PM orders review into Primodos and vaginal mesh

The Prime Minister has ordered a review of public health scandals involving the pregnancy test drug Primodos, the use of vaginal mesh implants and the anti-epilepsy drug sodium valproate.

Former Conservative health minister Baroness Cumberlege will lead an examination of the circumstances in all three cases and consider whether there are grounds for wider inquiries into the failings alleged by campaigners.

Sky News last year exposed a cover-up of the impacts of Primodos, a German drug prescribed as a pregnancy test that campaigners say was responsible for causing miscarriages and abnormalities including babies born with missing limbs, brain damage and heart defects.

Primodos: The Secret Drug Scandal

Video: Primodos: The Secret Drug Scandal

Research by the manufacturers acknowledged there was a one-in-five chance of birth defects, but the evidence was concealed to frustrate claimants.

Sky News has also been reporting on the impact of vaginal mesh implants for more than two years, drawing attention to women left in acute pain by the procedure, used to treat incontinence and prolapse since the 1990s.

Titles screen for mesh scandal special report.

Video: Special report: The mesh scandal

Thousands of women are suffering complications from a ‘quick-fix’ routine operation to cure stress urinary incontinence.

Women have been left in chronic pain, some unable to walk, work or have sex.

The official complication rate set by the medical regulator the MHRA is 1-3%, but Sky News revealed how NHS data shows the figure to be almost 10%.

Thousands of women have reported complications as a result of mesh, including chronic pain, being unable to work or have sex

Image: Thousands of women have reported complications as a result of mesh

The mesh is made out of polypropylene plastic and designed to be permanent so removing it is a highly dangerous operation.

Last year the use of mesh was heavily restricted in Australia and banned in New Zealand, and the National Institute for Health and Care Excellence has recommended their use be suspended in the UK.

Sodium valproate is an anti-epilepsy drug that has also been linked to birth defects in cases where it was prescribed to expectant mothers without a warning as to the potential consequences.

Documents uncovered by Sky News from the National Archive last year revealed that the dangers to pregnant women were kept from patients for decades despite evidence it could harm foetuses.


Image: Sodium valproate has also been linked to birth defects

In all three cases, campaigners believe the Government response has been inadequate and have called for full inquiries.

In addition to Baroness Cumberlege’s review, Health Secretary Jeremy Hunt has also announced plans to establish an independent adjudicator to review similar cases of alleged medicine and public health regulation failings.

Currently, the decision on whether to launch full inquiries largely depends on the tenacity of campaigners and media attention.

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The intention is for an independent body to examine cases such as these and advise the Department of Health and Social Care on the appropriate response.

Kath Sampson, from campaign group Sling the Mesh, said she was “thrilled” the review had been ordered but that “many women’s and families lives have been shattered by medical devices and drugs that were never tested on humans before being released en masse to women globally”.

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