All women with faulty breast implants should have them removed given the 'uncertainty and lack of knowledge' about the extent of the problems, a leading surgeon warned today.
Tim Goodacre, a member of the Government-commissioned panel investigating the scandal, said the latest estimate of rupture rates was "very much higher" than he would consider acceptable.
About 50,000 British women are thought to have received the silicone implants made by Poly Implant Prothese (PIP) filled with gel meant for mattresses.
The Medicines and Healthcare products Regulatory Agency (MHRA) has said the risk of rupture is only one per cent, but a cosmetic surgery chain told ministers privately that the figure could be as high as eight per cent.
Mr Goodacre, president of the British Association of Plastic, Reconstructive and Aesthetic Surgeons (Bapras), told BBC Radio 4's The World At One: 'Even with a very low rupture rate, we would want to see most implants removed on a staged basis.
'If you believe a device is faulty, I think this would be true in your car or any other object that you buy, you would want to have that replaced on a staged basis.
'Certainly this is a very much higher rupture rate than we would consider acceptable at all. Good implants put in by reputable people really have an extraordinarily low failure rate so this is quite out of the ordinary.'
Mr Goodacre stressed that there was 'no immediate cause for concern' as there was no cancer risk and no evidence of 'major health detriment'.
But he added: 'Given the fact that there is a degree of uncertainty and lack of knowledge in this, we really are recommending that all implants do come out.'
The taxpayer could be left to pick up the £150million medical bill for removing the faulty breast implants.
Some victims say private clinics are demanding up to £3,000 to remove the implants. The clinics argue that they bought the implants in good faith and would face financial ruin if they had to remove them free of charge.
Health Secretary Andrew Lansley has ordered an urgent review of the safety of the PIP implants and has promised that if there are concerns the Government will ‘act with whatever remedy required’.
He hopes to publish the review’s findings within days, and industry experts expect him to follow France in advising all women with PIP implants to have them taken out.
With each operation costing up to £3,000, the total sum involved could reach £150million.
However MPs and patient groups say it would be ‘outrageous’ for the taxpayer to foot the bill to correct operations which were in the main carried out privately and for cosmetic, rather than medical, reasons.
Leaks of silicone from the implants can cause agonising pain, as well as swelling and lumps in the breast and armpit, some of which can be easily mistaken by women for tumours, causing unnecessary anxiety.
There are also fears that the PIP implants, which were among the cheapest on the market, raise the risk of cancer.
The Daily Mail revealed concerns about the implants in June 2010, when a French inquiry found ‘serious irregularities’ in them.
A month ago, the implants hit the headlines again with the death from a rare form of cancer of a French woman who had breast augmentation in 2005. While the link with the implants was not established, the French Society of Reconstructive and Aesthetic Plastic Surgeons said the gel could have been an ‘aggravating factor’ in the cancer.
Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) has been accused of playing down the dangers.
Over the last fortnight it has repeatedly urged women not to panic, simply saying that anyone who was worried should contact her surgeon. While it banned further use of the implants, it said that there was only a 1 per cent chance of rupture, compared with a 5 per cent rate reported in France.
But on Friday night the MHRA received new data from one of Britain’s biggest chains of plastic surgery clinics. This placed the rupture rate at around 8 per cent, although it was not clear if the figure applied to patients or to individual implants.
On Saturday, Mr Lansley ordered an urgent review of the safety of the implants.
The review, which is due to report back early this week, will focus on the risk of rupture, as Mr Lansley is satisfied that the PIP implants do not raise the risk of cancer.
He said: ‘I want to give further reassurance to women that if there are any safety concerns we will act with whatever remedy that is required.’
He added that, as yet, there is no evidence which would justify routine removal.
Nigel Robertson, chief executive of the Transform cosmetic surgery chain, said that clinics bought the implants in good faith and would be forced out of business if they had to shoulder the costs of replacing them.
But an industry source said clinics have been ‘raking it in’ by using the cut-price implants. He said: ‘They should be insured and we shouldn’t feel too much sympathy for them and their claims they could go under.’
Fazel Fatah, president of the British Association of Aesthetic Plastic Surgeons, said: ‘The clinics didn’t know the implants were as bad as they are. But they bought them because they were so cheap and they made more profit on the package.’
Joyce Robins of the campaign group Patient Concern said: ‘If the NHS foots the bill, it is going to deprive others of possibly life-saving treatments. If the operation was done for cosmetic reasons, the people who put them in should bear the cost.’
Philip Davies, Tory MP for Shipley in West Yorkshire, said that only breast cancer patients who had reconstructive surgery on the NHS should have the implants taken out at the taxpayers’ expense.
‘It would be outrageous if the NHS picks up the tab,’ he said. ‘For those who had it done privately, it has absolutely nothing to do with the NHS and if they have a problem they should pursue whoever is liable through the courts.
‘The taxpayer shouldn’t be picking up the tab for mistakes made by private companies.’
John O’Connell of the TaxPayers’ Alliance said: ‘Taxpayers will wonder whether this is a priority for NHS budgets.
‘Of course patients in a critical state should be treated regardless of the cause, but people who choose to have cosmetic surgery shouldn’t expect hard-working families to pick up the tab if they change their mind.’
It is claimed that some clinics are refusing to allay women’s fears by telling them the type of implant used unless they pay to see their medical records.
Andy Burnham, the Shadow Health Secretary, said: ‘That is unacceptable. The Government should work with all healthcare providers to ensure all women have access to their records with delay and without charge.’
A Department of Health spokesman said predictions that the NHS will pay were ‘speculative’.
I'm so angry with myself - and scared
Mother-of-two Sarah House has been left unable to sleep and suffering a never-ending ‘nightmare’ after she found out a faulty implant had ruptured.
The former social worker and her husband Barry, a retired policeman, have had to remortgage their home in Hereford to cover the costs of treatment.
Mrs House, now 44, had the original implants put in nine years ago because she was unhappy with her 32AA bust.
Last month her left breast began to swell and she was told her PIP implant was to blame.
‘After tests I was told the implant had ruptured, the fluid had leaked and my body fluid had filled up my breast,’ she said.
Shortly before Christmas she had the implants replaced at a cost of £7,500. ‘It really is a complete nightmare,’ she said.
Having always felt self-conscious about her small bust, Catherine Kydd paid £4,000 to have her size increased from 32A to 34C in 2004.
Six months later, when her left breast began to feel uncomfortable, her surgeon told her the sensation was ‘normal’. But in 2009, the mother of two discovered a lump in her breast and an MRI scan revealed the implant had ruptured.
After learning she had been given sub-standard PIP implants, and terrified as a result of a family history of breast cancer, she persuaded the clinic – Transform – to replace them for free.
However, 18 months on, she remains afraid that her health has been damaged.
‘I was told the silicone had spread to my lymph nodes but the doctors told me they didn’t feel it was necessary to remove my lymph nodes, that it wouldn’t be a problem,’ said the 39-year-old beauty therapist, from Dartford in Kent.
‘But I am terrified. When I am feeling under the weather I get aches under my armpit.’
She set up a Facebook page for women affected by the PIP implant scandal and wants the law changed to ensure records of types of implants used in all surgery are kept in case of future problems.
Despite having been crowned Miss Great Britain, beauty queen Gemma Garrett always felt uncomfortable that her breasts were different sizes. So when her modelling career began to take off, she paid £4,500 for implants at a private clinic in London in 2008. They were supplied by PIP.
She contacted the clinic last year after a lump appeared in her left breast but was told the warranty had expired. She was later told by a specialist that an implant had ruptured.
Miss Garrett, 30, from Belfast, paid another £11,000 to have both implants removed, but her surgeon told her some of the silicone had fused into her breast, causing lasting complications.
‘I now have huge cavities in my breasts where the implants were and, every six weeks, I have to go to hospital, have a needle inserted into my breasts and the blood which has filled up in the cavities drained,’ she said.
‘It’s painful and unpleasant. I am so angry with myself for having the operation in the first place.
‘But I am also very scared. Am I going to be OK? I don’t know.’
source: dailymail.co.uk
