BioEnterics® LAP-BAND® System FACT SHEET

The BioEnterics LAP-BAND Adjustable Gastric Banding System (INAMED Health, Santa Barbara, CA) is the newest surgical treatment for morbid obesity in the United States. It induces weight loss by reducing the capacity of the stomach, thereby restricting the amount of food that can be consumed at one time. 
Like a wristwatch, the band is fastened around the upper stomach to create a new, tiny stomach pouch. As a result, patients experience an earlier sensation of fullness and are satisfied with smaller amounts of food. Since there is no cutting, stapling, or stomach rerouting involved in the LAP-BAND System procedure, it is considered the least traumatic of all weight loss surgeries. The surgeon makes several tiny incisions and uses long, slender instruments to implant the device. By avoiding the large incision of open surgery, patients generally experience less pain and scarring. In addition, the hospital stay is shortened to less than 24 hours, including overnight hospitalization. Patients can typically resume normal activities within 1 week, which is quicker than with other surgical alternatives.
The LAP-BAND System is an adjustable silicone band that connects to an access port below the skin by thin, kink-resistant silicone tubing. The port allows the surgeon to adjust the size of the band for a customized weight-loss rate for each patient. By adding or removing saline to inflatable balloon on the inner surface of the band, the amount and consumption rate of food can be controlled. Adjustments to the band, which are performed during simple outpatient visits, are determined by the patient’s weight loss, the amount of food that can be comfortably eaten, the exercise regimen, and other issues surrounding the patient’s health.

 The BioEnterics LAP-BAND System
Because no permanent changes are made to the body’s physiology, the procedure can essentially be reversed. If necessary, all of the system components can be removed from the body with no damage to the digestive organs. The stomach will generally return to its original form and capacity once the band is removed.
 
The effectiveness of the LAP-BAND System depends on the success of the surgical procedure and the ability of the patient to change his or her diet and eating behavior. Clinicians offering the LAP-BAND System treatment have committed to being able to provide long-term care for their patients, including dietary, behavior-modification, and counseling support. After surgery, LAP-BAND System patients must maintain scheduled follow-up visits. Follow-up may require four or more visits during the first year and include a review of the patient’s progress and discussion of any concerns or problems that are pertinent at that time. Patients are encouraged to eat a balanced diet and to avoid the problematic eating patterns of their pre-surgery lifestyle. The restrictive effect of the band produces feelings of early satiety and longer-lasting fullness. This reinforces the patient’s ability to be content with smaller meals when solid food is eaten and well chewed. At the appropriate time, patients are encouraged to increase physical activity and exercise, which is very important to weight loss, good health, and improved quality of life.
 
To date, more than 100,000 patients worldwide have undergone the LAP-BAND System procedure. Since the Food and Drug Administration’s approval of the LAP-BAND System in June 2001, interest in and use of the LAP-BAND System have been rapidly growing in the U.S. In line with its FDA-approved guidelines for indications, the LAP-BAND System is intended for people who are morbidly obese—those who are at least 100 pounds overweight or who are at least twice their ideal body weight. The term “morbidly” connotes the fact that individuals who carry this much excess weight face an increased risk of developing a number of serious health conditions, including diabetes, high blood pressure, cardiovascular disease, cancer, and osteoarthritis.
 
In February 2002, a report released by the United States Food and Drug Administration Office of Device Evaluation named the LAP-BAND System as one of the Significant Device Breakthroughs. The Office of Device Evaluation highlighted the LAP-BAND System with several other new products as significant medical breakthroughs “as they are first of a kind, e.g., they use a new technology or provide a major diagnostic or therapeutic advancement, such as reducing hospital stays and replacing the need for surgical intervention.”
 
For more information on the LAP-BAND System, please visit lap-band.com or call 877-LAP-BAND (877-527-2263).