Thank you for this opportunity to present a few brief remarks on the process I experienced, witnessed, and participated in as a panel member; on my role as an ethicist; and on some key ethical considerations related to breast implants.
I was a member of both the scientific advisory panel and the expert advisory panel on breast implants convened by Health Canada. This was the first time I have been asked to be a panel member for such a topic, so I had no preconceived ideas or expectations on what would happen.
First, I'll say a few words on the process. Let me begin with a quote: “There does not have to be agreement about the answers to all moral questions, but we do have to accept that everyone must agree on the procedure to be used in deciding moral questions”. This quote emphasizes nicely how important process is in determining answers to questions.
I can say with confidence that the process I participated in was open, transparent, and rigorous. Panel participants came from diverse backgrounds, with diverse experiences and knowledge. Few of us knew each other when we began, and we spent many hours rigorously deliberating on the issues and facts. All views offered in these discussions were treated with respect and all views were equally respected; in other words, there was not, in my experience, a preconceived right perspective that dominated or directed discussion. I witnessed what I call unity in diversity, where diverse views were offered by panel members contributing together to an emerging consensus.
Our task or role was clearly delineated by Health Canada and is available on their website. We were charged with responding to specific questions for feedback. Health Canada clearly outlined that our task was neither to make recommendations to approve breast implants nor to decide what was good for Canadian women.
The chair, Dr. Wells, did a remarkable job in facilitating the diverse views and in creating an environment for frank and honest discussion of the relevant facts and values. I felt free to express all of my views on this matter and felt free to ask any questions about any aspect of the scientific detail. In the public forum, we likewise heard from diverse views, ranging from strong support and enthusiasm to concern, reservations, and warnings. All views were listened to, respected, and incorporated into all the subsequent discussions.
And now I'll say a few words on my role. The context and field in which I work is called bioethics. Bioethics generally involves critical reflection on moral and ethical problems faced in the health care setting, with a view towards deciding what we should do, explaining why we should do it, and describing how we should do it. Ethicists, therefore, attend to the moral question, what should we do, as opposed to what can we do? We support answers with moral reasoning and invoke moral principles, many of which you are no doubt familiar with, such as autonomy, beneficence, and justice.
There are many myths about what ethicists do, and it's worth saying that we are not moral experts or the arbiters of right and wrong, or legal experts, or risk managers, or the moral police, or the decision-makers, or the all-knowing. Instead, ethicists are resources for health care professionals, patients, the public, and others to access when they need facilitation, negotiation of conflicts, case consultation, policy development, research, and education in ethics.
Key ethical considerations. Within the parameters set out by the questions posed by Health Canada, a key ethical consideration included informed consent. For example, questions arose around who should make decisions about breast implants and whether they were decisions that women patients should make, and around who should define risk, benefit, and harm.
It is generally acknowledged that what is a benefit to one person may not be shared by another. The circumstances in which we can impose what we believe are benefits on another person are very rare.
If we believe that we ought to practise patient-centred care, which is “an approach that consciously adopts the patient's perspective about what matters”, then what the patient thinks will affect the coordination and integration of care. In other words, we need to take our cues from the patient and what the patient believes is meaningful in terms of harm, benefit, and risk. This raises questions about what patients need to know to be informed.
In summary, some key ethical considerations include the following:
One, individuals need to determine what constitutes a risk, benefit, or harm. This would occur in a context of safe and effective devices.
Two, informed consent is a process, not an event. It occurs over time, and people can change their minds.
Three, there are risks, benefits, and harms to every treatment decision, and it is incumbent on those involved to make sure treatments are as safe and effective as possible and patients are informed of all relevant information.
Four, there are always known unknowns. That's data that will be revealed for example in time but that we do not have right now. There are also always unknown unknowns, and these might be unanticipated outcomes that may be risky or they might be beneficial. Both need to be expressed to the patient. Patients need to be informed of this information.
Five, finally, ongoing examination of this issue is important. Getting feedback on the process is crucial in understanding how to improve it for the future.
To close, I understand this process embarked upon for breast implants was the first of its kind for Health Canada. I believe it has proven to be open, transparent, and rigorous, and the results it has revealed can be considered with confidence.
Thank you very much. I'm happy to provide further information and answer any questions.