Up to 1,500 women in Ireland have breast implants made by the French firm PIP. Three of them tell
PETER McGUIREof the
worry, frustration and embarrassment they have experienced since problems with the implants were exposed
THE SILICONE WAS the type used in mattresses. Instead, it was put into breast implants, and these were put into women’s bodies. In Ireland, according to the Irish Medicines Board (IMB), up to 1,500 women who went for breast-enlargement operations were fitted with cheap, industrial-grade silicone implants made by the French firm Poly Implant Prothèse (PIP).
The suspect PIP implants were banned on safety grounds in France two years ago and have been removed from the market in several countries amid fears that they could rupture and leak silicone into the body. PIP was liquidated last year. On Thursday, its former director, Jean-Claude Mas, who is 72, was arrested in the south of France and placed under investigation on a criminal charge of causing bodily harm. He was released on €100,000 bail and is not allowed to leave France.
The PIP implants had received the CE – or European Conformity – mark, meaning they met the relevant EU safety requirements. But Mas has admitted to hiding from certification agencies for more than a decade the fact the company was using cheap, industrial silicone.
“Kyra” is a 31-year-old married mother of one, from Dublin, who works in residential care. Kyra is not her real name but a pseudonym she has used in online discussions. She had her breasts enlarged in 2006. The procedure was carried out by Harley Medical Group, using the PIP implants.
“I had never felt comfortable in my own skin,” she says. “I was constantly stuffing my bra, and using ‘chicken fillet’ bra inserts. I wanted to feel better about my self-image. It took me from an A-cup to a moderate C-cup. I picked a discreet surgeon who did natural-looking implants.”
Following a series of posts on boards.ielast week, Kyra received more than 30 messages, and has now set up an online petition, asking Minister for Health James Reilly to intervene on behalf of women carrying the PIP implants. She says Irish women have had to fight alone, without support from their clinics or from the Department of Health.
“The women are terrified of the effect this could have on their health. Nobody is asking the taxpayer to pay for any of this mess, but we want the cosmetic companies in Ireland to deal with this correctly. Women with these implants should be offered removal and replacement at no charge. In the long term, the industry needs stricter guidelines and regulations to stop this happening again.”
Debating the issue – with friends, with family or online – is difficult, says Kyra. She finds it frequently turns into an argument about the rights and wrongs of cosmetic surgery.
“I feel I’m constantly justifying myself. I’m asking people to park their personal opinions on cosmetic surgery. The issue is that the product is toxic, it didn’t deserve the quality mark it got, and the implants should be removed.”
Hence women with PIP implants have used online forums, particularly boards.ieand rollercoaster.ie, to communicate with each other. Comments have ranged from supportive to abusive. One person wrote that women who had breast implants were selfish and vain, and deserved to die of cancer.
Two more women with PIP implants who spoke to The Irish Timesare reluctant to speak out publicly, and – like Kyra – will not be identified by their real names. "The surgery I had is so personal," says "Marguerite", a civil servant from Co Kildare, who is 38. "It was difficult enough to make the decision in the first place, without now having to tell the world about it. I live in a small rural community. I don't ask anyone else's business, and I would find it very humiliating to have everybody knowing mine. There's a perception of extreme vanity and a fear that, if people know about it, they'll judge your character on one aspect of your life."
Three Irish clinics – the cosmetic-surgery unit at Clane General Hospital in Co Kildare, Harley Medical Group in Dublin and Shandon Street Hospital in Cork – are known to have used PIP implants. Shandon Street Hospital closed last year.
Marguerite’s operation was carried out at Clane General Hospital. She was examined this month and advised that her implants were intact. This week the hospital provided a follow-up scan, which confirmed that finding. If her implants had ruptured or were leaking, the hospital would remove and replace them without charge.
The PIP implants are more likely than other implants to rupture or leak in future, however, and Marguerite is worried that she will have to have, and pay for, regular scans. “It’s like paying top dollar for a faulty or dangerous product for your car, and being expected to drive around in it until something bad happens.”
THE WORRY WAS too much for “Jenny”, a 37-year-old retail manager who is originally from Latvia. Harley Medical Group operated on her in 2007, at a cost to her of €6,000.
She has already paid to have the implants removed and replaced. Last year, Jenny began to experience pain in her left breast, a possible side effect of breast augmentation, and became concerned. On January 9th this year she received an email from Harley Medical Group, informing her she may have PIP implants. After a series of phone calls and a visit to Harley Medical Group, she still felt frustrated. Harley told her on January 19th that she would have to wait until the end of February for a scan, she says. A scan by another doctor had revealed that her left breast contained excess fluid, but it was unclear whether it was leaking. “I was terrified,” she says. “I was drained, not sleeping, not eating. I couldn’t take it any more. I just wanted them out.”
Jenny borrowed money for surgery, and had her implants replaced by Cosmedico in Co Wicklow at a cost of €3,500. A spokesperson for Harley Medical Group declined to comment for this article.
In November 2010 Harley Medical Group told the IMB, which is responsible for the regulation of medical devices, that it had written to all its Irish patients who had PIP implants. It later admitted that it had not contacted the women; the IMB says it was misinformed by Harley Medical Group and that its instructions to the clinic were not followed. Harley Medical Group now says it will remove and replace PIP implants for women with a confirmed rupture within six years of implantation.
The IMB says there is no current evidence of particular health risks associated with PIP implants, and it has advised women to seek clinical advice from their implanting surgeon or GP. Dr Tony Holohan, the chief medical officer at the Department of Health, echoes this advice, and says no women in Ireland had the procedure carried out in a public hospital.
Sean Leyden, executive director of Clane General Hospital, says it is following the guidelines laid down by the IMB. “The problem here is these implants were CE-approved. If a hospital can’t rely on a CE cert, we may as well close our doors. But this was a clear-cut case of the CE certifiers being lied to; it was fraud.”
Avril Scally, a solicitor with the Dublin firm Lavelle Coleman, is representing a number of Irish clients with PIP implants. “Without full information from the hospitals, clinics, distributors and manufacturers, it is not possible to paint the full picture, but it is clear that the women at the very least will have claims for negligence and breach of duty on foot of defective product legislation, as well as possible claims for breach of contract,” says Scally.
“There’s a lot of giggling and judging going on about this,” says Kyra. “Women who have spoken out about this have been targeted with degrading comments; on one forum, I was told that I signed a consent form and knew what I was getting myself into.
“Yes, I knew the risks of any general anaesthetic, any procedure. I also knew I picked a good clinic and one of the best surgeons. I trusted that I would be fitted with an approved, safe product. That’s not what I got. I never knew for one minute that I was going to get an implant with a higher chance of rupturing and leaking, a toxic product that was made for industry, not human bodies.”
Kyra's online petition is at iti.ms/zzB7Ui
For PIP implant information, contact the Irish Medicines Board on 01-6764971
Implants and impropriety: How the PIP scandal is playing out around the world
Up to 400,000 women in 65 countries are believed to been given breast implants made by PIP. Different governments have taken different positions, with disagreement about who should pay to remove the PIP implants and whether they must be removed in all cases. An EU expert group is due to report on the matter within the next fortnight.
A French expert committee has said that there is no increased risk of cancer for women with PIP implants compared to women with other breast implants. Along with Czech and German health authorities, however, France has advised that all women who have PIP implants should have them removed.
Brazilian health authorities have threatened to fine any private health plans that refuse to remove and replace the implants.
The department of health in the UK says there is not enough evidence to recommend routine removal of the implants, but it accepts that the implants are “made of non-medical grade silicone and should never have been implanted in women in the first place”. The NHS has offered to remove and replace the PIP implants for about 2,000 women whose surgery was carried out by the NHS.
Private patients can have the implants removed, but not replaced, on the NHS if their clinic has closed or refuses to remove them, provided there is a medical need. Crucially, however, the NHS says that women who are “extremely anxious” about their implants can also have them removed.
