A brief description of relevant contraindications, warnings and adverse events of the LAP-BAND® System
Indications: The LAP-BAND System 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 35 with one or more severe co-morbid conditions, or those who are 100 lbs. or more over their estimated ideal weight.
Contraindications: The LAP-BAND System is not recommended for non-adult patients, 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 LAP-BAND System 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 LAP-BAND System 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.
Potential risks include something called slippage (3/100 people), where the band or the stomach can move out of the normal position. This can cause vomiting or
In a few cases, a dense adhesion ring forms between the band and the stomach. This band may cause vomiting, pain, and obstruction that is not reversible unless a second operation to cut this scar. Usually, this dense scar is not found until a couple of years after the operation.
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. More detailed risk information is available at www.lap-band.com or 1-877-LAP-BAND.