LAP-BAND® Adjustable Gastric Banding System
The LAP-BAND® Adjustable Gastric Banding System is the first adjustable medical device approved in the United States for individualized weight loss. The LAP-BAND® System was approved by the U.S. Food and Drug Administration 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. Used in more than 300,000 procedures worldwide, this simple medical device has safely helped many seriously overweight 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 million 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 cutting or 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
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, who are unwilling or unable to comply with the required dietary restrictions, or who currently are or may be pregnant.
The LAP-BAND® System is a long-term implant. Explant and replacement surgery may be required at some time. Patients who become pregnant or severely ill, or who require more extensive nutrition may require deflation of their bands. Patients should not expect to lose weight as fast as gastric bypass patients, and band inflation should proceed in small increments. Anti-inflammatory agents, such as aspirin, should be used with caution and may contribute to an increased risk of band erosion.
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, 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.
Not all contraindications, warnings, or adverse events are included in this brief description. More detailed risk information is available at www.lapband.com or 1-877-LAP-BAND. This is a brief introduction. Please contact your physician or surgeon regarding possible risk and benefits of obesity surgery. This device is restricted to sale by or on the order of a physician.