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Risk Information
A brief description of relevant contraindications, warnings and adverse events of the adjustable gastric band (AGB)
Indications:
The AGB is indicated for use in weight reduction for severely obese patients with a Body Mass Index (BMI) of at least 40 or a BMI of at least 30 - 35 with one or more severe co-morbid conditions, or those who are 100 lbs. or more over their estimated ideal weight.
Contraindications:
The AGB is not recommended for non-adult patients (will be evaluated on a case-by-case basis), patients with conditions that may make them poor surgical candidates or increase the risk of poor results, who are unwilling or unable to comply with the required dietary restrictions, or who currently are or may be pregnant.
Warnings:
The AGB is a long-term implant. Explant and replacement surgery may be required at some time. Patients who become pregnant or severely ill, or who require more extensive nutrition may require deflation of their bands. Patients should not expect to lose weight as fast as gastric bypass patients, and band inflation should proceed in small increments. Anti-inflammatory agents, such as aspirin, should be used with caution and may contribute to an increased risk of band erosion.
Adverse Events:
Placement of the AGB is major surgery and, like any surgery, death can occur. Possible complications include the risks associated with the medications and methods used during surgery, the risks associated with any surgical procedure, and the patient’s ability to tolerate a foreign object implanted in the body.
Band slippage, erosion and deflation, obstruction of the stomach, dilation of the esophagus, port problems, infection, or nausea and vomiting may occur. Reoperation may be required.
Rapid weight loss may result in complications that can require additional surgery. Deflation of the band may alleviate excessively rapid weight loss or esophageal dilation.
(Not all contraindications, warnings or adverse events are included in this brief description.)
