Date: Thu, 14 Dec 2000 09:29:02 -0800

The withdrawal of hydrogel breast implants has worried many, learns

ANNE JOHNSTONE

Two years ago Tracy-Ann McGlynn wanted to tell the world about her breast implants. The mother-of-two from Coalburn in Lanarkshire cheerfully posed for the press in a low-cut top, and joked about how her newly acquired 34DD bust qualified her ideally for her job. She was a barmaid.

Ironically, she had opted for hydrogel implants, rather than the usual silicone, having been assured that the salt and sugar gel was so safe that she could eat it. "I'd read some articles about silicone and I was frightened about the health implications if it leaked out. The hydrogel seemed harmless," she said.

At the private clinic in Glasgow where the operation was carried out, she was shown pictures of other women who had received hydrogel. "They looked great and I took it for granted that everyone was happy and it was completely safe. Now I realise I was being used as a guinea-pig."

McGlynn, now 29, greeted with anger the news this week that the government is withdrawing hydrogel implants. The department of health has stressed that "no definite health risks" had been identified in relation to them, but that it was unhappy about the makers' safety assessments.

"If I'd known there were doubts about them, I'd never have gone ahead," she says. She wants to know why these products have been licensed for use in Britain since 1993 if, as now appears, they hadn't been properly tested.

Her anger is tinged with relief, however, because she had the hydrogel implants removed four months ago. "After the operation, I was over the moon but less than two years later, my breasts had become spongy. I never felt ill with them but I was very unhappy and disappointed. I'd been told they would last for many years," she says.

And she revealed that the clinic had cut £1000 from the £4000 bill for the implants, on condition that she agreed to having her story and picture published in the Scottish press. "I had to agree because I couldn't afford it otherwise," she says. The balance of the cost came from money she inherited after her father's death. She now bitterly regrets the decision.

When she returned to the clinic to complain earlier this year, she saw a different surgeon. "He said to me: 'This is what happens with hydrogel.' I asked questions but didn't feel I was getting answers. I felt like asking for my money back but I didn't get the chance. Instead, they said they would replace the hydrogel with silicone and I was just whizzed in and it was done before I could think about it," she says.

She is unhappy with the silicone implants: "I feel my skin has stretched and on one side I can feel the implant through the skin. I can feel a corner sticking out. My current boyfriend is very understanding but if we split up, I think it would affect me going out with someone else. It's quite embarrassing."

McGlynn is now considering having the implants removed altogether and she is taking legal advice about possible compensation.

Pat H, aged 57, from Gloucester, is in an even worse situation. She opted for hydrogel implants only four months ago, having been advised by the government to have her previous soya-oil implants removed for safety reasons.

Several years ago she used a small legacy for "a boob job". "I've never had any boobs. I was 32A and could never get a swimming costume to fit. So when my cousin died and I had some money, that's what I decided to do with it. Now I'm 32DD. To me, it's important. I chose to spend my money that way, purely to please myself. I thought it would last a lifetime. Some people would say I'm selfish but then some women spend £4000 on a dress, don't they?"

Like McGlynn, Mrs H avoided the silicone option because she had been influenced by adverse publicity about possible health risks. She opted for Trilucent implants, an American product based on soya-bean oil. "I was a school cook and I'd been using soya for years. I thought that if you could feed it to kids, it couldn't possibly harm my insides. You tend to trust people when they say something is safe, especially when they are professionals."

Mrs H enjoyed her new shape but she was unhappy. "Nothing went wrong but they were very, very ripply." Then last year the department of health announced that Trilucent was being withdrawn from the market, amid fears that, if the oil leaked into the body, it could cause cancer.

On June 6 this year - Mrs H's 36th wedding anniversary - she was told that the government was advising everyone who had received a soya-oil implant to have it removed. "It was a terrible blow," she says.

The implants were finally removed in August. "It took a while to organise because I had a Dickens of a job finding a surgeon to do it." Again, Mrs H considered all the products on the market and opted for hydrogel, "because it seemed the safest."

She chose German-made NovaGold, one of two hydrogel-type products licensed in Britain. The other is PIP, made in France and supplied by Clover Leaf Products Ltd.

She was reasonably pleased with the result which she says gave her a better shape and didn't exhibit the "ripple effect" she had experienced with the soya-oil implants.

Mrs H was offered £5250 compensation from Trilucent, which she describes as "an insult, especially as I paid £4000 for the original operation". Then came the bombshell. She says she is "devastated" by this week's sudden withdrawal of PIP and NovaGold by the department of health.

Though the government isn't advising women with hydrogel implants to have them removed at this stage, Mrs H fears this will be the next step. "It's like being struck by lightning twice in quick succession. Now I face another operation and I could end up worse than when I started. It damn well shouldn't have happened again," she says.

Almost unbelievably, Mrs H says she is now considering a third implant. "This time I'll definitely opt for silicone. I can't imagine life without my boobs now. I'd feel less of a woman."

Her dilemma is that unless and until the government recommends the removal of hydrogel implants, she can't apply for compensation, so would be liable for the cost of removal. "I don't want to go under the knife again, but I don't want to live with the anxiety of worrying that I'm going to be ill, either."

Paul Balen, the solicitor who negotiated the Trilucent compensation package, told The Herald yesterday that he believes at least 50 British women are in the same "double-whammy" position as Mrs H - that is to say, they had their soya-oil implants replaced by hydrogel ones.

He said: "I've written to the two companies this week and asked them for their proposals with regard to the payment of medical expenses for those concerned about their implants and the cost of removal if they want them taken out. The mere withdrawal of these devices from the market, indicates that these products weren't as safe as we were led to believe. Those women who bought them thus have a case under the Consumer Protection Act."

Balen represents more than 2000 women who are unhappy about breast implants. The number includes several Scottish clients.

Bill Miller, a Glasgow MEP and a campaigner of longstanding for better regulation of breast implants, said yesterday that he would campaign for the hydrogel implants to be included in the legislation being brought forward in the European parliament next year. The new law will create a register of all women who receive implants and make impartial counselling before the operation compulsory. The operation will be restricted to women over 18, and there will be a follow-up programme lasting several years after the operation.

In Britain implants are regulated by the medical devices agency (MDA), under the aegis of the department of health. Critics of the current arrangement say that the EU licenses manufacturers of implants and the MDA has limited powers and resources to restrict the operation of a company holding such a licence.

Balen believes the entire system is ripe for reform: "The current mess isn't entirely the MDA's fault. The European licensing system should be stopped until there are satisfactory trials. At the moment 50 companies are licensed to sell implants in Europe. Clearly, some of them shouldn't be."

* Silicone Support UK 020 8806 6923

* Breast Implant Information Society 07041 471225

- Dec 14