TY - JOUR
T1 - A review of complications associated with vertebroplasty and kyphoplasty as reported to the food and drug administration medical device related web site
AU - Nussbaum, David A.
AU - Gailloud, Philippe
AU - Murphy, Kieran
N1 - Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.
PY - 2004/11
Y1 - 2004/11
N2 - 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.
AB - 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.
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U2 - 10.1097/01.RVI.0000144757.14780.E0
DO - 10.1097/01.RVI.0000144757.14780.E0
M3 - Article
C2 - 15525736
AN - SCOPUS:8444228488
VL - 15
SP - 1185
EP - 1192
JO - Journal of Vascular and Interventional Radiology
JF - Journal of Vascular and Interventional Radiology
SN - 1051-0443
IS - 11
ER -