The LAP-BAND® System

History of the LAP-BAND® System

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The advantages of laparoscopic abdominal surgery are well-known and include reduced pain and trauma, shortened hospital stay and quicker recovery. However, in the early 1990s when laparoscopic surgery became popular, laparoscopic weight-loss surgery was still a challenge due to the technical difficulties associated with patient excess weight.

LAP-BAND

Open adjustable silicone gastric banding (ASGB) was already introduced at that time by Dr. Lubomyr Kuzmak (New Jersey, U.S.). In 1991, Drs. Mitiku Belachew and M. Legrand (Huy, Belgium) working on a confidential project with INAMED (then Inamed Development Company) started the development of laparoscopic gastric banding for the treatment of the seriously overweight. After two years of design, development work and testing of various prototypes and variations of the surgical technique in an animal lab, a video of the laparoscopic adjustable gastric banding in an animal model was presented at the Annual Meeting of the American Society for Bariatric Surgery (ASBS) in June 1993.

The presentation was greeted with a lot of enthusiasm, and the first human the laparoscopic adjustable gastric banding procedure was performed on September 1, 1993, in Huy, Belgium. From September 1993 to February 1994, twenty-five consecutive patients underwent the laparoscopic adjustable gastric banding procedure in the clinical trial program in Belgium. In March 1994, the First International Workshop on laparoscopic adjustable gastric banding, including 30 surgeons from around the world, was held in Huy, Belgium.

Thereafter, more workshops were organized worldwide. A policy was developed by INAMED not to sell the device to surgeons before participating in a training program at an approved center. The requirements for surgeons before a training program included good experience in bariatric surgery as well as advanced laparoscopic skills. Experience and qualification in the management of seriously overweight patients were also necessary.

In July 1994, the LAP-BAND® System became available on the market outside the U.S. to be used by the trained surgeons. In June 1995, the Food and Drug Administration (FDA) approved clinical trials in selected U.S. centers. (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.) The LAP-BAND® System was approved for use in the United States in June 2001.

To date, over 200,000 devices have been implanted worldwide, allowing thousands of patients to lose weight and keep it off, reduce health risks and live a happier life. Benefits of this safe and least invasive procedure are now well-known in the U.S. and abroad. We at INAMED, now a division of Allergan, Inc, continue to refine the LAP-BAND® System and placement technique in conjunction with surgeons around the world to achieve better outcomes for our patients.

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 9/91 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
November, 2005 200,000 LAP-BAND® Systems implanted worldwide.
2006 First Lap-Band procedure performed by Bariatric and Minimally Invasive Surgery at Silver Cross Hospital