LAP-BAND® Adjustable Gastric Banding System
The LAP-BAND® Adjustable Gastric Banding System is the first adjustable medical device approved by the U.S. Food and Drug Administration (FDA) in the United States for individualized weight loss for obese patients whose weight is affecting their health. The LAP-BAND® System was originally approved by the FDA in 2001 for use in weight reduction for severely obese adults with a Body Mass Index (BMI) of 40 or more, or for adults with a BMI of at least 35 plus at least one severe obesity-related health condition, such as Type 2 diabetes, hypertension and asthma. In February 2011, the FDA approved the expanded use of LAP-BAND® for adults with obesity who have failed more conservative weight reduction alternatives, such as diet and exercise and pharmacotherapy, and have a Body Mass Index (BMI) of 30-40 and at least one obesity related comorbid condition. In addition, the LAP-BAND® System has been approved internationally since 1993. The LAP-BAND® System is now the first and only FDA-approved device for weight-loss surgery in patients with a BMI of 30-35.
Over the past 18 years, more than 650,000 bands have been distributed, leading to over two million patient years of exposure for the LAP-BAND® System. This simple medical device has safely helped many obese individuals successfully achieve and maintain significant long-term weight loss to reduce the health risks associated with severe and morbid obesity. Worldwide, approximately 1.6 billion adults are overweight, and it is estimated that obesity affects at least 400 million adults.1
Designed to be placed laparoscopically (via small incisions in the abdomen, usually 0.5 - 1.5 centimeters in length), the LAP-BAND® System does not require stapling of the stomach. Instead, an inflatable band is placed around the top portion of the patient's stomach, creating a small pouch that limits or reduces food consumption. The LAP-BAND® System is adjustable, which means that the inflatable band can be tightened or loosened to help the patient achieve a level of satiety while maintaining a healthy diet, supporting a patient's long-term weight loss success. Speak with your physician or bariatric surgeon about whether LAP-BAND® is right for you.
Important Safety Information
Indications: The LAP-BAND® System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 2 with one or more obesity related comorbid conditions.
It is indicated for use in adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives.
Contraindications: The LAP-BAND® System is not recommended for non-adult patients, patients with conditions that may make them poor surgical candidates or increase the risk of poor results (e.g., inflammatory or cardiopulmonary diseases, GI conditions, symptoms or family history of autoimmune disease, cirrhosis) who are unwilling or unable to comply with the required dietary restrictions, who have alcohol or drug addictions or who currently are or may be pregnant.
Warnings: The LAP-BAND® System is a long-term implant. Explant and replacement surgery may be required. Patients who become pregnant or severely ill, or who require more extensive nutrition, may require deflation of their bands. Anti-inflammatory agents, such as aspirin, should be used with caution and may contribute to an increased risk of band erosion.
Adverse Events: Placement of the LAP-BAND® System is major surgery and, as with any surgery, death can occur. Possible complications include the risks associated with the medications and methods used during surgery, the risks associated with any surgical procedure and the patient's ability to tolerate a foreign object implanted in the body.
Band slippage, erosion and deflation, reflux, obstruction of the stomach, dilation of the esophagus, infection or nausea and vomiting may occur. Reoperation may be required.
Rapid weight loss may result in complications that may require additional surgery. Deflation of the band may alleviate excessively rapid weight loss or esophageal dilation.
Important: For full safety information, please visit www.lapband.com, talk with your doctor or call Allergan Product Support at 1-800-624-4261.
CAUTION: Rx only.