Identifying Initial Patients

Identifying Initial Patients

The decision to perform bariatric surgery on an obese patient requires assessing the risk-benefit ratio in individual cases. At a minimum, candidates must meet the NIH criteria for bariatric surgery and must be able to care for themselves or have an adequate home-based caregiver during the postoperative and long-term follow-up process.

NIH, NHLBI Patient Selection Criteria¹ : Weight-loss surgery is an option in carefully selected patients with clinically severe obesity (BMI >40 or BMI >35 with comorbid conditions) when less invasive methods of weight loss have failed and the patient is at high risk for obesity-associated morbidity or mortality.

1. Excerpted from NHLBI. Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults: Executive Summary.

Allergan, Inc. Corporation Patient Selection Guidelines

Intended Use/Indications

The Allergan LAP-BAND^® System is indicated as a weight-reduction strategy for severely obese patients with a BMI >40, or a BMI >35 with one or more severe comorbid conditions, or patients >100 pounds over their estimated ideal weight according to the 1983 Metropolitan Life Insurance Tables. 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 changes in their eating habits for the rest of their lives.

Contraindications

The Allergan LAP-BAND^® System is contraindicated in non-adult patients, patients with conditions that may render them poor surgical candidates or increase the risk of poor results, or who are unwilling or unable to comply with dietary restrictions, which are required by this procedure. Placement of the Allergan LAP-BAND^® System is contraindicated for patients who currently are or may be pregnant. Patients who become pregnant after band placement may require deflation of their bands. Not all contraindications have been included. Please refer to the DFU for a complete listing of the contraindications.