The minimally invasive procedure is the only adjustable and reversible surgical weight-loss option available in the United States.
The LAP-BAND system, manufactured by INAMED Health, was approved by the FDA in June 2001 for use in adults. It has not received FDA approval for use in teens.
In the current trial, 50 patients ages 14 to 17 will be enrolled in a five-year study to look at weight loss and the long-term medical effects of weight loss after the LAP-BAND procedure.
In addition to surgery, patients will receive nutrition and psychological counseling. They will also be involved in a physical activity and behavior management program.
The surgery is available for teens with a body mass index of at least 35 and one or more obesity related conditions such as diabetes, hypertension, sleep apnea, or musculoskeletal, gynecological or psychological problems.
It is also available for teens with a body mass index of greater than 40 with no other health problems. Patients must have a history of obesity for at least five years, including failed attempts at diet and medical management of their obesity.
The adjustable gastric band is usually placed laparoscopically, requiring only small keyhole incisions, during outpatient surgery. It offers several advantages over gastric bypass surgery, including reduced pain, a shorter hospital stay and recovery period.
During LAP-BAND surgery, an adjustable silicone band is placed around the stomach to help the patient lose weight. The band separates the stomach into a small upper pouch and a larger lower pouch. When patients eat, the small upper pouch fills quickly, leaving the patient feeling full.
The band is connected to an access port just under the skin on the abdomen. The port allows the physician to adjust the tightness of the band by adding or removing fluid. This adjustability allows the system to change to suit the patient's weight loss needs, such as during illness or pregnancy.
Placement of the adjustable gastric band does not require any cutting or stapling of the stomach or bypass of the intestines. The band can also be removed at any time, unlike irreversible gastric bypass surgery, and the stomach returns to normal.
In studies, the mortality rate for the LAP-BAND surgery is approximately 0.01 percent, compared to 0.5 percent among gastric bypass patients. The incidence and severity of surgical complications are also significantly reduced.
Obesity is the second leading preventable cause of death in the United States and is increasingly affecting children and adolescents. In the United States, an estimated 10 to 15 percent of adolescents are obese.
According to the American Academy of Pediatrics, the prevalence of overweight and obesity among children and adolescents has doubled in the past two decades.
"The advantages of using LAP-BAND are clear in adult patients and we believe the same will hold true for teens," said Dr. Victor Gonzalez. "The use of the LAP-BAND provides significant weight loss with lower morbidity and mortality rates than gastric bypass in adults."
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