Gastric Balloon Procedure
Overview
The Gastric Balloon is a soft silicone balloon that is inserted into the stomach using a routine gastroscopy procedure and inflated with saline through a self-sealing valve. By partially filling the stomach, the Gastric Balloon induces feelings of satiety, thus reducing food intake and aiding weight loss. It is indicated for temporary use in weight-loss therapy for overweight and obese patients with a body mass index (BMI) >= 27 kg/m2.
The health risks of being overweight, in terms of cardiovascular disease, Diabetes Type 2, 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 2-3 fold greater risk of mortality in obese (BMI > 30) than non obese individuals, and a 20-40% increased risk of death in overweight (BMI > 25) subjects - confirming the dangers of excess body weight at all levels1.
National and international obesity guidelines demonstrate the importance of a range of effective pharmacological, psychological, endoscopic and surgical treatments, tailored to the needs of individual patients2-5.
The Gastric Balloon, used in conjunction with a long-term supervised diet and lifestyle modification programme, is designed to increase the possibility of sustaining long-term weight loss. The balloon is designed for maximum placement duration of six months.
Intragastric balloons have been used in the management of obesity for over 20 years. Early devices proved unsatisfactory due to their design, construction and integrity. The BIB system (now known as the Orbera System), which was originally introduced in 1997, addressed many of the concerns of previous devices. The device has undergone significant refinements and improvements to the acid resistant shell and valve design which were completed in 2004. Accumulating clinical experience indicates that this superior device is effective, reliable and well tolerated by patients6-8. As a result, there is growing interest in the use of the Gastric Balloon from physicians involved in the management of overweight and obese patients.
International intragastric balloon experts with experience in over 6000 patients collaborated on an Expert Consensus paper9, which forms the basis for the material to follow. The goal was to identify a global standard of care for managing the Gastric Balloon patient. Key issues addressed are: selecting, preparing and monitoring patients, inserting and retrieving the balloon and optimising outcomes.
Introduction
The Gastric Balloon system was introduced in 1997 and over 80,000 units have been implanted to date. Improvements to the balloon’s outer shell and valve were introduced in 2004 and the system has been shown to be safe and effective.
As part of a supervised diet and lifestyle modification programme the Gastric Balloon is a useful tool in helping patients with a BMI 27+ and previous poor record of dietary success to achieve significant weight loss over the six months that the device is in place.
The device may also help patients modify their eating behaviour to sustain weight loss post-removal.
To achieve the best outcomes, patients should be carefully selected, fully informed of the benefits and potential side effects of the procedure, well motivated and possessing realistic expectations for success.
Patient EligibilityGastric Balloon References:
1. Adams KF, et al., Overweight, Obesity, and Mortality in a Large Prospective Cohort of Persons 50 to 71 Years Old. New England Journal of Medicine 2006; 355: 763-7782. Fried M, et al., Inter-disciplinary European guidelines on surgery of severe obesity. International Journal of Obesity 2007; 31: 569-577
3. Buchwald H. Consensus Conference Statement. Bariatric surgery for morbid obesity: Health implications for patients, health professionals, and third-party payers. Surgery for Obesity and Related Diseases 2005; 1: 371-381
4. Lau DCW for the Obesity Canada Clinical Practice Guidelines Steering Committee and Expert Panel. Synopsis of the 2006 Canadian clinical practice guidelines on the management and prevention of obesity in adults and children. Canadian Medical Association Journal 2007; 176; 1103-1106
5. National Institute for Health and Clinical Excellence. Clinical guideline 43. Obesity guidance on the prevention, assessment and management of overweight and obesity in adults and children, December 2006
6. Genco A, et al. BioEnterics Intragastric Balloon: The Italian Experience with 2,515 Patients. Obesity Surgery 2005; 15: 1161-1164
7. Sallet JA, et al. Brazilian multicenter study of the intragastric balloon. Obesity Surgery 2004; 14:991-998
8. Mathus-Vliegen EM, Tytgat GN. Intragastric balloon for treatment-resistant obesity: safety, tolerance, and efficacy of 1-year balloon treatment followed by a 1-year balloon-free follow-up. Gastrointest Endosc. 2005;61:19-27
9. Cobourn C. et al., Expert Approaches to Weight Loss Management, Issue 1, The Allergan ORBERA™ Managed Weight Loss System
