Revealed: true scale of breast implant scandal
By Laura Donnelly, Robert Mendick, Harriet Alexander and Josie Ensor
The evidence was supplied privately to the Department of Health (DoH) on Friday by Transform, Britain’s biggest cosmetic surgery chain, The Sunday Telegraph can disclose.
It prompted the Government to question the official figures supplied to the regulator by private cosmetic surgery companies.
Mr Lansley was “very concerned” and “unhappy” that firms had not given the regulator full information about the failure rate.
The review could lead to the Government advising women to have the implants removed at an estimated cost of as much as £150?million. The implants were manufactured by Poly Implants Protheses (PIP), a French company, from industrial-grade silicone rather than medical-grade.
Mr Lansley said yesterday that evidence from around the world did not suggest a need for women to worry, but promised that the Government would act swiftly as information emerges.
The rupture rate of seven per cent – if replicated across the industry – is seven times higher than the one per cent official figure the British regulator was sticking to last week in its attempt to reassure tens of thousands of women.
Health officials will want to know urgently if Transform’s rupture rate is a one-off or symptomatic of the whole industry.
Women with the implants, including those recovering from breast cancer, fear future ruptures causing pain and inflammation and the leakage of industrial silicone into their bodies. There is no long-term data that assesses the risks, including the incidence of cancer, caused by the cheap silicone.
A source at Transform said: “One of our surgeons is helping the DoH. He has taken our data with him and we believe – and it needs rechecking – that the rupture rate is actually higher at about seven per cent.”
The source said the figures had been supplied to the Medicines and Healthcare Products Regulatory Agency (MHRA) since 2006 and questioned why the regulator had not picked up on them sooner. Last month the MHRA declared there was “no evidence of any disproportionate rupture rates other than in France”.
In France, the official rupture rate is five per cent, and women who have the implants are being offered free removal.
Other cosmetic surgery providers in the UK have now been ordered to comb through their data.
Mr Lansley has asked Prof Sir Bruce Keogh, the NHS Medical Director, to review all data relating to PIP breast implants and any possible danger they pose.
The Health Secretary said last night: “We have received data from an organisation yesterday that was not previously acknowledged or communicated to the MHRA. The validity of this data still requires full assessment and evaluation, so I have asked [Prof Keogh] to lead an urgent investigation so that we can establish exactly what has happened and whether we need to improve the regulatory regime.” Mr Lansley is “very concerned about the content and quality of the data that cosmetic surgery providers are sharing with the regulator”, his spokesman said. The review is expected to report its initial findings this week, with a decision on how to proceed – including whether to give women free breast implant removal operations – likely to be made at a later date.
The regulatory system will also come under scrutiny. Dr Susanne Ludgate, the MHRA clinical director, said yesterday: “It’s clear there is conflicting data coming from the cosmetic surgery sector. It raises doubts about the surveillance and reporting of incidents by these companies. We will urgently work to identify where problems may be.”
British surgeons warned about the PIP implants five years ago.
Brook Berry, who led an NHS plastic surgery unit in the north-east of England, was so alarmed by the damage a PIP implant caused to a woman recovering from breast cancer that he wrote to the British Journal of Plastic Surgery in 2007 that “the reliability of PIP implants must be questioned and, for myself, I intend to discontinue their use in favour of implants from other manufacturers”.
Mark Harvey, a lawyer who is planning to bring a case against up to 20 clinics on behalf of at least 350 women later this month, said yesterday: “There has been significant under-reporting of problems with these implants. There does not appear to be any follow-up regime to check on whether cosmetic surgery companies have been reporting incidents fully.”
His clients are seeking damages of between £15,000 and £20,000.
Donna Breeden, 31, a hairdresser from Southampton, who is planning legal action, said: “It is a ticking time-bomb. Every day, I am worried sick.”
She paid Harley Medical Group £4,250 for a breast augmentation operation in February 2010, just a month before the PIP implants were withdrawn.
She said the firm has refused to listen to her demands for the implants to be removed and replaced at no extra charge.
Catherine Kydd, 39, a mother of two from Dartford in Kent, suffered a rupture in 2009. “It was absolute hell,” she said. “I now have industrial silicone in my body and I have no idea what the long-term effects are. I have to now live with this for the rest of my life.”
Andrew Hay, managing director of Cloverleaf Products Ltd, the British supplier of the implants, told The Sunday Telegraph that his firm had supplied between 6,000 and 7,000 implants to the NHS, which were mainly used for women recovering from cancer surgery.
While some women will have had two implants, others may have had only one – meaning that the number of women receiving the PIP implants on the NHS is likely to be greater than 3,000.
Mr Hay expressed his shock that the PIP implants had turned out to be made from industrial silicone.
On Friday, the DoH said it had no current plans to contact NHS patients.
Nigel Robertson, Transform’s chief executive, said his company would begin this week to contact women who have PIP implants.
His company used PIP as its main supplier up until 2005 when it switched to another firm, based in the US, for “commercial reasons”.
Mr Robertson said the cosmetic industry could not afford to pay for the replacement of faulty implants. He estimated that the cost of such an operation is in the region of £3,000. This means the total cost to the industry would be £120?million, putting many clinics out of business.
Mr Robertson said greater regulation of the industry was needed.
The PIP implants were taken off the market in March 2010. Jean-Claude Mas, the company’s founder, is facing fraud charges and a manslaughter charge brought by the family of a woman who died of cancer in France. Studies so far have found no link between the implants and cancer.
Mr Lansley said yesterday that evidence from around the world did not suggest a need for women to worry, but promised that the Government would act swiftly as information emerged.