Intragastric Balloon Placement for Weight Loss

Michael C. Bennett, MD

Shelby Sullivan, MD

Intragastric balloons (IGBs) are endoscopically placed devices intended for the management of obesity. They work by occupying space in the stomach and delaying gastric emptying.¹ IGBs have been proven to outperform monitored diet and exercise programs in randomized controlled trials.²,³,⁴

As of this writing, three IGBs have been approved by the United States Food and Drug Administration (FDA): the ReShape Integrated Dual Balloon System (ReShape Medical, San Clemente, CA), the Orbera Balloon (Fig. 41.1, Apollo Endosurgery, Austin, TX), and the Obalon Balloon System (Fig. 41.2, Obalon Therapeutics, Carlsbad, CA). The ReShape Integrated Dual Balloon System, however, is no longer being manufactured and will not be discussed further. The Orbera balloon is a single, fluid-filled balloon made of medical-grade silicone that can be inflated to between 400 and 700 mL. It is placed endoscopically and removed endoscopically 6 months after placement. The Obalon Balloon System is a swallowable gas-filled intragastric balloon system comprises three balloons, each filled with 250 mL of a nitrogen-mix gas and removed endoscopically 6 months after administration of the first balloon.

INDICATIONS

Intragastric balloons should be considered for patients with:

Body mass index (BMI) between 30 and 40 kg/m²
Previous unsuccessful weight loss or weight maintenance attempts with lifestyle intervention alone
BMI outside accepted range above but with medical conditions necessitating weight loss and contraindications to alternate modalities, e.g., surgical therapy⁵

FIG. 41.1 Single fluid-filled balloon (Orbera Balloon). (Reprinted from Abu Dayyeh BK, Edmundowicz SA, Jonnalagadda S, et al. Endoscopic bariatric therapies. Gastrointest Endosc. 2015;81(5):1073-1086. Copyright © 2015 American Society for Gastrointestinal Endoscopy. With permission.)

CONTRAINDICATIONS

Prior foregut or bariatric surgery
Structural disorder of the gastrointestinal (GI) tract, such as stenosis, neoplasm, hiatal hernia (>2 cm for Obalon and >5 cm for Orbera), or congenital anomaly

Inflammatory or erosive disorders affecting the GI tract, such as esophagitis, ulcer disease, Crohn disease

FIG. 41.2 Swallowable gas-filled intragastric balloon system (Obalon Balloon System). Panel A, balloon in capsule attached to catheter. Panel B, balloon fully inflated. (Reprinted from Sullivan S, Swain J, Woodman G, et al. Randomized sham-controlled trial of the 6-month swallowable gas-filled intragastric balloon system for weight loss. Surg Obes Relat Dis. 2018;14(12):1876-1889. Copyright © 2018 American Society for Bariatric Surgery. With permission.)

Motor disorders, such as achalasia or gastroparesis
Conditions with potential for upper GI bleeding, such as varices or telangectasiasbullet
Coagulopathy
Severe comorbid conditions such as cirrhosis
Use of anticoagulants, antiplatelet medications, nonsteroidal anti-inflammatory drugs (NSAIDs)
Inability to take proton pump inhibitor (PPI)
Uncontrolled psychiatric illness, especially addiction or eating disorders
Pregnancy or breast feeding⁶,⁷

PREPARATION

Orbera (Single Fluid-Filled Intragastric Balloon) Placement

Routine preprocedure laboratory evaluation may include complete blood count, comprehensive metabolic panel, coagulation testing, lipid evaluation, hemoglobin A1c, testing for Helicobacter pylori infection, and pregnancy testing if applicable.
Use of a PPI is recommended while the IGB is in place. Begin use of a daily PPI 1 week prior to placement and continue for duration of IGB dwell.
A suggested regimen of antiemetics and antispasmodics beginning the day of placement and continuing until symptoms resolve: sublingual ondansetron 8 mg every 8 hours and sublingual hyoscyamine 0.125 mg every 4 hours, and aprepitant 40 to 80 mg taken 4 hours prior to placement can be used. Scopolamine patch placed the night before and promethazine can also be considered. Patients may also need pain control for the first few days after placement.
Prior to balloon placement, patients should have no food or drink for 12 hours.
Saline-filled balloons can be placed under moderate sedation or with monitored anesthesia care.

Orbera Removal

72 hours prior to balloon removal, patients should adhere to a full liquid diet, further restricting to a clear liquid diet 24 hours prior to removal. No food or drink should be consumed for 12 hours prior to the procedure.
Saline-filled balloon removal can be performed under monitored anesthesia care or general anesthesia.

Obalon (Swallowable Gas-Filled Balloon System) Placement

Patients considering Obalon IGBs should successfully complete swallows of one placebo Obalon capsule to ensure ability to swallow the encapsulated IGB.
A contrast esophagram is recommended to rule out structural contraindications such as large hiatal hernia or esophageal stricture.
Routine preprocedure laboratory evaluation may include complete blood count, comprehensive metabolic panel, coagulation testing, lipid evaluation, hemoglobin A1c, testing for H. pylori infection, and pregnancy testing if applicable.
Use of a PPI is recommended while the IGB is in place. Begin use of a daily PPI 1 week prior to placement and continue for duration of IGB dwell.
Antiemetics and antispasmodics should be used at the time of placement to reduce the incidence of side effects. A suggested regimen beginning the day before placement and continuing for 4 days includes sublingual ondansetron 8 mg every 8 hours and sublingual hyoscyamine 0.125 mg every 4 hours. This should be repeated for all three balloons, which are administered 2 to 4 weeks apart.
Prior to balloon placement, patients should have no food or drink for 12 hours.
Obalon balloon placement does not require sedation.
Fluoroscopy or digital x-ray is required for visualization of the balloon during placement.

Obalon Removal

All balloons are removed 6 months after the first balloon was administered.
Patients should be on liquids 24 hours before removal and should have no food or drink for 12 hours before removal.
Obalon balloon removal can be performed with monitored anesthesia care or general anesthesia.

EQUIPMENT

Obalon placement requires fluoroscopy, digital x-ray if using the EZ Fill Dispenser or the Obalon Navigation System with Touch Dispenser. Orbera placement and removal, and Obalon removal, require standard equipment for a diagnostic upper endoscopy, in addition to the following for each device:

Orbera Placement