PIP Implants
More than one in 10 faulty breast implants could have ruptured, according to a leading plastic surgeon, who yesterday said private clinics should pick up the £150m bill for removing them.
Fazel Fatah, one of the members of the government-commissioned panel investigating the scandal, said private clinics has an "ethical and moral obligation" to patients after fitting them with cheap implants.
Mr Fatah, president of the British Association of Plastic Surgeons, warned that number of faulty implants may be far higher than figures released by clinics at the weekend suggested.
He said all 40,000 women who have had the implants, which use industrial grade silicone, should have them removed because of the potential risk of them rupturing.
The price of the implants was so low it was "too good to be true", he said, and claimed they were mainly used by "cut-price" clinics keen to offer low package prices.
"My personal view is the clinics which originally profited from these implants have an ethical and moral obligation to these patients," he told The Daily Telegraph.
If the industry failed to act women would quickly lose confidence in it, he argued. His call for private clinics to pay rather than the NHS was welcomed by Conservative and Labour MPs.
Mr Fatah said it was "quite possible" that the true rupture rate was in double figures, significantly higher than the seven per cent reported by Transform, Britain's bigest cosmetic surgery chain, at the weekend.
The Medical Healthcare and products Regulatory Agency (MHRA) had previously said the figure was less than one per cent.
The discrepancy led Andrew Lansley, the Health Secretary, to call for the MHRA to review its data, while he also convened an expert panel to make recommendations.
On Sunday Tim Goodacre, another surgeon who is on the panel, said all implants should be removed if Transform's figures were verfied.
Mr Fatah, however, went further. He said: "The implants are not fit for purpose; they are not fit for use in humans.
"Regardless of the rupture rate, they should be taken out because the silicon is not of medical grade."
He added there was "no doubt the MHRA figures are unreliable" because they relied on voluntary registration of rupture, which rarely happened.
Even when the implants had not ruptured, he said there was evidence that the silicon could leak out into body tissue, blocking lymph nodes and causing pain and inflammation.
Some 40,000 women across Britain are thought to have PIP breast implants, including about 3,000 NHS patients for whom they were used for breast reconstruction after cancer surgery.
The Department of Health's position remains that there is "no evidence to make us think that they [women] should have the PIP implants removed" if they have not ruptured.
But that could change on Wednesday, when the panel convenes to discuss the data and make recommendations.
Many clinics fear they will be put out of business if made to stump up the full costs of removal, and say it is unfair for them to shoulder the whole burden when they bought the PIP implants in good faith.
The removal cost has been estimated at £150 million, higher than then £100 million annual turnover of the UK breast implant industry.
Women have reported that some clinics have tried to charge them £3,000 for removal, although others have offered to do so free of charge.
Last night Andy Burnham, the Shadow Health Secretary, said private clinics "must arrange for urgent removal at no expense to the individual and with any costs to the NHS reimbursed".
They should also give women free access to their medical records, so they could check if they had PIP implants or not, he said.
Stephen Dorrell, the Conservative MP and chairman of the Commons' Health Select Committee, said the cost of removing implants should be recovered from those who provided "sub-standard products".
"The first responsibility here would rest on those who were engaged in care that hasn't met proper standards, so the first responsibility rests on them," he told The World At One.
"Having said that, clearly if there is a health issue involved then ultimately the NHS exists to provide health assurance for all patients in the UK.
"But I think it would be entirely reasonable to seek to recover some of this cost off those who have provided sub-standard products."
Poly Implants Protheses (PIP), the French company that made the implants, substituted medical-grade silicon with much cheaper industrial-grade silicon several years ago.
At the same time it also removed a protective outer layer, according to industry reports, making them more prone to rupture.
It still sold them to clinics as containing medical-grade silicon, while misleading investigators about the true materials.
Yesterday, a French analysis of the PIP implants, commissioned by radio station RTL, claimed they contained Baysilone, Silopren and Rhodorsil.
Baysilone is a fuel additive, while Silopren and Rhodorsil and used in the production of rubber tubing.
A spokesman for RTL said these products "have never been clinically tested for their possible harmful effects on the body", while Andre Picot, the toxicologist who carried out the research, described the mix as "near criminal".
Philippe Courtoise, a lawyer acting for women given the implants, said the implants should be removed and analysed.
Both Mr Fatah's calls and the French analysis will add to pressure on Mr Lansley to recommend all the implants in British women be removed.
Both Mr Goodacre and Mr Fatah are calling for a nationwide register of implants, which they say would have identified problems with PIPs much sooner.
source: telegraph.co.uk
