Our Thoughts on the Mesh and Sodium Valproate Scandal

Back in February 2018, the then Secretary of State for Health and Social Care announced a review into the response to reports from patients concerning harmful side effects from medicines and medical devices. This followed campaigns surrounding the use of anti-epileptic drug ‘AED’ sodium valproate and surgical mesh.

Six years down the line, Ministers are finally addressing the report and its recommendations.

Vaginal mesh implants

Figures suggest that between April 2008 and March 2017 there were over 127,000 mesh implants to treat incontinence and pelvic organ prolapse. It is estimated that up to 10% of patients have had severe long-term problems.

The mesh is made of polypropylene, the same material used in drinks bottles, and was used to treat incontinence and to support prolapsed organs such as the uterus, bladder or urethra.

The review concluded that the pain and suffering caused by pelvic mesh eroding into the vaginal wall and bladder and causing infections was avoidable and that the healthcare system simply did not listen to reports by patients and their families. This has left thousands of women debilitated, with relationship breakdowns and out of work.

England’s Patient Safety Commissioner, Dr Henrietta Hughes has recommended interim payments of £20,000 to be paid to women injured by mesh implants. This should be followed by further payments as well as non-financial assistance to victims.

In Dr Hughes’ first report published in February 2023, 100 days into her role as Patient Safety Commissioner, she described how victims of pelvic mesh are sadly still being ignored, are experiencing long waits and not being referred to specialist pelvic mesh centres.

Sodium valproate and pregnancy

There have been an estimated 20,000 babies born with disabilities, since the 1970s, after their mothers took the AED sodium valproate in pregnancy. This is despite research since the 1980s reporting on a link between the drug and birth defects. It is understood that sodium valproate carries a 10% risk of physical disabilities, and a 40% risk of autism, low IQ, and learning disabilities.

The Medicines and Healthcare Products Regulatory Agency advises that for epilepsy, valproate should only be used if there is no suitable alternative, and mothers must be provided with information on the risks. Furthermore, if valproate is to be used during pregnancy the lowest effective dose should be prescribed, as daily doses greater than 1g are associated with an increased risk of teratogenicity.

European drug firm Sanofi has acknowledged increased risks of physical and cognitive problems associated with taking valproate during pregnancy. However, their acknowledgement comes too late for families in England and Wales, who dropped their case in 2010 against the drug firm after Legal Aid was withdrawn extremely late in proceedings.

Dr Hughes has called for initial damages of £100,000 to be paid to families affected by this scandal. This recommendation is timely, as International Epilepsy Day is around the corner on 12 February.

International Epilepsy Day

International Epilepsy Day is a key initiative to drive forward the implementation of the Intersectoral Global Action Plan on Epilepsy and other Neurological Disorders ‘IGAP’.

IGAP started in 2022 and aims to bring down the barriers to treatment, increase service coverage and update human rights legislation for people with epilepsy.

How to get involved

• Share a personal message
• Use the hashtag #EpilepsyDay and tag @IntEpilepsy on social media.
• Create your own epilepsy awareness video.
• Share seizure first aid posters.