 85% would recommend the intragastric balloon to others.

FACT: International ORBERA™ System experts, with experience in over 6,000 patients, have collaborated to identify a global standard of care for ORBERA™ System patients. Key issues, which are addressed, are: selecting, preparing and monitoring patients, placing and removing the intragastric balloon and optimizing successful outcomes.

FACT: Overweight and obese patients are a major health challenge for physicians working in a wide range of specialties and the long term risks of all levels of excess body weight are well recognized. The ORBERA™ System has proven efficacious and safe* since its introduction in 1997. Improvements of the intragastric balloon’s outer shell and valve were introduced in 2004 and, in the experience of the expert panel, no leakages or deflations have been seen with over 80,000 ORBERA™ System placements.

Who is a candidate?

While the ORBERA™ System does not require surgery, any medical procedure requires careful thought and consideration. Moreover, the ORBERA™ System is not going to be for everyone.

To qualify for the ORBERA™ System you must be

• At least 18 years old
• Overweight with a BMI of at least 27
• Motivated and ready to comply with a serious, medically supervised program

The ORBERA™ System advantage

The ORBERA™ System has several advantages over other weight-loss plans. With the ORBERA™ System you can:

• Have a feeling of fullness sooner and longer after meals to encourage portion control – no more hunger!
• Lose more weight than with other diet programs – achieve success!
• Be supported by a team of medical experts – we’re in this together!
• Learn principles for long-term success – so you can keep that lost weight off!
• Have the benefits of a non-surgical, non-pharmaceutical approach – easy as not eating pie!

Frequently Asked Questions:

Q: What exactly is The ORBERA™ managed weight loss system?
A: The ORBERA™ managed weight loss system is not a magic pill, but a set of tools to change your lifestyle: The intragastric balloon device to help kick-start your weight loss; A team of experts to guide you; and education and training to help you achieve a sustainable weight loss goal.

Q: How will my weight-loss results compare with other diet programs?
A: You can expect to lose more weight with the ORBERA™ System. Because you will feel full sooner and longer after small meals – a result of the intragastric balloon placed in stomach - you are better able to control your eating and make healthy changes in your eating habits.

Q: How is the intragastric balloon device placed and removed from my stomach without surgery?
A: Placement of the balloon generally takes about 20-30 minutes during which you will be lightly sedated. The deflated balloon is inserted into your stomach through your mouth (endoscopically). Immediately after the balloon is placed and filled with sterile water, you will regain complete awareness and remain in the clinic for observation until the doctor discharges you. The intragastric balloon is removed through the mouth in a similar manner, under the same supervised conditions.

Q: Will this intragastric balloon device limit my activity?
A: The first week you should not plan any heavy activity. Once your body has adjusted to the intragastric balloon however, you can continue your normal activities. Starting a regular exercise program is highly recommended and will improve your success.

Q: Can I eat anything I want? Are there specific food or alcohol restrictions?
A: You will not feel like eating as much as you used to. In addition, if you eat fatty foods or sweets, you may feel sick. Excessive overeating while the intragastric balloon in place can be dangerous and can result in a serious medical condition. Alcohol in moderation is fine.

Q: What about side effects or complications?
A: The first three to five days can be very difficult. Cramping, nausea and vomiting are normal and should be expected. It is very important that you follow your doctor’s instructions and drink plenty of fluids. Your doctor may prescribe you medications to help ease the discomfort.

Q: How long will it take to recover after the procedure?
A: You should plan at least three days of inactivity to recover from the procedure. You will be able to resume normal activity sooner or later than this depending on how quickly your body adjusts to the intragastric balloon.

Q: Will I be able to feel the intragastric balloon in my stomach?
A: There will be discomfort during the first few days. After that, the primary sensation of the device is a feeling of fullness.

Q: Does the ORBERA™ System require frequent visits to my doctor after the procedure?
A: The follow-up program is critical to success with the ORBERA™ System, and in learning new lifestyle skills. You should meet with your physician and support team at least monthly while the intragastric balloon is in place. During this time your progress will be evaluated and you will learn valuable principles of health, nutrition, and exercise that will provide you with a foundation for long-term success.

Q: Who do I talk about this, and where do I go to get the ORBERA™ System?
A: A qualified and trained physician is the best person to answer questions you may have and the only person who can start you on the ORBERA™ System weight loss journey. There are several such physicians practicing across the country: [Hyperlink: Find A Clinic]

Q: Why can the device only be used for 6 months?
A: The ORBERA™ System intragastric balloon must be removed after six months. If the intragastric balloon is not removed at this time interval, it can leak and deflate. It will likely pass through your body naturally, however in some cases it may need to be removed by your doctor.

Q: How quickly will I lose the weight?
A: The time frame for weight loss will vary from patient to patient, and will depend to large degree on how well they adapt to the ORBERA™ System, alter their eating behaviour, and adopt an exercise regimen. However, experience has shown that 70-80% of a patient's weight loss typically occurs during the first three months of treatment.

Q: Will I regain the weight after the ORBERA™ System is removed?
A: Patients who alter their eating behaviour, and adopt an exercise regimen have seen the greatest and most sustained success. There are no miracles in weight loss, as you well know.

Q: Will my insurance company cover the cost or offer assistance for this procedure?
A: Coverage varies for each insurance company. Please contact your insurance company and supply them with category number B-50000. We also strongly encourage you to contact a clinic near you for specific procedure costs and payment plans they offer.

Q: Does the Government offer assistance for this procedure?
A: Unfortunately, the government does not currently offer assistance for the ORBERA™ System procedure. There may be opportunities to receive a medical expense tax credit for this procedure. We encourage you to contact your accountant for assistance.