LAP-BAND® Overview

Introduction
Eligibility
Your Motivation
Risks

Introduction
Approved by the FDA in June 2001, the BioEnterics® LAP-BAND Adjustable Gastric Banding System is the newest and the only adjustable surgical treatment for morbid obesity in the United States. It induces weight loss by reducing the capacity of the stomach, which restricts the amount of food that can be consumed, improves hunger control, and increases satiety. Since its clinical introduction in 1993, more than 120,000 LAP-BAND procedures have been performed around the world.

Minimally Invasive Approach
During the procedure, your surgeon uses laparoscopic techniques (using small incisions and long-shafted instruments), to implant an inflatable silicone band into the patient's abdomen. Like a wristwatch, the band is fastened around the upper stomach to create a new, tiny stomach pouch that limits and controls the amount of food eaten. The Lap-Band creates a small outlet that slows the emptying process into the stomach and the intestines. As a result, patients experience an earlier sensation of fullness and are satisfied with smaller amounts of food. In turn, this results in weight loss.

Least Traumatic Procedure
Since there is no cutting, stapling or stomach re-routing involved in the LAP-BAND System procedure, it is considered the least traumatic of all weight loss surgeries. The laparoscopic approach also offers the advantages of reduced post-operative pain, shortened or no hospital stay and quicker recovery. If for any reason the LAP-BAND System needs to be removed, the stomach generally returns to its original form.

Adjustable Treatment
The LAP-BAND System is also the only adjustable weight loss surgery. The diameter of the band is adjustable for a customized weight-loss rate. Individual needs can change as you lose weight.

To modify the size of the band, its inner surface can be inflated or deflated with a saline solution. The band is connected by tubing to an access port, which is placed well below the skin during surgery. After the operation the amount of saline in the band is controlled by entering the port with a fine needle through the skin. This is an procedure done in the office without the need for general anesthesia.

Effective Long-Term Weight Loss
There have been more than 140,000 cases performed worldwide. Academic publications with up to 7 years of follow-up have been published showing the band to be an effective treatment for obesity.

Eligibility

LAP-BAND Candidates

The LAP-BAND is not right for everyone. Here are some of the things we will consider when evaluating your candidacy for obesity surgery.

The LAP-BAND System may be right for you if:

• You are at least 18 years old.
• Your BMI is 40 or higher or you weigh at least twice your ideal weight or you weigh at least 100 pounds more than your ideal weight. (BMI is calculated by dividing body weight (lbs.) by height in inches squared (in2) and multiplying that amount by 704.5). (Calculate your BMI)
• You have been overweight for more than 5 years.
• Your serious attempts to lose weight have had only short-term success.
• You do not have any other disease that may have caused your obesity.
• You are prepared to make substantial changes in your eating habits and lifestyle.
• You are willing to continue being monitored by Life Shape of Florida Surgical Weight Loss Center.
• You do not drink alcohol in excess.
• If you do not meet the BMI or weight criteria, you still may be considered for surgery if your BMI is over 35 and you are suffering from serious health problems related to obesity.

Contraindications
The LAP-BAND System may not be right for you if:

• You have an inflammatory disease or condition of the gastrointestinal tract, such as ulcers, severe esophagitis, or Crohn's disease.
• You have severe heart or lung disease that makes you a poor candidate for surgery.
• You have some other disease that makes you a poor candidate for surgery.
• You have a problem that could cause bleeding in the esophagus or stomach. This might include esophageal or gastric varices (a dilated vein). It might also be something such as congenital or acquired intestinal telangiectasia (dilation of a small blood vessel).
• You have portal hypertension.
• Your esophagus, stomach, or intestine is not normal (congenital or acquired). For instance you might have a narrowed opening.
• You have, or have experienced in the past, a stomach injury, such as a gastric perforation at or near the location of the intended band placement.
• You have cirrhosis.
• You have chronic pancreatitis.
• You are pregnant. (If you become pregnant after the BioEnterics LAP-BAND System has been placed, the band may need to be deflated. The same is true if you need more nutrition for any other reason, such as becoming seriously ill. In rare cases, removal may be needed.)
• You are addicted to alcohol or drugs.
• You are under 18 years of age.
• You have an infection anywhere in your body or one that could contaminate the surgical area.
• You are on chronic, long-term steroid treatment.
• You cannot or do not want to follow the dietary rules that come with this procedure.
• You might be allergic to materials in the device.
• You cannot tolerate pain from an implanted device.
• You or someone in your family has an autoimmune connective tissue disease. That might be a disease such as systemic lupus erythematosus or scleroderma. The same is true if you have symptoms of one of these diseases.

Your Motivation
While the LAP-BAND System is an effective treatment for morbid obesity, the pounds do not come off by themselves. The LAP-BAND System is an aid to support you in achieving lasting results by limiting food intake, reducing appetite and slowing digestion. However, your motivation and commitment to adopt a new lifestyle are extremely important for long-term weight loss. New eating habits must be adhered to for the rest of your life. Exercise is an equally important component of a changed lifestyle. Life Shape of Florida will help you learn the important behavioral changes you need to make in order to be a successful "Lap-Band patient".

Risk Information
A brief description of relevant 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, like 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 can 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.lap-band.com or
1-877-LAP-BAND.