Perspective
A Review of Complications Associated with Vertebroplasty and Kyphoplasty as Reported to the Food and Drug Administration Medical Device Related Web Site

https://doi.org/10.1097/01.RVI.0000144757.14780.E0Get rights and content

In 2002, approximately 38,000 vertebroplasties and 16,000 kyphoplasties were performed in the United States. As the use of both modalities for the treatment of vertebral compression fractures has increased, so have questions regarding safety and efficacy. The authors addressed this by reviewing both the current literature and complications data reported to the Food and Drug Administration (FDA) Center for Devices and Radiological Health through the on-line database (http://www.fda.gov/cdrh/maude.html) and through the Office of the Freedom of Information Act at the FDA. Although both procedures are largely safe, the FDA data highlight two main concerns: reactions to the use of acrylic (polymethylmethacrylate) bone cement, including hypotension and, in some cases, death, especially when multiple vertebral levels are treated in one setting; and a possible increased risk with kyphoplasty of pedicle fracture and cord compression.

Section snippets

FDA REPORTED COMPLICATIONS

We collected reports of complications related to vertebroplasty and kyphoplasty from the online FDA MAUDE database (http://www.fda.gov/cdrh/maude.html and through the Office of the Freedom of Information Act at the FDA. The search included the following keywords: vertebr, pedicle, Interpore, American Osteomedix, and Kyphon. The collected reports were filed during the period 1999 to June 27, 2003. Manufacturers were then contacted directly to clarify information regarding the exact techniques

DISCUSSION

In this study we collected and analyzed reports from the online FDA MAUDE database of complications in vertebroplasty and kyphoplasty procedures. In total, 52 patient complication reports were filed between 1999 and June 27, 2003. Of these, 33 underwent kyphoplasty, 14 underwent transpedicular vertebroplasty, and five underwent lateral approach vertebroplasty. During this same period, approximately 40,000 to 60,000 kyphoplasties, 130,000 to 160,000 transpedicular vertebroplasties, and 10,000 to

CONCLUSION

The online FDA MAUDE database provides a unique view of complications that occur within the medical community, outside the ivory tower of the academic medical center and super-specialized physician. These reports also provide primary patient data for comparison of standard vertebroplasty with modifications such as kyphoplasty and lateral vertebroplasty, about which there are few comprehensive studies published.

Our search identified complications in 52 patients who underwent either kyphoplasty

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    P.G. receives research support from W.E. Cook. K.M. is a consultant to W.E. Cook and has a royalty agreement. The other author has not identified a potential conflict of interest.

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