Breast implants danger: urgent probe ordered by government - Mirror.co.uk

PIP moulds abandoned (Pic:Reuters)

THE Government yesterday ordered an urgent inquiry into the risks of controversial French breast implants.

Confusion over rupture rates in British women has prompted Health Secretary Andrew Lansley to ask for a review of information provided by private clinics.

The cut-price implants, made by French company Poly Implant Prosthesis (PIP), have been fitted in around 40,000 British women. They contain low-grade silicone, made as mattress filler, and were never approved by health authorities.

Many women have complained of ­shooting pains, lumps and lethargy after the ­implants ruptured and leaked silicone into their bodies. The French Government last month recommended that, as a precaution, 30,000 women should have them removed. It has pledged to pay the estimated ­£60million bill.

However British women, who each paid between £2,500 and £6,000 for ­implants, were advised against having them removed after experts ­reported that rupture rates of one per cent here were much lower than the five per cent recorded in France.

But on Friday a large British provider of the implants put forward information suggesting that rupture rates could be much higher than previously thought.

Andrew Lansley

Mr Lansley said: "We have received data from an organisation that was not ­previously acknowledged or communicated to the Medicines and Healthcare products Regulatory Agency.

"The validity of this data still requires full evaluation, so I have asked Professor Sir Bruce Keogh to lead an urgent investigation so that we can establish whether we need to improve the regulatory regime. I want to reassure women that if any new data comes to light which calls into question the ­safety of these implants we will act swiftly to help them."

The MHRA, which advised against removing the implants, yesterday said there were "doubts" about the information it had received from cosmetic surgeons.

MHRA clinical director Dr Susanne Ludgate said: "It's clear there is conflicting data coming from the cosmetic surgery sector." Mark Harvey, a solicitor acting for more than 350 women who had PIP implants fitted in the UK, said the development added to fears that the health risks could be worse than first thought.

He added: "I've said all along that there was under reporting to the MHRA by some clinics of where their products were going wrong. I've spoken to very reputable surgeons who have said they would repair ­implants and just not bother doing the ­paperwork. Some of the clinics have shown a disgraceful attitude from the start."

Consultant plastic surgeon Nigel Mercer said last night: "I would urge women not to panic... but my personal view would be that they should all be removed. PIP implants contain material which has not been approved for humans so it should not be in the body."

The implants were originally approved for sale in Europe by German company TUV Rheinland, which is now suing PIP. When it discovered the irregularities in 2010 it cancelled the company's EU-wide licence, effectively banning the implants from sale.

Jean-Claude Mas

PIP's founder, multi-millionaire Jean-Claude Mas, 72, is facing criminal charges over a series of offences including ­manslaughter after the death of a woman with implants.

What patients need to know

How many British women have PIP implants?
Forty thousand Britons are thought to have had them in the past 10 years. PIP ­implants ­accounted for half of all ­implants at their peak.

What should women do if they believe they have had PIP implants?
Contact the clinic that did the ­operation as a record of the brand used should have been kept.

What are the main risks?
Rupture or leakage. The industrial silicone gel can be irritative, increasing the risk of inflammation. ­Women whose implants have ­ruptured have ­complained of pain, lumps and nausea. Rupture rates were ­believed to be lower in the UK than France (one per cent compared to five). New ­information has cast doubt on this hence the inquiry.

Is cancer a risk?
In France eight cases of cancer in women with the implants were reported – including five of breast cancer. But the country's National Cancer Institute said there was no evidence that women with the ­implants were more likely to develop cancer.

What is the latest ­Government advice?
Women with no ill-effects have been advised against removal as it involves ­major surgery. But that advice could change if evidence is found to back up claims of higher rupture rates.

Should women have them taken out?
Some private clinics are still resisting requests to ­remove PIP implants ­despite the British ­Association of ­Aesthetic Plastic Surgeons saying they have a "moral ­obligation" to do so.
Breast implants cost around £5,000 – even if clinics do the surgery at cost price the bill is still around £2,000. Implant company Nagor is offering free ­replacements for women whose PIP ­implants have ruptured, but surgery would still have to be paid for.

Can women sue?
PIP has gone into ­liquidation so boss Jean-Claude Mas and other directors cannot be pursued in court. Some UK law firms have launched group actions against private clinics.

We need more help

MUM-of-three Susan Cranley was one of the first British woman to have PIP implants – and has regretted it ever since.

She went under the knife in 2002, paying £3,500 to boost her chest from a 36B to a 36D. But a year later she started suffering severe health problems and found her implants were leaking. She forked out another £2,500 to have them removed.

The 55-year-old, from Liverpool, has since set up PIP Implant Support, representing 235 women affected by the problems.

Sue said: "The French women are getting lots of help now, but it feels like it will take a British woman to die from these faulty implants before we are listened to. Not enough is being done to help us. But we will keep fighting."