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Adjustable Gastric Banding System (Lap-Band)


Risk Information


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The LAP-BAND System is not right for everyone. You and your surgeon should work together to decide if this is the right treatment for you.

Here are some of the things your surgeon will consider.



Indications

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

  1. You are an adult (at least 18 years old).
  2. Your BMI is 40 or higher or you weight 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.



If your BMI is less than 35, the LAP-BAND System may not be right for you.
On the other hand, your surgeon may consider it if you have health problems that are related to obesity.
Your surgeon may also have other criteria he or she uses.
Ask him or her to discuss the criteria with you.



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 elangiectasia
    (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/experienced 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 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

When you are considering a weight loss procedure it is important that you realise that your surgeon will not undertake surgery unless he or she knows you are fully aware and understand the problems that carrying excessive weight is causing you. Your surgeon will also ensure that you know and understand that you have responsibilities in respect of your weight loss surgery. He or she will expect you to adopt new eating patterns and to maintain a healthier lifestyle. Only if your surgeon is convinced that you are prepared to play an active role in reducing your weight, will he or she consider the treatment.  Weight loss surgery of any type should be considered as permanent and as such your commitment and understanding of how things will need to change in your life and with your attitude to food, after surgery, has to be apparent.  But before you go any further your surgeon will want to make you aware of all the advantages, the disadvantages and the risks that your weight loss surgery represents.


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

It is true to say that all surgical procedures carry some degree of risk. When you decide on the procedure that you want to have, you need to know what the risks of that surgery will be. Take your time and talk in detail with your surgeon so that you are sure that you understand all the risks and complications that may be encountered.  Only when you have all the information you need, will you truly be able to make an informed decision.


What are the General Risks?

The LAP-BAND System is a major surgery and as such carries the same risks that come with any major surgeries. Coupled with this is the fact that there are additional risks in any operation for any patient who is very overweight.

Although it is highly unlikely, you should know that death is one of the risks of this and many other types of surgery and could occur at any time during the procedure or as a result of the operation. Death is a risk that can occur even when all precautions are taken. Another risk is gastric perforation (tearing of the stomach wall) during or even after operation, which if it occurs may lead to the need for further surgery. Statistics in the UK show that the death rate associated with gastric bypass surgery is about 1 in 100 operations The most common cause of death is the development of a blood clot in the lungs (pulmonary embolism) although this is far less likely in a patient with a BMI of 55 or under. On rare occasions, gastric bypass surgery patients maight develop an infection in the lungs or stomach or at the site where the reservoir is anchored under the skin,  This may delay recovery.  Additionally age can increase the risk faced from surgery, as does excess weight.

Certain diseases, whether related to or caused by obesity or not, will increase  surgical risk. Some risk can also come from medications and the methods used in the surgical procedure undertaken.

There are also risks associated with how your body responds to any foreign object implanted in it. Published results using data from past surgical procedure, however, does show that LAP-BAND System surgery may carry fewer risks than other weight loss surgery.

Complications after any surgery are always possible. Most complications are not very serious however some will need hospitalisation and may also involve another operation.   In the United States a clinical study that included a 3-year follow-up reported, 88% of the 299 patients in the study has suffered one or more adverse effects.  These ranged through the full range from mild and moderate side effects to severe effects.   These were reported in order for the most common as:

  • Nausea and vomiting (51%)
  • Gastro-oesophageal reflux (regurgitation) (34%)
  • Band slippage/pouch dilatation (24%)
  • Stoma obstruction (stomach-band outlet blockage) (14%)

Figures from this study showed that 25% of the patients had to have their band systems removed,  and in two-thirds of the cases this followed adverse events. Oesophageal dilatation or dysmotility (poor oesophageal function) was also reported as occurring in 11% of patients, the long-term effects of which are not known at present. Nine percent of patients suffered with constipation, diarrhoea and dysphasia (difficulty swallowing) and in a similar percentage a second surgery was needed to fix a problem that had developed with the band or initial surgery.

In a further 9% of the patients, an additional procedure was carried out to correct a twisted or leaking access port. It should be noted that access port design has seen considerable improvement in the recent past.

Four out of 299 patients (1.3%) experienced erosion of the fitted bands into the stomachs. These bands were subsequently removed in a second operation. Surgical techniques have also evolved considerably to reduce slippage. Surgeons, now with more specific laparoscopic experience and greater experience in performing these procedures now report fewer complications.

Other non serious adverse events and which occurred in less than 1% of the patients, included: oesophagitis (inflammation of the oesophagus), gastritis (inflammation of the stomach), hiatus hernia (some stomach bulging above the diaphragm), pancreatitis (inflammation of the pancreas), abdominal pain, hernia, incisional hernia, infection, redundant skin, dehydration, diarrhoea (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 oesophagus), hematemsis (vomiting of blood), asthenia (fatigue), fever, chest pain, incision pain, contact dermatitis (rash), abnormal healing, oedema (swelling), paresthesia (abnormal sensation of burning, prickly, or tingling), dysmenorrhoea (difficult periods), hypochromic anaemia (low oxygen carrying part of blood), band system leak, cholecystitis (gall stones), oesophageal ulcer (sore), port displacement, port site pain, spleen injury, and wound infection.

If you want to know more about these possible side effects, be sure to ask your surgeon and also ask him to explain any of these medical terms that you don't understand.



Is there a chance that my device will need to be removed?

The LAP-BAND System is intended to be a long-term implant, but it is possible that it will need to be removed or replaced at any time. As an example, the device may need to be removed to manage any adverse reactions you might experience. Sometimes a device may need to be removed, repositioned or even replaced if your weight loss is not as great as you and your doctor feel it should be.


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 can 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 may not always be possible.

The surgeon might need to switch to an "open" method of band placement for any of the reasons mentioned here. About  5% of the cases in the U.S. Clinical Study required this change of plan.  Additionally there are also problems that are directly related to the LAP-BAND System:

  • f the band spontaneously deflates because of leakage. That leakage can emanate from the band, the reservoir, or the tubing that connects the two.
  • Band slippage.
  • Stomach slippage.
  • Enlargement of the stomach pouch..
  • Blockage of the  stoma (stomach outlet).
  • Erosion into the stomach by the band.

Obstruction of the stomach can be caused by:

  • Food.
  • Swelling.
  • Improper placement of the band.
  • An over-inflated band.
  • Band or stomach slippage.
  • Twisting of the stomach pouch.
  • Enlargement of the stomach pouch.


There have been some reports that the oesophagus 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 oesophagus may be more prone to this problem. A weaker oesophagus is one that is not efficient at pushing food through. For this reason it is important that you tell your surgeon if you have difficulty swallowing so that this can be taken into account.

Weight loss with the LAP-BAND System is typically slower and more gradual than with some other weight loss surgeries where weight loss can be dramatic. Tightening the band too fast or making it too tight in an attempt to speed up weight loss is not a good idea. The stomach pouch and/or the oesophagus can become enlarged as a result, leading to further complications. You need to learn how to utilise your band as a tool that can assist you in reducing the amount that you eat.

Infection is always a possibility and it is also possible that the band can erode into the stomach. Although this rarely happens it can occur immediately after surgery or years later.

Complications can also cause a reduced weight loss and more significantly perhaps,  can also cause weight gain. Other complications can occur that will lead to further  surgery to remove, replace or reposition the band.

Some patients have more nausea and vomiting than others and some nausea and vomiting is counted as normal.  However you should see your physician immediately if  vomiting persists or is uncontrollable.


Weight loss that is too rapid may lead to symptoms of:

  • Malnutrition.
  • Anaemia.
  • Other related complications.


It is possible that you may not lose very much weight or, in fact, any weight at all and you could also have complications that are related to being overweight.
If any such complications do occur, it may be necessary to stay in hospital longer. You may also be asked to return to the hospital at a later date. Some less serious complications may occur but should have little effect on how long it takes you to recover from surgery.


If you have existing medical problems, such as diabetes, a large hiatus hernia (part of the stomach in the chest cavity), Barrett's oesophagus (severe, chronic inflammation of the lower oesophagus), or any emotional or psychological problems, other complications may arise.
Your surgeon will evaluate your symptoms and assess whether or not you are a good candidate to undergo the LAP-BAND System surgery.
There is also slightly more risk of complication if you've had surgery before in the same area. Any procedure must be done by an experienced laparoscopic surgeon if you want to minimise the risk of complications.

Certain common anti-inflammatory drugs such as aspirin and NSAIDs, may irritate the stomach, and should be used with caution.


In some patents it is necessary that they take folate and vitamin B12 supplements to maintain normal homocycteine levels. Elevated homocycteine levels need to be controlled because if they are not, they can increase risks to your heart and the risk of spinal birth defects.

The development of gallstones after a rapid weight loss is not uncommon andcan lead to the gallbladder being surgically removed.

No reports of autoimmune disease have been connected to the use of the LAP-BAND System. Autoimmune diseases and connective tissue disorders have, however, been reported after long-term implantation of other silicone devices. These problems can include:

  • systemic lupus
  • erythematosus
  • scleroderma.

At this time, however, there is no conclusive clinical evidence that supports a link between connective-tissue disorders and silicone implants. Long-term studies to evaluate this possibility are ongoing. It is important to note, however, that  if autoimmune symptoms develop after the band is in place, you might need further treatment. Three is also the remote possibility that the band may also need to be removed. Talk with your surgeon about this possibility. It is important you have all the facts about what you are about to undertake.
If you have symptoms of autoimmune disease at the time that you are looking into weight loss surgery, the LAP-BAND System may not be right for you.

Removing the Band

If the LAP-BAND System was originally placed laparoscopically, it may be possible to remove it in the same way. This is a definite advantage of the LAP-BAND System. An "open" procedure, however, might be necessary to carry out  a band removal. According to the results of the U.S. Clinical Study, 60% of the bands that were subsequently removed were done laparoscopically. Surgeons report that after the band is removed, the stomach soon returns to its normal condition. 

At this time, there is no known indication for a band to be removed or replaced unless this is done in response to a complication or in the event that no weight is being lost.   It is difficult, to say with certainly however, whether the band could or should stay in place for the rest of a patient’s life as it is possible that it may need to be removed or replaced at some point.

To remove the device a surgical procedure is required. That procedure will have all the related risks and possible complications that are inherent with surgery. The risk of some complication occurring, such as erosions or infection will increase concomitantly with any added or new procedure.




[Last Update: Rewrite 22nd May 2010]