Eligibility

Surgeon Selection and Training Guidelines

The LAP-BAND AP^® System requires a multidisciplinary approach to patient selection, perioperative management, and long-term follow-up.

To promote successful outcomes with the LAP-BAND AP^® System, Allergan follows established surgeon selection and training guidelines. Only surgeons who comply with these guidelines are permitted to use the LAP-BAND AP^® System.

LAP-BAND AP^® System surgeon selection and training guidelines are based on:

• Guidelines for Surgical Treatment of Morbid Obesity - Issued by the American Society for Metabolic & Bariatric Surgery (ASBS) and the Society of American Gastrointestinal Endoscopic Surgeons (SAGES); and
• Guidelines for Framework for Post-Residency Surgical Education and Training issued by SAGES.

Surgeon Eligibility Requirements

Use of the LAP-BAND AP^® System is restricted to surgeons with advanced laparoscopic skill, experience in treating obese patients, and the necessary staff and commitment to comply with the long-term follow-up requirements of obesity reduction procedures.

To ensure the successful use of the LAP-BAND AP^® System, we provide the LAP-BAND AP^® System only to surgeons who have completed an Allergan-sponsored LAP-BAND AP^® System workshop.

To participate in the Allergan LAP-BAND AP^® System Training Program, surgeons must:

• Demonstrate advanced laparoscopic skills and have the ability to suture laparoscopically by confirming they have performed at least 25 Nissen fundoplication procedures
• Confirm they have performed at least 25 bariatric procedures or have completed a comprehensive bariatric surgery course detailing the issues of patient selection, procedural options, perioperative care, and long-term management
• Confirm they have established a bariatric patient support program that includes:
  • Appropriate hospital facilities
  • Exercise and nutrition counseling
  • Psychological, general medicine, and radiology support personnel
• Participate in a comprehensive educational workshop or one-on-one training on patient selection, patient support, complication management, and procedural information specific to the LAP-BAND AP^® System
• Confirm their willingness and ability to perform and support at least 25 LAP-BAND AP^® System procedures per year
• Be observed during their first band placements by surgeons experienced in LAP-BAND AP^® System placement and use
• Be willing and able to have in-service training for operating room staff by Allergan-trained specialists

Allergan believes the key to successful use of the LAP-BAND AP^® System is comprehensive screening and training of bariatric surgeons and their staff. Making the device available only to qualified, trained surgeons, helps avoid the excessive reoperation rates often associated with older, more invasive and irreversible bariatric surgery procedures.

For more information on the training needed to become a LAP-BAND AP^® System-certified surgeon, click here to contact your local Allergan sales representative.