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”
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.
Junior Health Minister Nora Berra said the French government was recommending removal of the implants made from a suspect silicone gel as a precautionary measure. It came following complaints about abnormal rupture rates.
A British health chief said the French decision to remove the implants had caused “unnecessary alarm”
However, the Department of Health in the UK claimed the French move has caused ‘unnecessary alarm’ and there is no need for the implants to be routinely replaced. 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.
Implants which have ruptured should be removed, but experts say other women may face unnecessary complications from procedures to explant – take out – the implants.
French Junior minister for Health Nora Berra: She said the government were recommending the remove of implants made from a suspect silicone gel
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.’
Minister Berra admitted this morning that there was no conclusive evidence of a link between the sub-standard silicone and cancer.
She said those who did not want to have the implants removed could go for six-monthly checkups to make sure they weren”t on the verge of rupturing.
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.
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 are believed to be considering reimbursing the 30,000 women who had the implants for the expense of taking them 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.’