Concerns about women who have implanted or in situ medical devices undergoing magnetic resonance (MR) imaging engender the need for testing. Prior testing of the Copper T 380A intrauterine device (IUD) has been done using MR systems of 1.5 T or less. This study was performed to test this IUD in a MR system of 3.0 T.
Materials and Methods
In vitro safety testing was done via the Copper T 380A IUD using a GE Signa LX 3.0-T MR system. Variables tested included deflection, torque, heating and artifact.
No significant deflection, torque, heating or artifact was found in this in vitro testing model.
The outcomes measured revealed no safety concerns for the use of the Copper T 380A IUD at 3.0 T under the conditions of testing. This finding is compatible with the new standards adopted by the American Society for Testing and Materials and the Food and Drug Administration (FDA), with a rating of ���MR Conditional.���
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Published online: November 03, 2006
Accepted: July 28, 2006
Received: May 26, 2006
���This safety test was funded by FEI, the manufacturer of the Copper T 380A. The findings and conclusions of this report are those of the authors and do not necessarily represent the views of the funding agency.
© 2007 Elsevier Inc. Published by Elsevier Inc. All rights reserved.