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Since I last wrote here, my Review Team and I have been exceptionally busy, and we have made good progress, listening to the voices of people affected by these products, publishing draft terms of reference, and halting the use of mesh for SUI. I wanted to take some time to update you on what we have been doing.
In my last message, I spoke about the importance of listening to and learning from as many people affected by the three areas we are investigating – pelvic mesh, sodium valproate and Primodos - as possible.
That is why, as part of my commitment to hearing from as many people as I can, my team and I have met with patient groups for those affected to listen to their stories and understand what they think needs to be done in future to improve outcomes for patients.
We have begun a countrywide programme of visits to meet with people throughout the UK and learn from their experiences with Primodos, pelvic mesh and sodium valproate.
This has been an eye-opening experience. So far, we have visited Chichester, Leicester, London, and Manchester, and have spoken with dozens of women and families. For me, meeting and listening is an essential and moving part of learning, and I have been saddened, shocked and overwhelmed by so many of the stories we have heard, and what we have come to understand as a result.
My admiration for all of those I have met and heard from knows no bounds – their bravery in coming forward with their stories and in many cases advocating on behalf of others who have experienced similar hardships, is truly exceptional. I want to thank them all for their openness, bravery and generosity.
Our visits continue next month in Southampton, Hull and Leeds, and we’ll be posting information about other planned meetings in the coming weeks. I hope that we will be able to meet many of you at one of our meetings very soon.
During the first phase of our Review, we met with patient groups and politicians who have been advocating on patients’ behalf to learn more about each of the Review’s three areas for investigation, and to get an understanding of what people thought needed to be considered during the Review.
We have also met with clinical experts and academics to gain knowledge of current practice, and of the regulatory frameworks which guide, or guided, the use of the three medical interventions. These meetings have been invaluable, and we will continue to draw on this knowledge as the Review continues its work.
We have now completed this phase, and have published the Review’s draft Terms of Reference here. These outline what we will be doing in each of the three areas, and our approach to carrying out the Review as a whole. They have been drafted in light of those discussions with patient groups, politicians and clinicians. We are very grateful for their input.
On Tuesday 9th July, we called for a halt in the use of surgical mesh for the treatment of stress urinary incontinence (SUI) until a set of conditions around training, registration and licensing have been met. You may have seen the announcement made at the time, which set out our reasons for taking this step.
Having met with so many families affected by mesh, we have been truly appalled at the seriousness and scale of the tragic stories we have heard. Having taken all of this into account, we knew we simply had to act now.
Once the Terms of Reference are finalised, we will issue a call for evidence. This will include an open opportunity for you to tell us everything we need to know about the three areas we are looking at. If you have already given us information, in most cases we will check with you whether it should be considered as evidence. The call for evidence will also request evidence from other stakeholders, including regulators and manufacturers. We will in addition hold hearings to take evidence from some stakeholders.
In the opening stages of the Review, we have learned so much about the courage, dedication and selflessness of the people affected by Primodos, mesh and sodium valproate. What people have told me has affected me deeply. But it has also confirmed for me that we have many different factors to balance in conducting our Review. We must act quickly, but be thorough and accurate. We must act on what we hear, but be fair to all involved. We must be ambitious, in that we must ensure our recommendations are implemented.
The draft Terms of Reference have been sent to stakeholders, including patients groups, regulators and manufacturers, who have been given until 31 July 2018 to respond with any major observations. The finalised Terms of Reference will then be published on our website, after which the Review will issue a call to evidence. Click here to view
Department of Health and Social Care will accept recommendation
The Independent Medicines and Medical Devices Safety Review has concluded that there must be an immediate pause in the use of surgical mesh for the treatment of stress urinary incontinence (SUI). The Review’s conclusion follows meetings held in the initial stages of its work, over recent months, with women and families adversely affected by surgical mesh procedures.
Baroness Julia Cumberlege, Chair of the Review, has advised the Department of Health and Social Care and NHS England that surgical mesh should not be used for the treatment of stress urinary incontinence until a set of conditions to mitigate the risks of injury are met. Baroness Cumberlege has said that these conditions should be met by March 2019. The Department and NHS England have accepted the recommendation.
Baroness Julia Cumberlege, Chair of the Independent Medicines and Medical Devices Safety Review, said:
“We strongly believe that mesh must not be used to treat women with stress urinary incontinence until we can manage the risk of complications much more effectively. We have not seen evidence on the benefits of mesh that outweighs the severity of human suffering caused by mesh complications.
“I have been appalled at the seriousness and scale of the tragic stories we have heard from women and their families. We have heard from many women who are suffering terribly. Their bravery and dignity in speaking out is deeply moving, and their sadness, anger, pain and frustration at what has happened to them and others has been compelling. We had to act now.
“My team and I are in no doubt that this pause is necessary. We must stop exposing women to the risk of life-changing and life-threatening injuries. We must have measures in place to mitigate the risk, and those are sadly lacking at the moment.
“At this stage in our Review we are not recommending a ban, but a halt to procedures until the conditions we have laid down are met. I am pleased that both the Department of Health & Social Care and NHS England support our recommendation, and I look forward to its quick implementation.”
This follows NICE’s 2017 guidance that mesh for vaginal wall prolapse should only be used in the context of research. In 2014 the Scottish government put in place a suspension in the use of mesh for SUI.
Today’s recommendation does not apply to mesh for rectopexy procedures, which will be considered separately by Baroness Cumberlege’s Review.
The conditions of lifting the pause in the use of surgical mesh, which should be met by March 2019, are as follows:
The following dates have been published for the Review Team’s visits across the country to meet people affected by mesh, Primodos and valproate products: Click here to view
When you have an operation under anaesthetic, you have no choice but to put your trust in the surgical team. When you are prescribed a treatment, often you can barely pronounce the name, and you can only trust your doctor that it will do you good. Putting yourself in the care of a health professional can be a leap of faith, a step into the unknown, only made possible by trust in a nurse, a doctor, a hospital.
The trust between patients and the healthcare system is extraordinary and precious, it is what keeps the country healthy and keeps the NHS close to our hearts. That trust, though, is also fragile. When the healthcare you receive ends up causing you harm, those harmful effects are amplified. It can change who you are as a person.
It takes a truly extraordinary person, having experienced this kind of harm, to campaign to make sure that it doesn’t happen again, to improve the system for patients in the future. That is why, in my first blog as Chair of the Independent Medicines and Medical Devices Safety Review, I want to pay tribute to the inspirational people behind the campaigns that led to this Review being commissioned.
Of course, I understand that this Review will not provide all the solutions and answers that you are campaigning for. Of course, as Chair, I will look at the evidence in an entirely even handed manner and I have no pre-conceived views. But I could not begin without thanking you for your tireless work to put Primodos, sodium valproate and surgical mesh on to the agenda.
For my part, I can only pledge to do my best to make sure our Review is worthy of your efforts. I will be supported by an excellent team, but I will also need your help. As the Secretary of State said when he launched the Review, our work must pay heed to the voices of the patients, families and professionals who have campaigned on these issues. Without doing so, the system will not learn the lessons and make the changes that are needed.
When I Chaired the Maternity Review I met hundreds of inspiring women, midwives and doctors up and down the country, whose stories were both heart-warming and agonising. We made sure their voices weren’t just listened to, but properly heard.
That is why it is important that, in the coming weeks, I meet with patient groups and the politicians who have been advocating on their behalf, to discuss the Terms of Reference of the Review. I hope that will be a valuable process and will clarify how we will work together.
I am eager to get on and examine the evidence, and to hear your stories, but I am also conscious of the importance of getting this right, to ensure our health system never has to learn these lessons again.