Evaluation of Caffeic Acid Transport in an In Vitro 3D Model of Hepatocellular Carcinoma; Essure® by Bayer: A Care Ethics Analysis

Frazier, Ella, School of Engineering and Applied Science, University of Virginia
Laugelli, Benjamin, EN-Engineering and Society, University of Virginia
Wilkins, Luke, MD-RADL Angio/Interv, University of Virginia
Brautigan, David, MD-MICR Microbiology, University of Virginia

My technical work and STS research are connected through the field of medical technology development. Medical technology research and development (R&D) plays a crucial role in the field of medicine as it pushes the boundaries of what we know and how we can best treat patient conditions. Although both projects address this overarching theme, the two works differ in the area of R&D they explore. My technical work addresses the research and experimental side while my STS research focuses on the ethical considerations one must be cognizant of when looking to put a new technology on the market.

My technical work explores the research side of medical technology development through the design of a Hepatocellular Carcinoma (HCC) tissue model. Prior research by our advisors showed that the phytochemical, Caffeic acid (CA), when paired with a gold-standard HCC treatment, a trans-arterial embolization (TAE) procedure, causes more extensive reduction in HCC tumor volume than when compared to a TAE procedure alone. However, in-vivo determination of CA transport is difficult to obtain and very little is currently known. To address this gap in knowledge, my capstone team created an in-vitro, 3D Transwell model of HCC to assay for transport of various CA formulations. Ultimately, the goal of this project is to provide a basis of knowledge for CA transport to aid in the optimization of the improved TAE+CA procedure in future pre-clinical and clinical trials.

My STS research looks at the development of medical technology through the lens of ethical considerations. My research focuses in on the manufacturer Bayer with their product Essure®, a permanent form of female sterilization that was deemed superior to a tubal ligation as its insertion was quick, abdominal incision-free and anesthesia-free. Essure® was first put on the market in 2002, however, its lifespan was cut short when the FDA imposed a black box warning on the device in 2018 following an increase in adverse event reports. Using the framework of care ethics, I claim that Bayer failed to provide attentive, responsible, and competent care to their intended consumers, women seeking sterilization. The goal of this research is to gain a better understanding of ethical concerns one should consider when looking to place a new medical device on the market.

Working on these two projects simultaneously afforded me the opportunity to gain a better understanding of each one. My technical work not only informed me of the research process, but it also gave me the opportunity to immerse myself in the mindset that researchers must utilize to achieve results from their projects. This yielded a deeper understanding of some of the process work the Essure® manufacturers went through. Similarly, the research I conducted for my STS paper helped me form a better understanding of how to consider ethical implications in a medical technology, particularly in the development and testing phase. This translated to my technical project as I was better suited to frame the ethical considerations the project held and how the project would fall under certain regulations set forth by the FDA. Overall, I believe the opportunity to work on this technical work and STS research allowed me to gain a deeper understanding into the field of medical device development. I whole-heartedly believe that this experience will help inform and guide me in my future career as a physician as I hope to leave an impactful and ethical mark in the field of medicine.

BS (Bachelor of Science)
Hepatocellular Carcinoma, Caffeic Acid, tissue engineering, health, contraception, care ethics

School of Engineering and Applied Science
Bachelor of Science in Biomedical Engineering
Technical Advisors: Luke Wilkins, MD, FSIR and David Brautigan, Ph.D.
STS Advisor: Benjamin Laugelli, Ph.D.
Technical Team Members: Caroline Doyle and Lillian Way

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