Gastric Banding Procedure

Lap Band System

What is Morbid Obesity?

What is Morbid Obesity?

Morbid obesity or unhealthy excess weight exists when:

• a person weighs at least twice as much as his or her ideal weight; or
• a person weighs at least 45 kilos more than his or her ideal weight.

The above statements only provide a general description of the definition of morbid obesity. The precise degree of excess weight is calculated by using the Body Mass Index (BMI), which includes both weight and height to calculate the measurement.

We speak of "morbid obesity" because excess weight of this kind reduces life expectancy considerably and is associated with increased risk of developing conditions or diseases such as:

• Diabetes
• High blood pressure
• Joint problems
• Gallstones
• Cerebral infarction
• Heart and vascular diseases
• Psychosocial problems

By losing enough weight, your life expectancy can be increased, the risk of developing these conditions or diseases can be reduced, and the quality of your life improved.

How Can You Lose Weight?

Non-surgical intervention:

Many people who are unhealthily overweight have tried in vain to lose excess weight. The market is overflowing with all kinds of slimming diets, cures and products that advertise success.

DIETS WORK UNTIL YOU STOP THEM with many studies show that diets and slimming aids rarely succeed in helping people achieve the desired result of long lasting weight reduction. In fact, many people who have tried dieting gain back more than they lost when they go off the diet.

Surgery

If you have tried diets, cures, tablets or medicines and they haven't helped you lose and maintain a healthy weight, one option may be an operation to artificially reduce the amount your stomach can hold and decrease your appetite. A new surgical method which does this uses the Allergan LAP-BAND® System.

The LAP-BAND® System

The word LAP-BAND is the abbreviated combination of two words (LAP from laparoscopic and BAND from gastric band). The band is placed around the upper part of the stomach, thus dividing the stomach into two parts.

The small upper stomach pouch can only hold a small amount of food. The remainder of the stomach lies below the band. The two parts are connected by means of a small opening created by the band. Food will pass through from the upper stomach pouch more slowly, which means you will feel full longer.

One of the great advantages of the Allergan LAP-BAND® System is that the band opening is adjustable, which means that its diameter can be varied. The inner surface of the band contains a balloon that is connected by tubing to a reservoir, which is placed under the skin in the abdomen during surgery. After surgery, the surgeon can make the band opening larger or smaller by piercing the reservoir with a fine needle through the skin and adding or subtracting liquid to inflate or deflate the balloon. In this way the size of the opening (for which the medical name is "stoma") can be varied. This means that the Allergan LAP-BAND® System is a unique surgical treatment because the stoma can be modified without the need for another operation.

Obesity Solutions / Lap-Band®

Developed to aid in long-term weight loss, the LAP-BAND® System has been used by leading laparoscopic surgeons worldwide to treat severe obesity. Sustained weight loss with the LAP-BAND® System is achieved by reducing the capacity of the stomach.

The silicone adjustable band component of the LAP-BAND® System is placed around the upper part of the stomach, forming a small gastric pouch to limit and control the amount of food you eat and slow the emptying process from the stomach into the intestines. Limiting food intake and slowing the stomach emptying process results in weight loss.

LAP-BAND® System has been designed for laparoscopic placement/keyhole surgery, which offers the advantages of reduced trauma, reduced post-operative pain, shortened hospital stay and quicker recovery. No cutting or stapling of the stomach is required, and there is no need to bypass portions of the stomach or intestines. If for any reason the A LAP-BAND® System needs to be removed, the stomach generally returns to its original form.

The Allergan LAP-BAND® System and accessories contain no latex or natural rubber materials.

Laparoscopic Keyhole Surgery

The procedure has now been refined to the point where it generally requires 45 minutes of surgery, the patient coming in the same day, staying the night, and usually able to go home the following day, although most elect to stay an extra day before discharge.

Should you qualify for surgery,and there are few exclusions there are several steps to be taken before this actually occurs.

• A consultation with Dr Paul Anderson's team is the first step, where a medical history will be taken and any risk factors identified. Should there be significant risk factors, this may require further evaluation by other Specialists. At the first consultation a medical history is taken. and an examination performed. An explanation is given of the procedure, risks, complications and the commitment to the post-operative period. An indication is also given of the expected lifestyle changes, and changes in eating habits and diet.
• You are presented with a booklet which contains the information discussed with Dr Anderson in greater detail. Once this has been read, and possibly discussed with family members, a second consultation is arranged to enable any factors of concern to be discussed with Dr Anderson. At this point, there will usually be an agreement that you, as the patient, can proceed with the operation.
• the next step is a series of screening blood tests, and finally the go ahead is given to proceed with the surgery. Should there be any identifiable psychological problems, these will be investigated prior to surgery. There is generally a wait of 4 to 6 weeks from the beginning of the consultation to the surgical procedure, and this period is maintained so that full consideration can be given by both the Doctor and patient to the procedure. Risks and potential complications are then adequately assessed.

Why Patients Recommend the Lap-Band

Patient-friendly:

Of all the operations to reduce the size of the stomach, it is the least invasive, as the operation can usually be performed by means of laparoscopy (a surgical technique using small incisions and long instruments rather that a single large incision). The band may be adjusted afterward without surgery.

Precise:

It is the only operation in which it can be decided exactly what size the small stomach is to be and what the diameter of the stoma is to be.

Adjustable:

No extra operation is necessary to adjust the diameter of the stoma.

Less traumatic:

There is no cutting, stapling or crushing of the stomach and it is reversible.

No irreversible damage:

If, for unforeseen reasons, THE LAP-BAND® System needs to be removed, in all probability the stomach will revert to its original form. Although this is not the aim, the Allergan LAP-BAND® System can be removed without problems.

Fast:

You will normally be able to leave the hospital within ONE day after the operation.

How Much Weight Can You Lose with the LAP-BAND® System?

On average, you may lose between half and two-thirds of your excess weight with the help of the LAP-BAND® System. It is important to remember that the LAP-BAND® System is an aid to support you in achieving lasting results by reducing your appetite and slowing digestion. However, if the operation is to be successful, it is very important that you play an active part in the effort to lose weight and keep it off. Even with the band, you will have to adopt a different lifestyle and eating pattern for the rest of your life.

Who Can be Considered for the Allergan LAP-BAND® System?

Indications

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

1. You are an adult (at least 16 years old).
2. Your BMI is 30 or higher or you weigh at least twice your ideal weight or you weigh at least 100 pounds (45 kilos) more than your ideal weight.
3. You have been overweight for more than 5 years.
4. Your serious attempts to lose weight have had only short-term success.
5. You do not have any other disease that may have caused you to be overweight.
6. You are prepared to make major changes in your eating habits and lifestyle.
7. You are willing to continue working with the specialist who is treating you.
8. You do not drink alcohol in excess.

Contraindications

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, or Crohn's disease.
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. That 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).
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/experience an intra-operative gastric injury, such as a 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 Allergan 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.

Some surgeons say patients with a "sweet tooth" will not do well with the LAP-BAND® System. If you eat a lot of sweet foods, your surgeon may decide not to do the procedure. The same is true if you often drink milkshakes or other high-calorie liquids.

Your motivation is key

• Dr Anderson will not do the operation unless he or she knows you understand the problems your excess weight is causing.
• Also, he will want to make sure you know you have responsibilities. These include 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 procedure. Dr Anderson believes the research does not support this theory and that those with a sweet tooth will do as well as the non sweet tooth eaters.

Risks, complications, and adverse events you need to know about

All surgical procedures have risks. When you decide on a procedure, you should know what the risks are. There will be a discussion in detail about on two occasions to ensure that you understand all the risks and complications that might arise. Then you will have the information you need to make a decision.

What are the general risks?

• Using the LAP-BAND® System includes the same risks that come with all major surgeries. There are also added risks in any operation for patients who are seriously overweight.
• You should know that death is one of the risks. It can occur any time during the operation. It can also occur as a result of the operation. Death can occur despite all the precautions that are taken.
• There is a risk of gastric perforation (a tear in the stomach wall) during or after the procedure that might lead to the need for another surgery. In the U.S. clinical study this happened in 1% of the patients. There were no deaths during or immediately after surgery in the U.S. study.
• Your age can increase your risk from surgery. So can excess weight. Certain diseases, whether they were caused by obesity or not, can increase your risk from surgery.
• There are also risks that come with the medications and the methods used in the surgical procedure. You also have risks that come from how your body responds to any foreign object implanted in it. Published results from past surgeries, however, do show that Allergan LAP-BAND® System surgery may have fewer risks than other surgical treatments for obesity.

Patients can experience complications after surgery. Most complications are not serious but some may require hospitalization and/or re-operation. In the United States clinical study, with 3-year follow-up reported, 88% of the 299 patients had one or more adverse events, ranging from mild, moderate, to severe: nausea and vomiting (51%); gastroesophageal reflux (regurgitation) (34%); band slippage/pouch dilatation (24%); and stoma obstruction (stomach-band outlet blockage) (14%) were the most common post-operative complications.

In the study, 25% of the patients had their band systems removed, two-thirds of which were following adverse events. Esophageal dilatation or dysmotility (poor esophageal function) occurred in 11% of patients, the long-term effects of which are currently unknown. Constipation, diarrhoea and dysphagia (difficulty swallowing) occurred in 9% of the patients. In 9% of the patients, a second surgery was needed to fix a problem with the band or initial surgery. In 9% of the patients, there was an additional procedure to fix a leaking or twisted access port. The access port design has been improved. Four out of 299 patients (1.3%) had their bands erode into their stomachs. These bands needed to be removed in a second operation. Surgical techniques have evolved to reduce slippage. Surgeons with more laparoscopic experience and more experience with these procedures report fewer complications.

Adverse events that were considered to be non-serious, and which occurred in less than 1% of the patients, included: esophagitis (inflammation of the esophagus); gastritis (inflammation of the stomach); hiatal hernia (some stomach above the diaphragm); pancreatitis (inflammation of the pancreas); abdominal pain; hernia; incisional hernia; infection; redundant skin; dehydration; diarrhea (frequent semi-solid bowel movements); abnormal stools; constipation; flatulence (gas); dyspepsia (upset stomach); eructation (belching); cardiospasm (an obstruction of passage of food through the bottom of the esophagus); hematemsis (vomiting of blood); asthenia (fatigue); fever;chest pain; incision pain; contact dermatitis (rash); abnormal healing, edema (swelling); paresthesia (abnormal sensation of burning; prickly; or tingling); dysmenorrhea (difficult periods); hypochromic anemia (low oxygen carrying part of blood); band system leak, cholecystitis (gall stones); esophageal ulcer (sore); port displacement; port site pain; spleen injury; and wound infection. Be sure to ask your surgeon about these possible complications and any of these medical terms that you don't understand.

Is there a chance the device will need to be removed?

The LAP-BAND® System is a long-term implant, but it may have to be removed or replaced at any time. For instance, the device may need to be removed to manage any adverse reactions you might have. The device may also need to be removed, repositioned or replaced if you aren't losing as much weight as you and your doctor feel you should be losing.

What are the specific risks and possible complications?

Talk to your doctor about all of the following risks and complications:

• ulceration
• gastritis (irritated stomach tissue)
• gastroesophageal reflux (regurgitation)
• heartburn
• gas bloat
• dysphagia (difficulty swallowing)
• dehydration
• constipation
• weight regain
• death

Laparoscopic surgery has its own set of possible problems. They include:

• spleen or liver damage (sometimes requiring spleen removal)
• damage to major blood vessels
• lung problems
• thrombosis (blood clots)
• rupture of the wound
• perforation of the stomach or esophagus during surgery

Laparoscopic surgery is not always possible. The surgeon may need to switch to an "open" method due to some of the reasons mentioned here. This happened in about 5% of the cases in the U.S. Clinical Study.

There are also problems that can occur that are directly related to the Allergan LAP-BAND® System:

• The band can spontaneously deflate because of leakage. That leakage can come from the band, the reservoir, or the tubing that connects them.
• The band can slip.
• There can be stomach slippage.
• The stomach pouch can enlarge.
• The stoma (stomach outlet) can be blocked.
• The band can erode into the stomach.

Obstruction of the stoma can be caused by:

• food
• swelling
• improper placement of the band
• the band being over-inflated
• band or stomach slippage
• stomach pouch twisting
• stomach pouch enlargement

There have been some reports that the esophagus has stretched or dilated in some patients. This could be caused by:

• improper placement of the band
• the band being tightened too much
• stoma obstruction
• binge eating
• excessive vomiting

Patients who have a weaker esophagus may be more likely to have this problem. A weaker esophagus is one that is not good at pushing food through. Tell your surgeon if you have difficulty swallowing. Then your surgeon can evaluate this.

Weight loss with the Allergan LAP-BAND® System is typically slower and more gradual than with some other weight-loss surgeries. Tightening the band too fast or too much to try to speed up weight loss should be avoided. The stomach pouch and/or esophagus can become enlarged as a result. You need to learn how to use your band as a tool that can help you reduce the amount you eat.

Infection is possible. Also, the band can erode into the stomach. This can happen right after surgery or years later, although this rarely happens.

Complications can cause reduced weight loss. They can also cause weight gain. Other complications can result that require more surgery to remove, reposition, or replace the band.

Some patients have more nausea and vomiting than others. You should see your physician at once if vomiting persists. Rapid weight loss may lead to symptoms of:

• malnutrition
• anemia
• related complications

It is possible you may not lose much weight or any weight at all. You could also have complications related to obesity.

If any complications occur, you may need to stay in the hospital longer. You may also need to return to the hospital later. A number of less serious complications can also occur. These may have little effect on how long it takes you to recover from surgery.

If you have existing problems, such as diabetes, a large hiatal hernia (part of the stomach in the chest cavity), Barrett's esophagus (severe, chronic inflammation of the lower esophagus), or emotional or psychological problems, you may have more complications. Your surgeon will consider how bad your symptoms are, and if you are a good candidate for the Allergan LAP-BAND® System surgery. You also have more risk of complications if you've had a surgery before in the same area. If the procedure is not done laparoscopically by an experienced surgeon, you may have more risk of complications.

Anti-inflammatory drugs that may irritate the stomach, such as aspirin and NSAIDs, should be used with caution.

Some people need folate and vitamin B12 supplements to maintain normal homocycteine levels. Elevated homocycteine levels can increase risks to your heart and the risk of spinal birth defects.

You can develop gallstones after a rapid weight loss. This can make it necessary to remove your gallbladder.

There have been no reports of autoimmune disease with the use of the Allergan LAP-BAND® System. Autoimmune diseases and connective tissue disorders, though, have been reported after long-term implantation of other silicone devices. These problems can include systemic lupus erythematosus and scleroderma. At this time, there is no conclusive clinical evidence that supports a relationship between connective-tissue disorders and silicone implants. Long-term studies to further evaluate this possibility are still being done. You should know, though, that if autoimmune symptoms develop after the band is in place, you may need treatment. The band may also need to be removed. Talk with your surgeon about this possibility. Also, if you have symptoms of autoimmune disease now, the Allergan LAP-BAND® System may not be right for you.

Removing the band

If the LAP-BAND® System has been placed laparoscopically, it may be possible to remove it the same way. This is an advantage of the LAP-BAND® System. However, an "open" procedure may be necessary to remove a band. In the U.S. Clinical Study, 60% of the bands that were removed were done laparoscopically. Surgeons report that after the band is removed, the stomach returns to essentially a normal state.

At this time, there are no known reasons to suggest that the band should be replaced or removed at some point unless a complication occurs or you do not lose weight. It is difficult, though, to say whether the band will stay in place for the rest of your life. It may need to be removed or replaced at some point. Removing the device requires a surgical procedure. That procedure will have all the related risks and possible complications that come with surgery. The risk of some complications, such as erosions and infection, increase with any added procedure.

What will it cost you to have the surgery, should you be eligible? Currently the health funds in Australia will cover all costs other than what individual surgeons charge either as an administrative fee/first consultation fee/or Gap payment. Not included in this are the small gaps which may be charged for blood tests, pathology or occasionally if x-rays are required. For those people who are not insured or are from overseas there are several options. The total cost of the laparoscopic gastric band inserted in a private hospital in South Australia is approximately A$15,000. This cost includes surgical and anaesthetic fee, hospitalisation and purchase of the band. Costs are considerably less than the East Coast of Australia but Dr Anderson does insist on having patients present a week prior to surgery and reserves the right to postpone operations should there be further tests that need to be performed.

The move towards slow weight loss has opened up the discussion of whether patients will eventually require additional surgery such as tummy tuck, breast reduction, arms and legs trim (Lipectomies). It depends on the weight loss. Many patients do decide to go onto to plastic/cosmetic surgery. The Surgical Obesity centre has a dedicated cosmetic surgeon who is very experienced. She is available for advice and surgery should the patient decide to proceed.