A Methodology for Determining Standard of Care Status for a New Surgical Procedure

Breidenbach, Warren C.; Meister, Edward A.; Türker, Tolga; Becker, Giles W.; Gorantla, Vijay S.; Levin, L. Scott

doi:10.1097/prs.0000000000001892

Cited by 21 publications

(18 citation statements)

References 34 publications

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“…The first stage coincides with initial scientific attempts when we ask ‘what can we do?’ As advances occur, the question shifts to ‘what should we do?’ This is demonstrated by the increase in publications and the establishment of a regulatory ethics framework after the first clinical achievement in 2011 . This question gains more importance when the procedure is not life‐saving but life‐enhancing, such as face and upper extremity transplantation, which have, and continue to face, similar ethical challenges as they become more successful . During these early stages, the principle of nonmaleficence dominates, a trend that is also reflected in the upper extremity and face transplantation literature .…”

Section: Discussionmentioning

confidence: 99%

The changing paradigm of ethics in uterus transplantation: a systematic review

et al. 2020

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Summary The first uterus transplantation was performed in 2000. As key milestones are reached (long‐lasting graft survival in 2011, and first birth from a transplanted womb in 2014), the ethical debate around uterus transplant evolves. We performed a systematic review of articles on uterus transplantation. Ethical themes were extracted and categorized according to four bioethical principles. Papers were divided into time periods separated by key events in uterus transplant history: Phase I (first technical achievement, 2002–2011), Phase II (clinical achievement, 2012–2014), and Phase III (after the first childbirth, 2015–2018). Eighty‐one articles were included. The majority of ethics papers were published in Phase III (65%, P < 0.0001), that is after the first birth. Eighty percent of papers discussed nonmaleficence making it the most discussed principle. The first birth acted as a pivotal point: nonmaleficence was discussed by a lower proportion of articles (P = 0.0073), as was beneficence (P = 0.0309). However, discussion of justice increased to become the most discussed principle of the time period (P = 0.0085). The ethical debate surrounding uterus transplantation has evolved around landmark events that signify scientific progress. As safety and efficacy become evident, the focus of ethical debate shifts from clinical equipoise to socioeconomic challenges and equitable access to uterus transplantation.

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Section: Discussionmentioning

confidence: 99%

The changing paradigm of ethics in uterus transplantation: a systematic review

et al. 2020

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“…[6][7][8][9][10][11][12][13][14][15][16][17] Though it offers sensation, function, cosmetic, and psychological benefits, there are significant risks associated with the lifelong immunosuppressive medication required with transplantation. 4,5,7,12,[18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34] This article aims to outline the challenges of hand transplantation by discussing patient selection, effect on quality of life, financial burden, functional outcomes, and risks of immunosuppression.…”

Section: Introductionmentioning

confidence: 99%

Hand transplantation: current challenges and future prospects

Alolabi¹,

Augustine²,

Thoma³

2017

TRRM

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Over the last two decades, 113 vascularized composite allotransplantation (VCA) of the hand have been performed in 76 patients globally. The procedure that was once regarded as experimental has certainly emerged as a clinical reality with multiple centers worldwide now performing it. The psychological and physical impact of losing an upper extremity is profound. Amputees face significant challenges contributing to disability and dependence even with activities of daily living. Hand transplantation offers functions with restoring sensation, voluntary motor control, and proprioception, as well as a sense of feeling "whole" again. Along with these benefits, however, transplantation carries a significant risk profile attributed to the complications of life-long immunosuppression and possible rejection. Moreover, the procedure carries a significant financial burden to the health care system. As hand VCA is becoming more widely accepted and performed worldwide, there are still many challenges that will face its rapid growth. This review highlights some of the challenges facing hand VCA including patient selection, effect on quality of life, financial burden, functional outcomes, and complications of immunosuppression.

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“…For instance, we drive to the pharmacy to purchase painkillers to cure our headaches, despite the 1:112 lifetime risk in the USA of dying in a car accident 3. Some authors have noted this fact as providing ethical support for hand transplantation 4. And much of the rationale for entering hospice care, which requires forgoing further efforts at cure, consists of balancing increased quality of life against pursuing a longer life.…”

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confidence: 99%

A quiet revolution in organ transplant ethics

Caplan

Purves

2017

J Med Ethics

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A quiet revolution is occurring in the field of transplantation. Traditionally, transplants have involved solid organs such as the kidney, heart and liver which are transplanted to prevent recipients from dying. Now transplants are being done of the face, hand, uterus, penis and larynx that aim at improving a recipient's quality of life. The shift away from saving lives to seeking to make them better requires a shift in the ethical thinking that has long formed the foundation of organ transplantation. The addition of new forms of transplants requires doctors, patients, regulators and the public to rethink the risk and benefit ratio represented by trade-offs between saving life, extending life and risking the loss of life to achieve improvements in the quality of life.

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A Methodology for Determining Standard of Care Status for a New Surgical Procedure

Abstract: Hand transplantation is moving from acceptance as an ethical surgical experiment to the standard of care.

Cited by 21 publications

References 34 publications

The changing paradigm of ethics in uterus transplantation: a systematic review

The changing paradigm of ethics in uterus transplantation: a systematic review

Hand transplantation: current challenges and future prospects

A quiet revolution in organ transplant ethics

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