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 higher, or a BMI of at least 35 with one or more co-morbid conditions. It is indicated for use only in severely obese adult patients who have failed more conservative weight reduction alternatives such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant and permanent eating habits.

Only qualified surgeons (surgeons with advanced laparoscopic surgical skills and experience with obesity surgery) who have participated in a training program authorized by the manufacturer or authorized distributor should implant the LAP-BAND System.

Surgeons should have previous experience in treating obese patients and have the staff and commitment to comply with the long-term follow-up requirements of obesity procedures.