Important LAP-BAND^® System Safety Information

Indications: The LAP-BAND AP^® Systems is indicated for use in weight reduction for severely obese patients with a Body Mass Index (BMI) of at least 35 or a BMI of at least 30 with one or more severe comorbid conditions, or those who are 100 pounds or more over their estimated ideal weight according to the 1983 Metropolitan Life Insurance Tables (use the midpoint for medium frame). It is indicated for use only in severely obese patients 14 years and older 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. Weight loss associated with the LAP-BAND^® System has been shown to improve or lead to remission of type 2 diabetes in patients with BMI greater than or equal to 35.

Contraindications: The LAP-BAND^® AP System is not recommended for patients under 14, 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^® AP 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^® AP 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 contact LapBandEU@ReShapeLifesci.com , or talk with your doctor.