PATIENT INFORMATION

Obesity: A Disease
Obesity is emerging as a health epidemic around the world. According to the Centers for Disease Control and Prevention, obesity is rapidly spreading across all regions and demographic groups. An estimated 97 million adults in the United States are overweight or obese. That figure represents more than 50% of the American adult population. Of this group, 11 million adults suffer from severe obesity.

Obesity is an excess of total body fat, which results from caloric intake that exceeds energy usage. A measurement used to assess health risks of obesity is Body Mass Index (BMI). BMI is calculated by dividing body weight (lbs.) by height in inches squared (in2) and multiplying that amount by 704.5. The metric calculation for BMI is kg/m2.

The American Obesity Association reports that obese individuals have a 50-100% increased risk of death as compared to normal weight individuals, with 300,000 to 587,000 deaths each year. This substantial increase in health risks has made obesity the second leading cause of preventable death in the United States.

Morbid Obesity
A person who generally weighs at least twice or 100 pounds more than his or her ideal weight or has a BMI of 40 or more is diagnosed as morbidly obese. The National Institutes of Health report that morbid obesity may considerably reduce life expectancy and is associated with an increased risk of developing conditions or diseases such as:
  • Diabetes
  • Stroke
  • Hypertension
  • Joint Problems
  • Sleep Apnea
  • Cancer
  • Coronary Artery Disease
  • Respiratory Problems



Treatment Options
Non-Surgical Treatment Dieting, exercise, and medication have long been regarded as the conventional methods to achieve weight loss. Sometimes, these efforts are successful in the short term. However, for people who are morbidly obese, the results rarely last. For many, this can translate into what's called the "yo-yo syndrome," where patients continually gain and lose weight with the possibility of serious psychological and health consequences. Recent research reveals that conventional methods of weight loss generally fail to produce permanent weight loss. Several studies have shown that patients on diets, exercise programs, or medication are able to lose approximately 10% of their body weight but tend to regain two-thirds of it within one year, and almost all of it within five years.1 Another study found that less than 5% of patients in weight loss programs were able to maintain their reduced weight after five years.2 Surgical Treatment Over the years, weight-loss surgery has proven to be a successful method for the treatment of morbid obesity.3 Surgical options have continued to evolve and Heartland Surgical Associates is pleased to be able to offer patients the LAP-BAND® System surgery. This procedure is the safest, least traumatic and only adjustable and reversible obesity surgery available in the United States. The LAP-BAND System provides a unique tool that can help you achieve and maintain significant weight loss, improve your health, and enhance your quality of life.

1. American Association of Clinical Endocrinologists (AACE) / American College of Endocrinology (ACE) Statement on the Prevention, Diagnosis, and Treatment of Obesity (1998 Revision). AACE/ACE Obesity Task Force. Endocr Pract. 1998; Vol. 4 No. 5: 297-330. 2. Kramer FM et al. Long-term follow-up of behavioral treatment for obesity: patterms of weight regain among men and women. Int J Obes 1989; 13:123-136. 3. SAGES/ASBS Guidelines for Laparoscopic and Conventional Surgical Treatment of Morbid Obesity. American Society for Bariatric Surgery. http://asbs.org/html/guidelines.html LAP-BAND® System Overview

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Approved by the FDA in June 2001, LAP-BAND System is the safest, least invasive and 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. Since its clinical introduction in 1993, almost 150,000 LAP-BAND procedures have been performed around the world and over 30,000 in the U.S. alone.

Minimally Invasive Approach
During the procedure, surgeons usually use 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 you eat. It also 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.

Safest and Least Traumatic Procedure
Since there is no cutting, stapling or stomach re-routing involved in the LAP-BAND System procedure, it is considered the safest and least traumatic compared to other weight-loss surgeries. The laparoscopic approach to the surgery also offers the advantages of reduced post-operative pain, shortened 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. Your individual needs can change as you lose weight. For example, pregnant patients can expand their band to accommodate a growing fetus, while patients who aren't experiencing significant weight loss can have their bands tightened.

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 surgeon can control the amount of saline in the band by entering the port with a fine needle through the skin.

The LAP-BAND® System Advantage Minimal Trauma
  • Least invasive surgical option
  • No intestinal re-routing
  • No cutting or stapling of the stomach wall or bowel
  • Reduced patient pain, hospital length-of-stay and recovery period

Fewer Risks and Side Effects
  • Significantly lower mortality risk than with other obesity surgeries1
  • Low risk of nutritional deficiencies associated with gastric bypass
  • Reduced risk of hair loss
    ∑ No "dumping syndrome" related to dietary intake restrictions

Adjustable
  • Allows individualized degree of restriction for ideal, long-term weight loss
  • Adjustments performed without additional surgery
  • Supports pregnancy by allowing stomach outlet size to be opened for 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
  • Almost 150,000 cases performed worldwide
  • Standard of care for hundreds of practices around the world
  • Academic publications with up to 8 years of follow-up

1. Executive summary: Laparoscopic adjustable gastric banding for the treatment of obesity (Update and Re-appraisal). The Australian Safety and Efficacy Register of New Interventional Procedures – Surgical (ASERNIPS) 2002; 1. (Laparoscopic adjustable gastric banding surgery, like the LAP-BAND surgery, is associate with a mean short-term mortality rate of around 0.05% compared to 0.50% for Gastric Bypass and 0.31% for Vertical Banded Gastroplasty.

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LAP-BAND Candidates

The LAP-BAND® System 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).
  • 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 the specialist who is treating you.
  • 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 at least 35 and you are suffering from serious health problems related to obesity.   A BMI of 30-34.9 are considered on a case by case basis.

The LAP-BAND System is not 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 an intra-operative gastric 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.


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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.

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

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Insurance Information
The FDA approved the LAP-BAND® System on June 5, 2001 (for details go to http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01087.html.

Insurance Verification
To determine if your insurance policy covers obesity (or "bariatric") surgery, refer to the insurance policy package that you have received after paying your first premium or provided through a plan offered by your employer.

Typically, there are two sections that describe the extent and limits of coverage. The first is usually called "What Is Covered" or "Covered Expenses." These are the healthcare benefits for which the company will pay. The other section is "What Is Not Covered" or "When the Plan Does Not Pay Benefits." In this section, look for any statement that the company excludes coverage for weight control, for the treatment of obesity, for the surgery for weight control, or for the complications of the surgery for weight control. Some policies will outright exclude bariatric surgeries. Others may have certain parameters around which bariatric procedures they cover and how much of the costs they cover. Look for statements such as, "Surgery for the treatment of obesity is covered when deemed medically necessary," or "Surgery for the treatment of obesity is (specifically) excluded except when medically necessary." If this surgery is a covered benefit when medically necessary, then it should be covered when patients meet national guidelines for care for morbid obesity.

Submission Requirements
A Letter of Medical Necessity and weigh-loss history are necessary to obtain prior authorization for obesity surgery. A Letter of Medical Necessity states why significant weight loss is medically necessary for a patient and usually includes the following information:
  • Patient's weight (which should be 100 pounds or more above ideal weight or a BMI more than 40 or at least 35 with associated medical problems to qualify)
  • List of medical problems associated with obesity, such as type 2 diabetes, sleep apnea, hypertension, etc.
  • Number of years patient has been overweight (which should be at least five or more)
  • Number and types of failed weight-loss programs attempted in the past


If you create a document or packet listing all your weight-loss attempts (self-controlled or medically supervised) and their results, you can substantially increase your chances of getting insurance coverage for the LAP-BAND procedure. You should include any commercial diets or medical records of your weight-loss efforts.

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Q: Will I be sick a lot after the operation?
Q: How long will it take to recover after surgery?
Q: How much weight will I lose?
Q: How do the weight-loss results with the LAP-BAND compare to those with the gastric bypass?
Q: Does the LAP-BAND require frequent office visits after surgery?
Q: Does the LAP-BAND limit any physical activity?
Q: How is the band adjusted?
Q: Do I have to be careful with the access port just underneath my skin?
Q: Can the band be removed?
Q: Will I need plastic surgery for the surplus skin when I have lost a lot of weight?
Q: Will I feel hungry or deprived with the LAP-BAND?
Q: What will happen if I become ill?
Q: What about pregnancy?
Q: Will I need to take vitamin supplements?
Q: What about other medication?
Q: What if I go out to eat?
Q: What about alcohol?
Q: Can I eat anything in moderation?
Q: Will I suffer from constipation?
Q: Is it true that the LAP-BAND seems "tighter" in the morning?

Q: Will I be sick a lot after the operation?
A: The LAP-BAND System limits food intake. If you feel nauseated or sick on a regular basis, it may mean that you are not chewing your food well or that you are not following the diet rules properly. However, it could also mean that there is a problem with the placement of the band so you should contact us if this problem persists. Vomiting should be avoided as much as possible. It can cause the small stomach pouch to stretch. It can also lead to slippage of part of the stomach through the band, which would reduce the success of the operation. In some cases, it would also require another operation.

Q: How long will it take to recover after surgery?
A: If LAP-BAND surgery is performed laparoscopically, patients typically spend less than 24 hours in the hospital. It takes most patients about a week to return to work and a month to six weeks to resume exercising. In the case of open surgery or if there are complications, recovery may take longer.

Q: How much weight will I lose?
A: Weight-loss results vary from patient to patient, and the amount of weight you may lose depends on several things. The band needs to be in the right position, and you need to be committed to your new lifestyle and eating habits. Obesity surgery is not a miracle cure, and the pounds won't come off by themselves. It is very important to set achievable weight-loss goals from the beginning. A weight loss of 2 to 3 pounds a week in the first year after the operation is possible, but one pound a week is more likely. Twelve to eighteen months after the operation, weekly weight loss is usually less. Remember that you should lose weight gradually. Losing weight too fast creates a health risk and can lead to a number of problems. Your main goal is to have weight loss that prevents, improves, or resolves health problems connected with severe obesity.

Q: How do the weight-loss results with the LAP-BAND compare to those with the gastric bypass?
A: You should focus on long-term weight loss and remember that it is important to lose weight gradually while reducing obesity-related risks and improving your health.

Q: Does the LAP-BAND require frequent office visits after surgery?
A: Check-ups are a normal and a very important part of the LAP-BAND System follow-up.

Q: Does the LAP-BAND limit any physical activity?
A: The LAP-BAND does not affect or hamper physical activity including aerobics, stretching and strenuous exercise.

Q: How is the band adjusted?
A: Adjustments are often carried out in the X-ray department. They are done there so the access port can be clearly seen. When X-rays are used, your reproductive organs should be shielded. Sometimes adjustments can be done in an outpatient clinic or office. Local anesthesia may or may not be needed. A fine needle is passed through the skin into the access port to add or subtract saline. This process most often takes only a few minutes. Most patients say it is nearly painless.

Q: Do I have to be careful with the access port just underneath my skin?
A: There are no restrictions based on the access port. It is placed under the skin in the abdominal wall, and once the incisions have healed it should not cause discomfort or limit your movements or any physical exercise. The only sensation you may have from the port is when you go in for adjustments. If you feel persistent discomfort in the port area, let us know as soon as possible.

Q: Can the band be removed?
A: Although the LAP-BAND System is not meant to be removed, it can be. In some cases this can be done laparoscopically. The stomach generally returns to its original shape once the band is removed. After the removal, though, you may soon go back up to your original weight or even gain more.

Q: Will I need plastic surgery for the surplus skin when I have lost a lot of weight?
A: That is not always the case. As a rule, plastic surgery will not be considered for at least a year or two after the operation. Sometimes the skin will mold itself around the new body tissue. You should give the skin the time it needs to adjust before you decide to have more surgery.

Q: Will I feel hungry or deprived with the LAP-BAND?
A: The LAP-BAND makes you eat less and feel full in two ways – by --- reducing the capacity of your stomach and increasing the time it takes food to get through the digestive system. After a small meal, the amount of which varies from person to person, you should feel full. If you follow the nutrition guidelines when you choose your food and then chew it well, you should not feel hungry or deprived. Remember that the LAP-BAND is a tool to help you change your eating habits.

Q: What will happen if I become ill?
A: One of the major advantages of the LAP-BAND System is that it can be adjusted. If your illness requires you to eat more, the band can be loosened by removing saline from it. When you have recovered from your illness and want to lose weight again, the band can be tightened by increasing the amount of saline. If the band cannot be loosened enough, it may have to be removed.

Q: What about pregnancy?
A: Becoming pregnant can be easier as you lose weight. Your menstrual cycle may become more regular. If you need to eat more while you are pregnant, the band can be loosened. After the pregnancy, the band may be made tighter again, and you can resume losing weight.

Q: Will I need to take vitamin supplements?
A: You may. It's possible you may not get enough vitamins from three small meals a day. At your regular check-ups, your specialist will evaluate whether you are getting enough vitamin B12, folic acid, and iron.

Q: What about other medication?
A: You should be able to take prescribed medication. You may need to use capsules, break big tablets in half or dissolve them in water so they do not get stuck in the stoma and make you sick. You should always ask the doctor who prescribes the drugs about this.

Q: What if I go out to eat?
A: Order only a small amount of food, such as an appetizer. Eat slowly. Finish at the same time as your table companions. You might want to let your host or hostess know in advance that you cannot eat very much.

Q: What about alcohol?
A: Alcohol has a high number of calories. It also breaks down vitamins. An occasional glass of wine or other alcoholic beverage, though, is not considered harmful to weight loss1.

Q: Can I eat anything in moderation?
A: After your stomach has healed, you may eat most foods that don't cause you discomfort. However, because you can only eat a little it is important to include foods full of important vitamins and nutrients such as those recommended in the nutrition section of this booklet and as advised by your surgeon and/or dietitian. If you eat foods that contain lots of sugar and fat or drink liquids full of "empty" calories, such as milkshakes, the effect of the LAP-BAND may be greatly reduced or cancelled.

Q: Will I suffer from constipation?
A: There may be some reduction in the volume of your stools, which is normal after a decrease in food intake because you eat less fiber. This should not cause you severe problems. If difficulties do arise, let us know as soon as possible.
Q: Is it true that the LAP-BAND seems "tighter" in the morning?
A: This is a fairly common feeling, especially for people with bands that are tight or just after an adjustment. During the day the water content in the body changes and this may cause the band to feel "tighter" some of the time. Some women have also noticed that the LAP-BAND feels tighter during menstruation.


One final point:
It is important that you ask us all the questions you have about obesity surgery and the LAP-BAND System.

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