THE Prime Minister has ordered a review into three women's health disasters – vaginal mesh implants, the pregnancy drug Primodos and Valproate, given to women suffering bipolar that caused birth defects.
The health system needs to improve how it responds to concerns about medicines and devices used in treatments, the Health and Social Care Secretary Jeremy Hunt will say today as he announces a major review into how side effects and other problems reported by patients after treatment are addressed and used as a source of learning.
Theresa May said: "There has been a concern across the house in view of vaginal mesh, Primodos and valproate.
"There's an issue with our regulation in the health care system."
[perfectpullquote align="left" bordertop="false" cite="" link="" color="" class="" size=""]"We need to do better."[/perfectpullquote]
"I was very struck by the stories I have heard."
"Jeremy Hunt will be setting out plans for a review."
Mr Hunt has also asked the review to consider whether we need to establish an independent committee to recommend to ministers the appropriate course of action in individual situations, including independent inquiries, full public inquiries, or other courses of action.
The review comes after high profile, patient-led campaigns on three NHS treatments: the hormone pregnancy test used up until 1978, Primodos, the anti-epilepsy medication sodium valproate, and the use of vaginal mesh.
Patients have raised a range of concerns associated with each of these treatments which has highlighted a flaw in the responsiveness of the healthcare system to such issues.
Speaking in the House of Commons, Mr Hunt will say that the response these groups received from the NHS and its regulators after raising concerns was "not good enough" and will ask Baroness Julia Cumberlege to conduct a review into what happened in each of these three cases, including whether the processes pursued to date have been sufficient and satisfactory.
Kath Sanson, a campaigner against mesh, said: "We are delighted that at last a review is to be carried out but also deeply saddened that so 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.
[perfectpullquote align="left" bordertop="false" cite="" link="" color="" class="" size=""]"We were the human guinea pigs.[/perfectpullquote]
"These are three huge women's health disasters.
"The people who benefited most were the share holders and big CEOs.
"It is wrong that women have had to fight for YEARS to get their voices heard, often being dismissed as mad, hysterical or a minority suffering.
"Had men been hurt by drugs or implants on this scale there would be an outcry.
"Instead we have been left to suffer in silence.
"Every woman affected by Primodos, Valproate or mesh implants has suffered personal tragedies that can never be compensated for."
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Baroness Julia Cumberlege's review will consider:
- Whether any further action is required in response to the issues raised by patients in relation to Primodos, sodium valproate and vaginal mesh – up to and including whether a full investigation or inquiry is necessary.
- The robustness of processes followed by the NHS and regulatory bodies after patients report their concerns – including how they communicate with patients;
- How to ensure good communication between the relevant bodies and groups raising concerns;
Health and Social Care Secretary, Jeremy Hunt 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.
"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.
"I want to see if we can establish a fairer and quicker way of resolving these concerns both now and in the future."
Chair of the review, 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."
The review will also look at how to improve the way the healthcare system responds to patient-reported concerns about clinical interventions in future – and will make recommendations about a new model to be established.
The Government has pledged to strengthen the system for monitoring the safety of medicines in pregnancy following the recent review into whether there is a possible link between hormone pregnancy tests and birth defects.
This includes better training and support for obstetricians and more information for women on the risks associated with medicines in pregnancy.
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The Health Minister Lord O'Shaugnessy will now lead an oversight group to make sure these measures are delivered.
Other measures to be set out by the Health and Social Care Secretary include:
On Valproate,
- A push for valproate to be contradindicated for women of childbearing potential not using effective contraception.
- Stronger and more tailored advice on risks and contraception for those women for whom sodium valproate is an effective treatment
- A new, clear warning symbol on sodium valproate packaging to highlight the potential complications.
On surgical mesh,
- An audit of patient outcomes after vaginal mesh surgery to understand the nature of potential harms.
- An investment of £1.1m to develop a comprehensive database for vaginal mesh to improve clinical practice and identify issues
