No need for breast implant removal, says Government

 

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The Government said it would not follow France's lead after French authorities advised all women with breast implants that sparked health concerns to have them removed.

French health minister Xavier Bertrand said that although the implants made by French company Poly Implant Prostheses (PIP) were not linked to cancer there remained a risk they could rupture and leak silicone gel.

He recommended that the 30,000 or so women who have them should get them taken out "as a preventive measure not of an urgent nature".

The French state also said it would foot the bill for the removals.

But the Department of Health said it was not echoing the French advice as there was no evidence to support it.

Chief medical officer Dame Sally Davies said: "Women with PIP implants should not be unduly worried. We have no evidence of a link to cancer or an increased risk of rupture.

"If women are concerned, they should speak to their surgeon. I will be writing to GPs so that they are aware of the concerns women may have and can talk them through with their patients.

"While we respect the French government's decision, no other country is taking similar steps because we currently have no evidence to support it.

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

Health experts will continue to examine any further evidence from France and across the world on the issue and the Government will keep the situation under close review, she added.

The Medicines and Healthcare products Regulatory Agency (MHRA) pointed out that there was no evidence of any disproportionate rupture rates other than in France.

A spokesman said: "We therefore do not believe that the associated risks of surgery from breast implant removal can be justified without further evidence.

"We will continue liaising with the French medicines and medical devices regulator and we are awaiting the evidence to support the decision made in France.

"This will be evaluated as a matter of priority by our clinical and toxicological experts and we will issue further advice if necessary.

"In the absence of strong clear evidence to the contrary, we see no reason to alter our current advice that there is no need to routinely remove these PIP breast implants."

Tens of thousands of women in France, Britain, Italy, Spain, Portugal and other countries in Europe and South America have had implants made by PIP, which has now closed.

The implants are filled with an unapproved non-medical grade silicone believed to be made for mattresses and there have been reports that the protective barriers are faulty.

More than 270 women in the UK intend to sue the clinics where they underwent surgery to be fitted with them.

Lawyers acting for them welcomed the recommendation by the French authorities and said they thought the women should have the implants removed.

Mark Harvey, a partner at Hugh James solicitors, which is representing more than 250 women, said some of his clients had complained of inflammation, fatigue and fibromyalgia, a musculoskeletal pain disorder.

Speaking after the Government said it did not recommend removal, he said: "I'm worried that what people are losing sight of is that what's in there is a product which we now know can rupture.

"We now know that the silicon in there isn't what we would call healthy silicon. This was an industrial silicon that has irritant properties.

"We know the harm that these products do and that's why they should be removed."

He criticised the way the situation had been handled as it had caused panic and suggested the Government should order clinics to remove and replace theimplants at their cost and not the taxpayer's.

"A number of the clinics went into liquidation when this blew up and aren't around so in that respect the Government will have to step in, but the reality is there's still a large number of clinics out there that are still trading and they're saying if you want the implants removed and replaced you'll have to pay for them all over again."

Another lawyer, Kevin Timms from Garden House Solicitors, has lodged a group action with the High Court and expects a hearing may be held by summer next year.

The action involves 27 complainants and 13 defendants who are the clinics where patients had their surgery.

Mr Timms said: "I think it's good for women to have them out to ease the concerns they have. Though there might not be any cancer there are still inherent problems with the implants. To say there's no health risk is not accurate.

Figures from the MHRA suggest 84,300 PIP implants have been sold in the UK since 2001.

Based on the assumption that each woman has two implants, at least 42,000 women in the UK could be affected, according to the regulator.

But the figure could be higher because women undergoing breast reconstructive surgery following cancer may only have had one implant.

PA

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