Copper T 380A IUD and magnetic resonance imaging.
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.


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.


CONCLUSIONS
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."
Zieman
Miriam
M
Department of Gynecology and Obstetrics, Emory University School of Medicine, Atlanta, GA 30303, USA. mzieman@comcast.net
Kanal
Emanuel
E
D003267:Contraception; D005260:Female; D006801:Humans; D007435:Intrauterine Devices, Copper; D008279:Magnetic Resonance Imaging; D009682:Magnetic Resonance Spectroscopy; D008422:Materials Testing; D012449:Safety; D013696:Temperature