First Do No Harm: the review into mesh, HPTs and sodium valproate

A long-awaited review into the experiences of patients who have suffered life-altering side effects from pelvic mesh implants, hormonal pregnancy tests (HPTs) and sodium valproate prescriptions has finally been published.

The Independent Medicines and Medical Devices Safety Review published the report earlier this week, reaching damning conclusions over the healthcare system’s failings to listen, represent and protect recipients of these three medical interventions.

talkhealth was behind this campaign from the very beginning; our CEO Catriona Williams went to the House of Commons back in 2018 as part of a campaign to discuss the forming of the All Parliamentary Party Group against surgical mesh implants. While this report doesn’t just focus on mesh, it is largely centered around interventions done to women and the side effects they and their families have had to endure. We absolutely applaud all the hard work that campaigners like Kath Sansom have done to bring these issues to the public’s attention.

The Independent Medicines and Medical Devices Safety Review has published a report looking into the experiences of women who have had pelvic mesh implants, hormonal pregnancy tests and sodium valproate products.

First Do No Harm was published earlier this month after the Government commissioned the review back in 2018. Since then, Baroness Cumberlege and her colleagues have been busy collating information and testimonials from women who have had the three medical interventions.

In a letter to the Secretary of State, Baroness Cumberlege explained that she and her team chose the title ‘First Do No Harm’ after ‘having spent two years listening to heart wrenching stories of acute suffering, families fractured, children harmed and much else’.

The review team travelled the length and breadth of the UK to chat with over 700 people (mostly women), along with their partners, other family members and children. Baroness Cumberlege calls patients’ stories ‘harrowing’.

The review looked at the following three medical interventions:

• Hormonal pregnant tests (HPTs) like Primodos (thought to be associated with birth defects and miscarriages)
• Sodium valproate (an anti-epileptic drug which causes physical malformations, autism and developmental delay in children when mothers take it during pregnancy)
• Pelvic mesh implants (linked to crippling, life-changing complications)

Key findings

Common themes in patient stories include:

• Being given a lack of information to make informed choices

The report found that there’s been a consistent failure of informed consent when it comes to these procedures, with women saying that they feel as though they’ve been part of a ‘cruel experiment’.

‘Had I realised the full implications of the medication, I would never have taken it.’

Baroness Cumberledge says that she was appalled by the numbers of women who came forward to say that they never knew that they’d had mesh inserted or that they didn’t know that when they’d consented to have ‘tape’ inserted, that meant being implanted with mesh. Many who consented to have mesh removal surgery believed that it would be a full removal – which, months later, turned out not to be the case. Then there were women who were never warned about the potential side effects of their epilepsy medications on their unborn children or who were told that any risks were low.

• Lack of awareness of who to complain to
• Struggle to be heard or believed

One mesh-affected patient said that she had been ‘gaslighted’ and ‘fobbed off’ by HCPs when she reported having complications, while another said: ‘The person I once was, she has gone and no-one seems able to help me. No-one is listening’.

The report says that the consequences of not being believed or listened to are ‘far-reaching’, with patients feeling ignored, belittled and vulnerable.

• Being dismissed and abandoned by HCPs
• Life-changing consequences for them and their families – often leading to a breakdown in family life

The normalisation of female pain means that women are seeking help far later than they should and that takes its toll physically, mentally and emotionally on them and their loved ones.

• Loss of jobs, identity, self-worth and futures

Because of the lack of understanding around these procedures and the devastating impact that they’ve often had on patients, women have struggled to work or receive adequate benefits. The report highlights the need for additional training for those carrying out assessments for the Department of Work and Pensions, which should help assessments to reach adequate conclusions.

Children who have been left disabled by these medicines can face additional hurdles in the education system, living with learning disabilities and behavioural problems. Again, because of the lack of awareness, there are often delays in receiving adequate diagnoses and referrals to support services. That means extra pressure on families as well as potentially leaving some children behind.

• Children becoming their mothers’ carers
• Clinicians being too ill-educated to make a proper diagnosis and refusing to learn from their patients

One retired GP said: ‘I could guarantee you if you walked into any general practice in the UK and showed the GPs a piece of mesh, very few of them would know immediately what it was. They have no idea.’

• The response of the healthcare system is not sufficiently robust, speedy or appropriate – resulting in avoidable harm

Recommendations

The report made the following suggestions for better protecting patients going forward:

• The government should issue an immediate and fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh implants.
• An independent Patient Safety Commissioner should be appointed. They’d be patients’ port of call and advocate who is accountable to Parliament and who holds the healthcare system to account.
• Create a new, independent Redress Agency for those harmed by medicines and medical devices, which can then make decisions about systemic failings – ensuring that victim-blaming doesn’t happen.
• Set up separate schemes for HPTs, valproate and pelvic mesh patients to meet the cost of providing additional care and support to those affected.
• Create a network of specialist centres to provide comprehensive treatment, care and advice for those affected by mesh; set up another to deal with those affected by taking medications during pregnancy.
• The Medicines and Healthcare products Regulatory Agency (MHRA) needs to be revised so that it engages more with patients.
• Set up a new database to collect the patient details of all those who have had devices implanted so that their outcomes can be tracked efficiently.
• Better transparency of payments made to clinicians, with mandatory reporting for pharmaceutical and medical device companies of payments made to teaching hospitals, research institutions and individual clinicians.
• The government should set up a task force to implement the Review’s recommendations and a timeline for their implementation.

Going forwards

talkhealth is committed to advocating for change and representing the voices of patients who have been let down by the healthcare system. We know how traumatising it can be to go through something as physically devastating as these interventions, only to have pleas for help and advice ignored or poorly seen to. As such, we want your stories so that we can further publicise the issues at hand. If you’ve struggled to receive help for the side-effects of vaginal mesh, hormonal pregnancy tests (HPTs) or sodium valproate, then please do email us. Sharing these stories may be hard but it really does help others to process what they’ve been through and adds to the pressure put on Government and the NHS to own up to their failings.

If you have any experience of these three issues, email us at info@talkhealthpartnership.com. Please let us know if you wish to remain anonymous and we will publish your story without names and identifiable details.

Where to go for help if you’ve been affected

If you’ve been affected by mesh, HPTs or sodium valproate, then the first thing you need to do is chat with your GP. Write notes on a piece of paper and take someone in with you to the appointment so that you have extra support. Push for a referral to a gynaecologist if you wish to have pelvic mesh removed, or ask your GP exactly where you can go to lodge complaints about being prescribed potentially harmful medications.

There are plenty of solicitors out there who specialise in clinical negligence; for some people, compensation can help manage the trauma – particularly if it enables you to access specialised, private support. Have a search online for law firms who specialise in these topics and ask for a free consultation.

On Facebook, there are various support groups – from Valproate Victims UK to Association for Children Damaged by Hormonal Pregnancy Tests and Mesh Problems. Your GP may also be able to point you towards groups in your local area. It’s really important to connect with other people so that you feel less alone and stay up-to-date with developments as they happen. We at talkhealth will endeavour to publish any information that we think is helpful or new too so do check in on our latest articles and social media posts.