A review of complications associated with vertebroplasty and kyphoplasty as reported to the food and drug administration medical device related web site

David A. Nussbaum, Philippe Gailloud, Kieran Murphy

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1185-1192
Number of pages8
JournalJournal of Vascular and Interventional Radiology
Volume15
Issue number11
DOIs
StatePublished - Nov 2004

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

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