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About Complications Related to the Use of Bone Cement
Bone cements have been used for many years for the fixation of metal and plastic prostheses in joint replacement and less frequently in the fixation of pathological fractures. Existing bone cements and bone void fillers designed for uses other than the treatment of spinal compression fractures are generally modified for this use. Modifications to bone cements and bone void fillers may vary from physician to physician and among procedures.
There have been serious complications from the use of acrylic bone cements in treating compression fractures of the spine, an indication for which these products had not been cleared. Reported complications include pulmonary embolism, respiratory and cardiac failure, and death. Bone void fillers are cleared for use only in non load bearing applications.
Physicians who are considering vertebroplasty or kyphoplasty using bone cements and bone void fillers that are not cleared by FDA for this purpose should be especially attentive to patient selection, treatment techniques, potential complications, and patient monitoring.
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(Ref : http://www.fda.gov/cdrh/safety/bonecement.html)
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