The heart of the matter: An ethical exploration of regenerative implants

Abstract

Scientists in the field of regenerative medicine are developing a new type of synthetic implants that stimulate the growth of new tissue. After implantation, the implants slowly break down and are replaced by living tissue. This technology is referred to as in situ tissue engineering. Regenerative implants have great therapeutical potential. They also raise ethical questions that have currently not been sufficiently addressed in available literature. The central aim of this thesis is to identify the ethical implications of regenerative implants, and to provide ethical guidance for their development and implementation, with particular attention to the lived experience and the needs of implant users. Regenerative heart valve, palatal, and meniscus implants serve as the main showcases. In part I, we aim to identify the ethical implications of the development and implementation of regenerative implants. Based on a systematic review of the ethical implications of tissue engineering, we identify a broad range of ethical implications, mapping the development from bench to bedside. A focus group study shows that experts by experience and professional experts emphasise the importance of patient-centred research and care and hold ambivalent attitudes towards several characteristics of regenerative implants. A conceptual and ethical analysis of the development of smart lifelike materials for the design of regenerative implants points out two ethical implications: the implantation procedure is highly irreversible, and the embodied experience of the recipient might be affected by living with a regenerative implant. In part II, we aim to understand in more detail how the embodied experience of implant users might be affected by living with regenerative implants. Drawing on phenomenological literature, we hypothesise that the transformation of the synthetic implant into living tissue might be comforting for some and alienating for others. We argue that the interwovenness and intimate relationship of people living with regenerative implants should be understood in terms of ‘entanglement’. We then reflect on the outcomes of a project called Intimate Implant in which we engage with the arts to engage a broader public to reflect on the possibility of entering an emotional relationship with an implant. In part III, we aim to identify which moral conditions should be met to prevent bias and promote inclusive design of regenerative implants. By analysing two cases of racism in medical devices, we explore which differences between users are morally significant for the design of regenerative implants. We then investigate the requirements for inclusive design of regenerative implants. We construe a values hierarchy, in which we translate the value of justice into norms and design requirements. We argue that regenerative implants should be designed to account for relevant user differences, be affordable and be suitable for global distribution, and the design process should involve inclusive design teams, engage users, and use inclusive communication. Overall, this thesis provides ethical guidance to researchers and clinicians developing regenerative implants, helping them to foresee the consequences of choices in the design and implementation of the implants for clinical practice and the everyday lives of the implant recipients.