PIP BREAST IMPLANTS – LONDON WELBECK HOSPITAL ADVICE TO ITS PATIENTS IN THE LIGHT OF HEALTH SECRETARY ANDREW LANSLEY’S STATEMENT.

Health Secretary, Andrew Lansley asked an expert group led by Professor Sir Bruce Keogh to review all available evidence and data on PIP implants. The group’s main findings and the response of the NHS (dated 6 January) together with a statement from Mr Lansley and Professor Sir Bruce Keogh are reproduced below.

The London Welbeck Hospital has taken careful note of both the findings of the expert group and the response of the NHS and Mr Lansley’s statement. The hospital notes first and foremost the group’s conclusion that the advice given by the MHRA still stands and that there is NOT enough evidence to recommend routine explantation of PIP breast implants and that the group also agrees there is no link with cancer.

However the London Welbeck Hospital remains very much aware that there are many women with PIP implants who despite regard to the MHRA advice and the expert group’s conclusion, will still feel very concerned. The London Welbeck Hospital wishes to do all it can to provide responsible advice and care to patients. The hospital has already been responding to calls received from concerned patients and has been providing up to the minute advice. Today it wishes to announce the following:

1. Provision of Services to the London Welbeck Hospital’s own Private Patients:

        i.            The London Welbeck Hospital (LWH) will provide free consultation with a surgeon to any of the LWH’s own private patients who request a consultation.

      ii.            The LWH will pay for the removal of PIP implants where there is clinical evidence of rupture of the implant.

    iii.            The LWH will charge a fixed price for PIP implant removal (and breast augmentation) in the case of patients who do not present any clinical evidence of a problem (ie for those who are simply seeking reassurance).

2. Provision of Services to Non London Welbeck Patients i.e. patients of private surgeons and other clinics:

        i.            The London Welbeck Hospital (LWH) will provide free consultation with a surgeon to any patient who requests a consultation.

      ii.            The LWH will charge a fixed price for PIP implant removal (and breast augmentation) in the case of patients who do not present any clinical evidence of a problem (ie for those who are simply seeking reassurance).

Any patients wishing to seek further information or clarification regarding this are asked to contact the hospital on Tel: 020 7224 2242.

The London Welbeck Hospital, Tuesday, 10 January 2012.

Department of Health statement on breast implants and response to expert group report

January 6, 2012

The wellbeing of women who have had PIP breast implants is our main priority. That is why the Health Secretary asked an expert group – led by the NHS Medical Director, Professor Sir Bruce Keogh – to review all available evidence and data on PIP breast implants.

The group has concluded that the advice given by the MHRA still stands and that there is not enough evidence to recommend routine explanation of these breast implants. The group also agrees there is no link with cancer.

However, it is undeniably the case that these implants are made up of non-medical grade silicone and therefore should not have been implanted in women in the first place. We recognise that this will be worrying for women with PiP implants and that they need to be properly supported by those that performed the implantations.

We have always recommended that if women are concerned they should speak to their surgeon or GP.

The NHS will support removal of PIP implants if, after this consultation, the patient still has concerns and with her doctor she decides that it is right to do so. The NHS will replace the implants if the original operation was done by the NHS.

We expect the private sector to do the same for their patients. We believe that private providers have a duty to take steps to provide appropriate after-care to patients they have treated.

Private providers have legal obligations to their patients. The NHS will offer a package of care for its patients, and we expect the private sector to do the same.

The NHS offer is:

• All women who have received an implant from the NHS will be contacted to inform them that they have a PIP implant and to provide relevant information and advice. If in the meantime NHS patients seek information about the make of their implant then this will be provided free of charge.
• Women who wish to will able to seek a consultation with their GP, or with the surgical team who carried out the original implant, to seek clinical advice on the best way forward.
• If the woman chooses, this could include an examination by imaging to see if there is any evidence that the implant has ruptured.
• The NHS will support removal of PIP implants if, informed by an assessment of clinical need, risk or the impact of unresolved concerns, a woman with her doctor decides that it is right to do so. The NHS will replace the implants if the original operation was done by the NHS

We are working with the private sector to best ensure an equivalent model of care is provided – we do not think it is fair to the taxpayer for the NHS to foot the bill.

If a clinic that implanted PiP implants no longer exists or refuses to care for their patient – where that patient is entitled to NHS services, the NHS will support the removal of PiP implants in line with the guidance above. Any NHS service in that respect would not include the replacement of private cosmetic implants. The Government will pursue private clinics with all means at its disposal to avoid the taxpayer picking up the bill.

The expert group has not been able to establish if the rupture rate is higher for PiP implants than for others.

Reports show that, of the PIP implants that have been tested, there is no risk of dangerous toxins leaking into the body if an implant did rupture.

However, we are not confident that the manufacturer did not change the silicone in the implants, so cannot rule out the possibility that some are toxic.

Going forward, we need to do everything we can to ensure the safety of people having cosmetic surgery.

It’s clear from the information we have received from the industry that the safety information it has provided to the regulator is patchy. Without good data, we have no way of knowing when problems arise.

Bruce Keogh’s Expert Group will examine the wider issues around quality of data, surveillance and enforcement of the sector and sector regulation more generally.

The Care Quality Commission is reviewing the evidence of providers’ compliance with registration requirements and considering a fuller programme of inspections based on that.

Franceand theUKwill continue to work together to share information and data. There is a shared determination between the two countries to prevent this situation from occurring again and theUKwould like to work with countries across the EU to understand fully where the failures of this incident fall.

Health Secretary Andrew Lansley said:

“Throughout the past few weeks, my main concern has been for the safety of and compassion for women who have had PIP implants. It has been a worrying time for these women. We have at every stage sought to offer them as much advice and evidence as is available to us.

“Our advice remains the same that there is not sufficient evidence to recommend routine removal. We have always recommended that women who are concerned should speak to their surgeon or GP. The NHS will support removal of PIP implants if, after this consultation, the patient still has concerns and with her doctor she decides that it is right to do so.

“We believe that private healthcare providers have a moral duty to offer the same service to their patients that we will offer to NHS patients – free information, consultations, scans and removal if necessary.

“Throughout this process we have followed expert advice. The data available to the experts has not been good enough to enable them to give a clear recommendation of the risk posed by PIP implants. We will therefore support women, including removal of the implant, if needed.”

Professor Sir Bruce Keogh said:

“The overriding consideration of the group is the safety and compassionate treatment of women with PiP implants.

“On the basis of the information we have, we do not think it is necessary to recommend the routine removal of these implants. But we understand that some women will be very concerned so we support the Government’s position that the NHS will support removal of PIP implants if the patient has concerns and with her doctor she decides that it is right to do so.”

PIP BREAST IMPLANTS – LONDON WELBECK HOSPITAL ADVICE TO ITS PATIENTS.

There has been considerable interest in the report of a special committee of the French government that has looked at the issue of PIP breast implants. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued advice on its website which is reproduced below.

We at the London Welbeck Hospital fully appreciate how the media coverage is raising concern among women who have had breast implants and would therefore like to refer patients to the advice of the MHRA who currently have no evidence of any increase in incidence of cancer associated with these implants.Health Secretary Mr. Andrew Lansley has asked the MHRA to continue reviewing all the evidence they have.

Any patient who has had an implant procedure undertaken at the London Welbeck Hospital, whether manufactured by PIP or any other manufacturer, and who remains concerned, should feel free to contact us for advice on the following telephone number: 0207 224 2242.

The MHRA’s latest advice together with their contact details is reproduced below:-

The London Welbeck Hospital 3 January 2012

MHRA Press statement

“Following the announcement in France today, the Medicines and Healthcare products Regulatory Agency (MHRA) is not recommending routine removal of PIP silicone gel breast implants in the UK.

We recognise the concern that some women who have these implants may be feeling but we currently have no evidence of any increase in incidents of cancer associated with these implants and no evidence of any disproportionate rupture rates other than in France.

We therefore do not believe that the associated risks of surgery from breast implant removal can be justified without further evidence.

We will continue liaising with the French medicines and medical devices regulator and we are awaiting the evidence to support the decision made in France. This will be evaluated as a matter of priority by our clinical and toxicological experts and we will issue further advice if necessary.

In the absence of strong clear evidence to the contrary, we see no reason to alter our current advice that there is no need to routinely remove these PIP breast implants.

In the meantime we would recommend that all patients who have questions about their PIP breast implants should seek advice from their implanting surgeon.

We had discussions on 21 December 2011 with other health or regulatory experts from France, the Netherlands, Portugal, Italy, Ireland, Hungary, Austria, Denmark and Malta. They all agreed that there was no evidence of any increase in incidents of cancer associated with PIP breast implants and no evidence of any disproportionate rupture rates other than in France. Information obtained from the Australian Regulatory Authority (TGA) is consistent with the figures from all the above European countries other than France in terms of rupture. They have no reported cases of lymphoma.

We have continually monitored the safety of these breast implants. In March 2010 we advised clinicians not to implant these devices and at the same time advised patients who were concerned about their PIP implants to consult their implanting surgeon. MHRA commissioned toxicity testing on the unapproved silicone gel used to fill PIP breast implants, including genotoxicity and chemical toxicity. The results of these tests have been discussed with relevant experts and we have concluded that there is no safety issue related to this filler material. Similar testing carried out by the French medicines and medical devices regulator confirmed these conclusions.”