For Bariatric Surgeons and Their Clinical Staff
Risk Information
A BRIEF DESCRIPTION OF RELEVANT INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS, AND ADVERSE EVENTS FOR 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 comorbid conditions, or those who are 100 lbs. or more over their estimated ideal weight. The LAP-BAND® is indicated for use only in severely obese 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 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, 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 malnutrition, anemia, or other 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).
Important: For full safety information, please visit www.lapband.com or call Allergan Product Support at
CAUTION: This device is restricted to sale by or on the order of a physician.
Featured Item
Surgical Aid in the Treatment of Morbid Obesity booklet - Spanish
This pre surgery brochure should be given to all patients who want to learn more about the risk and benefits of LAP-BAND® System surgery. It includes detailed information about the potential complication of the LAP-BAND® System and is intended to fully inform every patient who decides to proceed with the LAP-BAND® System surgery. Two forms in this book need to be signed by the patient and stored in his or her file, (1) record of book receipt and (2) Informed consent