A Study of the Laparoscopically-placed Adjustable Gastric Band for the Management of Obesity in Adolescent Patients

Inclusion Criteria:

- BMI >= 35 kg/m2 and at least one serious comorbidity (type 2 diabetes mellitus,
moderate or severe obstructive sleep apnea, pseudotumor cerebri, and severe
steatohepatitis)

- BMI => 40 kg/m2 and a serious comorbidity (as listed above or at least one other
comorbidity (mild obstructive sleep apnea, hypertension, insulin resistance, glucose
intolerance, dyslipidemia, impaired quality of life or activities of daily living)

- Must live in Dallas/Fort Worth area so that necessary follow-up can be ensured.

Exclusion Criteria:

- Intention to have another surgical procedure for weight reduction within 12 months of
LAP-BAND® placement

- History of pregnancy, or the intention to become pregnant within the next 12 months

- History of substance abuse within one year prior to surgery

- Obesity caused by medically correctable condition

- History of gastric or esophageal surgery, or the presence of an esophageal dysmotility
disorder

- Eating disorder that is untreated

- Chronic use of aspirin and/or nonsteroidal anti-inflammatory medications and
unwillingness to discontinue the use of these medications

- History of previous bariatric surgery, intestinal obstruction, or peritonitis

- Presence of localized or systemic infection at the time of surgery

- History of congenital or acquired anomalies of the gastrointestinal tract

- History of immunocompromise, or auto-immune, hematologic or dermatologic condition
that increases risk of bleeding, breakdown of skin integrity (due to port), or
infection.

- Planning to or having high likelihood of moving out of region within 2 years

- Portal Hypertension or Cirrhosis

- Uncorrectable coagulopathy or severe bleeding disorder

- Use of weight loss medications within 6 weeks of procedure