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Risks and possible problems with the procedure

Risks and possible problems with the procedure

What the studies said

The most common problems after balloon kyphoplasty were cement leaks and new fractures. In one study cement leaks happened after 11% of procedures (11 in every 100). In one patient a cement leak damaged the nerve roots but the patient recovered after treatment and rehabilitation. In another study cement leaks occurred after 7% of procedures but they did not cause the patients any problems.

New fractures happened after the procedure in 23% of patients (225 procedures) in one study. In another study 7 out of 40 patients (18%) who had balloon kyphoplasty had new fractures compared with 10 out of 20 patients (50%) who had standard treatments.

Other problems have happened occasionally during or after balloon kyphoplasty. The balloon burst in two cases, there was bleeding around the spine in another case and in another case a nerve was damaged and the patient lost the use of one leg.

The US Food and Drugs Administration has been told about 33 major problems out of roughly 40,000 to 60,000 balloon kyphoplasty procedures. These included one death, five cases of paralysis or other major problems with nerves resulting in loss of physical function, and 13 cases of damage to the spinal cord (the nerves in the spine).

What the experts said

The experts said that cement leakage was the most common problem after balloon kyphoplasty. They said that infection, allergy and injury to the spinal cord or nerve root because of the needle being put in incorrectly were possible problems that could occur.