The following is brief description of warnings and adverse events that can be associated with the LAP-BAND® system:

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.

Band slippage, erosion and deflation, obstruction of the stomach, dilation of the esophagus, 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.