Sarah Boseley 

In the name of beauty

Last week 5,000 women were told to have their soya bean breast implants taken out. What few would have realised when they signed up for surgery was that such devices do not undergo clinical trials: they are never tested on people.
  
  


Nipples that leak yellowish toxic yoghurt; an implant a surgeon kept in the back of a drawer and which now smells like an old chip-fryer - these were some of the stomach-churning insights into the artificial beauty business that emerged when the department of health last week advised 5,000 women with soya bean breast implants to have them taken out.

The oil, promoted as a natural alternative to the vilified silicone, may potentially degrade into toxic aldehydes that can cause cancer and birth defects. Beauty is only skin deep indeed. How many women are now left fearfully wondering what is happening underneath their enhanced curves, the D-cup of their dreams? Are their breasts stealthily seeping fermenting carcinogenic fluid? It's like a horror movie in the worst possible taste.

There has always been this powerful Frankenstein element about cosmetic surgery. The quest for beauty beyond our genetic inheritance or youth in spite of advancing time can go grotesquely wrong. Labour MP Ann Clwyd, who has been campaigning against cowboy cosmetic surgery clinics for the best part of a decade, has an enormous file of scarred and mutilated women.

"The result was dreadful, resulting in to date five operations to try to rectify the damage he had done," says one. Another speaks of "unbearable pain during surgery, tattoo scars on bellybutton and hips and post-traumatic stress disorder".

Yet even major scandals like that of the Trilucent soya bean implants seem unlikely to stem the flow of candidates for the knife. Barry Jones, president of the Association of Aesthetic Plastic Surgeons, who was on the committee that recommended removal of the implants, does not think it will have any impact. "Although common sense might say 'yes', history would say 'no'," he says. "Breast enhancement is a very common and popular operation. Body contour is very important to some people. There are a number of women who are quite disturbed by it."

The 40 women who have had Trilucent implants at his clinic all received a letter from him on the day of the announcement, inviting them to come and see him and discuss what happens next - they are the lucky ones, because most will have found out via the newspapers and television. Advice from the Medical Devices Agency, which regulates implants, was that the women should not get pregnant or breastfeed until they have been taken out.

Among Mr Jones's cohort are one who has had a baby and another who is pregnant. "They are anxious," he says with an element of under-statement. The anxiety will be worsened because he believes nothing immediate can be done. "I think the right advice is to wait until the breast is not post-pregnancy anymore. Surgery on a lactating breast is quite risky."

He will do his best to reassure them, because his personal belief is that the Trilucent implants are not a problem until they rupture and the oil meets air and oxidises - which will only happen outside the breast. He wants to involve either the MDA's scientists or the manufacturers in research on the 40 or so implants he will be removing to test the theory. "When something like this happens, for the individual concerned it is an unfortunate event, but if we don't learn from it, it is even more unfortunate," he says.

Many women with Trilucent implants will no doubt be thinking of replacing them with silicone or saline. Yet the MDA had no advice for them whatsoever last week. Under heavy questioning Dr Susanne Ludgate, medical director of the MDA, stuck to her statement that they had no evidence as to whether or not it was safe to put in a different kind of implant once the soya bean oil device had been removed. Her argument may be scientifically immaculate, but the women affected may well feel deserted. They are advised to talk to their surgeon, but how are they to trust the cosmetic surgery clinic that sold them their safe and super-natural carcinogenic implant?

The fiasco has illuminated a major problem - implants are not licensed. Although these foreign objects which can and do leak and rupture are to be inserted inside a woman's body, they do not have to be tested on people before they come on the market. They do not undergo clinical trials, as drugs must. Instead, they are given the CE mark - a kitemark that shows they meet a European standard, just like cuddly toys and dishwashers.

There are a number of commercial agencies around Europe, although mostly in Germany and the UK, that can hand out this kitemark, and they are approved by governmental bodies like the MDA here. But if TUV Munich - as happened with Trilucent - says an implant is OK, under European law the UK government is not supposed to interfere with it being sold here.

Some countries don't play the game. "The French just say 'non'," says Mr Jones. They make unilateral decisions. Like the United States, they banned silicone breast implants. But the UK sticks to the rules. The MDA now says it is pressing Europe to strengthen them, and to introduce a requirement for clinical trials for implants. None too soon.

There is a fashion in cosmetic surgery, and right now top of the list is lip augmentation. Everybody wants Liz Hurley's pouting mouth (although she says hers is natural). But according to Mr Jones, none of the techniques used currently are very good.

Collagen injections are temporary - the stuff just disappears into the body. And then there are implants. The main lip implant used was marketed very heavily and directly to the public. Jones says: "I didn't use a lot of it - less than 10 patients. Most of them had to be revised."

He had to bring them back in for further surgery either to remove or alter the implant in some way. "You can always feel it," he says, "and you can often see it. Sometimes the ends of it will be apparent."

He is not alone in his experience. A respected plastic surgeon called Claude Lassus, who operates in Nice, told the recent International Confederation of Plastic Surgeons that he used quite a lot of the implants and had to remove most of them.

Other techniques, such as face-lifts and tummy tucks, should not in themselves be cause for concern, says Mr Jones, but implants are a problem because they are not properly tested and regulated, and so are cowboy surgeons. Anybody can set up a cosmetic surgery clinic and call themselves a consultant and operate on people as long as they don't claim to be a doctor, points out Ann Clwyd. "I think there are lots of cowboys operating in the private cosmetic industry. They ought to be regulated and patients ought to be protected.

"Sir Norman Browse, a past president of the Royal College of Surgeons, said animals are better protected than humans - you have to be a qualified vet to operate on animals."

Clwyd knows of one woman who had liposuction carried out by a GP, who gave her a general anaesthetic without an anaesthetist, while she was lying in a dentist's chair. The woman says she came round towards the end of the operation and was in agony. But even if a qualified Fellow of the Royal College of Surgeons is conducting the procedure, it doesn't mean he has done any training in plastic surgery; he could be a gynaecologist or ENT specialist.

Jones believes things will change radically in a few years time, once revalidation is underway - doctors will not be allowed to practice either in the NHS or the private sector unless they can prove to the satisfaction of the General Medical Council that they are up to standard every five years.

Two more changes are needed to clean up the cosmetic surgery business, he says. Ads in the back of glossy magazines and newspapers should be banned from using photos of attractive bodies. "You don't need a picture of a pretty pair of breasts to know what they look like," he says. "That is to entice." Clinics should also be banned from using a lay counsellor to screen customers - only surgeons can advise the patient as to whether the operation is right or wrong for her. "We are very anxious to improve the situation. In the mainstream, I'm sure they are practising properly and the surgeons are properly trained," he says.

But change seems to take forever in cosmetic surgery. There have been any number of scandals. The Consumers Association produced a damning report in October 1997 after sending a couple of models into clinics, wired for sound to experience the hard-sell.

It is widely accepted that many people who go to the clinics are deeply vulnerable, with very low self-esteem and often nobody to talk to because they are ashamed to tell their families and friends what they are doing. The House of Commons health select committee expressed many anxieties two years ago about misleading advertisements, inadequate information to customers and under-trained surgeons.

The government now says it will tackle some of these issues in the forthcoming Care Standards Bill. What no regulation can achieve is any change in the culture of glossy, busty, pouting Hollywood models and actresses which is imbibed by vulnerable young girls and boys and makes them risk their health for the sake of a more exotic body which is unlikely, in the end, to make them happy. Why else do the clinics universally require payment in advance?

 

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