PIP Implants Scandal: Surgery Firm Defends Rupture Rate
A leading cosmetic surgery company which carried out a large proportion of PIP implant operations on British women insisted today that its "rupture record" left them with no cause for concern.
The Harley Medical Group said it had conducted 13,900 procedures with the implants in the UK between September 2001 and March 2010.
Since starting to collect rupture data in September 2004, it had recorded 213 ruptures by November last year, resulting in an aggregate rupture rate of 1.8%.
"This is well within available measurements," the company said.
While experts have concluded there is no evidence to recommend routine removal of the implants, they have said they could not entirely rule out that some were toxic.
More than 40,000 women in the UK received the implants, manufactured by now-closed French company Poly Implant Prostheses (PIP), which were filled with non-medical grade silicone intended for use in mattresses.
On Friday the Government said those patients who had their implants on the NHS as part of breast reconstruction surgery - believed to be around 5% of the total - will be able to have them removed and replaced if they are concerned.
This has led to a number of private health companies also pledging to remove them free of charge if they received the implants from them.
BMI Healthcare said it will remove and replace them for free, while Nuffield said it would cover the cost of taking them out providing it was safe to do so.
Ramsay Health Care, which has around 150 patients with PIP implants, said it was offering concerned women the chance to be examined and if there is a rupture or clinical need they would be removed and replaced free of charge.
Cosmetic surgery group Transform said its surgeons would be available to any concerned patients "to discuss the available options and offer appropriate counselling and guidance".
Meanwhile surgeons from Glasgow-based Confidence Cosmetic Surgery said they would reduce their normal costs for breast surgery by up to 60% for patients concerned about the PIP implants.
However many other private companies have not yet commented on whether they will waive or reduce their fees.
The Government has said it intends to pursue clinics where women paid for their implants privately to offer their removal for free to avoid the taxpayer picking up the bill.
Personal injury firm Thompsons Solicitors said that companies who offered the PIP implants could have a duty to pay compensation to those affected under consumer protection legislation.
The Sale of Goods Act 1979 offers consumers a series of legal rights, one of which is that with the sale of goods the item must be of satisfactory quality.
It is launching a free advice line to anyone worried about PIP implants, which from tomorrow morning will give people access to free legal advice and assistance with taking forward any compensation claims.
If the private clinic that provided PIP implants has closed down, the NHS has said it will pay for removing the implants if the patient is entitled to NHS care. But it will not pay for replacements in these patients.
A spokesman for the Department of Health said: "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 expert group behind the review concluded 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. But 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.
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 said. "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.
"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 has 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."
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 surgery sector.
The Care Quality Commission is also reviewing whether clinics comply with registration requirements and is considering fuller inspections.