Identifying Initial Patients

Identifying Initial Patients

The decision to perform bariatric surgery on a severely obese patient requires assessing the risk-benefit ratio in individual cases. Candidates must meet the criteria for LAP-BAND^® System 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.

LAP-BAND^® System Indications for Use

The LAP-BAND^® System is indicated for use in morbidly obese patients who:

• Have a BMI ≥ 40 kg/m²
• Have a BMI ≥ 35 kg/m2 with one or more severe comorbid conditions
• Are ≥ 100 pounds over their estimated ideal body weight
• Have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modifications programs
• Are willing to make the commitment to accept significant changes in their eating habits for the rest of their lives
• Are willing to adhere to post-operative care and follow-up

Contraindications

The LAP-BAND^® System is contraindicated for:

• Non-adult patients (< 18 years of age)
• Patients with conditions that may render them poor surgical candidates or increase the risk of poor results
• Patients who are unwilling or unable to comply with dietary restrictions, which are required by this procedure
• 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 Directions for Use for a complete listing of the contraindications.

These Indications for Use are consistent with the NIH/NHLBI Patient Selection criteria.

NIH, NHLBI Patient Selection Criteria¹ :

Weight-loss surgery is an option in carefully selected patients who meet the following criteria:

• Clinically severe obesity (BMI ≥ 40 kg/m2)
• BMI ≥ 35 kg/m2 with comorbid conditions
• Have failed less invasive methods of weight loss
• Are at high risk for obesity-related comorbidity or mortality

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