6 Jan 2012

‘No need for removal of breast implants’

As the government announces that women with PIP breast implants do not need to have them removed, two people tell Channel 4 News they want theirs replaced but cannot afford to pay.

Around 40,000 British women have implants manufactured by the now-defunct French company Poly Implant Prostheses (PIP).

Health Secretary Andrew Lansley ordered an inquiry at the end of 2011 because of concerns about the implants rupturing.

The government said on Friday the review had concluded there was no evidence to recommend the routine removal of implants, but the 5 per cent of women who had had their operations on the NHS and were worried would be able to have them replaced at the taxpayer’s expense.

In its advice also issued on Friday, the German government followed France and advised all women with PIP implants to have theirs removed.

Private sector

The inquiry team said it expected private firms to offer the same deal to women who were anxious and also wanted their implants taken out.

Professor Bruce Keogh told Channel 4 News that all women with PIP implants would be contacted by the NHS and would receive specialist consultation to help advise them on whether to have their implants removed. “That sets the gold standard for the duty of care that women can expect,” he said. “The committee that I chair also wishes to throw out that standard to the private sector to meet that duty of care.”

The inquiry team added that private providers have legal obligations to their patients. “The NHS will offer a package of care for its patients, and we expect the private sector to do the same,” the team said.

The NHS will offer a package of care for its patients, and we expect the private sector to do the same. PIP inquiry team

The review concluded that women with PIP implants were not at greater risk of harm than those with other implants. But experts decided that anxiety was a form of health risk and recognised that many women would be worried.

If a private clinic has now closed and a former client wants her implants removed, the NHS will foot the bill if she is entitled to NHS care, but it will not pay for replacements.

‘Moral duty’

Mr Lansley said: “Our advice remains the same, that there is not sufficient evidence to recommend routine removal.”

He said the private sector had a “moral duty” to remove implants.

In France, where 5 per cent of implants are believed to have ruptured, the government has told women they should have them removed after they were found to contain non-medical grade silicone intended for use in mattresses.

In Britain, the Medicines and Healthcare products Regulatory Agency has said its figures indicate only 1 per cent of implants have ruptured. But the Transform cosmetic surgery group has reported a rupture rate of 7 per cent. The review was unable to establish if the rupture rate was higher for PIP implants than for others, but concluded there was no cancer risk.

PIP’s former boss, Jean-Claude Mas, has sparked controversy by reportedly telling French police that women who had received implants were “only complaining in order to receive money”.

Two women’s stories

Rowena Mackintosh, 30, from West Moores, near Poole in Dorset, paid £4,200 for implants at a private hospital in 2009 to “boost” her confidence after the birth of her second child.

“They were fine initially, they settled down quite nicely and I was happy with them,” she told Channel 4 News.

Eight months later, Ms Mackintosh began to suffer from “weird” stabbing pains in her left breast and after talking to her mother, discovered her implants were made by PIP.

“I did some research on the internet. Everyone said the same thing, that they were rubbish and had a high rupture rate.”

The rupture rate is so high, the chances are that they’re going to rupture at any moment. Rowena Mackintosh

She was told she could not have a scan on the NHS to find out if they had ruptured because she had been to a private clinic for her operation, so she contacted the surgeon responsible for the implants.

He examined them and reached the conclusion that they had not ruptured, but said she needed an NHS scan to be sure. She was given an ultrasound scan to test for cancer.

“It came back clear, but I was told they wouldn’t test for silicone leakage,” she said.

Read more: Government orders review of breast implant risks


Now Ms Mackintosh, who owns a beauty salon, wants her surgeon to remove and replace her implants free of charge.

“Personally, I would like the clinic to take responsibility for the fact that they bought these implants for a very low price, and since 2005, according to the literature I can find, there has been something dodgy going on and they neglected to mention this to me at my consultation.

“Ideally, I would like my own surgeon to replace them because I trust him and he took time out of his day to see me when he didn’t have to. I feel quite safe with him.”

I want them out and replaced, but I don’t know what lines to go through. Leanne Lavelle

Ms Mackintosh is worried her implants will rupture: “The rupture rate is so high, the chances are that they’re going to rupture at any moment.”

She cannot afford to pay for another £4,000 operation.

She said: “If there are no health risks then the clinic should be sorting it out. But if there are health problems, I’d expect the NHS to be there for me.”

Leanne Lavelle, 27, from Fazakerley, Liverpool, paid more than £4,000 for PIP implants in 2006 because she felt “self-conscious”, but now wants them removed. The company she used has gone into liquidation and she is trying to track down the surgeon who carried out the operation.

She is not in pain and her implants have not ruptured, but they ache.

“It’s like a wave effect in the skin,” she told Channel 4 News. “You can feel a ripple all the time and you can see it. I want them out and replaced, but I don’t know what lines to go through.”

Ms Lavelle cannot afford to pay for another operation, and does not care how it is funded – on the NHS or privately – as long as her implants are replaced.

“I haven’t got another £4,000 to correct somebody else’s problem. I couldn’t care less who deals with the problem.”

Rules and regulations
The new head of Europe's drugs watchdog said on Friday there should be tighter regulation of medical devices, including implants. Guido Rasi, executive director of the London-based European Medicines Agency, told Reuters: "I see an urgent need to regulate devices at the same level of science and attention as with drugs."

At present, unlike presciption medicines, devices only need a simple quality certificate before being sold to the public. But Mr Rasi said overhauling the current regulations could take time. "There is resistance from sectors of the industry and resistance from some national authorities, so I don't expect anything fast, but we need something for public health protection," he said.