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Monday 2 January 2012

Breast implants: Adviser calls for 'staged removal'


A defective silicone gel breast implant, which was removed from a patient and manufactured by French company Poly Implant Prothese Globally, it is thought more than 300,000 implants were sold by PIP in the last 12 years
A surgeon advising the government has called for a staged removal of faulty breast implants, following a health scare in France.
Tim Goodacre, part of a panel looking at products made by French company PIP, said the reported risk of rupture was "quite out of the ordinary."
The government said the failure rate was 1%, but a private clinic now believes it could be up to 7%.
"This is very much higher than anything we'd consider acceptable," he said.
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 extraordinary 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."
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 last year 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.
Chairman of the Commons health select committee Stephen Dorrell said the cost of removing implants 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."
Shadow health secretary Andy Burnham said the government needed to issue clear guidelines to calm the fears of those affected by the issue.
"Mixed messages from the Department [of Health] have not helped and families affected are looking for a stronger response from the government," he said.
"As a minimum, it must include these three basic points - first, that all medical records will be provided on request without delay and without charge. It is unacceptable that some women are being asked to wait or even pay an 'admin fee' to see their records.
"Second, 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.
"Third, that all women given PIP implants must be offered an urgent, free consultation with a doctor once the results of the urgent review are known to discuss options."
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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