The Cutting Edge: A Surgical Case Study in Field Philosophy

Introduction

Refraining a project on surgical innovation as an example of field philosophy has provided a fruitful way for us to think about our research. Using the lens of field philosophy furnishes a framework to better understand the challenges raised in our work, the lessons we learnt from our project, and how we could improve what we do in the future.

Background

In the late 1990s DePuy Orthopaedics launched two new hip prostheses—the articular surface replacements (ASR) hips. Compared to their competitors these new devices promised smaller surgical incisions, reduced risk of fracture and dislocation, good positional sensitivity, and greater longevity. In fact, one of the prosthetics appeared so advantageous in terms of speedy recover}' rates and greater mobility that it opened up a whole new cohort of potential recipients for whom new hips would not usually be considered, namely, young and active patients. However, in spite of their promise, problems quickly emerged with the ASR hips. They were implicated in localized and systemic health problems and needed to be replaced at a higher rate than other hips—apparently due to their design, which led to metal grinding on metal. Such grinding contributed to the erosion of the hip, leakage of cobalt and chromium ions, and toxicity. After a protracted campaign in which they denied problems with the hips, DePuy issued a world-wide recall of the ASR in 2010 (Johnson and Rogers 2014).

Innovations in surgery (including via the development of new devices and prostheses like hips) are vital to medical progress, contributing to increased longevity and enhanced quality of life. Yet, despite this tremendous potential for good, the novel, unproven and frequently unregulated nature of surgical innovation generates significant risks of harm, as demonstrated in the case of the ASR hips. In recognition of troubling cases such as this one, the Australian Research Council funded a project, “On the cutting edge: promoting best practice in surgical innovation,” for three years beginning in 2012. In acknowledgment of the value philosophers could bring to conceptual analysis of the issues and their clear ethical dimensions, the bioethicist who led the project involved us from the start. Lawyers, surgeons, and a hospital manager were also part of the research team. This project formed part of ongoing work on surgical innovation centred at Macquarie University in Sydney, Australia. For the purposes of this chapter I will focus on our discrete project, rather than the larger research endeavor.

The Project

Our project was concerned with three main issues raised by surgical innovation: defining surgical innovation, the ethical challenges generated by innovative practice, and legal and regulatory dimensions.

With respect to definition, there is uncertainty as to what actually constitutes surgical innovation. Although there are clear cut cases (e.g., the first heart transplant), the territory quickly becomes murky when considering examples such as the first time a procedure is rolled out in hospital or with a new team, or when a piece of equipment is used for a different operation or a different type of patient. Depending on the details, any of these may constitute instances of surgical innovation. Finding a definition that captures and distinguishes all the relevant instances, and avoids including routine surgical variation of the kind that surgeons engage in all the time in response to differences between patients, was a crucial element of what we set out to achieve with our project. In the absence of a workable definition of surgical innovation, those charged with oversight struggle to identify the practices they are required to regulate.

We were also interested in the ethical issues raised by surgical innovation. In work leading up to this project we identified four types of ethical concern (Johnson et al. 2010). The first involved the possible harms to patients that may occur with surgery that is not well established in the profession (such as when there is a new hip prosthesis), or with surgeons new to a procedure and still scaling the learning curve. Second was the question of informed consent. Patient consent to surgery could be compromised as they may be inadequately informed about various elements of the procedure they are to undergo. For instance, patients may be unaware of the innovative nature of their operation and of the risks associated with new procedures. There could also be poor safety and efficacy data to inform their decision, and patients may not be cognizant of where their surgeon sits on the learning curve.

Third, there are various potential conflicts of interest, for surgeons, hospitals, and regulators, which may compromise surgical decision-making and risk harms to patients. For instance, surgeons involved in developing a new device may be over-inclusive in how they select patients to receive the device, and may prefer their own device over similar devices for no good clinical reason. And, finally, surgical innovations are frequently more expensive than standard treatments, so there are ethical issues over the just distribution of finite healthcare dollars. For example, in Australia, most prostatectomies are now done with the aid of a robot. Factoring in both capital and maintenance costs, robotic procedures are more expensive than an open prostatectomy, meaning less money is available for other procedures. Moreover, in order to remain safe and the best value for money, a sufficient volume of patients need to have the robotic procedure. In Australia, this means robots should be located in more densely populated urban areas. But this raises additional concerns regarding justice since in these areas both population health and access to healthcare are already better; indigenous populations and patients with lower socio-economic status are more likely to live in rural and remote regions (Hutchison et al. 2016).

Governance, oversight, legal, and regulatory issues are also a major concern in surgical innovation, and these are related to but distinct from the ethical concerns. Although, as philosophers, our primary' focus was on ethical and definitional questions, our approach as field philosophers meant we were motivated to keep these practical constraints in mind too. On the whole, surgeons are resistant to regulatory oversight; moreover, due to the nature of surgical practice, it is a challenging area to regulate. Furthermore, in the case of surgical innovation, there is the additional complexity of its definitional imprecision, which undermines the capacity for innovation to actually' be captured by' regulation. The lawyers on our research team were primarily responsible for this dimension of our research so it will not be a focus of this chapter.

Our Research Partners

The Australian Research Council (ARC) has a nationally competitive government-funded scheme for Linkage Projects that encourages the development of relationships between academia and industry', aimed at addressing research questions of importance to the non-academic sector. Under the direction of Professor Wendy' Rogers from Macquarie University' in Sydney, our research team formed to develop a Linkage proposal. In addition to philosophers, this interdisciplinary team comprised surgeons, lawyers, and a hospital manager. The ethical and definitional challenges generated by' surgical innovation articulated above were well established in the academic literature, such that the initial impetus for the project came from this source rather than direct engagement with stakeholders. However, our non-academic partners included a number of key stakeholders with whom these problems resonated.

We partnered with four organizations outside academia—Sydney West Area Health Service (SWAHS, which later became Western Sydney Local Health District),¹ The Royal Australasian College of Surgeons, via the Australian Safety and Efficacy Register for New Interventional Procedures-Surgical (ASERNIP-S),² Bellbery Limited,’ and Houston Thomson Limited.⁴ All of these partners joined the project with a capacity to contribute to the research as well as to benefit from the work. In total, our final research team comprised four nonacademic partners, 11 Chief and Partner Investigators, a postdoctoral researcher, and a research assistant.