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Written Statement - Poly Implant Prothese (PIP) Breast Implants

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Lesley Griffiths, Minister for Health and Social Services

I wish to update Assembly Members on the action the Welsh Government is taking regarding the safety concerns identified in Poly Implant Prothese (PIP) breast implants.

I need to make clear from the outset we accept the advice of the Expert Group established by the UK Government. There is no clear evidence to suggest women should have PIP breast implants removed. Our advice to women with any concerns or questions is to seek a consultation with their implanting surgeon in the first instance or their General Practitioner if that is not possible. 

I deeply regret the anxiety caused by the use of these sub-standard products and understand why women are fearful and in need of reassurance. I can also assure you we are working hard to establish the extent of PIP implants in women in Wales and shall keep the Assembly, the NHS and the public informed of developments as soon as further data can be identified.

Establishing reliable numbers and costs is one of our main priorities. However, it is important to recognise not all the women affected will need or want to have their implants removed or replaced if they are not experiencing problems. Women need to be aware of all the risks associated with surgery when considering whether to have their implants removed. This can only be done when a woman has all the available evidence.  

Our initial investigations suggest the number of women affected in Wales is low.  However, we have no clear estimate for Wales at this stage.
 
We have been advised the main private healthcare providers in Wales have not used these implants, but we do not know how many women resident in Wales have had implants outside of Wales.

I can assure Members we will apply as much pressure as we have at our disposal on the private providers to honour their duty of care to their patients in the first instance. Where the private provider refuses, or is unable to perform the procedure, removal and replacement will be available from the NHS if deemed to be clinically appropriate. Indeed, I announced earlier this week that all women in Wales who are assessed clinically as needing PIP breast implants removed will be offered replacement implants on the NHS regardless of whether they received the initial implant privately or from the NHS.

My overriding concern is to ensure the health and wellbeing of the women affected. Everyone in Wales has an equal right to NHS care of the highest quality. We must ensure we offer the same standard of support to all when they present themselves with health concerns to the NHS. The women who received these implants did so on the understanding the implants met with surgical standards and were safe. This was not the case, hence the need for the Welsh Government to move swiftly to provide the necessary support and reassurance. 
 
Removing the PIP implants and not replacing them could result in poor cosmetic results for some patients and could have a serious psychological impact. Replacing the implant as part of the same operation for those women in whom this is clinically required, is a simple addition and avoids the woman needing to undergo a second operation. This view is supported by a number of plastic surgeons working in Wales. I refute the UK Government’s view such a decision will allow the private providers off the hook. We will pursue the private providers to recover the costs with equal vigour and determination, making every effort to recover those costs through appropriate legal action if necessary.

Rather than encouraging private clinics to turn patients away, I expect our intervention to place additional pressure on private providers to recognise their duty of care to their patients and ensure the best possible clinical outcomes for the women affected.  I believe this approach will set the standard for the private providers. 

I have asked the Welsh Health Specialised Services Committee (WHSSC), who secure plastic surgery services across Wales to work with officials and the National Specialist Advisory Group for Plastic and Reconstructive Surgery to develop a process for women referred by their GP. 

The aim will be to establish a process for all patients who are left with no recourse by their implanting private provider, to have a consultation with an NHS plastic surgeon in the first instance.  If surgery is deemed necessary then this will be planned without impacting on other patients, so there is no detriment to the care received by others.  As this is not an emergency situation, however, some patients maybe expected to wait some time before this takes place,

The costs of our decision to treat the women affected will vary depending on the complexity of each case.  We will have better cost information once we have increased clarity on the numbers. 

What we do know for certain is costs are likely to be lower and clinical outcomes better if patients receive a single procedure.  As I have said, we have a responsibility to all who present to the NHS, irrespective of their past care, so I believe the final costs will be both appropriate and necessary. The costs for any treatment will be met by the NHS through the WHSSC which has responsibility for funding plastic surgery procedures across Wales. 

The Medical Director for NHS Wales will be meeting with private providers and their representatives at the earliest opportunity to explore the issues and agree a process for patients to access plastic surgery services in Wales.  I have also asked him to discuss with ethical implant manufacturers to see if a special low price can be negotiated for this specific situation.

I shall continue to update Members as the situation develops.