The LAP-BAND^® System Patient

Obesity: A National Epidemic

According to the US Census Bureau, 43% of the American population is overweight or obese. Approximately 15% of this group, equivalent to about 19 million people, is severely or morbidly obese with a Body Mass Index (BMI) of 35 or greater. It is estimated that these numbers will increase significantly over the coming years. By 2012, nearly half of the population will be classified as overweight or obese with a BMI of 25 or greater, and approximately 16%, or about 25 million Americans, will be severely or morbidly obese. Fortunately, there is something we can do now to help people control their weight and keep these projected numbers from becoming a reality.

Identifying the LAP-BAND^® Adjustable Gastric Banding System Patient Candidates

The LAP-BAND^® System is indicated for use in morbidly obese patients who have:

• A BMI of at least 40, or a BMI of at least 35 with 1 or more severe comorbid conditions,
  or those who are 100 pounds or more over their estimated ideal weight
• Failed more conservative weight loss treatments, such as a medically supervised diet, exercise, and behavior modification programs
• Made a commitment to accept significant changes in their eating habits for the rest of
  their lives

What You Should Know About the Procedure

The LAP-BAND^® Adjustable Gastric Banding System is inserted laparoscopically. The slip-through buckle design of the LAP-BAND^® System facilitates placing the band around the stomach. The procedure itself generally takes anywhere from 30 minutes to an hour depending on the amount of experience the physician has working with the LAP-BAND^® System.

Three techniques can be used to place the band: perigastric, where dissection starts on the lesser curve at the midpoint and continues behind the stomach toward the angle of His; pars flaccida, where dissection begins lateral to the midpoint in the space of the pars flaccida and continues over to the angle of His; and pars flaccida to perigastric, which begins with the pars flaccida technique, but ends with the band being placed from the angle of His through to the perigastric opening.

Perigastric technique	Pars flaccida technique	Pars flaccida to perigastric

Information on Follow-up and Aftercare

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.

The LAP-BAND^® Adjustable Gastric Banding System gives you the opportunity to monitor a patient’s progress through his or her weight loss experience. Patients typically visit their physicians 6 weeks after surgery to have the LAP-BAND^® System adjusted for the first time. Subsequent visits continue every 6 weeks during which the stoma size can be adjusted―by injecting or removing saline through the access port―to help patients get just the right fit. The preformed circular shape of the LAP-BAND^® System allows for controlled, even inflation and deflation to increase or decrease restriction. Adjustments are typically made for at least 1 year so healthy, continuous weight loss can be optimized.

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.