FDA Expands Use of Weight Loss Banding System
The Food and Drug Administration has expanded the use of Allergan's LAP-BAND Adjustable Gastric Banding System, a device implanted around the upper part of the stomach to limit the amount of food that can be eaten at one time.
The Feb. 16, 2011, approval expands the use of the LAP-BAND to include obese individuals with a BMI of 30 to 34 who also have an existing condition related to their obesity.
FDA approved the LAP-BAND in 2001 for use in severely obese patients with a body mass index (BMI) of at least 40, those with a BMI of at least 35 and who also have an existing severe condition related to their obesity, such as heart disease or diabetes, or those who are at least 100 pounds overweight. BMI is a general measure of body fat based on an individual's weight and height.
The LAP-BAND is intended to be used for weight loss in adults who have not lost weight using non-surgical weight loss methods. The newly-approved indication is limited to patients with a BMI of 30 to 34 and at the highest risk of obesity-related complications. This represents a narrower indication than originally sought by Allergan. The company had also proposed to expand the indication to include people with a BMI of 35 to 39 and no obesity related condition. Patients using the LAP-BAND must be willing to make major changes to their lifestyle and eating habits.
"Obesity is a major public health concern in the United States," said William Maisel, M.D., M.P.H., deputy director for science at the FDA's Center for Devices and Radiological Health. "A healthy lifestyle and weight loss are keys to improvements in health and a person’s overall quality of life."
Use of the LAP-BAND in patients with BMIs between 30 and 40 was examined in a U.S. study. Results showed that 80 percent of patients lost at least 30 percent of their excess weight and kept it off for one year. Some patients in the study lost no weight, while others lost more than 80 percent of their extra weight.
In the same study, more than 70 percent of patients experienced an adverse event related to LAP-BAND, most often vomiting and difficulty swallowing. The events ranged from mild to severe but most were mild and resolved quickly.
Seven out of 149 patients needed other procedures after implantation: four to remove the LAP-BAND, two for port revisions, and one to reposition the LAP-BAND.
The LAP-BAND works by limiting the amount of food that can be eaten at one time and increasing the time it takes for food to be digested, to help people eat less. It is placed around the upper part of the stomach during a surgical procedure. The band creates a small stomach pouch that holds a small amount of food.
The LAP-BAND should not be used in certain people, for example, those who are poor candidates for surgery, have certain stomach or intestinal disorders or an infection, take aspirin frequently, or are addicted to alcohol and/or drugs. It should also not be used in those not able or willing to follow dietary and other recommendations.
The LAP-BAND is marketed by Allergan Inc., based in Goleta, Calif. For more information on FDA's device approvals and clearances, click http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm.