Just hours after UK health chiefs say controversial breast implants are safe, French government tells 30,000 women “have them removed”
British health official accuses French government of causing “unnecessary alarm”French officials say they will cover the cost of implant removal. British officials deny decision not to remove made on cost grounds
The French government has urged tens of thousands of women today to have their breast implants removed just hours after doctors and safety chiefs in Britain insisted they caused no health risk.
French health minister Xavier Bertrand said all of the 30,000 women in France with breast implants made by French company Poly Implant Prostheses should have them removed “as a preventive measure not of an urgent nature”.
Panic: Amanda Harrison developed lumps on her spine after her breast enlargement operation
The French government says it will foot the bill for the removals of the implants made from a suspect silicone gel, following complaints about abnormal rupture rates.
The corrective surgery in France will bepaid for out of public health funds, with a new implant funded if the treatment was done as part of reconstructive surgery following breast cancer.
While the French are likely to spend millions reversing implant operations, the British authorities have continually denied that they are trying to save money by not doing the same thing.
At least 250 British women are taking legal action against the clinics that treated them to try and recoup some costs. They are unlikely to be able to sue the implant company itself because it has been declared bankrupt as it has no money and no assets.
However, the Department of Health in the UK has claimed the French move has caused ‘unnecessary alarm’ and there is no need for the implants to be routinely replaced in Britain.
They said they had consulted with nine countries over safety concerns before making the decision.
Around one in 100 women in the UK receiving a French-made PIP implant has suffered rupture, where the seal has split, exposing the silicone to body tissue.
Burst: Plastic surgeon Denis Boucq holding defective silicone gel breast implants, which were removed from a patient
Amanda Harrison, from Ramsgate, was one such unlucky patient who suffered a ruptured implant four years after surgery.
Her Harley Street surgeon waived his fee to remove it this year but she still had to pay 1,500 for hospital costs and the anaesthetist.
The 40-year-old is still suffering today. The leaked silicone has spread to her lymph nodes and a scan has revealed two bulging lumps on her spine.
Gemma Garrett, 30, who was Miss Great Britain 2008, and beauty therapist Catherine Kydd, 39, have also had the implants removed after suffering painful complications.
While implants which have ruptured should be removed, experts say other women may face unnecessary complications from procedures to explant – take out – the implants.
Sufferers: Catherine Kydd and Gemma Garrett had complications after having PIP implants
Around 270 women are considering legal action, although the company responsible has gone into liquidation so claims are being directed against clinics and individual surgeons.
Sally Taber, director of the Independent Healthcare Advisory Services (IHAS) supported moves made by Health Secretary Andrew Lansley and the Medicines and Healthcare Regulatory Agency (MHRA) to reassure women.
She said ‘We are pleased to see that health and regulatory experts from the Netherlands, Portugal, Italy, Ireland, Hungary, Austria, Denmark, Malta and Australia have all confirmed no evidence of any increase in incidents of cancer associated with PIP breast implants and no evidence of any disproportionate rupture rates.
‘France are looking increasingly isolated in their stance and their pre-emptive statements have caused unnecessary alarm.
‘Our advice is that anyone concerned about their breast implants should contact their GP or implanting surgeon.
‘There is no evidence to suggest explantation is necessary and on top of that there are, of course, the associated risks with going under general anaesthetic that women should consider before rushing into any surgery.’
The French government admitted this morning that there was no conclusive evidence of a link between the sub-standard silicone and cancer.
The PIP implants were pulled off the market last year, when the manufacturers were closed down by French authorities after being accused of fraudulently using a non-approved silicone gel for almost 10 years.
The non-medical grade silicone is believed to have been originally designed for mattresses.
A British health chief said the French decision to remove the implants had caused “unnecessary alarm”
They have a higher than normal rupture rate – up to five per cent among French women – and have been linked to the death of a French woman from a rare form of cancer called anaplastic large cell lymphoma (ALCL), and implicated in at least seven other cancer cases.
In June, the US Food and Drug Administration (FDA) said women with breast implants may have a very small but increased risk of developing ALCL, with 34 cases of ALCL identified worldwide.
French authorities will cover the cost for women to have the implants taken out.
But UK regulators have insisted there is no link with cancer – no such cases have been reported here – and there is no need for women to have them removed.
Figures from the MHRA suggest 84,300 PIP implants have been sold in the UK since 2001, with 411 cases of failure including rupture since 2001.
Based on the assumption that each woman has two implants, at least 42,000 women in the UK could be affected, according to the MHRA.
In the UK, women are advised to contact their breast implant surgeon if they have concerns.
Douglas McGeorge, ex-president of British Association of Aesthetic Plastic Surgeons (BAAPS) said ‘There is no medical evidence that these implants need immediate replacement.
“The current guidelines are that individuals with PIP implants should go back to their treatment facility, where the integrity of the implants can be assessed and a regime for monitoring planned.
‘Clearly many patients may choose to have something done in advance of implant failure, knowing the problems associated with these implants.’
British lawyers claim the MHRA should have acted sooner and more decisively to protect women.
Mark Harvey, a partner at Hugh James solicitors, which is representing more than 250 women, said some of his clients had complained of inflammation, fatigue and fibromyalgia, a musculoskeletal pain disorder.
He said: ‘I do not believe that MHRA’s reaction to date has been satisfactory. I am and have been very critical of their role throughout the history of this product.’