Proctored Surgeries

All prospective LAP-BAND AP^® System surgeons must be proctored on their initial cases by an Allergan-approved proctor experienced in the use of the LAP-BAND AP^® System. This requirement is in accordance with the ASMBS/SAGES joint guidelines.

Proctoring facilitates the transfer of the technical aspects of advanced laparoscopic procedures. Proctors are surgeons with recognized proficiency or documented expertise in the specialty area being proctored. Typically, two proctored surgeries are required before a surgeon can be certified for LAP-BAND AP^® System surgery.

The Framework for Post-residency Surgical Education & Training includes proctoring as a component of post-residency surgical education. The guidelines stipulate that certain clinical situations, or simple humanitarian concerns, may dictate that the proctor become a consultant to the applicant or actually intervene to assist in a procedure.

The Allergan training and proctoring policy stipulating that an extensively experienced surgeon be scrubbed into the initial proctored cases was important in the FDA's approval of the LAP-BAND AP^® System. Allergan believes proctoring significantly shortens the learning curve of newly trained surgeons and potentially reduces unnecessary peri-operative complications. The process has been repeated thousands of times around the world and at more than 1,000 centers in the US.

It is the proctor's responsibility to pass or fail the surgeon being proctored. Generally, two surgical cases are adequate for newly trained surgeons to demonstrate they possess the necessary skills to proceed independently. In rare situations, a surgeon may need further proctoring to reach the required skill level. Allergan relies on the professional judgement of our proctors to identify these rare situations.

Allergan's policy stipulates that the surgeon must attend a second workshop if proctoring does not occur within one year of the initial workshop date. Additionally, completion of a fellowship that includes LAP-BAND AP^® System experience does not eliminate or replace Allergan's obligation with the FDA conditions of approval to provide training and proctoring.

1. American Society for Metabolic & Bariatric Surgery and Society of American Gastrointestinal Endoscopic Surgeons. Guidelines for laparoscopic and open surgical treatment of morbid obesity. Obes Surg. 2000;10:378-379.