Scientific Publications by FDA Staff

IEEE Trans Electromagn Compat 2017 Oct;59(5):1390-9

RF safety evaluation of a breast tissue expander device for MRI: numerical simulation and experiment.

Park BS, Razjouyan A, Angelone LM, McCright B, Rajan SS

This study describes the MRI-related radio frequency (RF) safety evaluation of breast tissue expander devices to establish safety criteria. Numerical simulations and experimental measurements were performed at 64 MHz with a gel phantom containing a breast expander. Additionally, computational modeling was performed (64 and 128 MHz) with an adult female model, containing a virtually implanted breast tissue expander device for four imaging landmark positions. The presence of the breast tissue expander device led to significant alterations in specific absorption rate (SAR) and B1+ distributions. The main source of SAR alterations with the use of the breast expander device was the saline-filled pouch of the expander. Conversely, the variation of RF magnetic field B1+ was mainly caused by the metallic port. The measured values of electric field magnitude did not increase significantly due to the introduction of the expander device. The maximum 1g- or 10g-averaged SAR values in tissues near the implant were lower than those expected in other regions of the patient body with normalization of both B1+ equal to 2 µT at the coil isocenter and whole body averaged SAR equal to 4 W/kg.