PIP Implants Scandal: Surgery Firm Defends Rupture Rate

Pip Implants Scandal

First Posted: 08/01/12 20:01 GMT Updated: 08/01/12 20:01 GMT   PA

A leading cosmetic surgery company which carried out a large proportion of PIP implant operations on British women insisted today that its "rupture record" left them with no cause for concern.

The Harley Medical Group said it had conducted 13,900 procedures with the implants in the UK between September 2001 and March 2010.

Since starting to collect rupture data in September 2004, it had recorded 213 ruptures by November last year, resulting in an aggregate rupture rate of 1.8%.

"This is well within available measurements," the company said.

While experts have concluded there is no evidence to recommend routine removal of the implants, they have said they could not entirely rule out that some were toxic.

More than 40,000 women in the UK received the implants, manufactured by now-closed French company Poly Implant Prostheses (PIP), which were filled with non-medical grade silicone intended for use in mattresses.

On Friday the Government said those patients who had their implants on the NHS as part of breast reconstruction surgery - believed to be around 5% of the total - will be able to have them removed and replaced if they are concerned.

This has led to a number of private health companies also pledging to remove them free of charge if they received the implants from them.

BMI Healthcare said it will remove and replace them for free, while Nuffield said it would cover the cost of taking them out providing it was safe to do so.

Ramsay Health Care, which has around 150 patients with PIP implants, said it was offering concerned women the chance to be examined and if there is a rupture or clinical need they would be removed and replaced free of charge.

Cosmetic surgery group Transform said its surgeons would be available to any concerned patients "to discuss the available options and offer appropriate counselling and guidance".

Meanwhile surgeons from Glasgow-based Confidence Cosmetic Surgery said they would reduce their normal costs for breast surgery by up to 60% for patients concerned about the PIP implants.

However many other private companies have not yet commented on whether they will waive or reduce their fees.

The Government has said it intends to pursue clinics where women paid for their implants privately to offer their removal for free to avoid the taxpayer picking up the bill.

Personal injury firm Thompsons Solicitors said that companies who offered the PIP implants could have a duty to pay compensation to those affected under consumer protection legislation.

The Sale of Goods Act 1979 offers consumers a series of legal rights, one of which is that with the sale of goods the item must be of satisfactory quality.

It is launching a free advice line to anyone worried about PIP implants, which from tomorrow morning will give people access to free legal advice and assistance with taking forward any compensation claims.

If the private clinic that provided PIP implants has closed down, the NHS has said it will pay for removing the implants if the patient is entitled to NHS care. But it will not pay for replacements in these patients.

A spokesman for the Department of Health said: "Private providers have legal obligations to their patients. The NHS will offer a package of care for its patients, and we expect the private sector to do the same."

The expert group behind the review concluded there is no link between the implants and cancer, as reported in one French case.

But it said it was "undeniably the case" that the implants are made up of non-medical grade silicone and should not have been implanted in women in the first place.

The expert group was unable to establish if the rupture rate is higher for PIP implants than for others. But it could not be confident that PIP did not change the silicone in the implants, so could not rule out the possibility that some are toxic.

Health Secretary Andrew Lansley said his main concern has been for the safety of women who have had PIP implants.

"It has been a worrying time for these women," he said. "We have at every stage sought to offer them as much advice and evidence as is available to us.

"Our advice remains the same, that there is not sufficient evidence to recommend routine removal.

"The NHS will support removal of PIP implants if, after this consultation, the patient still has concerns and with her doctor she decides that it is right to do so.

"We believe that private healthcare providers have a moral duty to offer the same service to their patients that we will offer to NHS patients - free information, consultations, scans and removal if necessary."

Mr Lansley said data from the industry has not been good enough to enable them to give a clear recommendation on the risk posed by PIP implants.

"We will therefore support women, including removal of the implant, if needed."

In France, the government has told 30,000 women they should have the implants removed while the Czech and German authorities have recommended that women should also have them taken out.

The boss of PIP has reportedly told police the victims are money-grabbers and he had "nothing to say" to them.

In the UK, the expert group will now examine wider issues around quality of data, surveillance and regulation of the cosmetic surgery sector.

The Care Quality Commission is also reviewing whether clinics comply with registration requirements and is considering fuller inspections.

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A leading cosmetic surgery company which carried out a large proportion of PIP implant operations on British women insisted today that its "rupture record" left them with no cause for concern. The ...
A leading cosmetic surgery company which carried out a large proportion of PIP implant operations on British women insisted today that its "rupture record" left them with no cause for concern. The ...
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02:32 AM on 01/13/2012
With the low grade manufacturing these silicone implants had a high risk for ruptures. With that, the woman with the implants are exposed to this dangerous materials. That's it pays to be responsible when you decide to have breast implants or any form of cosmetic surgery. Check my site here, http://www.esteemstudio.com.au/
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10:14 AM on 01/09/2012
The NHS refuse treatment to smokers so why should perfectly heathy people who put their bodies through unnesesery sugery be any different .
09:17 PM on 01/09/2012
I think of it as self inflicted wounds, you chose it, you paid for it, you pay your way out of it.
12:58 AM on 01/18/2012
so when a person has cancer due to smoking or obese people get treatment for eating too much, people who get infections for tattoos, piercings etc, treatment for injuries caused by dangerous sports, the list is endless. heart attacks brought on by smoking, over weight etc, are these all exceptions, as a lady who puts her trust in a company that fit a product kitemarked by the goverment, she has as much right to use the nhs as any one else, the goverment is also quite happy to take the tax on the operations profit margin which im sure is millions a year. whats good for one should be good for another.
09:55 AM on 01/09/2012
https://submissions.epetitions.direct.gov.uk/petitions/26446/signature/new
SIGN HERE IF YOU WANT THE PRIVATE COMPANIES TO PAY & NOT THE NHS! don't want the nhs to pay for the private companies mess! The largest company isn't doing anything for them & the 2nd largest have said they think the government should pay! MAKE THEM PAY WHEN THEY PROFITED! Otherwise these woman will have to go to the nhs!!!
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SATCHMAN99
09:52 AM on 01/09/2012
There is an issue that if the implants do rupture and cause a medical problem like cancer then the NHS will be treating these women anyway. Or will they just say..sorry we can't help you go back to the place you had the implants put in?
HUFFPOST SUPER USER
meddleman
09:38 AM on 01/09/2012
This is the classic illustration of what is dangerous about privatisation in the NHS. The executives and shareholders make a mint out of shoddy,poorly regulated malpractice; they take the profits,close the firm down and other associate private companies shrug their shoulders and the taxpayer is left to foot the bill. If you listen carefully to Lansley's words, he is clearly moving towards offering these women free corrective surgery whether they had the implants on the NHS or not. There are many cases now: there will be many more in Cameron's future NHS: the unregulated private sector bodges a treatment and the NHS picks up the bill. No wonder so many private sector US firms are itching to get their hands on the NHS.
09:18 PM on 01/09/2012
If the nhs did it fair enough the nhs should pay, for those who did it on the private, they should pay themselves.
09:32 AM on 01/09/2012
Missing the point entirely. It's not the rupture rate but the damage that is caused by what is in the implants when they do rupture.

A disgraceful attempt to avoid their responsibilities.
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11:19 AM on 01/09/2012
Make them pay, and also compensation for pain andf distress as well
04:17 AM on 01/09/2012
Ironic story for such a drama, the victims compensations are where do we place the "rupture record" and the solutions are never addressed because the "rupture record" has more weight. Now for the "rupture record" will all surgeries have failure rating with money back guarantees?
ThinkCreeps
Seriously, it's time.
12:15 AM on 01/09/2012
It's not the rupture rate that's the big deal - it's that the spilled contents do not meet the required quality standard for medical use.
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09:37 AM on 01/09/2012
Industrial grade silicone I believe but PIP weren't aware of that, were they?
ThinkCreeps
Seriously, it's time.
09:45 AM on 01/09/2012
As a medical device manufacturer, it is very much their business to be very aware of that.

Should they deliver sub-standard products that become difficult to access once used, it doesn't remove their obligation to fix the problem with their products.
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maggiemosaic
11:05 PM on 01/08/2012
when cancer patients get reconstructive surgery, the last thing they should to worry about is, is them rupturing, why should the public have to put with the garbage sold to them??? just do the right thing and take care of the problem!!!
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LonaMarie
11:55 PM on 01/08/2012
You're right it really doesn't seem that complicated does it?
12:11 AM on 01/09/2012
The debate is not about reconstructive surgery for breast cancer suffers, it is about those who for the sake of vanity got an operation to insert things into themselves.
If they had the money to get any form of insert, they should pay for the removal if they want it removed.
Why should our taxes pay for their mistakes?
08:39 AM on 01/09/2012
You don't think the PRIVATE companies should pay?
Why do you assume that everyone wants the NHS to pay - if you read it says that only woman who had them originally done with the nhs (those who had breast cancer etc - Medical problems) would have them removed & replaced.. nobody is asking the nhs to pay for the ones that made a choice & gave money to the private companies, you can see they are just expecting the people who originally received their money to correct their mistakes.. not the tax payer.
If the company doesn't exist then if they are required to be removed which would be due to rupturing which could mean this unregulated substance leaking into their body then they MAY be entitled to have them removed.. they will not have replacements..
that's pretty much the same to me as having a lump which COULD be cancerous removed as these COULD have problems they don't know about yet&we do those kind of removals on people who smoke&have these lumps yet don't see you complaining about that too? If that was the situation then they are just toxic lumps & is want them out of my body&if I couldn't get anyone else to help me then I would want the nhs to be there for me but I wouldn't go to them first!
Maybe its just me but I tend to read & try to understand the situation when I think my taxes are involved.
08:41 AM on 01/09/2012
Hmm another point would be that these women have also paid taxes & even though none of them seem to want the nhs to sort out the problem, if they did then if you paid taxes & an issue that effected you came up then if you did want the nhs to help then I'm sure you'd want their support especially if you've paid your taxes which had been used to help others.. you'd kinda feel like it should kinda be "your turn" & you wouldn't expect an argument on whether you had put yourself at an unnecessary risk or if it was "your fault" regardless of the situation but that points only valid if they WERE expecting the nhs to sort it out.. which they are NOT.
10:29 PM on 01/08/2012
Seriously, the people who got these implants could afford to put them in, they should use their own money to take them out, if they wish to relieve themselves of this sillycon (spelling intended) it should be at their cost.
The NHS has better things to do with limited funds than bail out these egocentric , well I will not use the word,
11:53 PM on 01/08/2012
Given what you say would mean that anything self induced should be paid for by the person, in that case smokers would have to pay for any ill health caused by their smoking overweight people likewise etc etc. If this is the case the national health will have nothing to pay for at all.
12:06 AM on 01/09/2012
Sounds good to me, self inflicted injuries should not be paid for by the taxpayer, childbirth exepted.
08:49 AM on 01/09/2012
The nhs is only paying in cases where the implants were put on the nhs.
Instead of saying how the nhs should not be paying for those who did pay money to private companies - which no-one has asked the nhs to do - then how about you say that you expect the private companies who made money off them sort the problem out & not us.
The more of us that put pressure on these companies then the higher the chance they will feel obligated to do something but if all you all assume the nhs will pay, which isn't even the case at the moment for these women, then that IS what will happen.
If you don't want to foot the bill then tell the private companies to do it because the more people are talking about it the more likely they will decide that everyone needs them removed & nobody wants to be paying that so let's get the people who profited originally paying it!
10:25 PM on 01/08/2012
oops, the company went bust!
08:41 AM on 01/09/2012
After its own product
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09:41 AM on 01/09/2012
Censorship does rule

Are you saying the company lost support?