LAP-BAND Forum

LAP-BAND  System Risk Information
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: 

• You are an adult (at least 18 years old).
• Your BMI is 40 or greater or you weigh at least twice your ideal weight or you weigh at least 100 pounds (45 kilos) more than your ideal weight.
• 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 you to be overweight.
• You are prepared to make major changes in your eating habits and lifestyle.
• You are willing to continue working with the specialist who is treating you.
• You do not drink alcohol in excess.

Your surgeon may consider whether the LAP-BAND ® is right for you if your BMI is at least 35 and you have a health problem that is related to obesity. Your surgeon may also have other criteria he or she uses. Ask him or her to discuss the criteria with you.

Contra-indications
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 Crohns 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. 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).
• 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/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 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.

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
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 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 treatment. First, though, your surgeon will want to make sure you know about the advantages, disadvantages, and risks involved.

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. Talk with your surgeon in detail about 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, indicate that 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, diarrhea 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 thediaphragm), 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 dont 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 arent 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

• 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

• 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.

• Food
• Swelling
• Improper placement of the band
• The band being over-inflated
• Band or stomach slippage
• Stomach pouch twisting
• Stomach pouch enlargement

• Improper placement of the band
• The band being tightened too much
• Stoma obstruction
• Binge eating
• Excessive vomiting

• 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), Barretts 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 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 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 LAP-BAND ® System may not be right for you.

Removing the LAP-BAND ® System
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.

*SAGES/ASBS Guidelines for Laparoscopic and Conventional Surgical Treatment of Morbid Obesity. American Society for Bariatric Surgery.  http://asbs.org/html/guidelines.html

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