Miriam Zieman1, Emanuel Kanal. 1. Department of Gynecology and Obstetrics, Emory University School of Medicine, Atlanta, GA 30303, USA. mzieman@comcast.net
Abstract
BACKGROUND: 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. RESULTS: No significant deflection, torque, heating or artifact was found in this in vitro testing model. CONCLUSION: 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."
BACKGROUND: 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 CopperT 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 CopperT 380A IUD using a GE Signa LX 3.0-T MR system. Variables tested included deflection, torque, heating and artifact. RESULTS: No significant deflection, torque, heating or artifact was found in this in vitro testing model. CONCLUSION: The outcomes measured revealed no safety concerns for the use of the CopperT 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."
Authors: Simon Bussmann; Roger Luechinger; Johannes M Froehlich; Constantin von Weymarn; Carolin Reischauer; Dow Mu Koh; Andreas Gutzeit Journal: PLoS One Date: 2018-10-09 Impact factor: 3.240