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PIP breast implants 'are up to six times as likely to rupture'; But they don't cause cancer, finds inquiry
Royal College of Surgeons say there should be mandatory databases on patient safety for all surgical implants and associated techniques
00:56 GMT, 19 June 2012
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, an inquiry has found.
But leading plastic surgeons said it would still be best for women to have the implants removed.
Lawyers said official acknowledgement that the implants are sub-standard clears the way for women to sue.
A panel of experts, led by NHS medical director Professor Sir Bruce Keogh, examined the safety of the French-made PIP implants.
A plastic surgeon displays a defective silicone gel breast implant manufactured by French company Poly Implant Prothese after he removed it from a patient
The investigation 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.
Up to 47,000 British women – most of whom were private patients – were fitted with the implants, which were fraudulently filled with an industrial-grade silicone designed for mattresses.
Professor Keogh, who led the team of surgeons, statisticians and ethicists who put together the report, said he hoped its conclusions would put patients’ minds at rest.
The report acknowledges that anxiety can be a real risk to a woman’s health and reiterates that the NHS will remove implants put in privately – but not replace them.
Professor Keogh said: ‘This 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.
‘Repeated tests on different batches
of PIP implants have been carried out in the UK, France and Australia
according to international standards.
‘Those tests have shown that the
implants are not toxic and therefore we do not believe they are a threat
to the long-term health of women who have PIP implants.
‘I sincerely hope this helps to reassure women that their long-term health is not at risk.’
Anger: PIP breast implant patients protested outside The Harley Medical Group after they refused to remove and replace them for free
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.
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.
Nigel Mercer, former president of the
British Association of Aesthetic Plastic Surgeons, said that although
the industrial filling does not kill cells, it can still pose problems –
with leaks triggering the formation of golf ball-sized lumps in the
Mr Mercer said: ‘Our position is that
these are sub-standard implants and should not be in the human body. If
a member of my family had them, I’d want them out.’
Mark Harvey, of Hugh James
Solicitors, said: ‘We 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.
‘We 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.’
Last month, a separate report revealed that surgeons had raised doubts over the safety of the implants as long ago as 2006.
But watchdogs failed to issue a warning, fearing that doing so would lead to an ‘unwarranted scare which could have serious commercial implications’.
The review, by Health Minister Lord Howe, found that existing regulation alone could not have prevented the scandal as it was down to ‘deliberate fraud’ by the manufacturers.