Bariatric Times

MAR 2016

A peer-reviewed, evidence-based journal that promotes clinical development and metabolic insights in total bariatric patient care for the healthcare professional

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13 Emerging Technologies Bariatric Times • March 2016 INTRAGASTRIC BALLOONS: Closing the Gap on Weight Loss Treatment Options by JAIME PONCE, MD, FACS, FASMBS Bariatric Times. 2016;13(3):13–18. BACKGROUND The use of intragastric balloons for the treatment of obesity in the United States dates back to 1985 when the United States Food and Drug Administration (FDA) approved the Garren-Edwards Gastric Bubble (American Edwards Laboratories, Irvine, California), a cylindrical-shaped device that was inserted into the stomach through the mouth and then filled with 220cc of air. The device was meant to be left in the stomach for 3 to 4 months and then removed. After the product's approval, prospective, randomized, clinical trials showed that its use did not result in significantly more weight loss than diet and behavioral modification alone. 1 It was also associated with a significant number of clinical complications that included erosions, migrations, and bowel obstructions. 2 In 1992, the manufacturer (now Edwards Lifesciences) took the device off the market voluntarily. In the early 1990s, the BioEnterics Intragastric Balloon (BIB, Inamed Health, Santa Barbara, California) was developed and approved outside of the United States. Genco et al, 3 Sallet et al, 4 Lopez-Nava et al, 5 and others (see sidebar "Participants in Intragastric Balloon Research") have demonstrated good short-term weight loss and a small percentage of complications with the BIB outside of the United States. In 2008, a meta-analysis 6 of 3,442 cases showed a mean BMI loss of 5.7 points and 32.1 percent excess weight loss (%EWL) with few complications, including 0.9 percent deflations, 0.8 percent obstructions, 0.1 percent perforations, and 0.1 percent mortality. Outside of the United States, the balloon has been used successfully in patients with overweight (body mass index [BMI] ≥25–29.9kg/m 2 ), obesity (BMI ≥30–39.9kg/m 2 ), and morbid obesity (BMI ≥40kg/m 2 ), and as a bridge therapy for bariatric surgery. There are several types of balloons, including air- filled, adjustable, swallowable, and excretable. Currently, two intragastric balloon devices are FDA approved in the United States: Orbera ™ Intragastric Balloon System (Apollo Endosurgery Inc, Austin, Texas) and ReShape ® Integrated Dual Balloon System (ReShape Medical, Inc., San Clemente, California). Both are saline-filled balloons. These devices are indicated for patients with obesity (BMI 30–40kg/m 2 ). Intragastric balloons may fill the gap in the treatment of obesity between lifestyle modification/ pharmacotherapy and bariatric surgery. PROCEDURE AND PROGRAM Intragastric balloon systems were designed to create a feeling of fullness in the patient by occupying space in the stomach. With both Orbera Intragastric Balloon and Reshape Integrated Dual Balloon, the system is placed into the gastric cavity through the mouth during a minimally invasive endoscopic procedure while the patient is under mild sedation. Orbera Intragastric Balloon is a weight-loss system that uses a single gastric balloon. The Reshape Integrated Dual Balloon is made up of two connected, independently sealed balloons. The balloons are filled with sterile saline and a small amount of methylene blue. They remain in the stomach for a period of six months. The balloons in the ReShape Integrated Dual Balloon System have a fill volume of 750–900cc and are designed to conform to the natural shape of the stomach. Also, the dual balloon design reduces the potential for migration of the device from the stomach to the intestines if a balloon deflation occurs, which helps to reduce risk of intestinal obstruction. Injection of the methylene blue into the saline solution in the balloons helps to provide an indicator of balloon deflation by turning the patient's urine blue-green and signaling the need for the patient to call the physician. 7 ,8 The Orbera system is a single balloon filled with 400–700cc of saline (most commonly 550–650cc). Extensive experience internationally has shown very low rate of deflations causing migration and bowel obstruction. 6,9. After balloon insertion, patients return to the clinic monthly for the six months the balloons are in place and for six months following balloon removal, totaling 12 months of medical supervision from an experienced bariatric multidisciplinary team. During these regular appointments, the integrated health team supports the patient in adhering to the weight loss program. They help patients develop healthy weight management skills and set goals and monitor the patients' progress. OUTSIDE THE UNITED STATES EXPERIENCE Orbera intragastric balloon has an extensive clinical history in Europe and Latin America. A recent meta-analysis 9 of 82 international publications demonstrated a 13.1 percent total body weight loss at six months based on 6,845 patients. At 12 months, six months after balloon removal, the mean total body weight loss was 11.1 percent and excess weight loss was 25.4 percent. Nausea, vomiting, and E M E R G I N G TECHNOLOGIES This column investigates current research in the surgical and clinical aspects of obesity treatment and educates bariatric care professionals with the most up-to-date information on emerging t echnologies in the field. JAIME PONCE, MD, FACS, FASMBS Chattanooga Bariatrics, Chattanooga, Tennessee ABSTRACT At the end of July and beginning of August 2015, the United States Food and Drug Administration (FDA) approved two intragastric balloon systems for the treatment of obesity—the ReShape Integrated Dual Balloon System (ReShape Medical, San Clemente, California) and Orbera Intragastric Balloon System (Apollo Endosurgery, Austin, Texas). This article discusses the clinical trials evaluating the safety and effectiveness of the intragastric balloons. The author also provides an overview of how intragastric balloon systems work and discusses their role among current obesity treatments. KEYWORDS Obesity, intragastric balloons

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