HISTORY OF THE LAP-BAND® ADJUSTABLE GASTRIC BANDING SYSTEM:
Working to improve obesity surgery and disappointed with results with early gastric band materials and methods, Dr. Lubomyr Kuzmak began using a gastric band made of silicone elastomer reinforced with polyester mesh. Dr. Kuzmak later improved this by utilizing a pouch and stoma calibration method, and by adding an inflatable portion, which allowed for percutaneous adjustments to the stoma size, This was the Adjustable Silicone Gastric Band (ASGB) System (21).
The ASGB - Adjustable Silicone Gastric Banding System:
The ASGB System included a belt-like band, which was positioned around the stomach and sutured closed. Extraneous band material was trimmed from the belt ends. The inflatable portion of the band was attached via a catheter to an access port that was placed intramuscularly. This enabled stoma adjustments to be made without the need for further surgery. The band was placed by an open procedure. A calibration tube and electronic sensor were utilized for pouch sizing and stoma calibration during placement. The ASGB System was used by surgeons in many European countries (22) (23) and in the United States as part of a FDA regulated clinical trial (24) (25).
With the advancement and proliferation of laparoscopic surgical skills and instrumentation, the patient benefits obtainable through laparoscopic surgery, and the recognition of the advantages of the ASGB System, came a demand for an adjustable gastric band that could be placed laparoscopically. In response, BioEnterics Corporation designed the LAP-BAND System to facilitate laparoscopic placement and to incorporate additional improvements. The overall design modifications included:
· A self-locking closure system which required no suturing or trimming of the band. This eliminated the need for manual tightening and suturing, and eliminated the possibility of sharp or inappropriately cut edges that might increase the possibility of band erosion or adhesions.
· Larger standard internal diameter (when empty), and a larger inflatable portion, encompassing a greater percentage of the inside circumference of the band. The appropriate stoma size is achieved by inflating the band with saline rather than tightening the band. This is designed to increase adjustability and reduce the possibility of over-tightening.
· Two band sizes selected on the basis of the measurements on ASGB bands and early clinical use in Europe. Although most surgeons utilize the smaller size, some surgeons prefer to utilize a slightly modified placement procedure with the larger size.
· A circular-shaped inflatable portion of the band allows the band to inflate evenly and smoothly without significant folds or creases. Folds can result in differential pressure on the stomach as well as pinching of tissue. These could result in tissue necrosis and subsequent erosion. In addition, similar creases in underinflated mammary prostheses has been reported to result in an unacceptably high incidence of leakage due to what is now known as "fold-flaw failure." The folded, creased silicone eventually weakens and leaks. The LAP-BAND System is designed to avoid these problems.
· Radiopacity of all components. This avoids the need to use a radiopaque liquid such as is used in other bands. Some radiopaque liquids have been reported to cause allergic reactions.
The LAGB System has been used in Europe since 1993 (22). It has been reported that laparoscopic placement of the band is less painful than open placement and is associated with reduced hospitalization and disability (26).