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Pressure mounting over implants

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A PIP breast implant Around 40,000 women in the UK have been fitted with PIP implants

The Health Secretary for England, Andrew Lansley, is facing calls for more decisive action to help women concerned about PIP breast implants.

The Independent Healthcare Advisory Services (IHAS) says women are more confused and anxious than ever.

Mr Lansley says private clinics that fitted implants have a "moral duty" to remove them.

But IHAS director Sally Taber says its members are "as much a victim of this fraud as the NHS and the patients".

In a statement on behalf of the trade body - which represents many of the companies involved - she said: "If there is any moral or ethical obligation outstanding it lies with the government's regulatory agency, the MHRA.

"But the overriding issue here is that it is in everyone's interest to work together to ensure that patients are treated with compassion."

Around 40,000 women in the UK have been fitted with PIP implants.

"Unclear"

On Wednesday the Harley Medical Group - which fitted 13,900 women with the implants between September 2001 and March 2010 - said it would not replace them free of charge.

Its chairman Mel Braham said the company didn't have the resources, surgeons or operating facilities necessary.

Mr Lansley said the NHS would pay to remove, but not replace, implants if a private clinic refused or no longer existed.

But speaking in the House of Commons, he said it was not fair for the taxpayer to foot the bill and that if the NHS was forced to remove an implant "the government would pursue private clinics to seek recovery of our costs".

Ms Taber said whilst the intention was to offer guidance, Mr Lansley had confused patients.

She said: "With the current government position remaining unclear, patients want to know the timeline for the further investigations into PIP implants by the MHRA."

She went on to complain that IHAS has been unable to meet officials to discuss a solution, something the Department of Health strongly denies.

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Welsh NHS to replace all implants

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Welsh health minister Lesley Griffiths said not replacing the PIP implants could put women at unnecessary risk

The Welsh government says it will pay to replace banned breast implants for women who were treated privately.

Last week they said NHS patients would have implants replaced, but private patients would only have them removed.

To have the operation, women must prove they sought redress from their private care provider and be resident and registered with a GP in Wales.

Health minister Lesley Griffiths said not replacing the PIP implants could put women at unnecessary risk.

The implants from French firm Poly Implant Prothese (PIP) were banned last year after they were found to contain a non-medical-grade silicone filler.

In December, French authorities recommended that 30,000 women have faulty breast implants removed as a precaution.

Last week the UK government reaffirmed its view that the implants, which 40,000 UK women have, did not require routine removal.

A spokesman for the Department of Health said it had been advised by the NHS medical director Sir Bruce Keogh's expert group.

"We do not recognise the advice that Wales has received," he said.

"Sir Bruce's expert group, which included some of the foremost experts in plastic surgery, made clear recommendations last week for patients in England, and concluded that there is no significant increased clinical risk in cases where implants are not replaced.

"We have been very clear about the standard of care we will offer to NHS patients, and our expectation that private sector providers should match this."

It is thought 95% of women had the operation privately, 5% on the NHS.

Around 2,000 women in Wales are estimated to have the implants.

Complication risk

Ms Griffiths announced last week that the NHS in Wales would remove PIP implants if there was a clinical need.

On Tuesday, she said: "We said then that we would replace implants which were put in by the NHS, and today we are going one step further by announcing we will also replace those which were put in privately.

"Removing the implants and not replacing them could result in unsightly scarring, loose skin, and potentially the accumulation of fluids, need for drainage, and risk of infection."

It is feared that putting women through two separate operations increases the risk of complications.

But Ms Griffiths stressed that NHS treatment would be a last resort for women who were treated privately.

"Safeguards will be put in place to hold the private sector to account and ensure that everything possible is done to seek redress from private providers before the NHS steps in," she said.

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'No evidence' to remove implants

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Breast implantThe implants were manufactured by the French company Poly Implant Prothese (PIP)

A government review into the rupture rate of banned PIP breast implants has, so far, found no evidence for removing them, according to the health secretary Andrew Lansley.

The review he ordered is due to report by the end of the week.

The implants caused a health scare after French authorities found a rupture rate of 5% and recommended implants were removed.

However, figures in the UK have suggested a much lower rate.

Mr Lansley told the BBC: "The overwhelming evidence continues to support the advice we've given women previously.

"It is not advisable for women to routinely have implants removed because the risk associated with an operation of that kind would outweigh the benefit of removing these implants."

Rupture rate unknown

The implants by the French firm Poly Implant Prothese (PIP) were banned in 2010 after they were found to contain industrial grade silicone gel, rather than medical grade and had an increased risk of rupturing.

However, data from the Medicines and Healthcare products Regulatory Agency (MHRA) suggested that the rupture rate was 1% - in line with other implants.

It led the chief medical officer for England, Prof Dame Sally Davies, to say before Christmas that: "We currently have no evidence to make us think they should have the PIP breast implants removed.

However, Mr Lansley ordered a review of rupture rates after conflicting data was submitted. Some reports suggested a rate of up to 7% in the UK.

The organisation which represents the majority of UK private breast implant clinics says the rupture rate of the banned PIP implants is not abnormally high.

The Independent Healthcare Advisory Services (IHAS) has submitted evidence to the investigation collected from thousands of patients with companies including Transform, The Harley Medical Group, Spire Healthcare, BMI Hospitals and The Hospital Group.

Its director Sally Taber said: "Following an audit of our members, which includes data on thousands of patients...we can confirm that the average rupture rates reported for PIP implants are within the industry standard of 1-2%."

About 40,000 British women have been fitted with the implants.

Never know

Tim Goodacre, president of the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS), said: "Even if the rate is 1-2% I am still concerned as that is higher than the normal rate."

Fazel Fatah, president of the British Association of Aesthetic Plastic Surgeons, said there were "many reasons for these figures not being reliable".

He said implants may have ruptured without the patient knowing or patients may have changed private clinicians or moved into NHS care if there was a problem.

"We do not know the exact rupture rate in the UK," he added.

The health secretary acknowledged that data from private companies had been "inconsistent" and was sometimes "inadequate" and of "poor quality".

This morning he held discussions with the chief medical officer, the Medicines and Healthcare products Regulatory Agency (MHRA) and Sir Bruce Keogh, the NHS medical director who is the review of the rupture rate data.

Prime Minister David Cameron's spokesman said: "We need to let Sir Bruce Keogh conduct the review before thinking about the next steps."

The full review group will meet tomorrow to discuss the preliminary findings. An announcement is expected by the end of the week.

Globally more than 300,000 implants are believed to have been sold to 65 countries by PIP over the last 12 years.

More than half of its exports went to South America.

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Surgeon urges removal of implants

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Tim Goodacre: "If it is 7% I would suggest there needs to be a programme set up... to begin to remove all intact implants"

A surgeon advising the government has called for the removal of all faulty breast implants, following a health scare in France.

Tim Goodacre, a member of a panel looking at products made by French firm PIP, said the reported risk of rupture was "quite out of the ordinary".

The government said the failure rate was 1%, but private clinic Transform believes it could be up to 7%.

"This is very much higher than anything we'd consider acceptable," he said.

Health Secretary Andrew Lansley ordered an inquiry - to which the panel will report - after private clinic Transform suggested the failure rate could be higher than previously thought.

He said that based on all available evidence, the government did not believe there was any cause for concern, but the Transform data needed assessment and evaluation.

Speaking on the BBC's The World at One, Mr Goodacre, who is president of the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS) said he did not think there was any risk of cancer as a result of the faulty implants, but he was still advising what he called removal on a "staged basis".

"If you believe a device is faulty in your car or any other object you buy you would want to have that replaced on a staged basis," he said.

"Good implants put in by reputable people have an extraordinarily low failure rate, so this is something quite out of the ordinary.

"These implants have been in for a while and there is no immediate cause for concern, there's no cancer risk, and even if implant gels have ruptured, there's no evidence to suggest that that in itself is of any major health detriment.

"But given the fact there is a degree of uncertainty and a lack of knowledge, we're recommending all implants come out."

Shadow health secretary Andy Burnham said that given the conflicting nature of the advice that was coming out, the government needed to issue clear guidelines to calm the fears of those affected by the issue.

"Where there is evidence of a rupture, private providers must arrange for urgent removal at no expense to the individual and with any costs to the NHS reimbursed," he said.

He also said all those affected must have access to their medical records as soon as possible, and they must be offered a free consultation with a doctor after the results of the government review were known.

Last week the French government recommended the precautionary removal of implants from 30,000 women, with the government covering the costs.

PIP went into administration in 2010 and its products are now banned, after it was discovered they had used non-medical-grade silicone believed to be made for mattresses, which had an increased likelihood of splitting.

'First responsibility'

Chief Medical Officer Professor Dame Sally Davies said she had written to GPs so they were aware of the views of patients who may want to discuss the matter with them.

"We currently have no evidence to make us think they should have the PIP breast implants removed," she continued.

"Because of this, and because removing these implants carries risk in itself, we are not advising routine removal of these implants."

Chairman of the Commons health select committee Stephen Dorrell said the cost of any possible implant removal should be recovered from those who had provided "sub-standard products" in the first place.

"The first responsibility here would rest on those who were engaged in care that hasn't met proper standards, so the first responsibility rests on them," he said.

"Having said that, clearly if there is a health issue involved then ultimately the NHS exists to provide health assurance for all patients in the UK."

PIP is believed to have sold over 300,000 implants in 65 countries over the last 12 years, with South America accounting for more than half the exports.

Western Europe was another major market, with Spain, Italy, Germany and Ukraine known to have imported the products, as well as the United Kingdom.

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