New Disclaimers from Allergan

February 11, 2010

I'm glad Allergan is being much clearer about contraindications and possible

problems with the Band:

Sandy r

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IMPORTANT LAP-BAND® SYSTEM SAFETY INFORMATION

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 comorbid 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 (e.g., inflammatory or cardiopulmonary

diseases, GI conditions, symptoms or family history of autoimmune disease,

cirrhosis), who are unwilling or unable to comply with the required dietary

restrictions, who have alcohol or drug addictions, 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. Patients who become pregnant or severely ill, or who

require more extensive nutrition may require deflation of their bands.

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, as with

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.

Band slippage, erosion and deflation, reflux, 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 may require additional

surgery. Deflation of the band may alleviate excessively rapid weight loss or

esophageal dilation.

Important: For full safety information please visit www.lapband.com, talk with

your doctor, or call Allergan Product Support at 1-800-624-4261.

CAUTION: Rx only.

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