- Royal College of Surgeons say there should be mandatory databases on patient safety for all surgical implants and associated techniquesÂ
By Claire Bates and Fiona Macrae
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The faulty breast implants at the centre of a health scare are up to six times as likely to rupture as other brands - but do not cause cancer.
The ruling, by a panel of experts investigating the safety of the Frech-made PIP implants, was revealed today.
Their analysis revealed that although the devices could cause irritation, there was no evidence that the gel inside was toxic or were carciogenic.
Lawyers said official acknowledgement that the implants are sub-standard clears the way for women to sue.
A plastic surgeon displays a defective silicone gel breast implant manufactured by French company Poly Implant Prothese after he removed it from a patient
Up to 47,000 British women, most of whom were private patients, were fitted with the controversial implants which were fraudulently filled with an industrial-grade silicone.
The investigation, led by the NHSâs medical director, included specially-commissioned tests on toxicity.
It found that although the implants are between two and six times as likely to perish or break open than other brands, their contents do not pose any long-term threat to health.
The report found PIP implants had between six and 12 per cent chance of rupturing after five years rising to 30 per cent after 10 years.
Professor Sir Bruce Keogh, led the surgeons, statisticians and ethicists who put together the report. It was based on data from 240,000 implants of differing brands that had been given to 130,000 women in England.
Professor Keogh said he hoped its conclusions would put patientsâ minds at rest. It acknowledges that simple anxiety can be a real risk to a womanâs health - and reiterates the advice that the health service will remove implants put in privately but not replace them.
Professor Keogh said: âThis has been an incredibly worrying time for women. We have been determined to look thoroughly at all available evidence so we are able to give them the best clinical advice possible.
âRepeated tests on different batches of PIP implants have been carried out in the UK, France and Australia according to international standards.
âThose tests have shown that the implants are not toxic and ther efore we do not believe they are a threat to the long-term health of women who have PIP implants.
âI sincerely hope this helps to reassure women that their long- term health is not at risk.â
However, the British Association of Aesthetic Plastic Surgeons said that women should still have them out.
Nigel Mercer, the associationâs past president, said that although while industrial filling does not kill cells, it can still pose problems, with leaks triggering the formation of golf ball-sized lumps in the arm pits.
Mr Mercer said: âOur position is that these are sub-standard implants and should not be in the human body.
âIf a member of my family had them, Iâd want them out.â
Lawyers said official acknowledgement that the implants are sub-standard clears the way for women to sue.
Mark Harvey, a partner at Hugh James Solicitors in Cardiff, said: âWe again call on the private implanting clinics to take responsibility for this scandal and remove and replace free of charge all the PIP breast implants that they have fitted.
âWe would also now expect the clinics to agree to compensate our clients without further argument as to whether these products are not fit for purpose or of satisfactory quality.â
Anger: PIP breast implant patients protested outside The Harley Medical Group after they refused to remove and replace them for free
In January the Government announced that anxious women given PIP breast implants on the NHS would be able to have them removed free of charge, with private firms expected to offer the same deal.
However, it said any woman refused help by a private company would be able to visit their GP and access NHS care.
THE BOSS BEHIND THE SCANDAL
PIP boss Jean-Claude Mas, 72, is currently in prison awaiting trial after failing to pay all of his bail money. He faces charges of causing 'involuntary injuries and 'causing bodily harm.'
The former travelling salesman who started out selling meat and wine, founded PIP in 1991 to take advantage of the booming market for cheap cosmetic implants.
Using a substandard gel enabled him to save the company about £1million a year and still increase sales.
He insists that there was nothing wrong with the cut-price implants which, at the height of his career as a medical supplies businessman, made him a millionaire many times over.
He has also accused women who are trying to sue him of doing so solely 'for the money'.
Mas has since claimed that all the money has gone, although investigators believe that much of his fortune was simply passed on to Dominique Lucciardi, his former girlfriend, and their two grown-up children.
The latest data from the Department of Health shows that almost 750 women are to have the implants removed on the NHS - 490 of whom had their PIP implants put in at private clinics.
The report called for surgeons and clinics that have used PIP implants to contact their patients and share the latest information with them.
Professor Norman Williams, president of The Royal College of Surgeons, said: 'The PIP breast implant issue brought into sharp focus the need for better regulation and surveillance for all surgical implants.
'With the publication of the final report by the expert group, it is time to look to the future to ensure no patient experiences unnecessary harm or distress from substandard surgical implants.
'It is the view of the College that we should, as a minimum, have mandatory databases for all surgical implants and associated techniques which would provide ongoing patient safety data.
'New surgical devices, and the techniques required to implant them, must be regulated so that they can be safely introduced into our healthcare system, disseminated appropriately and monitored in the long term.'
Last month a separate report revealed that raised official over the safety of PIP breast implants as long ago as 2006.
However, watchdogs failed to issue a warning, fearing that to do so would lead to an âunwarranted scare which could have serious commercial implications.â
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Camilla's Mum, Plummers Plain UK, 18/06/2012 12:38 What a horrible, sour and bitter women you are. How dare you judge people you don't even know and call them vein for having implants..... You have no idea what their stories are or why they decided to have them. Personally they are not something I'd have done, but I do not judge those who have them- each to their own. Nobody's perfect and that includes you.
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celestina, 20:43. Yet another ignorant, ill informed person making comments on this site. If the materials are safe for human use then there is no problem restoring your figure with breast implants. It isn't hurting anyone else and how can it be vain if you are restoring your body back to the size and shape it was before the atrophy or removal of your breasts? You obviously have a problem.
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I fully understand the ones who make their living out of their breasts -playboy bunnies etc-, nonetheless the rest of them -who haven't suffered from a terminal illness touch wood- are basically vain, superficial human beings who go through the procedure in order to attract men. It's their prerogative, however I won't feel sorry when it's self-inflicted.
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Yet again: there is NO responsible data linking breast implants with cancer, or auto-immune diseases--women must unfortunately find other causes to blame. Read your research--not anecdotal wails but well-developed research from responsible, respectable institutions.
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katieconker, 20:14. katie, a great deal of women do lose their breasts, but not to mastectomy due to cancer but to breastfeeding. I have lost both my breasts to breastfeeding and it has devastated me. I have lost my female identity and it is depressing. There is nothing left. Nothing at all. It is not necessary for women who have had mastectomies to have reconstructive surgery and have silicon implants put in. They could just have the wound sewn up with no implants put in. They choose to have implants put in to preserve their female identity and restore their confidence. Women who have lost their breasts to breast feeding pay for the surgery to to their original pre pregnancy size. If the materials are safe and good quality I don't see what is wrong with that. It's interesting to note that men often have fake testicles put in, made of silicon, when they have an undescended testicle or have had to have it removed , yet nobody seems to judge them for doi ng it.
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Apart from having them fitted if you have lost a breast, why on earth would you want something like that inserted into your body? Even a gold earring can affect some people and anything that is liable to leak or rupture would frighten the life out of me.
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My view, 18:54. I think you are missing the point, completely. These implants were being produced with a licence from the French authorities and had a CE mark. They were safe when the factory first started making them, in the ninties They had a cross meshed double shell, which prevented the gel leaking through into the body and the gel was made of MEDICAL GRADE silicon. Now, fast forward to 2003 or so and a very different scenario is going on. The man who owned the factory ordered the workers to make the implants with cheaper, non medical grade silicon, and to remove one of the two outer shells. This went directly against European rules on the standard for medical prosthetics. After the company been given the go ahead to produce the implants with the CE mark the company SHOULD NOT have changed the formula. The company changed the formula and didn't tell the authorities. Why did they change the formula? GREED. Buy American implants. Medical grade and sa fe.
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Lots of substances that are 'classed' NOT poisonous will make a person seriously ill if left inside the body! Don't play with words. The government gave the green light for these PIP products and will down play it's bad decision as much as possible. The plastic surgerys have dealt with this appallingly and hide their responsibility to their clients behind the governments bad decision. They both need to ask who is in danger, who trusted them and is paying the price, who is being exploited? It is about time these cosmetic surgerys paid out they've had it good for too long!
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You have 4?!!! I have these pip implants,I paid 4 through hard work.I wouldn't ask the taxpayer -which I am one of by the way!!! to foot the bill for removing or replacing them as I believe it's the clinic were I had them done that should compensate me. - alf, liverpool, 18/6/2012 16:04
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I can tell you for sure these implants DO make you ill sooner or later. I know because I'm only 36 and have a whole myriad of health issues relating to the on-set of implantation. I had them removed over a year ago I'm still very poorly so whoever conducted this study obviously didn't consult with women like me there are thousands of them. We can't all be wrong!
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