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 indude:

• spleen or liver damage (sometimes requiring spleen removal)
• damage to major blood vessels
• lung problems
• thrombosis (blood dots)
• 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 rases 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 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 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.

Important

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 retum 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.