The Department of Health and Social Care has confirmed that there will be a review of three treatments used by the NHS, following ongoing concerns from patients.
The DHSC said the review would focus on vaginal mesh implants, the anti-epilepsy drug sodium valproate and the hormone pregnancy test Primodos, which was used up until 1978.
“Patients and their families have had to spend too much time and energy campaigning for answers”
Health and Social Care Secretary Jeremy Hunt said he had announced the review into how the health system responds to reports from patients about side effects from treatments.
Mr Hunt said that the response these groups of patients had previously received from the NHS and its regulators was “not good enough”.
Babies exposed to valproate medicines in the womb have a 10% chance of developing physical abnormalities and a 40% chance of developing cognitive problems.
Despite efforts to make the risks from the drug more explicit over the past few years, parents who have had babies born with disabilities claim they were not sufficiently warned about them.
- Epilepsy drug warnings during pregnancy ‘not reaching women’
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- Nurses ‘must have time’ to discuss valproate risks
- Reminder on valproate risk for pregnant women
More recently, there have been reports of vaginal mesh implants cutting into the vagina and women being left in permanent pain, unable to walk, work or have sex. More than 800 women are currently taking legal action against the NHS and mesh manufacturers.
Meanwhile, campaigners claim Primodos caused birth defects in their children, such as blindness, deafness, spina bifida and heart and limb defects, as well as cleft palates.
Baroness Julia Cumberlege has been chosen to lead the review. She has been asked to consider whether any further action is needed relating to the complaints around three products.
She will also look at the processes followed by the NHS and its regulators when patients report a problem, and how to make sure communication between the different groups involved is good.
Baroness Cumberlege previously chaired a major national review into maternity services in England, which published its findings in 2016.
- ‘Distressingly’ wide variation in quality of maternity services
- Call for ‘radical’ changes to maternity staffing models
- The key recommendations from the maternity review
Mr Hunt noted that he had requested that the new review set up an independent committee to help ministers decide on the best approach to resolving these issues.
He said: “Over the years, there have been significant concerns raised by individuals and campaign groups about the potentially harmful effects of three products used by the NHS.
“The response they have received from those in positions of authority has not always been good enough,” said Mr Hunt.
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“From Primodos to mesh and sodium valproate, patients and their families have had to spend too much time and energy campaigning for answers in a way that has added insult to injury for many,” he said.
He added: “I want to see if we can establish a fairer and quicker way of resolving these concerns both now and in the future.”
Baroness Cumberlege said: “I look forward to undertaking this tremendously important review and in particular to working with patients to ensure that our health system learns from those it may have failed.
“It’s essential that voices aren’t just listened to, but properly heard, and that whenever appropriate, the system promptly learns lessons and makes changes,” she added.
The government has previously agreed to carry out a full audit of how many women in England have suffered complications as a result of vaginal mesh implants.
In addition, a European review is examining whether warnings are strong enough about risks to unborn babies from maternal use of sodium valproate for epilepsy.
Meanwhile, the UK’s Commission on Human Medicines said last year that the evidence did not support a “causal link” between use of Primodos and birth defects and miscarriages.