Risk assessment of copper-containing contraceptives: the impact for women with implanted intrauterine devices during clinical MRI and CT examinations
To assess the risks for implant users with copper-containing intrauterine devices (IUDs) during MR and CT examinations.
A tissue-mimicking phantom suitable for all experiments within this study was developed. Seven different types of copper IUDs were evaluated. Heating and dislocation of each IUD were investigated at two clinically relevant positions in 1.5 T and 3 T MR scanners. Artifacts in the field of view caused by each tested IUD were determined for clinical MR and CT imaging.
No significant heating of any tested IUD was detected during MR measurements. The temperature increase was less than 0.6 K for all IUDs. Neither angular deflection nor translation of any IUD was detected. Artifacts in MR images were limited to the very vicinity of the IUDs except for one IUD containing a steel-visualizing element. Streaking artifacts in CT were severe (up to 75.5%) in the slices including the IUD.
No significant risk possibly harming the patient was determined during this phantom study, deeming MR examinations safe for women with an implanted copper IUD. Image quality was more impaired for CT than for MR imaging and needs careful consideration during diagnosis.
• Risk assessment of copper-containing IUDs with regard to heating, dislocation, and artifacts during MR and CT imaging.
• Neither significant heating nor dislocation was determined in MR; image quality was more impaired for CT than for MR imaging and needs careful consideration during diagnosis.
• The tested IUDs pose no additional risks for implant users during MR and CT examinations.
KeywordsIntrauterine devices, copper Patient safety Magnetic resonance imaging Phantoms, imaging Tomography, X-ray computed
American Society for Testing Materials
Field of view
True fast imaging with steady-state free precession
Turbo spin echo
The authors are grateful to Marius Siegfarth (Fraunhofer PAMP) for his assistance during temperature measurements.
The IUDs used for this study were supplied by the manufacturers who had no further influence on the study.
This research project is part of the Research Campus M2OLIE and funded by the German Federal Ministry of Education and Research (BMBF) within the Framework “Forschungscampus: public-private partnership for Innovations” under the funding code 13GW0092D.
Compliance with ethical standards
The scientific guarantor of this publication is Frank G. Zöllner.
Conflict of interest
The authors declare that they have no conflict of interest.
Statistics and biometry
No complex statistical methods were necessary for this paper.
Written informed consent was not required for this study because it was a phantom study.
Institutional Review Board approval was not required because it was a phantom study.
• Performed at one institution
- 2.United Nations Population Fund (2016) TCu380A intrauterine contraceptive device (IUD) WHO/UNFPA technical specification and prequalification guidance. United Nations Population Fund, NY, USAGoogle Scholar
- 3.World Health Organization (ed) (2009) Medical eligibility criteria for contraceptive use – 4th ed. World Health Organization, GenevaGoogle Scholar
- 4.United Nations Department of Economic and Social Affairs (2011) World contraceptive use 2011. United Nations Department of Economic and Social Affairs, NY, USA. Available via http://www.un.org/esa/population/publications/contraceptive2011/wallchart_front.pdf. Accessed 01 Aug 2018
- 18.Kalender WA (2011) Computer Tomography, 3rd edn. Publicis MCD Verlag, GermanyGoogle Scholar
- 23.ASTM Standard F2119-07 (2007) Standard test method for evaluation of MR image artifacts from passive implants. ASTM International, West ConshohockenGoogle Scholar
- 24.ASTM Standard F2182-11a (2011) Standard test method measurements of radio frequency induced heating on or near passive implants during magnetic resonance imaging. ASTM International, West ConshohockenGoogle Scholar
- 25.ASTM Standard F2213-06 (2006) Standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environment. ASTM International, West ConshohockenGoogle Scholar
- 26.EN60601 (2017) Medical electrical equipment - Part 2–33: particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis. Beuth Verlag, BerlinGoogle Scholar
- 27.Neumann W, Lietzmann F, Schad LR, Zöllner FG (2017) Design of a multimodal (1H/23NaMR/CT) anthropomorphic thorax phantom. Z Med Phys 27:124–131Google Scholar
- 31.Optocon AG (2012). Reference manual for fiber optic thermometer FOTEMP1-4. Available via http://www.optocon.de/en/products/fiber-optic-temperature-signal-conditioners/fotemp1-4-fiber-optic-single-channel-thermometer/. Accessed 01 Aug 2018
- 34.Ulaby FT, Michielssen E, Ravaioli U (2015) Fundamentals of applied electromagnetics, global edition. Pearson Education Limited, EssexGoogle Scholar