The History of the LAP-BAND® Adjustable Gastric Banding System

alex · 04-10-2008, 01:07 AM

Many potential and post-surgical patients are well aware of the distinct advantages of laparoscopic surgery - reduced pain and trauma, shorter hospitals stays, and faster recovery. However, in the early 1990's, when this type of surgery became popular, laparoscopic weight loss surgery was not yet perfected.

An American surgeon, Dr. Lubomyr Kuzmak (New Jersey) did introduce open adjustable silicone gastric banding (ASGB) at this time. In 1991, Allergan (then Inamed Development Company) began a confidential project with two Belgian surgeons, Drs. Mitiku Belachew and M. Legrand, developing innovative laparoscopic gastric banding for the treatment of significant excess weight. The first human laparoscopic adjustable gastric banding procedure was performed on September 1, 1993, in Huy, Belgium, and a clinical trial program was started at the same time. Upon its conclusion, in March 1994 the First International Workshop on laparoscopic adjustable gastric banding, including 30 surgeons from around the world, was held in Huy, Belgium.

Additional workshops were held internationally, and Allergan set a strict policy that only surgeons who have participated in a training program at an Allergan-approved center would be allowed access to the Lap Band® System. Any surgeon utilizing the Lap Band® System must have good experience in bariatric surgery, in addition to advanced laparoscopic skills. Each surgeon must also be qualified and experienced in the treatment of seriously overweight patients.

In July 1994, the Lap Band® System became available on the market outside the U.S. to be used by the trained surgeons. After the Food and Drug Administration (FDA) established U.S.-based clinical trials in 1995 (The FDA regulations require clinical trials in approved centers before an implantable device, such as the Lap Band® System, can be used widely in the U.S. in a surgical procedure), they approved the Lap Band® System for general use in June 2001. To date, over 350,000 Lap Band® System devices have been distributed worldwide to allow thousands of patients to lose and control their weight, reduce their health risks, and live happier, more active lives. Allergan continues to refine the Lap Band® System and surgical technique in conjunction with surgeons around the world to achieve better outcomes for our patients. The latest generation of the Lap Band® System - the Lap Band AP® - became available to U.S. patients in 2007.

Timeline

June 1986 First use of open adjustable silicone gastric banding (ASGB)
April 1990 First use of ASGB in Europe
December 1990 ASBG FDA-approved clinical trial started in the U.S. with the first patient surgery
September 1991 First ASGB workshop in Europe
September 1993 First laparoscopic adjustable gastric band used in Europe
March 1994 First Lap Band® System workshop in Europe
June 1995 Lap Band® FDA-approved clinical trial started in the U.S. with the first patient surgery in the United States
June 2001 The Lap Band® System is approved by the FDA for use in the United States
January 2008 350,000 Lap Band® Systems sold worldwide.