Clinically severe obesity has been categorized as being approximately 100 pounds over the patient’s estimated ideal weight, as provided in the 1983 Metropolitan Life Height and Weight Tables, or a body mass index (BMI) of 40. BioEnterics Corporation, in its most recent LAP-BAND System Clinical Trial Protocol, No. LAGB-001B (FDA – IDE #G950047) states that potential candidates for the clinical study must have a BMI of at least 40, or a BMI of at least 35 with one or more co-morbid conditions. The BMI will be calculated as follows:

Weight (Kg) divided by height (m) squared: ( w h2 ) or ( Kg m2 )

Obesity is a known risk factor for a number of medical conditions associated with serious mortality and morbidity. The reduction in quality of life and premature death are the major burdens placed on society and are directly associated with both obesity and diseases (co-morbidities) for which obesity is the primary contributing factor (1). Obesity is directly linked to several chronic diseases and disabilities such as diabetes and cardiovascular disease (2).

Because there are serious health risks associated with severe obesity as well as negative societal repercussions for the obese patient, considerable attention has been given toward obesity therapy. The treatment of obesity is approached by two different methods, non-surgical treatment and obesity surgery.