RF Safety Evaluation of a Breast Tissue Expander Device for MRI: Numerical Simulation and Experiment

Park, Bu S.; Razjouyan, Amir; Angelone, Leonardo M.; McCright, Brent; Rajan, Sunder S.

doi:10.1109/temc.2017.2678201

Cited by 6 publications

(13 citation statements)

References 28 publications

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“…MRI uses a strong static magnetic field, time-varying magnetic fields, and radiofrequency (RF) fields, each of which may adversely impact certain implants resulting potential patient injuries or fatalities [2,13,14]. With specific reference to MRI-related heating (i.e., the sensation experienced by one patient found in our literature review), RF pulses deposit energy in the patient as a result of the coupling of the electric field and the induction of eddy currents [2,8,13]. When a metallic implant is present, the induced currents can generate temperature rises in the surrounding tissues [2,8,13].…”

Section: Discussionmentioning

confidence: 99%

“…With specific reference to MRI-related heating (i.e., the sensation experienced by one patient found in our literature review), RF pulses deposit energy in the patient as a result of the coupling of the electric field and the induction of eddy currents [2,8,13]. When a metallic implant is present, the induced currents can generate temperature rises in the surrounding tissues [2,8,13]. This type of heating has been investigated for more than three decades.…”

Section: Discussionmentioning

confidence: 99%

“…The level-of-evidence was relatively low (Table 1). Of the included articles, one was a commentary, two were case reports, and five employed ex vivo testing [3,4,7,8,[10][11][12].…”

Section: Literature Reviewmentioning

confidence: 99%

“…To understand the mechanisms whereby an MRI examination could result in TE issues, we performed a literature search. Surprisingly, the data from multiple ex vivo studies and a large clinical series indicated that MRI may not create serious problems for patients with breast TEs that have magnetic ports if special precautions are taken [3][4][5][6][7][8]. Notably, there are several implants that incorporate magnetic components which are labeled "MR Conditional," permitting patients with those items to undergo MRI exams including a reflux management system; a magnetically-programmable, spinal distraction system; various programmable cerebral spinal fluid shunt valves; and cochlear im-plants [2].…”

Section: Introductionmentioning

confidence: 99%

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Reconsidering the “MR Unsafe” breast tissue expander with magnetic infusion port: A case report and literature review

et al. 2019

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Breast tissue expanders (TEs) with magnetic infusion ports are labeled “MR Unsafe.” Therefore, patients with these implants are typically prevented from undergoing magnetic resonance imaging (MRI). We report a patient with a total submuscular breast TE who inadvertently underwent an MRI exam. She subsequently developed expander exposure, requiring explantation and autologous reconstruction. The safety profile of TEs with magnetic ports and the use of MRI in patients with these implants is surprisingly controversial. Therefore, we present our case report, a systematic literature review, and propose procedural guidelines to help ensure the safety of patients with TEs with magnetic ports that need to undergo MRI exams.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

“…The level-of-evidence was relatively low (Table 1). Of the included articles, one was a commentary, two were case reports, and five employed ex vivo testing [3,4,7,8,[10][11][12].…”

Section: Literature Reviewmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Reconsidering the “MR Unsafe” breast tissue expander with magnetic infusion port: A case report and literature review

et al. 2019

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“…Computational models of anatomy or physiology include improved drug delivery in the cornea with ultrasound energy ( 24 ); physiological models of heart cells ( 25 ), renal circulation ( 26 ), hemodynamic responses to blood volume perturbations ( 27 ), left bundle branch block ( 28 ), gas dynamics in the retina ( 29 ), coupled electrical and mechanical activity in the heart ( 30 ); energy absorption in patients with deep-brain stimulators ( 31 – 34 ), breast tissue expanders ( 35 ), in pregnant women and fetus during MRI exams ( 36 ); subthalamic nucleus ( 37 ), the breast ( 38 ), cancellous bone ( 39 ), the head ( 40 ) and whole body models ( 41 , 42 ).…”

Section: Computational Modeling Researchmentioning

confidence: 99%

Advancing Regulatory Science With Computational Modeling for Medical Devices at the FDA's Office of Science and Engineering Laboratories

et al. 2018

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Protecting and promoting public health is the mission of the U.S. Food and Drug Administration (FDA). FDA's Center for Devices and Radiological Health (CDRH), which regulates medical devices marketed in the U.S., envisions itself as the world's leader in medical device innovation and regulatory science–the development of new methods, standards, and approaches to assess the safety, efficacy, quality, and performance of medical devices. Traditionally, bench testing, animal studies, and clinical trials have been the main sources of evidence for getting medical devices on the market in the U.S. In recent years, however, computational modeling has become an increasingly powerful tool for evaluating medical devices, complementing bench, animal and clinical methods. Moreover, computational modeling methods are increasingly being used within software platforms, serving as clinical decision support tools, and are being embedded in medical devices. Because of its reach and huge potential, computational modeling has been identified as a priority by CDRH, and indeed by FDA's leadership. Therefore, the Office of Science and Engineering Laboratories (OSEL)—the research arm of CDRH—has committed significant resources to transforming computational modeling from a valuable scientific tool to a valuable regulatory tool, and developing mechanisms to rely more on digital evidence in place of other evidence. This article introduces the role of computational modeling for medical devices, describes OSEL's ongoing research, and overviews how evidence from computational modeling (i.e., digital evidence) has been used in regulatory submissions by industry to CDRH in recent years. It concludes by discussing the potential future role for computational modeling and digital evidence in medical devices.

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A new method to improve RF safety of implantable medical devices using inductive coupling at 3.0 T MRI

Park¹,

Guag

Jeong

et al. 2023

Magn Reson Mater Phy

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Objective To enhance RF safety when implantable medical devices are located within the body coil but outside the imaging region by using a secondary resonator (SR) to reduce electric fields, the corresponding specific absorption rate (SAR), and temperature change during MRI. Materials and methods This study was conducted using numerical simulations with an American Society for Testing and Materials (ASTM) phantom and adult human models of Ella and Duke from Virtual Family Models, along with corresponding experimental results of temperature change obtained using the ASTM phantom. The circular SR was designed with an inner diameter of 150 mm and a width of 6 mm. Experimental measurements were carried out using a 3 T Medical Implant Test System (MITS) body coil, electromagnetic (EM) field mapping probes, and an ASTM phantom. Results The magnitudes of B1+ (|B1+|) and SAR1g were reduced by 15.2% and 5.85% within the volume of interest (VoI) of an ASTM phantom, when a SR that generates opposing electromagnetic fields was utilized. Likewise, the Δ|B1+| and ΔSAR1g were reduced by up to 56.7% and 57.5% within the VoI of an Ella model containing a copper rod when an opposing SR was used. Conclusion A novel method employing the designed SR, which generates opposing magnetic fields to partially shield a sample, has been proposed to mitigate the risk of induced-RF heating at the VoI through numerical simulations and corresponding experiments under various conditions at 3.0 T.

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RF Safety Evaluation of a Breast Tissue Expander Device for MRI: Numerical Simulation and Experiment

Cited by 6 publications

References 28 publications

Reconsidering the “MR Unsafe” breast tissue expander with magnetic infusion port: A case report and literature review

Reconsidering the “MR Unsafe” breast tissue expander with magnetic infusion port: A case report and literature review

Advancing Regulatory Science With Computational Modeling for Medical Devices at the FDA's Office of Science and Engineering Laboratories

A new method to improve RF safety of implantable medical devices using inductive coupling at 3.0 T MRI

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