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Consumer Information on: LAP-BAND Adjustable Gastric Banding System - P000008/S017

Thu, 03/24/2011 - 12:34pm
U.S. Food & Drug Administration

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: LAP-BAND® Adjustable Gastric Banding System

PMA Applicant: Allergan, Inc.

Address: 71 S. Los Carneros Road, Goleta, CA

Approval Date: February 16, 2011

Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/p000008s017a.pdf

What is it? The LAP-BAND® System is a surgically implanted device that helps adults, who are at least 18 years old, eat less and lose weight. The LAP-BAND® consists of a silicone band, tubing, and an access port. The inner surface of the silicone band is inflatable and is connected by the tubing to the access port.

How does it work? The band is placed around the upper part of the stomach during a surgical procedure. The band is connected to an access port that is placed close to the skin. Later, the surgeon can adjust the band (adding or removing fluid) by piercing the access port through the skin with a needle. The band creates a small stomach pouch that can hold only a small amount of food. The narrowed opening between the stomach pouch and the rest of the stomach controls how fast food passes from the pouch to the lower part of the stomach. Inflating the band (adding saline) makes the opening smaller, causing food to pass slower. Deflating the band (removing saline) makes the opening larger, permitting food to pass faster. The band limits the amount of food that can be eaten at one time and increases the time it takes for food to be digested, helping people to eat less.

When is it used? The LAP-BAND® System is used for weight loss in obese adults who have a Body Mass Index (BMI) of 30-40, with one or more obesity-related medical conditions (such as Type II diabetes and hypertension), and when non-surgical weight loss methods (such as supervised diet, exercise, and behavior modification) have not been successful. Patients must be willing to make major changes in their eating habits and lifestyle.

What will it accomplish? The LAP-BAND® System will help patients lose weight and maintain the weight loss, and it may help improve their health. In a U.S. study of patients with a BMI between 30-40, 80% of patients lost at least 30% of their excess weight and kept it off for one year. There were some patients who lost no weight and others who lost over 80% of their excess weight. The quality of life for patients enrolled in the study improved significantly.

When should it not be used? It should not be used for someone who is a poor candidate for surgery, has certain stomach or intestinal disorders, has to take aspirin frequently, or is addicted to alcohol or drugs. It should not be used if someone is not able or willing to follow dietary and other recommendations.

Additional information : Summary of Safety and Effectiveness and labeling are available online.

Other Resources:

    

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