Risks and Complications of LAP-BAND® Surgery

A brief description of relevant contraindications, warnings and adverse events of the LAP-BAND® System

Indications: 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 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 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 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.

Complications

• Mortality < 0.5%
• Major Complications
  ▪ Pulmonary embolism
  ▪ Bandage slippage, erosion and deflation
  ▪ Obstruction of the stomach
  ▪ Dilation of the esophagus
  ▪ Other         (Reoperation may be required)
• Minor Complications
  ▪ Port-site complications
  ▪ Minor infections
  ▪ Bleeding
  ▪ Nausea or vomiting
  ▪ Gallstones
  ▪ Nutritional deficiency
  ▪ Other

Band slippage, erosion and deflation, obstruction of the stomach, dilation of the esophagus, infection, or nausea and vomiting may occur. Reoperation may be required.

Rapid weight loss may result in complications that can require additional surgery. Deflation of the band may alleviate excessively rapid weight loss or esophageal dilation.

Not all contraindications, warnings or adverse events are included in this brief description. More detailed risk information is available at http://www.LAP-BAND®.com or 1-877-LAP-BAND®.