5:26 PM
samizares
IT is a piece of gel close to many a womans heart and would have remained there had it not been for a nasty piece of profiteering.
Interest in silicone br*ast implants has gone stratospheric since it emerged that French-made PIPs Poly Implant Prothese had been manufactured with cheap industrial-grade silicone instead of the much higher spec medical grade, causing fears of rupturing and cancer.
In the UK, focus has turned to Nagor, the country's only manufacturer of br*ast implants.
Where PIPs are the rather shambolic mopeds of the implant industry, these are the Rolls-Royces and they are made in Cumbernauld.
And while PIPs sold at a rather economical 50 pounds, Nagor implants cost between300 and 500 pounds the difference in this case between quality and ill-health.
Nagor national sales manager Douglas Black said: It is beyond us how you can manufacture something and make a profit to sustain yourself for the long term at that kind of price.
Well, I suppose you can if you do things in certain ways.
Nagor makes around 80,000 implants a year, mainly by hand.
In an era where almost everything is done in conveyor-belt fashion, it is intriguing to watch the care put into every one of these implants.
The atmosphere is clinical in the company's "clean room", the air regularly changed to lower the chance of dust and staff must cover up and scrub in.
The silicone comes from one of only two manufacturers in the world who make medical-grade silicone.
Every barrel is tested to make sure it complies with stringent quality controls.
Operations manager Stephen Barsanti said: "We have four validation points product integrity, user needs, bio compatibility and sterility.
"If we have a power failure, we have to shut everything down, clean it and start again the next day.
"Basically, we lose a day. But it is important that we maintain the integrity of what we are doing."
The shells of the implants are dipped in silicon several times by hand on mandrels or moulds.
When they are ready, they are removed by hand. Each one is then inflated by pressure hose and immersed in water to check for leaks before being closed off and filled with gel.
Any air is sucked out in a vacuum chamber and then any remaining bubbles are removed by hand.
The implants are oven-cured to finish them off before being packed individually for sterilisation.
They will be sent out through an air lock to protect the womb-like lab that gave them birth.
It is the type of procedure designed to reassure women there is quality in an industry which is taking a severe beating from bad publicity.
Douglas has pledged to replace free of charge any PIP implants which have ruptured. He sees himself as a man with a mission to help women who have found themselves, through no fault of their own, at the centre of this fiasco.
But he also wants to reassure them that there is quality control.
At the same time, he is adamant that some form of registry must be created to protect both patients and the industry from this sort of thing ever happening again. He has called upon the clinics and hospitals who have not yet stepped up to the mark to come forward and extend a helping hand to their patients.
He said: "The ethical companies have already come forward but, by anyone's reckoning, that only makes up 16 per cent of the women with implants in this country. That leaves 42,000 women.
"It's about time the people who provided those 84 per cent of women with their implants stopped pointing the finger and started doing something about it. They know who they are.
"People need to be helped first before we find someone to blame and we are trying to be as pro-active as we can to help these patients.
"There's going to be a cost but it can be low and its better than what is being offered out there for these women.
"Some women are being told its going to be another 2800 pounds for something that's not their fault
"Many will have already saved up for these procedures and it is going to be difficult to get that money again. We have got to stop this panic."
Douglas has already written to Health Secretary Andrew Lansley, offering to help, but has yet to receive a reply.
He said: "If the Government is going to help these women as they have said they will, then it is going to cost the taxpayers money and as yet no one has approached us, the country's only manufacturer."
Nagor made their name by working closely with surgeons. They make implants for reconstructive surgery as well as cosmetic work and export all over the world.
As part of their quality control procedures, they send implants to Australia and back and test them for wear and tear.
Black is immensely proud of Nagor's products, designed to match implants with women of all different heights and sizes. He has refused orders for job lots of 20,000 because, as he points out, 20,000 women will not all be the same size and that would just be a case of surgeons putting exactly the same implant in each of them.
It is a difficult time to be in the cosmetic surgery industry but the key, argues Black, is not to shirk on quality.
His hope for the future is a registry. One already exists in the orthopaedic industry where surgeons have told him they can tell within three months if a product is going to work.
Now he wants something similar set up for cosmetic surgery.
He said: "It would holds details of the product, the surgeon and his techniques and the clinic.
"That way, if anything goes wrong, there is a record. If there is something wrong with a product, surgeons should be able to report faults and that will throw up a pattern.
"I am passionate about this. This is a great industry. We give confidence back to so many women.
"We do our job well and all I want is that others should do theirs too."
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