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Independent review finds ‘health system failed in its responsibilities’ by causing avoidable harm

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The independent medicines and medical safety review, chaired by Baroness Cumberlege, has published a report into the use of Primidos, sodium valproate and vaginal mesh. The report also considered the treatment of the victims who had reported harmful side effects from these medicines and medical devices.

Commonly used treatments and products caused harm

Primidos was a form of hormonal pregnancy test primarily used between the 1950s and 1970s. It has been linked to miscarriage and a wide range of foetal malformations such as heart defects, limb abnormalities, cleft palates, bowel issues, spina bifida and many others.

Sodium valproate is used to treat epilepsy. When used by pregnant women it has been linked to development disorders in their children, such as autism, dyspraxia and attention deficit disorder. 
Vaginal mesh has been used to treat vaginal prolapse and incontinence in women. Research suggests the mesh can harden or stiffen, causing chronic pain, recurrent infections, mobility problems, sexual difficulty and incontinence for example.

Wide ranging consultations

Hundreds of patient stories were given as part of the review, in addition to evidence being obtained from the NHS, private hospitals, regulators and manufacturers. From reviewing the patient stories, Baroness Cumberlege reported that:

“We met with people…whose worlds have been turned upside down, their whole lives and often their children; lives, shaped by pain, anguish and guilt…it has been a shocking and truly heart-rending experience. We owe it to the victims of these failings, and to thousands of future patients, to do better”.

Failings in the system itself

The review also identified failings in the healthcare system itself and the way it had responded to patient complaints. Baroness Cumberlege recommended that a Patient Safety Commissioner be appointed to listen to and advocate on behalf of patients. This role would also hold the system to account, monitor tends and demand action.

Baroness Cumberlege recommended that the government should immediately issue a fulsome apology on behalf of the healthcare system to the families affected by Primidos, sodium valproate and pelvic mesh. Similarly, redress and other independent schemes should be set up to assist those in seeking additional care and support for those who have been negatively affected.

Shoosmiths clients’ experience

Our client, Christine Stevenson, who had mesh inserted at Sandwell Hospital in November 2009, which led to pain and disability until it was removed in 2017, said:

“The impact goes beyond the pain I endured all those years. My relationship with my husband was destroyed leaving me depressed and isolated. I feel robbed of the best years of my life and aggrieved by the battle that I have had to go through”.

Natasha Read, Principal Associate, said:

“We welcome the report and the fact that the pain and suffering endured by so many women has finally been acknowledged. Obtaining the patients’ fully informed consent to any form of treatment is a fundamental principal of medical care. We will all require medical treatment at some point in our lives, but we can only have the confidence to proceed if we are told about the risks and listened to when things go wrong. Our clients have suffered devastating side effects of these treatments and been frustrated by the lack of recognition”.

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