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                                            Safety Information Article
                      Information on this page is limited by the terms of our Disclaimer.  Please Read!

       ESSURE Device 

The Essure Device (Conceptus Incorported and Bayer) is a metallic implant developed for permanent female contraception. The presence of this implant is intended to alter the function and architecture of the fallopian tube, resulting in permanent contraception. The Essure Device is composed of 316L stainless steel, platinum, iridium, nickel-titanium alloy, silver solder, and polyethylene terephthalate (PET) fibers.

The MRI assessment of this device involved testing for magnetic field interactions (1.5-Tesla), heating, induced electrical currents, and artifacts using previously described techniques. There were no magnetic field interactions, the highest temperature changes were < +0.6 degrees C, and the induced electrical currents were minimal. Furthermore, artifacts should not create a substantial problem for diagnostic MR imaging unless the area of interest is in the exact same position as where this implant is located. Thus, the findings indicated that it is acceptable for a patient with the Essure Device to undergo an MR procedure at 1.5-Tesla or less.

MRI at 3-Tesla and the Essure Device. The Essure Device has been evaluated (i.e. tested for magnetic field interactions and MRI-related heating) at 3-Tesla and found to be acceptable for patients undergoing MR procedures at this static magnetic field strength.

REFERENCES

Shellock FG. Biomedical implants and devices: Assessment of magnetic field interactions with a 3.0-Tesla MR system. J Magn Reson Imag 2002;16:721-732.

Shellock FG. New metallic implant used for permanent female contraception: Evaluation of MR safety. Am J Roentgenol 2002;178:1513-1516.

www.essure.com



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