Risks Associated with the The LAP-BAND® System

Indications: The The LAP-BAND® System is indicated for use in weight reduction for severely obese patients with a Body Mass Index (BMI) of at least 40 or a BMI of at least 35 with one or more severe co-morbid conditions, or those who are 100 lbs. or more over their estimated ideal weight.

Contraindications: The The LAP-BAND® System is not recommended for non-adult patients, patients with conditions that may make them poor surgical candidates or increase the risk of poor results, who are unwilling or unable to comply with the required dietary restrictions, or who currently are or may be pregnant.

Warnings: The The LAP-BAND® System is a long-term implant. Explant and replacement surgery may be required at some time. Patients who become pregnant or severely ill, or who require more extensive nutrition may require deflation of their bands. Patients should not expect to lose weight as fast as gastric bypass patients, and band inflation should proceed in small increments. Anti-inflammatory agents, such as aspirin, should be used with caution and may contribute to an increased risk of band erosion.

Adverse Events: Placement of the The LAP-BAND® System is major surgery and, like any surgery, death can occur. Possible complications include the risks associated with the medications and methods used during surgery, the risks associated with any surgical procedure, and the patient’s ability to tolerate a foreign object implanted in the body.

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
• Infection
• Death

Other problems which may occur are:
• 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

Weight loss with the band 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 the weight loss process 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.

Complications can cause reduced weight loss. They can also cause weight gain. Certain complications may require that you return to surgery to remove, reposition, or replace the band.