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Benefits and Risks – Kyphon Balloon Kyphoplasty

Spinal Fractures

Benefits

Kyphon® Balloon Kyphoplasty has been shown to achieve restoration of vertebral body height and correction of vertebral body deformity. Additional benefits include:1-3

  • Significant and sustained reduction in back pain
  • Sustained vertebral body height restoration
  • Significant and sustained improvement in quality of life
  • Significant and sustained improvement in mobility
  • Significant and sustained improvement in ability to perform activities of daily living
  • Significant reduction in number of days per month that a patient remains in bed due to back pain
  • Significant and sustained reduction in number of days per month when pain interferes with daily activities such as walking, hobbies, and work

Numerous studies have documented favorable treatment outcomes in balloon kyphoplasty patients, with a follow-up of at least 2 years.

Risks

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. Please consult your Health Care Professional for a discussion of these and other risks and whether this procedure is right for you.

References

1

Garfin, S.R., R.A. Buckley, and J. Ledlie, Balloon kyphoplasty for symptomatic vertebral body compression fractures results in rapid, significant, and sustained improvements in back pain, function, and quality of life for elderly patients. Spine. 2006. 31(19): p. 2213-20.

2

Ledlie, J.T. and M.B. Renfro, Kyphoplasty treatment of vertebral fractures: 2-year outcomes show sustained benefits. Spine. 2006. 31(1): p. 57-64.

3

Gaitanis, I.N., et al., Balloon kyphoplasty for the treatment of pathological vertebral compressive fractures. Eur Spine J. 2005. 14(3): p. 250-60.

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