Informed consent: it’s not a reality for too many patients
The previous post highlighted the growing focus internationally on overuse of healthcare.
When I interviewed Carol Bennett, CEO of the Consumers Health Forum of Australia, for an article on related themes at Inside Story, she stressed the the need for patients and the public to have better information about the pros and cons of healthcare interventions, in order to enable true informed consent.
The findings of the recent Senate Committee inquiry into Poly Implant Prothese (PIP) breast implants and related matters have underscored her concerns about the quality of information available to patients and the broader community.
Informed consent: we need to do better
Carol Bennett writes:
The Chief Medical Officer’s factsheet on silicone gel filled breast implants is unequivocal:
“All silicone gel filled breast implants are considered high risk medical devices. They have a limited lifespan – the risk of rupture increases with time, with an estimate of 10-15 percent rupturing by 10 years.”
So the quotes below make compelling reading:
“He told me at my six week post-op check-up that ‘everything was fine and I would have them for life’.”
“He assured me breast implants were safe and that they would likely last a lifetime. I had no reason to doubt him.”
These quotes are from submissions to the Senate Community Affairs Committee Inquiry into ‘the role of Government and the Therapeutic Goods Administration (TGA) regarding medical devices, particularly Poly Implant Prosthese (PIP) breast implants’.
They come from women who had been implanted with PIP breast implants, and who are now experiencing considerable uncertainty and distress as a result of the major issues that have arisen with these implants.
There are many lessons to be learned from the PIP experience, including about how device safety is monitored on the market, and how safety concerns are communicated to consumers.
But there is another lesson that we can’t allow to be lost in the midst of these other issues – the question of informed consent.
Recommendation 1 of the PIP inquiry report is that there should be rigorous systems in place to ensure medical practitioners provide consumers with all the information needed to allow them to give fully informed consent.
Several women with PIP implants submitted to the Senate inquiry that they were told that issues with their implants were unlikely, and they would probably not need to have them replaced. The quotes above are just two examples.
But, as is clearly stated in the Chief Medical Officer’s report on the PIP implants, all silicone gel filled breast implants – not just PIP implants – are considered to be high risk medical devices.
They have a limited lifespan, and the risk of rupture increases with time, with an estimated rupture rate of 10 to 15 percent at the 10-year mark. Information provided to patients often contains only a general warning that reoperation might be necessary, without any indication of the likelihood.
The question we need to ask is whether these women had all the information they needed to make a truly informed choice about whether or not they would have breast implants.
If they were given accurate information about rupture rates – rather than comforting statements that they would have their implants ‘for life’ – would they have made different choices?
Informed consent is arguably of particular importance in relation to implantable medical devices – removing these when something goes wrong is often not straightforward – but the issue is certainly not limited to devices.
In CHF consultations over many years, consumers have raised concerns about a lack of informed consent when making decisions about their healthcare. The issue comes up again and again, in relation to medicines, diagnostic imaging, pathology testing, eHealth, choice of treatments… the list goes on.
But what is informed consent? At the most basic level, it is captured by two principles in the Australian Charter of Healthcare Rights: I have a right to be informed about services, treatment, options and costs in a clear and open way, and I have a right to be included in decisions and choices about my care.
How this takes place is more complex. Various guidelines and resources on informed consent (and the just as fraught question of informed financial consent) exist, but the College of Anaesthetists’ Guidelines on Consent for Anaesthesia and Sedation captures many of the key elements of what constitutes informed consent. The key point is:
The patient should be provided with the information that a reasonable patient in the position of that patient might wish to know, and to which she/he might attach significance. It is necessary to provide information about all material risks inherent in any proposed treatment.
There is further, useful detail about how to ensure consent is informed – including providing the information in a form that the patient/consumer is likely to understand, but the core principle is that consumers should be provided with all the information that they might wish to know and to which they might attach significance. If we apply this test to the women who were told their breast implants would last them a lifetime, we can see that their consent was not truly informed.
An increasing body of evidence suggests that health outcomes are improved when consumers are viewed as partners. However, when consumers do not have all the information that they need to make informed healthcare decisions, they are not empowered to play an active role in their healthcare.
We have to move beyond the ‘doctor knows best’ mentality and empower consumers to ask the right questions when they are not receiving the information that they need, so that they can provide truly informed consent and be confident that the decisions they are making about their healthcare are right for them.
Consumers who are informed and engaged in their healthcare are likely to play a greater role and be active partners in managing their own health – and everyone will benefit.