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.

What are the risks?

  • The silicone inside the implants is not medical grade – but was intended for use in mattresses
  • Tests have not shown any increased risk of toxicity from this filler compared to normal implants
  • But mechanical testing has shown the implant covers have an increased risk of rupturing
  • The gel inside can be irritative, increasing the risk of inflammation reaction – making removal more difficult
  • There is no increased breast cancer risk
  • One case of a rare form of cancer called anaplastic large cell lymphoma (ALCL) was recently reported in France
  • French and US experts suggest there is a small but increased risk of this cancer for women with breast implants in general

    “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.

BBC

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