Results of the independent review into Surgical Mesh and Sodium Valproate

An independent review into the experiences of people who say their health was affected by three different medicines or medical devices has published their recommendations.

The Independent Medicines and Medical Devices Safety Review was chaired by Baroness Cumberlege and spent 2 years listening to over 700  individuals and families affected by pelvic mesh, the hormone pregnancy test Primidos and epilepsy drug Sodium Valproate, to consider how the Healthcare system reports harmful side effects from medicines and medical devices, and help build a “system that listens, hears and acts…” 

What did the review find?

The review identified that the Healthcare System “is not good enough at spotting trends in practice and outcomes that give rise to safety concerns.” and said that “patients have been affected adversely by poor or indifferent care, have suffered at the hands of clinicians who do not, or who chose not to listen, and have been abandoned by a system that fails to recognise and then correct its mistakes at the earliest opportunity.” resulting in avoidable harm.

The overall recommendation is the need for a “patient voice” with statutory powers that will hold the system to account and make sure the system takes prompt action when there is a potential danger to patient safety.

The review focused on:

• Primodos – a hormone pregnancy test which was withdrawn from the market in 1978 and is alleged to be associated with birth defects and miscarriages. Since the 1950 it was  identified that these types of medication could cause abnormalities to the baby.
• Sodium valproate (commonly known by brand names Epilim, Episenta and Depakote) – an effective anti-epileptic drug for preventing seizures but thought to cause physical malformations, autism and developmental delay in many children when taken by their mothers during pregnancy.
• Pelvic mesh – surgical implant used to repair pelvic organ prolapse and manage stress urinary incontinence, but accused by many women of leaving them with crippling, life-changing, complications. Since July 2018 the procedure has been paused and only been offered on the NHS in exceptional circumstances under the strictest supervision. When the review was first implemented, a pause was placed on the implantation of vaginal mesh, pending certain conditions being met.  It has been concluded that these conditions have not yet been met and it has been recommended that NICE update their guidance.

Important Data has not been recorded

The review acknowledges the many lives saved and wonderful things achieved by medical care innovation but goes on to talk about the need to balance this with a robust system of long-term monitoring.  The report says that the healthcare system does not know how many women have been treated for stress urinary incontinence and the repair of pelvic organ prolapse using polypropylene mesh, or how many have gone on to develop chronic, life altering conditions. Nor does it know how many women took sodium valproate and then became pregnant without understanding either the risks or the alternative options which were available to them. Just how many of those children were born with autism, developmental delay or considerable malformations is not on record.

From the various patient meetings conducted around the country and the emails and letters received, the review identified themes which patients repeatedly described:

• The feeling of being dismissed. Mesh injured women reported reactions including “it’s all in your head” and “these are women’s issues” leaving them feeling vulnerable and that they had no voice.
• Parents feeling guilt for taking Sodium Valproate during pregnancy, without being aware of the risks and the use of the Primodos hormone pregnancy test which they took not knowing the potential to cause damage.
• The failure to obtain informed consent. The review panel was “appalled by the numbers of women who have come forward to say they never knew they had had mesh inserted, or where they gave consent for ‘tape’ insertion they did not know they were being implanted with polypropylene mesh or were misinformed as to the extent of longer term adverse side effects….”.
• The desire for improvements in data collection to assist in the identifying of long-term effects of devices and medication.

A more in-depth consideration of each of the three review areas revealed that patient campaign groups were pivotal in the raising of concerns, especially against the background of many feeling their concerns were not being listened to.

What happens next?

As a result of the review, nine recommendations have been made:

1. The Government should issue an apology to the families of those affected by Primodos, Sodium Valproate and Pelvic Mesh.
2. The appointment of an independent Patient Safety Commissioner who would listen to patients to seek improvements to patient safety and hold the healthcare system to account.
3. The implementation of an independent Redress Agency to help resolve disputes.
4. Setting up a discretionary payment scheme to meet the cost of providing additional care and support to those who have experienced avoidable harm.
5. Setting up separate specialist centres to provide treatment for those affected by mesh and by medication taken during pregnancy.
6. Substantial revision of the MHRA in relation gathering/recording data and raising awareness of its public protection role.
7. Setting up a central database to record details of the implantation of all devices.
8. Provide transparency of financial or other links between doctors and pharmaceutical/medical device companies.
9. The implementation of a task force to take forward the other eight recommendations.

Primodos, Sodium Valproate, Pelvic mesh and Medical Negligence

As we’ve seen in the results of this review, many patients raised concerns about their treatment but felt they were not listened to by doctors. If that’s true for you, you may be able to bring a claim for medical negligence. Contact us today to find out more, or find out more about our work with women affected by surgical mesh here.