The Scottish Government last night said around 4,000 Poly Implant Prosthese (PIP) implants have been used in Scotland, the vast majority in the private sector. It is the first time a figure has been put on the number of Scots affected.
France, Germany and the Czech Republic have all urged anyone with PIP implants to have them taken out, but the UK government last night said there was no evidence Britain should follow suit.
The cut-price implants contain non-medical grade silicone. Women who had them implanted on the NHS and are anxious about any health risks will be allowed to have them taken out for free. The government is urging private providers to do the same.
Spire Healthcare, the UK’s second-largest private hospital provider, yesterday said it would offer every patient free removal and replacement. Spire’s sites include Murrayfield Hospital in Edinburgh.
Health secretary Nicola Sturgeon said: “We have been given expert advice that there is no evidence for routine removal of PIP breast implants, although more evidence is needed and is being gathered.
“However, I completely understand the concerns women who have had PIP implants will have, and the anxiety they will be experiencing. That is why it is right that the NHS offers advice and support where appropriate.
“We have no records of PIP implants being used by the NHS in Scotland. However, boards are continuing to check their records, and if a woman does have a PIP implant fitted by the NHS they will be contacted, offered a consultation and, if clinically necessary, offered removal and replacement.”
She added: “I expect private surgery providers to take responsibility for their patients and offer the same service. Where a private provider is no longer in operation or does not offer appropriate care, the NHS will support removal of implants where that is the clinically appropriate course of action.”
Across the UK, about 40,000 women received the implants, manufactured by the now-defunct French company, Poly Implant Prosthese, which were filled with silicone intended for use in mattresses.
The UK government said those patients who had their implants on the NHS as part of breast reconstruction surgery – believed to be around 5 per cent of the total – will be able to have them removed and replaced if they are worried. The government expects private firms to give the same offer to anxious women who paid for their implants privately and also wish to have them taken out.
All women who have received an implant on the NHS will be contacted and offered a consultation with their GP or their original surgical team. They could be offered scans to see if there is any evidence that their implant has ruptured.
With the support of their doctor, women who still have concerns will be able to have them removed and replaced free of charge on the NHS.
The Scottish Government said if women cannot contact their private surgeon and are concerned about their implants, they should contact their GP to discuss options for referral to a specialist for a clinical review.
If it is agreed that the most appropriate outcome would be removal of the implant, NHS Scotland will carry out the procedure, but would not replace the implant with an alternative unless there was a clinical reason to do so.
The expert group behind the review concluded there is no link between the implants and cancer, as reported in one French case.
However, it said it was “undeniably the case” that the implants were made up of non-medical grade silicone and should not have been implanted in women in the first place.
The expert group was unable to establish if the rupture rate is higher for PIP implants than for others.
It could not be confident that PIP did not change the silicone in the implants, so could not rule out the possibility that some are toxic.
Westminster Health Secretary Andrew Lansley said his main concern has been for the safety of women who have had PIP implants.
“It has been a worrying time for these women,” he added. “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.”
Mr Lansley said data from the industry had not been good enough to enable them to give a clear recommendation on the risk posed by PIP implants.
“We will therefore support women, including removal of the implant, if needed,” he said.
Advice from the Medicines and Healthcare products Regulatory Agency (MHRA) has not changed: there is still no evidence of health risks to support routine removal of the implants.
However, experts behind the review concluded that anxiety was a form of health risk and recognised that many women would be anxious.
In France, the government has told 30,000 women they should have the implants removed, while the Czech and German authorities have recommended that women should also have them taken out.
The boss of PIP has reportedly told police the victims are money-grabbers and he had “nothing to say” to them.
In the UK, the expert group will now examine wider issues around quality of data, surveillance and regulation of the cosmetic industry sector.
The Care Quality Commission is also reviewing whether clinics comply with registration requirements and is considering fuller inspections.
Fazel Fatah, president of the British Association of Aesthetic Plastic Surgeons, said women should be reassured that removal was a precautionary measure.
But he added: “It is accepted that these implants are sub-standard and not of a high medical grade.
“When they rupture, they cause significant disruption, and it is not acceptable.
“This is a sensible decision, and we support that.”