Evidence, truth, reality and power: A Foucauldian analysis of the ethics of testing and using novel medical devices

[摘要] ENGLISH ABSTRACT: From the onset of time, human beings have used substances in all forms andshapes to promote health. Prior to the nineteenth century, traditional folk medicine,religious ceremonies, magical practices, herbs and the balancing of the 'humors'were popular methods of healing amongst others practiced by the Greeks. Thevarious earlier Egyptian papyri detail the ancient Egyptian concepts of disease andcures, various ailments and anatomical observations. Informed consent wassimplistically manifested by patient trust and cooperation. The nineteenth andtwentieth centuries witnessed significant medical advancement is all spheres ofmedicine i.e. opening of hospitals, training of doctors, era of antibiotics, developmentof universities and research centres. Since the quest for science and health was apriority, doctors earned a high social standing and began to enjoy the privilegedstatus in society.This resulted in the birth of a heavily professionalized discipline. Developing MichelFoucault's ideas, we may regard that discipline is a specific technique of power,which aims to objectify human beings using three main practices i.e. dividingpractices (e.g. birth of hospitals and asylums), scientific classification (medicineregarded as a discipline) and subjectification of human beings (humans consideredas subjects). Using Foucauldian ethics, this thesis aims to deconstruct the powerversus knowledge relationship between physicians and the healthcare industry incontext of adopting novel medical devices.The last century has been challenged by the invention of medical devices by thehealthcare industry. Some of these medical devices have raised both scientific andethical issues because patients suffered harm. The use of transvaginal mesh forpelvic organ prolapse is currently a global topic questioning how harm came towomen. The rationale for mesh development, regulatory clearance anddissemination to society, and conflict with the four ethical principles is discussed.Three other gynaecological devices will also be the focus of this thesis.The power of regulatory authorities to clear medical devices using a substandard clearance mechanism, and the power of the healthcare industry to employ vicious marketing strategies to physicians is critically analysed. Physicians as bodies of knowledge adopt these procedures with noble intentions. The implications of using novel medical devices are significant as physicians represent the final point of care for patients during which informed consent is finalized. The interplay between physicians and the healthcare industry illustrates the clash between the urge to 'develop' and market new technology (medical devices in this case) and the ethics of responsibility espoused by physicians to protect against harm, notwithstanding the role of regulatory authorities. Medical device innovation will continue to expand. Physicians aided by sound science and ethical principles have the responsibility to implement safe and efficacious treatment. As this may be not sufficient to prevent harm, the addition of virtue ethics and shifting of the power balance toward physicians is proposed.

[发布机构] Stellenbosch University