Feb. 17, 2011 -- Allergan Inc. has announced that the FDA has approved the Lap-Band Adjustable Gastric Banding (LBAGB) System for obese adults with at least one obesity-related medical condition.
The Lap-Band is an inflatable band that is placed around the upper part of your stomach; it helps limit the amount of food that can enter your stomach.
The FDA's approval means Lap-Band surgery will now be available to patients with a body mass index (BMI) of 30 or higher who have at least one obesity-related condition, such as diabetes.
Previously, the Lap-Band system could only be used in adults with a BMI of at least 40 or a BMI of 35 or higher with at least one severe obesity-related medical condition.
Obesity and the Lap-Band
Obesity is a growing global health threat. About 37 million Americans have a BMI of 30 to 40 and at least one obesity-related condition, according to a news release issued by the Lap-Band manufacturer. Obesity increases your risk for serious diseases, including diabetes, high blood pressure, heart disease, stroke, and even some types of cancer.
The Lap-Band is now the only FDA-approved device for weight loss surgery in people with a BMI of 30 to 35. However, it should only be used when diet changes and other weight loss therapies have not worked.
"The Lap-Band System meets an unmet clinical need, as it provides an effective treatment option, which is used in combination with diet and exercise, to enable sustained weight loss,” clinical trial investigator Robert Michaelson, MD, PhD, of Northwest Surgical Weight Loss Surgery in Everett, Wash., says in a news release.
The Lap-Band is a long-term implant that requires significant diet changes and a commitment to stick to new eating habits.
It should not be used in children, pregnant women, or patients who may have diseases or conditions that increase the risk of complications or poor results. Such conditions include alcohol or drug addiction, cirrhosis, GI disorders, heart or lung problems, inflammatory disease, or a personal or family history of autoimmune disease.
Measuring Success With the Lap-Band
The expanded approval is based on a review of data from a five-year study of the LBAGB system in patients with a BMI between 30 and 40, either with or without a co-existing obesity-related health problem. The study included 149 patients who had been obese for an average of 17 years.
In order for the trial to be considered successful, at least 40% of patients had to lose a "clinically meaningful" amount of weight in one year. That meant each patient had to lose at least 30% of their excess weight or lose the weight above their medically determined ideal weight.
About 84% of patients in the study lost at least that much weight within a year of the Lap-Band surgery. In fact, more than 65% were no longer considered obese after that time. Patients kept the weight off during the second year of the study. The manufacturer plans to continue to follow the progress of the Lap-Band patients for five years.