French PIP breast implants: an ongoing global health scandal
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It’s been eight years since the French authorities first drew attention to a French company selling faulty, and potentially dangerous, breast implants.
The implants, manufactured by French company Poly Implant Prothèse (PIP), were made with cheap, unapproved silicone designed for use in mattresses. Hundreds of thousands of women all over the world were affected – and all are still waiting for compensation.
In 2010, the French medicine and healthcare watchdog Afssaps withdrew the PIP implants from the market, after surgeons reported a higher-than-usual rate of rupture. The same day, Poly Implant Prothèse was placed into compulsory liquidation.
What followed was a drawn-out health scandal that took years to skewer those responsible. Jean-Claude Mas, the founder of PIP was only condemned for fraud six years later. He launched an appeal, which was eventually rejected by France’s highest court in September this year, and he will be serving a sentence of four years in jail and forced to pay a fine of €75,000.
While this was a French affair, PIP exported 80 percent of its production overseas. So around 400,000 foreign women have borne the brunt of a global health scandal that originated in France.
Forty women contacted FRANCE 24 to share their experiences of living with PIP implants. For some, the struggle was not over – they still had the implants in and could not afford to have them taken out. For others, they had had the implants removed, and were waiting on compensation. Others had suffered – and continue to suffer – long-term health complications that they think are caused by the implants, and have been waiting years to see any damages payment from the companies concerned.
Carly Ahlen, a British woman, was one of the first women to have PIP implants. She had them put in in 2000, when she was 24 years old. It was only years later, when she was working in Greece at a charity she had founded, that she saw a news report about the scandal in 2012 – the year that the UK government released a public report about the risks of the implants.
“I was devastated but I didn’t know what to do,” she told FRANCE 24. “I contacted my surgeon and he told me not to worry. I didn’t want to leave my work so decided to wait and see”.
Two years later, by which point she was living back in the UK, her implants had badly ruptured and were leaking industrial-grade silicone into her body. She rushed to hospital after one breast had flushed red and swelled to three times its normal size.
'Mental, as well as physical, anguish'
The UK government, like the French and German governments, had announced that the national health service would remove PIP implants free of charge, but it would not replace them. For many women, this wasn’t enough. One woman FRANCE 24 spoke to mentioned the “mental, as well as physical, anguish” of not having the implants replaced and being forced to live with the scars or deformities left from the operation – as though it were “a punishment for our ‘vanity’”.
For Ahlen, this wasn’t an option. She didn’t want the cost for an operation she had originally chosen to be borne by the public health service, and acknowledges that she was fortunate enough to be able to pay to go private.
But Ahlen has continued to suffer health problems after she had them removed, with her right lung collapsing four times – although doctors have not definitively drawn a link between that and the PIP implants.
“It’s had a huge impact on my life. My breasts are damaged from the implants. I have indents in them – it’s horrid, like a horror movie. That’s my confidence, my health, my social life affected all because I trusted a doctor to put implants inside me when I was young and naïve.”
For other women, the financial cost of having them removed was prohibitive. Olivia Nolan, an Irish woman who had them put in in Ireland in 2004, discovered that she had PIP implants when one of her breasts began to hurt. She had to wait six years before she had enough money to pay for an operation to have them removed – and went to Prague to do it, because it was the cheapest option. She says the Irish government offered no support for women who had the implants.
“It’s hard to get the money when you have four kids and a house to run,” she said. “I felt selfish. My kids needed stuff and I was saving for cosmetic surgery. But it was like having a ticking bomb inside your body. You don’t know what is going to happen.”
'No evidence the implants cause harm'
Women who have had the PIP implants think that there have not been enough studies into the long-term health risks. The women FRANCE 24 spoke to reported a number of different symptoms and illnesses: numbness, pain, fatigue, a lowered immune system, chronic bacterial infections, endocrine disorders and auto-immune disorders. Several women also mentioned their fears about breastfeeding, and what toxicity, if any, may have been passed on to their children.
Dr Kefah Mokbel, a lead consultant breast surgeon at the London Breast Institute of the Princess Grace Hospital in the UK, co-authored a 2015 study into the ramifications of the PIP implants. The study states PIP implants are more likely to rupture than other types of implants, which can cause painful side effects, but there is no lasting damage.
Reached by telephone, Dr Mokbel told FRANCE 24, “The overall impression is that there’s really no scientific evidence that the PIP implants cause much harm. The industrial silicone should not have been used, of course, but we did not find that it causes much harm to the body at this concentration.”
Paperwork in French
The case goes on. Back in November 2013, TÜV Rheinland, the German safety certifier that approved the silicone gel used in the implants, was ordered by a French court to pay damages to the women. That decision was reversed in July 2015. This year, it goes back to the courts. Paris’s Court of Cassation will make a decision on the initial claim brought against TÜV Rheinland on 10 October – which will have a knock-on effect on subsequent claims brought by thousands of women across the world.
Many of these women are stuck in bureaucratic limbo, wading their way through the complex legalese of what is essentially a French court case. Olivier Aumaître, a Paris-based lawyer, is representing over 13,000 women from different countries. Aumaître has called the case “the biggest class action in the world”.
Over the past few weeks, a large number of UK-based plaintiffs received an alarming stack of court papers from TÜV Rheinland, all in French, and some with no accompanying translation. Lost in paperwork like this, these women created Facebook groups, on which they support each other and share valuable information.
Without one of these groups, Catalina Colmenares would be totally in the dark about how to seek justice. Colmenares is Polish, but had her implants put in in Costa Rica in 2008, where she lived. By the time the scandal came out, she had moved to Poland. She tried to contact the surgeon.
“Of course, he had disappeared off the face of the earth,” she said. “The Costa Rican authorities have done nothing. Support has been non-existent, so the Facebook groups are very helpful.”
Vidya Ernstsson, a Swedish woman whose implants ruptured and who suffers from ongoing health problems, agrees. “The struggle is too hard for me to deal with by myself, and with no help it’s impossible. The women are being cheated by the system.”
The story is the same all over the world. Guadalupe Grisales is Colombian and got the implants put in in 2006. After they ruptured, she had to have an emergency operation to take them out. She contacted the Latin American branch of Stanton Fisher, a financial claims firm, which put her in contact with the French lawyer. However, she cannot speak French or English, has no direct contact with Aumaître, and when she has questions Stanton Fisher directs her back to the Paris office.
Grisales launched her claim four years ago, and has yet to receive the small interim payment of €3000 TÜV was ordered to pay each woman. After the fees taken by Aumaître’s office, this sum is derisory. It is not even enough money to cover the cost of the initial implants, let alone their removal and replacement, or the scores of other medical appointments as a result. A typical breast augmentation operation costs upwards of €4,000. A removal and replacement can cost more than €7,000.
The October court case is just dealing with the first group of women to file a legal case. There are three other groups, who are all nervously waiting to see the outcome, and whether those who have already received the interim payment will be required to return it.
Olivia Nolan says it feels like the case has been forgotten. “Cosmetic surgeons have got away scot-free, simply by trading under new names. We need to shame these companies. This is the only bit of dignity we have left – exposing what they’ve done.”