National Health Service (Transvaginal Mesh Implants)

– in the Scottish Parliament on 20th December 2016.

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Photo of Neil Findlay Neil Findlay Labour

1. To ask the Scottish Government how many women have had transvaginal mesh implants since it requested that NHS boards suspend their use in June 2014. (S5T-00274)

Photo of Shona Robison Shona Robison Scottish National Party

The independent review on transvaginal mesh implants is in the process of producing its final report, which will be published early in the new year and will contain the information for which Neil Findlay has asked. The Scottish Government has made it clear that health boards should consider suspending the use of synthetic mesh products in surgery for pelvic organ prolapse and stress urinary incontinence until the review makes its final report. The request to suspend procedures will remain until the review’s recommendations have been put in place.

In the light of the Scottish Government’s request, the number of women receiving mesh implants has fallen. However, I give my assurance that if women experience very distressing symptoms and still want to proceed with a mesh implant, all clinicians are expected, prior to a decision to proceed, to have a detailed discussion with their patient in which they explore and explain the risks, so that a shared decision can be made and fully informed consent can be given. I also stress that any woman who has concerns about her implant should call the national health service helpline that was specially set up last year or, alternatively, should not hesitate to contact her general practitioner or surgeon.

Photo of Neil Findlay Neil Findlay Labour

Organ damage, loss of a kidney, bladder removal, constant and excruciating chronic pain, pelvic inflammation, pierced vaginal walls, nerve damage, mental breakdown, reliance on wheelchairs and walking aids, husbands and partners injured during intercourse and family and marital breakdown: those are just some of the devastating and life-changing consequences that have been experienced by women who have received transvaginal mesh implants and who have been failed by some health boards, some health professionals, the Medicines and Healthcare products Regulatory Agency and manufacturers, whose arrogance and complacency on mesh have been startling. According to the media, another 400 Scottish women have had implants since the so-called Scottish suspension in 2014. What message does the Cabinet Secretary for Health and Sport have for those women? Will she now make it clear to all NHS boards that they should follow the line of some health boards and ensure that no other women are fitted with mesh, pending the findings of the Government’s working group?

Photo of Shona Robison Shona Robison Scottish National Party

As Neil Findlay will be aware, the Scottish Government has no authority to withdraw the products. That is the role of the MHRA, and it has not done so.

The Scottish Government knows of nine health boards that have carried out the stress urinary incontinence procedures. As I explained in my first answer, and as we said way back at the beginning of the process—I think that I said it at the Health and Sport Committee at the time—if a woman wants to go ahead with the procedure, she can make an informed decision to do so in full consultation with her clinician and with absolute clarity and information about the risks. That is a discussion between the woman and her clinician, as has been clear throughout the process.

I hope that Neil Findlay welcomes the independent review that will be published early in the new year. We need to wait and see what it says but, in the meantime, it is important that women are fully informed of the risks. As I said, any woman who has concerns should phone the national health service helpline that was specifically set up last year in consultation with members of the patient group. As Neil Findlay has, I have met the group on a number of occasions. It has been extremely helpful in ensuring that full information is given to women so that they can make an informed choice about whether to go ahead with the procedure.

Photo of Neil Findlay Neil Findlay Labour

Given what we know about mesh and the complications that have been highlighted, does the cabinet secretary agree that it is not a procedure that she or I would recommend that someone should get?

Photo of Shona Robison Shona Robison Scottish National Party

As I said, transvaginal mesh implants are not a banned product. The Scottish Government has no authority to withdraw the products and the MHRA has not done so. Therefore, it is important that the information that clinicians give to women who might be considering the procedure is such that they are fully informed of the risks. That is the proper way to proceed.

We are awaiting the outcome of the independent review on transvaginal mesh implants, which is coming in the new year. Once we get the information, I will be happy to meet Neil Findlay and the patient group, which has—as I said earlier—been extremely helpful in ensuring that women have the right information: it asked for the helpline that we set up. It is important that women make informed decisions; such decisions are not taken lightly.

As I said in my initial answer, where women are experiencing distressing symptoms and still want to proceed with the procedure, it is important that they do so having given informed consent. That process has been put in place and the chief medical officer has been ensuring that that is the case.

Photo of Jackson Carlaw Jackson Carlaw Conservative

Because of the issues that we are discussing, we have tended to speak about the subject in the most careful tones. However, last month in the Australian Parliament, Senator Derryn Hinch gave an absolutely blistering speech in which he lambasted medical watchdogs and manufacturers for once again letting down women, and compared the scandal of mesh implants to that of thalidomide. I include the MHRA in my criticisms. I know that it is a United Kingdom body, but when the Public Petitions Committee took evidence from it, we learned that its detailed analysis amounted to three postgraduate students doing a desktop exercise for two weeks at a cost of £20,000.

All of us in this Parliament welcomed the Scottish Government’s announcement of a moratorium and many health boards have respected that moratorium. Can we conclude other than that the health boards that have not done so have wilfully acted in a way that has put women’s lives at risk?

Photo of Shona Robison Shona Robison Scottish National Party

I do not think that that is fair. I noted what Jackson Carlaw said about the MHRA. He will be aware that on at least two occasions I have written to the MHRA making clear the strong views that have been expressed in Parliament about its role as regulator. However, we cannot get away from the fact that it is the job of the MHRA to regulate medical devices across the UK and that, so far, it has not issued a medical device alert regarding the implants. The Scottish Government does not have the authority to withdraw the products—it lies with the MHRA.

We find ourselves in the position that we find ourselves in. That is, of course, why Alex Neil issued the guidance that he issued and which I have supported. However, all along, we have made it clear that when a woman decides, in full consultation with her clinician, that because of distressing symptoms that she is experiencing, and despite all the risks that have been explained to her, she still wants to go ahead with the procedure, it has to be allowed to go ahead, because it involves an agreement between the clinician and the woman.

Again, as I said to Neil Findlay, it is important that we get the independent review in the new year. I would be happy also to meet Jackson Carlaw to discuss the findings and recommendations of that report, once we get it.

Photo of Elaine Smith Elaine Smith Labour

Having listened to the cabinet secretary’s response to colleagues, I ask her whether she is confident that all the women who have been fitted with the mesh since the moratorium in 2014 agreed to the procedure after being fully informed of the many and often horrendous risks of the procedure?

Photo of Shona Robison Shona Robison Scottish National Party

When the chief medical officer and I appeared in front of the Health and Sport Committee at the time it was made very clear that it was to be required that women be fully informed of the risks of the procedure. That is exactly what I expect every clinician to do. If Elaine Smith or anyone else has evidence that that has not been happening, I would be very concerned about that. The chief medical officer was very clear in her guidance to clinicians that that should happen in every case, so that women make informed decisions. If Elaine Smith has evidence to the contrary, I want to know about it.