The Regenerating Body: An ethical analysis of personalized regenerative implants

Abstract

A new generation of personalized regenerative implants is being developed for use in healthcare. These implants break down after implantation and facilitate tissue regeneration. While these innovations hold the promise to improve many lives, they also raise important ethical questions and concerns. The aim of this dissertation is to identify the ethical implications of personalized regenerative implants and to evaluate how these implants can be developed and used in an ethically responsible manner. We focus on implants that treat cleft palate, joint defects, and heart valve defects. The first part of the dissertation examines diverse ethical implications concerning personalized regenerative implants. A literature review identifies nine different ethical themes: digitalization, irreversibility, responsibility, gender, first-in-human trials, N-of-1 studies, commercialization, human identity and embodiment, and the ontological status of personalized regenerative implants. A focus group study with patients, parents of children, and professional experts highlights two important themes: patient-centered research and care and ambivalent attitudes towards personalized regenerative implants. The second part of the dissertation explores the importance of the intimate relationship between humans and technology for the responsible development and use of these implants. Drawing from phenomenological literature, we aim to understand how the embodied experience of implant recipients might be affected by living with regenerative implants. We argue that the interwoven and intimate relationship of people living with regenerative implants should be understood in terms of entanglement. This entangled relationship can lead to implant recipients feeling alienated or could promote their embodied experience. After this, we reflect on the Intimate Implant project, in which we engaged with the arts and a broader public to explore the implications of these implants for the relationship with our bodies. The third part of the dissertation outlines an inclusive approach to personalized regenerative implants. We begin to discuss the importance of considering gender in various facets of healthcare. By focusing on an example within the field of 3D bioprinting, we demonstrate that accounting for sex and gender differences is crucial in mitigating bias during the development of new technologies. Then, we explore various strategies for preventing biases. Biases often stem from overlooking or incorrectly considering differences between people. To prevent this, we argue that if medical devices are tailored to different groups, differences should be defined by specific and morally significant characteristics rather than using broader categories as proxies, and the causal explanations for the significance of such specific differences should be scrutinized for biases. We then explore the requirements for inclusive design of regenerative implants. Regenerative implants should be designed to account for relevant user differences, be affordable and suitable for global distribution, and be developed by inclusive design teams using inclusive communication and engaging users. Overall, this thesis provides an ethical analysis of personalized regenerative implants, contributing to their responsible development and use.