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The Chron looks at the impact the PIP implant debate is having on professionals and patients

Published on Tuesday 10 January 2012 08:26

COSMETIC surgery has always been a controversial subject but the industry has arguably never before faced a scandal as great as the recent debate over PIP breast implants.

The story began in France when it was discovered the French company Poly Implant Prosthese had manufactured its implants using industrial grade silicone.

The revelation sparked panic among thousands of women throughout Europe, prompting the British Government’s announcement last week that women who have had PIP implants should be able to have them removed for free.

On Friday, Health Secretary Andrew Lansley said the Government would pay for all women who had received the implants on the NHS to have them replaced if they were worried, and advised that private cosmetic surgery firms had a “moral duty” to do the same.

Meanwhile, the NHS will also support the removal, but not replacement, of private PIP implants in cases where a doctor has agreed there is a clinical need.

Many women in Northamptonshire and elsewhere are now faced with an uncomfortable wait to find out whether private clinics will agree to replace PIP implants at no cost. The PIP furore has led to widespread debate within the public and the industry itself over how far people’s confidence in the safety and regulation of cosmetic surgery will have been tarnished by this controversy.

The Patients

Eileen Newitt

It was during the 1960s when Blisworth resident Eileen Newitt underwent surgery to have lumps removed from her breasts.

Although it was found that these lumps were not cancerous, the operation left Mrs Newitt requiring cosmetic implants to restore the appearance of her breasts.

These implants were not PIP but the scandal which has been gracing newspaper headlines in recent weeks certainly sparked unpleasant memories as, since her operation in 1985, her implants have ruptured twice.

The first rupture, in 1993, resulted in a court case for compensation in which she was awarded $50,000 in compensation from an American company, losing all but $850 to legal fees.

She also underwent another operation to have this implant replaced.

She said: “I did not appeal as I did not have the finances or the legal know-how to do it. When the call came to say they had been granted the permission (to take legal fees from the compensation) there was nothing left.”

Her doctors have advised her that no urgent action needs to be taken about her most recent rupture, which was discovered 11 years after the first, in 2004.

But the recent story about PIP has left her worried.

She said: “The consultant at the hospital said I need not do anything as it would not harm me. I have spoken to my GP and he also assured me there was nothing to worry about as the substance they are made of is inert. I accepted this as I suffer no effects from it but since the report about PIP implants I can’t help but think about it.”

The 64-year-old said she would like to see more research and regulation into the manufacture of breast implants.

She said: “If they were more solid there would be nothing to leak.

“It is no different to having a new hip or knee, which are put into people’s bodies all the time, but with these sorts of things if they can rupture they really need to be looked at.”

Alison

For months now, breast implant patient Alison has been suffering from pins and needles and numbness in one arm.

This week, according to Alison, her GP confirmed suspicions that one of the PIP implants placed inside her during 2008 by a clinic in London had ruptured.

Alison, aged 46, who lives in South Northamptonshire and did not want to reveal her surname, said she had telephoned the clinic but, at the time when she spoke to the Chron yesterday, had been unable to get through. She believes she now faces an operation to have the implants taken out through the NHS, but is unsure how or when she will be able to have them replaced.

Regarding a replacement operation, Alison said: “I think they are not going to do it but I want to hear what the clinic has to say. I would like them to do the whole thing free of charge because I paid £4,500 and everyone should have a guarantee.

“I think the Government could have done better in making the clinics do something, they say they have a moral duty so it’s like saying ‘if you want to do something you can.’ In my situation I can’t afford to wait months and months, I have to do what the doctors say, get them taken out and be disfigured.”

She said: “So many people think you have implants to be like a glamour girl. For myself, I had been bullied all my life for being flat chested and I felt I had to have this operation. It makes me really angry that even women think you are a tart or a glamour girl because you have had them done.”

Louise

Among the PIP implant patients waiting to find out what the next step will be is 25-year-old Northampton mum Louise.

Louise, who did not want her surname revealed, had implants put in through the same clinic in London, to help repair the effects to her body which had happened following the birth of her child.

She said; “Before I had the surgery I did think about the complications that can happen but when you have paid for something in a situation like this, where do you turn, who do you speak to?

“If I have to have them taken out, will I have to pay to have them replaced? I had them done for a reason.”

She continued: “If they are going to be taken out, I think someone somewhere along the line is going to need to replace them.”

THE surgeons

Adrian Richards

Despite the fact the Aurora Clinics, based in Northampton, have never used PIP implants, the clinics’ phones have been busy taking calls from worried women.

Surgical director Adrian Richards has been offering free advice to callers who are unsure of the next step to take. He believes that if all clinics kept to a compulsory registration system, recording and monitoring the types of implants patients have, it would be easier to identify the suppliers with higher rupture rates.

The idea is that, if a problem emerges with one particular implant, women anywhere in the country who have received it could be contacted straight away through a central registration system.

He said: “I have never done these (PIP implants) but the impact is that we have become fairly busy. There are 30-40,000 women in the UK who have had implants and a lot of women don’t know if they have them. I have been arguing for years that I would like a registration system.”

He continued: “A lot of women don’t know what type of implants they have had, some women know they have got PIP implants and some women think they may have them but there is no way of scanning to see what implants they have, you have to see by physically looking at the implants.”

He added: “It should be more like America where they only allow two or three types of implants, it is very strict. Surgeons will tend to use the best products but the bigger companies are all about profit.”

Nitin Vaingankar (pictured)

As a consultant plastic surgeon who carries out work privately, and for NHS patients at Northampton General Hospital, Nitin Vaingankar has never used PIP implants.

His work at NGH involves putting breast implants into certain patients who have had medical conditions such as cancer, although a very small number of purely cosmetic procedures can also be carried out on the NHS, for example in cases where breasts are seriously underdeveloped.

He said the hospital has been busily taking calls from anxious women who are unsure about whether or not they have had PIP implants.

He commented: “The reporting of the story about PIP has caused a lot of anxiety in patients who have had breast implants, but if they know they have not had PIP implants they don’t need to be worried at all.”

He added: “There has been some concern that PIP implants haven’t been made using medical grade silicone and that is the problem. But patients who have had the implants shouldn’t panic, they should contact their surgeon or clinic to confirm what make implants they have had and for further advice and management.”

Mr Vaingankar said: “It would be untrue to say implants don’t rupture at all, silicone can rupture but it is usually a long term process and doesn’t normally cause any health problems to the patient. Our five year data for the implants we use show a zero per cent rupture rate, I have done no repairs on patients with these implants in. The implants manufactured in his country are manufactured to a high standard.”

Statement from London based medical clinic

“The advice from the Department of Health continues to be that there is not sufficient evidence to recommend routine implant removal and women who are concerned should speak to their GP. The Department of Health’s expert review has not established if the rupture rate is higher for PIP implants than for other implants. It has also confirmed that there is no evidence of any cancer risk from the materials used.

“PIP implants were licensed in the UK by the MHRA, an agency of the Department of Health, for use in the UK. As a result, the NHS, private clinics, private hospitals and private surgeons used these implants in cosmetic and reconstructive surgery.

“Today, some media have quoted inaccurate numbers of operations carried out by our group involving PIP implants. We have been auditing our rupture records for many years now and have not found, to date, cause for concern.”

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