The men who rebuild breasts

Adam Searle makes an unlikely Cassandra. A plastic and recon-structive surgeon who consults in Harley Street and works at the Royal Marsden, he is a past president of the British Association of Aesthetic Plastic Surgeons, has an immaculate track record and chooses his words with care. ‘I don’t want to be too much of a misery guts, but over the past 15 years I feel I have constantly been saying, “Be careful, be careful!” and this [the Poly Implant Prosthèse or PIP scandal] is just what one dreaded unfolding.’

He is not alone in viewing the debacle of PIP breast implants as a disaster that was waiting to happen, thanks to a lack of quality control across the cosmetic surgery industry and a society that has started to view breast enhancement more as a fashion statement than a serious surgical procedure. ‘We haven’t seen the end of this,’ warns Professor Laurence Kirwan, a consultant plastic and reconstructive surgeon with practices in London and the US. ‘This is a healthcare crisis of major proportions.’

The awful saga of PIP implants may no longer be headline news but it is far from over. Cheaply made from industrial-grade rather than medical-grade silicon by the French company run by millionaire medical supplies businessman Jean-Claude Mas (now facing criminal charges in France), the implants were sold to clinics around the world as a bargain alternative to standard breast prostheses. At around one-fifth of the price of better-known implants, you would have hoped that someone would have questioned PIP’s credentials but no one did, least of all the Medicines and Healthcare products Regulatory Agency (MHRA) which approves such products in the UK. In the US, the Food and Drug Administration refused to allow PIP to sell its implants as it judged the safety data to be inadequate.

PIPs weren’t popular with independent surgeons: ‘I’d like to say I used my super-human powers to deduce that they were bad,’ says Dr Kirwan, ‘but of course I couldn’t. But I did think that they were too cheap and after trying them twice, chose not to use them.’ They proved irresistible to the cosmetic surgery clinics which carry out the bulk of breast enhancements in the UK: here was a chance both to keep prices down and improve their profit margins. The NHS used a fair number, too; altogether around 50,000 pairs found their way into British women’s breasts. The number isn’t exact as there is no national register for implants.

Two years ago, the MHRA was told by the French authorities that PIP implants had been found to be substandard, and advised British surgeons and clinics not to use them, but the public remained largely unaware of the issue until last December when the French government announced that it would fund the removal and replacement of all PIP implants there because of concerns about high rates of rupture. Suddenly, the UK media were up in arms: what was the government going to do for all the women who had been fitted with PIPs, many of whom were now coming forward complaining of pains, swelling and lymph problems? How did they know for sure if they had been given these dodgy implants (clinics’ records haven’t always proved reliable; plenty of women have now had their implants removed to find they weren’t PIPs after all). And how could they tell whether they were leaking? The government response was that women who had received PIPs on the NHS could have them replaced free of charge, and that the private sector had a moral obligation to do the same.

Dr Kirwan has little but scorn for the way the government has responded. ‘For some reason, the government decided that this was a moral failing on the part of the physicians using the implants – which is a non sequitur, as the NHS had used them, too – and they had been freely and legally available. It is very sad that our government is so reluctant to take the blame. We depend on the government for analysing and certifying many things that are sold and if we can’t depend on it for this it is a serious failing. Even if it was an honest mistake, it was a mistake and should be put right. This is a health crisis and the government is pussyfooting around with select committees to justify a conclusion that it has already reached.’ To him, the issue is very simple. ‘If it’s industrial silicone, and you don’t know what the potential risks are, it has to come out.’ He has offered to replace both sets of PIPs that he used, free of charge: ‘Not because I have responsibility but because the government isn’t stepping up to the plate. I feel the patient always comes first.’

Adam Searle has never used PIP implants, but, like many surgeons, has found himself dealing with the fallout. ‘It is very difficult,’ he says. ‘It needs a long consultation. We’re not just in the business of swapping these things like an inner tube on a bicycle. We need to think carefully about the patient’s history, needs and expectations. While some women say, “I’m so scared, take them out, I never want to see an implant again, even if I’m left with an empty breast,” others may need complex reconstruction. One of my patients is 20 weeks pregnant and terrified. Should she have an anaesthetic? Should she tough it out? Is she poisoning her baby?’

So who should pay for all this? The last time there was a breast implant scandal – over the soya-oil implants made by Trilucent, in the 1990s – the manufacturer’s insurers paid for every woman who had received them to have them removed. Since PIP has already collapsed, that’s not an option in this case. The French insurance company that had insured PIP’s implants cancelled its cover in 2006, accusing PIP of misleading the regulators over the safety of its products; another warning sign that wasn’t picked up.

One enterprising woman, who found that the clinic that fitted her PIP implants had closed down, managed to get her credit card company to refund the money she paid for them, on the grounds that she had been sold faulty goods; others may be able to follow her lead.

The trouble with the government’s decision that private clinics have a moral obligation to look after their PIP patients is that they’ve effectively left the decision of what to do about PIPs to individual clinics. Some are removing PIPs and replacing them, at no charge, with better-quality implants. But some will only replace PIPs if there has been a rupture and are making women pay for the scan to determine this, and for the replacement implants. The anguished women who can’t get the answers they need, or helpful advice, or who can’t afford to pay for further treatment, are venting their fury on the internet. The Facebook page of the Harley Medical Group, which fitted almost 14,000 women with PIPs and is only now offering removal and replacement, at different costs subject to varying criteria, does not make for easy reading.