History of the LAP-BAND® Device
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Overview of the LAP-BAND® System
The presentation was greeted with a lot of enthusiasm, and the first human laparoscopic adjustable gastric banding procedure was performed on September 1, 1993, in Huy, Belgium. From September 1993 to February 1994, 25 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. Allergan developed a policy that required surgeons to be trained at an approved center before they could purchase the LAP-BAND device. Before admission to a training program, Allergan required surgeons to have:
- Significant experience in bariatric surgery
- Advanced laparoscopic skills
- Experience and qualification in managing seriously overweight patients
In July 1994, the LAP-BAND System became available on the market outside the US to be used by the trained surgeons. In June 1995, the Food and Drug Administration (FDA) approved clinical trials in selected US 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 US in a surgical procedure.) The LAP-BAND System was approved for use in the United States in June 2001.
As of 2011, 650,000 devices had been sold worldwide, allowing thousands of patients to lose weight and keep it off, reduce health risks, and live more fulfilling lives. Benefits of this safe and least invasive procedure are now well known in the US and abroad. Allergan continues to partner with surgeons across the world to improve patient outcomes by refining the LAP-BAND System and the techniques for its surgical placement.
- 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 US 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 US with the first patient surgery in the US
- June 2001: The LAP-BAND System is approved by the FDA for use in the United States
- April 2007: 300,000 LAP-BAND Systems implanted worldwide
- January 2011: 650,000 LAP-BAND System devices sold worldwide
- February 2011: The LAP-BAND System is approved by the FDA for use with people who have a Body Mass Index (BMI) of at least 30 kg/m2 with one or more obesity related co-morbid conditions