Chamber and committees

In such situations, it is really important that we work with the evidence that is available. I know that, sometimes, the evidence is limited and the full picture is not clear, but the available evidence points to the benefits outweighing the risks in most cases, as we have said.

As well as working with the evidence, we have to work with the principle of realistic medicine. You will know that that has been an important principle in Scotland for a number of years. It was considered to be almost revolutionary when Catherine Calderwood wrote the first report on realistic medicine, and we have come some way since then. I say that we have come some way but I am confident that we are not at the point at which we can be absolutely 100 per cent sure that every patient in every case and at every time engages in a shared decision-making process. There is on-going work to ensure that surgeons are confident about raising issues and that they raise them in a manner that enables people to ask questions. There is a power imbalance in medicine that makes it difficult for patients to ask questions of surgeons, so we need to make sure that patients are empowered and that shared decision making takes place.

You mention women being more able than men to get together to create strength through numbers. That is an interesting observation. One of the reasons for the women’s health plan is that there is evidence that women face inequalities in access to healthcare, and one of the reasons for those inequalities is the general power imbalance for women and the fact that they are easy to ignore, as are many other groups of people who suffer health inequalities.

We are working on the issues in many different ways. With regard to gynaecological procedures that have not been halted, there is a high-vigilance protocol in place that will systematically gather evidence over time on the issues. It is unfortunate that Terry O’Kelly is not here but, to provide a bit more information, a system of unique device identification is being worked up, which will mean that a barcode is entered on patients’ electronic records to give information about the device that was used, the surgeon who did the operation and other details about the surgery. That will enable NHS Scotland to follow cases through for a number of years, and we will have good quality data available to us.

On the general thrust towards informed decision making—

I cannot make a decision on funding until I see the full proposal, but the committee should rest assured that the Government is willing to look very closely at any information that comes forward. We are well aware of the need for a good, solid evidence base in this area.

To be fair, I cannot recall where I left things, convener. However, I will say that, with regard to the second report that is coming, I am more than happy to offer to come back to the committee to discuss that, if required. We will certainly inform the committee when that report is published and available.

No. That was perfect.

As I understand it, it is the Medicines and Healthcare products Regulatory Agency that grants licences for those products on a United Kingdom-wide basis. David Bishop might want to come in on this but, as I understand it, the transvaginal mesh situation prompted a review of all those processes. I think that on-going work is still being done on that.

Our feeling in the Scottish Government is that the MHRA’s procedures should be absolutely robust and that there were lessons to be learned from that situation. We are keen to ensure that those lessons are learned.

I invite David Bishop to give some more information on that front.

That would be a challenging undertaking retrospectively. However, on the use of mesh in other sites for gynaecological procedures that was not subject to the halt, the high-vigilance protocol has a number of procedures in place that ensure that that is perfectly possible. There is documentation of all the procedures and complications and on the reporting of complications on an agreed database. Crucially, documentation is given to every single patient who is treated with mesh that details their procedure and the mesh product used, along with the name of the patient. Therefore, in future, the precise situation that you have outlined will be less likely to arise in gynaecological procedures in which mesh is used.

I am not sure how that would happen, given the scale of the procedures, with 5,000 to 6,000 per year being carried out since the 1980s. However, as Mr O’Kelly outlined, patients should first present at their GP.

People must be listened to, because the key point that has come out through all the testimonies is that people do not feel listened to. We must learn from the transvaginal mesh incident—people’s concerns have to be taken seriously and acted on appropriately. In many areas, there will be a multidisciplinary team in place, as Mr O’Kelly outlined. There is a complexity in dealing with mesh complications, and the multidisciplinary team and clinical networks will together look at each individual case. However, it must be straightforward for patients to access that level of expertise when they find themselves in the situation that Mr Kidd describes.

To be absolutely clear, the process of informed decision making is about the patient and the clinician sitting down together, understanding the condition that the patient presents with and talking over the options. It involves consideration of the elements of the acronym that is gaining popularity in realistic medicine circles, which is BRAN—the benefits, the risks, the alternatives and the effect of doing nothing. Alternatives are absolutely part of that process. That approach is becoming ingrained in medical practice—for example, the acronym appears in advertising campaigns in the virtual waiting room for NHS services in my area. The intention is to normalise that process.

The clinician should be sitting with someone and discussing alternatives. They should say, “Here’s what you’ve got and this is my understanding of the factors that are significant for you as an individual. What do you need me to understand about you as an individual? Let’s see what alternatives are on the table and make a decision together.” That is how it should be. The onus should not be on the patient to ask questions. We intend to create an atmosphere in which it is normal for the patient to ask questions. It is their body that is the subject of the process, and it is altogether more satisfactory if the patient is empowered to make a decision in such situations.