Around 7,000 more women than previously thought have been fitted with the banned PIP breast implants, says the government.
French authorities had advised that only PIP implants used after 2001 held the unauthorised non-medical grade silicone, normally used in mattresses, that has been linked to rupture and swelling in the body.
But following an investigation by the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), French authorities said that pre-2001 implants may also be affected.
Earlier investigations into the safety of Poly Implant Prothese (PIP) looked only at those fitted after 2001. now that 7,000 more women who had them fitted before then may be at risk, the number of UK women now affected has risen to 47,000 .
It now looks as though the time bomb has completely exploded – I don’t think we will definitely have caught all the women. Nigel Mercer, British Association of Aesthetic Plastic Surgeons
The UK government has held back from advising women to have implants removed. But in January, the government said women who had implants fitted on the NHS could have theirs removed for free, and said private firms should be expected to do the same.
The vast majority of operations involving PIP implants were carried out in private clinics, including those run by Transform and the Harley Medical Group.
Health Secretary Andrew Lansley confirmed that more women may be affected by the “criminal activity” of the implant manufacturer PIP.
“These women are the victims of a fraudulent company and I know this situation is causing a huge amount of anxiety. I want to reassure those affected by the news today that they will be provided with all the help they need from the NHS,” he said.
“We are still working to get private clinics to live up to their responsibilities and look after their patients.”
PIP implants – the private sector
– 4,534 patients who had PIP implants fitted privately, have been referred to the NHS
– 2,170 of these patients have had scans
– 224 patients decided to have their implants removed
– 51 operations have been performed to date
PIP implants – on the NHS
– 725 NHS patients have been contacted about their PIP implants
– 98 of these women have opted to remove their implants
– 34 scans have been completed
– 12 have had their removed
Following the news, the Dutch Health Ministry on Thursday issued an official warning to thousands of women who had PIP implants made before 2001, to have them removed to avoid the risk of leaking silicone – extending its previous warning, which applied only to post-2001 patients.
In recent weeks, Dutch authorities had asked France to confirm when PIP implants were sold in Europe.
In a letter to several European countries, dated March 12, the French authorities said that the PIP implants were sold in Europe before 2001, according to Reuters.
Reuters also said that PIP silicone implants were banned in France between 1995 and 2001 due to health concerns, but were still manufactured and exported by PIP to other European countries.
In France, 1,262 of the some 300,000 breast implants sold in the 1990s have split open. PIP’s former owner, Jean-Claude Mas, is in prison after failing to pay for bail, and is awaiting a criminal hearing.
Nigel Mercer, from the British Association of Aesthetic Plastic Surgeons (BAAPS), said the UK may never know the extent of how many women had PIP implants fitted.
“It now looks as though the time bomb has completely exploded – I don’t think we will definitely have caught all the women,” he said.
“We know of some patients who do not know what implants they have got in and they have been unable to find out. Either the clinic has gone bust or the women were not told at the time of the original operation what was being put in.”
Chief medical officer Professor Dame Sally Davies repeated the government’s advice, based on MHRA research.
“The expert group advises that there is no evidence to suggest that every woman with a PIP implant should have them removed. But we know this is a worrying time for them and want them to be able to see a GP or specialist to get reassurance and have them removed if necessary,” she said.
“We will be placing adverts in the weekend papers again to inform all women with PIP implants about the advice from the experts and how they can get help if they are concerned.
“I have also written to GPs today to remind them that we want them to help women with PIP implants.”