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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.^1,2

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****urred in 11% of patients, the long-term effects of which are currently unknown. Constipation, diarrhea and dysphagia (difficulty swallowing****urred 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, *****ly, 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.

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

Weight loss with the 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), 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.