The BioEnterics LAP-BAND^® System is designed to help you lose excess body weight for resolution of obesity-related health conditions and enhancement of life. In partnership with leading bariatric surgeons, an approach has been developed that eliminates many of the known associated operative risks and provides unique benefits compared to other obesity surgeries. This effort has resulted in the LAP-BAND^® System, the only adjustable and reversible obesity surgery that does not require cutting and stapling of the stomach or gastrointestinal re-routing to bypass normal digestion.

Patient benefits include reduced surgical trauma, complications, pain, and scarring, as well as shorter hospitalization and recovery time compared to other obesity surgeries. The name LAP-BAND^® comes from the surgical technique used (laparoscopic) and the name of the implanted medical device (gastric band).

LAP-BAND^® SYSTEM OVERVIEW
The body gets energy from food while it passes through the alimentary canal, which consists of the mouth, esophagus, stomach, and small and large intestines. Digestion starts in the mouth with chewing and the addition of saliva. After food passes through the esophagus, this process continues in the stomach. The stomach then provides temporary storage for food. Gastric juices, which contain enzymes, break down the food so that it can be absorbed and the energy can be carried through the body by the blood.

The LAP-BAND^® System is a silicone elastomer ring designed to be placed around the upper part of the stomach and filled with saline on the inner surface. This creates a new small stomach pouch and leaves the larger part of the stomach below the band so the food storage area in the stomach is reduced, and the pouch above the band can hold only a small amount of food. The band also controls the stoma (stomach outlet) between the two parts of the stomach. The size of the stoma regulates the flow of the food from the upper to the lower part of the stomach. When the stoma is smaller, you feel full sooner and have a feeling of satiety so you are not hungry between meals.

The band is connected by tubing to an access port that is placed beneath the skin during surgery. Later, the surgeon can change the stoma size by adding or subtracting saline inside the inner balloon through the access port. This adjustment process helps drive the rate of weight loss. If the band is too loose and weight loss inadequate, adding more saline can reduce the size of the stoma to further restrict the amount of food that can move through it, if the band is too tight, the surgeon will remove some saline to loosen the band and reduce the amount of restriction.

LAP-BAND^® SYSTEM PLACEMENT
The LAP-BAND^® System is usually placed laparoscopically under general anesthesia. First the surgeon makes a few small incisions in the abdominal wall for the insertion of long, thin surgical instruments. A narrow camera is also passed through a port so the surgeon can view the operative site on a nearby video monitor. A small tunnel is made behind the top of the stomach to let the band through and allow it to be wrapped around the upper part of the stomach, almost like a wristwatch. The band is then locked securely in a ring around the stomach. The LAP-BAND^® is usually left empty or only partially inflated for the first 4-6 weeks after surgery.

LAP-BAND^® SYSTEM WEIGHT-LOSS RESULTS
The LAP-BAND^® System is a tool to help you achieve sustained weight loss by limiting how much you can eat, reducing your appetite, and slowing digestion. Remember, though, the the LAP-BAND^® System by itself will not solve morbid obesity, nor will it ensure that you reach your goal weight or even that you lose weight at all. The amount of weight you lose depends both on the band and on your motivation and commitment to a new lifestyle and eating habits. Below is a sample of published results from around the world:

Some people lost more than others, and though you may never each your ideal weight, chances are good that with weight loss our health and self-image will improve

LAP-BAND^® SYSTEM REMOVAL
If there is a problem with the band, if you can't lose enough weight or can't adjust to the new eating habits, your surgeon may suggest removal of the band. This decision will come after your surgeon consults with you. Generally after LAP-BAND^® System removal, your stomach will be restored to its original form, and the digestive tract should function normally. Please keep in mind that when the band is removed your weight will likely increase.

LAP-BAND^® SYSTEM ADVANTAGES
Minimal Trauma

• Least invasive surgical option
  
• No intestinal re-routing
  
• No cutting or stapling or the stomach wall or bowel
  
• Small incisions and minimal scarring
  
• Reduced patient pain, length of hospital stay and recovery period

Fewer Risks and Side Effects

• Significantly lower mortality risk compared to other obesity surgeries
  
• Low risk of nutritional deficiencies associated with BPD and Gastric Bypass
  
• Reduced risk of hair loss
  
• No "dumping syndrome" with certain dietary elements

Adjustable

• Allows individualized degree of restriction for ideal, long-term weight-loss rate
  
• Adjustments performed without additional surgery
  
• Supports pregnancy by allowing stomach outlet size to be opened to accommodate increased nutritional needs

Reversible

• Removable at any time
  
• Stomach and other anatomy are generally restored to their original forms and functions

Effective Long-Term Weight Loss

• More than 100,000 LAP-BAND^®S placed worldwide
  
• Standard of care for hundreds of surgeons around the world
  
• Academic publication with up to 7 years of follow-up

LAP-BAND^® SYSTEMS CANDIDATES
You may be eligible for LAP-BAND^® System surgery if:

1. You are at least 18 years old
2. Your BMI is > 40 or you weigh at least 100 pounds more than your ideal weight
3. You have been overweight for more than 5 years
4. Your serious weight-loss attempts have only had short-term success
5. You are not suffering from any other disease that my have caused your obesity.
6. You are prepared to make substantial changes in your eating habits and lifestyle
7. You are willing to continue being monitored by the specialist treating you
8. You do not drink alcohol in excess

If you do not meat 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 causes by your weight. Your surgeon may have additional criteria to those listed above.

LAP-BAND^® SYSTEM CONTRADICTIONS
The LAP-BAND^® System is not right for you if:

1. You have an inflammatory disease or condition of the gastrointestinal tract, such as ulcers, severe esophagitis.
   
2. You have severe heart or lung disease that makes you a poor candidate for surgery.
   
3. You have some other disease that makes you a poor candidate for surgery
   
4. 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 telangiectasias (dilation of a small blood vessel).
   
5. You have portal hypertension
   
6. Your esophagus, stomach, or intestine is not normal (congenital or acquired). For instance you might have a narrowed opening.
   
7. You have or have experienced an intra-operative gastric perforation at or near the location of the intended band placement.
   
8. You have cirrhosis.
   
9. You have chronic pancreatitis
   
10. You are pregnant. (If you become pregnant after the 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).
    
11. You are addicted to alcohol or drugs.
    
12. You are under 18 years of age.
    
13. You have an infection anywhere in your body or one that could contaminate the surgical area.
    
14. You are on chronic, long-term steroid treatment
    
15. You cannot or do not want to follow the dietary rules that come with this procedure.
    
16. You might be allergic to materials in the device.
    
17. You cannot tolerate pain from an implanted device
    
18. 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 surgeon will not do the operation unless he or she knows you understand the problems your excess weight is causing. Also, your surgeon will make sure you know that you have responsibilities, such as adopting new eating patterns and a new lifestyle. If you are ready to take an active part in reducing your weight, your surgeon will consider the treatment. You should be well-informed about the advantages, disadvantages, and risks involved. Be sure to investigate whether this treatment is right for you.