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Important Safety Information

Spinal Fractures

Kyphon® Balloon Kyphoplasty

PATIENTS

Although the complication rate for Kyphon® Balloon Kyphoplasty is low, as with most surgical procedures, serious adverse events, some of which can be fatal, can occur, including heart attack, cardiac arrest (heart stops beating), stroke, and embolism (blood, fat or cement that migrates to the lungs or heart). Other risks include infection; leakage of bone cement into the muscle and tissue surrounding the spinal cord and nerve injury that can, in rare instances, cause paralysis; leakage of bone cement into the blood vessels resulting in damage to the blood vessels, lungs and/or heart. This procedure is not for everyone. A prescription is required. Please consult your physician for a discussion of these and other risks and whether this procedure is right for you.

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