title: A review of complications associated with vertebroplasty and kyphoplasty as reported to the Food and Drug Administration medical device related web site.
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.
authors.affiliation: Division of Interventional Neuroradiology, Department of Radiology and Radiological Sciences, The Johns Hopkins Hospital, 600 North Wolfe Street, Baltimore, Maryland 21287, USA.
authors.forename: David A
authors.initials: DA
authors.lastname: Nussbaum
authors.forename: Philippe
authors.initials: P
authors.lastname: Gailloud
authors.forename: Kieran
authors.initials: K
authors.lastname: Murphy
mesh_terms: D022126:Access to Information; D001416:Back Pain / Q000209:etiology / Q000517:prevention & control; D001843:Bone Cements / Q000009:adverse effects / Q000627:therapeutic use; D016208:Databases, Factual; D004864:Equipment and Supplies / Q000009:adverse effects; D005593:Fracture Fixation, Internal / Q000009:adverse effects* / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D007738:Kyphosis / Q000628:therapy; D009862:Online Systems; D019904:Polymethyl Methacrylate / Q000009:adverse effects / Q000627:therapeutic use; D011183:Postoperative Complications / Q000209:etiology; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data; D016103:Spinal Fractures / Q000628:therapy*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001843:Bone Cements; D019904:Polymethyl Methacrylate