Balloon kyphoplasty is a minimally invasive, orthopedic procedure for stabilizing spinal fractures that may reduce back pain, correct angular vertebral deformity and restore vertebral body height.
The National Osteoporosis Foundation cites osteoporosis as a major public health threat affecting 44 million Americans, or 55 percent of people 50 years of age and older. Osteoporosis causes 1.5 million fractures annually, with more than 700,000 of these fractures occurring in the spine.
Spinal fractures can also be caused by cancer, the most common being multiple myeloma, breast, lung and prostate. According to the Multiple Myeloma Research Foundation, 55-70% of Multiple Myeloma patients already have VCFs at the time of diagnosis and 15-30% develop new VCFs annually. 1
The change in the shape of the vertebral body following fracture alters the body’s center of gravity. Multiple spinal fractures can affect the alignment of the entire spine. Over time, this alteration in spinal configuration may lead to reduction of motion and strength and well as visible spinal deformity known as kyphosis or “dowager’s hump.”
Balloon kyphoplasty typically takes about one hour per fracture treated. It can be performed on an inpatient or outpatient basis and under local or general anesthesia (both determinations are based on medical necessity). Your physician will discuss with you which options are appropriate for you.
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.
For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please reference the devices’ Instructions for Use.
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