Product Information
A Minimally Invasive Approach to the Treatment of Obesity
The LAP-BAND® Adjustable Gastric Banding System is specially designed to limit food consumption in severely obese patients. The inflatable band forms a small gastric pouch and stoma, and can be adjusted to control the amount of food that can be consumed comfortably.
The LAP-BAND® System is designed to be placed laparoscopically and is intended for use by surgeons with advanced laparoscopic skills. Click here for more information on eligibility.
The laparoscopic placement of the LAP-BAND® System means that the procedure is done through very small incisions, with instruments passing through small tubes (ports), rather than having a large, open incision. And there is no cutting or stapling of the stomach. Because placing the LAP-BAND® System is typically performed via a minimally invasive procedure, patients are usually back home the day after the surgery. The shorter stay allows patients to resume their regular activities sooner and also places less strain on hospital resources.
Postoperative adjustments to the stoma can be made by changing the amount of saline in the band using a subcutaneous access port, eliminating the need for additional surgery to make adjustments to the band size.
Safe, Successful Weight Loss
The LAP-BAND® Adjustable Gastric Banding System is an effective way for the morbidly obese patient to lose weight, with an average excess weight loss comparable to gastric bypass surgery at 5 years post-op. One year after surgery, excess weight loss can average 44%.1 And, the
LAP-BAND® System has a perioperative severe complication rate of less than 1%.2
Patients using the LAP-BAND® System continue to absorb nutrients from their meals because their gastrointestinal tract has not been drastically altered. Patients who receive gastric bypass surgery, on the other hand, may be required to take vitamin supplements for the rest of their lives since they may not absorb the proper amounts of nutrients.
RISK INFORMATION
A BRIEF DESCRIPTION OF RELEVANT INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND ADVERSE EVENTS OF THE LAP-BAND® SYSTEM
Indications: The LAP-BAND® System is indicated for use in weight reduction for severely obese patients with a Body Mass Index (BMI) of at least 40 or a BMI of at least 35 with one or more severe co-morbid conditions, or those who are 100 lbs. or more over their estimated ideal weight.
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, who are unwilling or unable to comply with the required dietary restrictions, 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 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.
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, 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 in the Directions for Use (DFU).
CAUTION: This device is restricted to sale by or on the order of a physician.
The LAP-BAND® System contains no latex or natural rubber materials.
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