Document Type

Capstone Experience

Graduation Date

8-2024

Degree Name

Master of Public Health

Department

Health Promotion

First Committee Member

Chad Abresch, PhD

Second Committee Member

Eleanor G. Rogan, PhD

Third Committee Member

Wael ElRayes, MBBCh, PhD, MS, FACHE

Fourth Committee Member

Steve Peters, MA

Abstract

Purpose

This capstone project aims to conduct a scoping review to identify breast tissue expanders that are safe for high-risk breast cancer survivors, ensuring safe magnetic resonance (MR) examinations. The goal is safe MR examinations for early detection of recurrent cancer, post-operative evaluation, monitoring, and reducing preventable morbidity and mortality.

Background

The MR safety of manufacturers' tissue expanders is defined according to the United States Food and Drug Administration (FDA) guidelines and regulations as MR Conditional or MR Unsafe. Before 2023, there was a safety concern about using tissue expanders containing a magnetic port during the first stage of breast reconstructive surgery, as these were categorized as MR Unsafe for breast cancer survivors (Clausen-Oreamuno, 2024; Dibbs et al., 2019). FDA magnetic resonance imaging (MRI) medical device guidelines state that MR Unsafe devices pose unacceptable medical risks for patients having an MR examination, creating barriers for cancer survivors needing safe MR examinations (FDA, 2023b). Consulting with MR safety experts provided a deeper understanding of ensuring safe MR examinations and potential concerns related to surgically implanted medical devices.

Methods

The scoping review involved a comprehensive literature search on Medline, Science & Technology Collection, Google Scholar, and Cochrane. This search aimed to gather data from research studies to conduct a scoping review to identify breast tissue expanders that are safe for high-risk breast cancer survivors, ensuring safe MR examinations, earlier detection of recurrent cancer, post-operative evaluation, monitoring, and reducing preventable morbidity and mortality.

Results

The search initially yielded 52 articles, of which 11 were selected for inclusion in this scoping review. Articles unrelated to tissue expander and MRI compatibility were excluded. Additional resources included consulting with MRI experts and stakeholders, reviewing the FDA 510(k) clearance process, FDA guidelines, imaging and plastic surgery standards, and MR safety regulations.

Conclusion/Implications

This scoping review applies the Health Belief Model to explain the factors that influenced the adoption of the first MR Conditional tissue expander in the United States in 2023. The scoping review highlights the controversy surrounding MR examinations for patients with breast tissue expanders containing magnetic ports. The scoping review and stakeholder consultations provided further insight into the necessary steps for a medical device to progress through the FDA 510(k) clearance for surgical use and emphasized the importance of MR safety guidelines and medical device safety guidelines. Implementing the new MR Conditional tissue expander in 2023 aims to ensure safer MR examinations and earlier detection of recurrent cancer in cancer in high-risk patients, ultimately reducing preventable morbidity and mortality.

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