Government to pay for removal of NHS implants
Friday 06 January 2012
There is no evidence to recommend the routine removal of PIP implants from about 40,000 women in the UK, the Government said today.
But it said the 5 per cent of women who had their implants on the NHS as part of breast reconstruction surgery will be able to have them removed and replaced if they are concerned, and following consultation with their doctor.
The Government said it expects private firms to offer the same deal to anxious women who also wish to have their implants removed.
A Government review ordered by Health Secretary Andrew Lansley has concluded there is no clear evidence that patients with PIP implants are at greater risk of harm than those with other implants.
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.
But experts behind the review concluded that anxiety is a form of health risk and recognised that many women would be anxious.
All women who have received an implant on the NHS will be contacted to inform them that they have a PIP implant and to provide relevant information and advice.
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.
This could include scans to see if there is any evidence that the implant has ruptured.
According to the NHS offer, "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."
The expert group behind the review agreed there is no link between the implants and cancer, as reported in one French case.
But it said it was "undeniably the case" that the implants are 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 said that in those PIP implants that have been tested, there is no risk of dangerous toxins leaking into the body from rupture.
But experts could not be confident that PIP did not change the silicone in the implants, so cannot rule out the possibility that some are toxic.
In a statement published by the Department of Health, it said it expected private firms to match the NHS offer on removal and replacement of the implants among those women with concerns.
"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."
If the clinic that provided PIP implants has closed down, the NHS will pay for removing the implants if the patient is entitled to NHS care.
It will not pay for replacing the implants with new ones in those patients who originally went private.
The Government also intends to pursue private clinics to avoid the taxpayer picking up the bill.
Mr 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."
In France, the government has told 30,000 women they should have the implants removed after they were found to contain non-medical grade silicone intended for use in mattresses.
Earlier today, the Czech health ministry said some 2,000 women there should have the PIP implants removed.
In the UK, the Government said it was clear that the safety information provided by the industry to the MHRA was "patchy".
The expert group will now examine the wider issues around quality of data, surveillance and regulation of the cosmetic industry sector.
The Care Quality Commission is also reviewing the evidence on whether clinics comply with registration requirements and is considering fuller inspections.
Professor Sir Bruce Keogh, who led the expert group, 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."
The boss of the now-closed French company Poly Implant Prostheses (PIP) reportedly told police the victims were money-grabbers and he had "nothing to say" to them.
Jean-Claude Mas said during questioning in October that the certifying body had been deceived by what his firm was up to and said "the victims are only complaining in order to receive money", according to French media.
He reportedly told police: "It was routine. I give the order to hide any document relating to non-approved PIP gel and the staff dealt with getting rid of the containers...
"We did it for 13 years without any problem."
He has reportedly denied being motivated by financial concerns.
In a previous interview with police in November 2010 he is said to have insisted he had "nothing to say" to the women affected and claimed he had "knowingly used a non-approved gel".
When police put to him that the gel posed a health risk, he was said to have replied: "Not to my knowledge."
Yesterday, it was reported that PIP also made male chest and testicle implants filled with the same non-medical gel.
But the MHRA said none of these male PIP implants had been distributed in the UK.
A joint statement was published by the Association of Breast Surgery (ABS), British Association of Plastic and Reconstructive Surgeons (BAPRAS), British Association of Aesthetic Plastic Surgeons (BAAPS), the Federation of Surgical Speciality Associations (FSSA) and the Royal College of Surgeons (RCS).
It said: "The news that all women who have received a PIP breast implant will be provided with support, and that all NHS patients will be offered monitoring, advice and remedial treatment if desired is welcome news.
"Surgeons' organisations applaud those private cosmetic clinics who have committed to offer treatment to their patients free of charge and fully back the Government call for the rest to follow suit.
"This situation raises again the need for better regulation and surveillance for all surgical implants and the surgical profession believes mandatory databases should be the next step - not least because this issue has exposed poor record-keeping."
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