The terrifying story of how a former French butcher earned millions from selling faulty breast implants made from mattress fillingCompany has allegedly been manufacturing faulty implants since 2001Thousands of women around the world suffered ruptured breast implantsJean-Claude Mas, founder of PIP, denies charges of manslaughter
Scandal: Alexandra Blachere, who heads an association of women with faulty breast implants
Strong gusts of wind sweeping in from the nearby Mediterranean blow discarded order forms and medical documents across the litter-strewn site of an abandoned factory.
It was here, until it was forced to close, that 120 staff manufactured silicone breast implants. The workers wore blue gowns, surgical gloves and masks to give their work an air of scientific respectability and professionalism.
The reality, though, was very different. Today, Poly Implant Prosthese (PIP), in the industrial town of La Seyne-sur-Mer, is in liquidation after it emerged that since 2001, as well as manufacturing implants from more expensive medical-grade silicone, many more were produced using low-grade industrial silicone — the type used to fill mattresses — and which were never approved by health authorities.
Costing as little as 100 (up to 700 less than the medical-grade version), their popularity helped PIP corner the market in cut-price prostheses. However, this cynical business has left thousands of women, many of whom attended private clinics in Britain for their implants, terrified for their health.
Many women with the cheap implants have complained of shooting pains, lumps and lethargy after they ruptured — probably through a weakened outer membrane — leaking industrial silicone into their bodies. There have been worries, also, that the gel could cause cancer, although tests in the UK suggest that is not likely.
This month, the French and Venezuelan governments agreed to meet the costs for women in their countries to have the implants removed. The total bill in France alone is expected to be 60 million.
Elsewhere, thousands of women in other countries (including tens of thousands in the UK) are left worrying that their implants could burst if they do not undergo expensive and painful surgery.
To confuse matters, Britain’s Medicines And Healthcare Products Regulatory Agency (MHRA) has advised against removal because of the risks associated with the surgery.
Theimplants were originally approved to be sold in Europe after tests by TUV Rheinland, an independent certification company based in Cologne, Germany.
Arrested: Jean-Claude Mas was detained by police following the defected implants that his firm sold
TUV Rheinland has now issued legal proceedings against PIP, claiming the French company ‘continued to mislead’ it when its staff made regular inspections at the site. A spokesman says inspectors were shown the approved silicone, which was then replaced by ‘another silicone’ in the manufacturing process when the inspectors left.
When the German company discovered the irregularities in 2010 it cancelled EU-wide approval of the product, banning it from sale.
For their part, the French authorities moved to shut down PIP when they realised the firm had been using non-medical silicone for as long as nine years. Immediately, the British regulatory body advised against surgeons using the implants.
As events unfold, PIP’s founder, Jean-Claude Mas, is said to be ‘unwell’ and his family claim that, under‘French privacy laws’, he doesn’t have to explain what happened.
Thetruth is that at one point his company was selling 100,000 implants a year, the vast majority being exported, to 65 countries. It is believed that as many as 400,000 women worldwide have been fitted with PIP implants. About five per cent of implants in France have split, while just one per cent in Britain have also ruptured.
AsMas this week remains in his luxury villa on the Riviera, concerns are growing that the 72-year-old multimillionaire is making moves to protecthis fortune from those trying to bring him to account. Mas is facing criminal proceedings with regard to a series of offences, including manslaughter (resulting from the death of one French woman who was fitted with the implants).
Jean-Claude Mas, pictured holding a breast implant, is facing charges including manslaughter following the collapse of Poly Implant Prothese
Mas’s rise from part-time butcher and one-time wine merchant to founder and chief executive of a leading international breast implant company is the stuff of business legend in France. In the weeks after the scandal broke over the safety of his firm’s implants, claims emerged of a man prone to heavy drinking, gambling and who is wanted by police in Costa Rica for motoring offences.
Mas began his working life in his mother’s butcher’s shop in his home town of Tarbes, near the Pyrenees mountains on the Spanish border.
He is believed to have also worked as a delicatessen proprietor before becoming a medical sales rep.
According to his lawyer, Mas developed a ‘passion’ for implants after meeting a plastic surgeon called Henri Arion, who introduced implants to France in 1965. Mas realised how these jelly-like moulds had huge commercial potential in a world where women — some very vulnerable — were desperate to attain a ‘perfect’ body.
Mas and Arion set up a number of companies before Arion died in a plane crash. Mas then decided to go it alone and launched PIP in 1991.While selling 30,000 implants in France and 40,000 in Britain, it was the hugely lucrative American and Latin American markets that were his ultimate goal.
Dr Patrick Baraf, a Parisian surgeon who met Mas at a medical conference in the 1990s, recalls him as being a businessman with an uncompromising sales patter — ‘a faker, a crook’ who ‘wanted to succeed at all costs’.
Dr BARAF said: ‘He told me my implants were rubbish, and that I should use his. He was very pushy. He seemed ready to do anything to grab a big market share, and he pursued this very aggressively. It ended up with a sort of dumping of his products at a price no one could complete with.’
Burst: Plastic surgeon Denis Boucq holding defective silicone gel breast implants, which were removed from a patient
Undercutting competitors was not Mas’s only business technique. In 2000, following an inspection, the U.S. Food And Drug Administration (FDA) sent Mas a strongly worded letter listing 11 ‘deviations’ from ‘good manufacturing practices’.
Although not sufficient to warrant being closed down, the inspectors were concerned that the firm’s saline implants — as opposed to the silicone ones at the centre of the current health scare — were ‘adulterated’.
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Proof: Rita De Martino from Venezuela poses with her removed defective silicone gel breast implants
His financial affairs — now under investigation by the French authorities — are inextricably linked with those of Dominique Lucciardi, the mother of his two children.
The 66-year-old lives in a lavish villa in the town of Six Four Les Plages, with the couple’s eldest son, Nicolas, 27. She runs a real estate company which owns the 5 million site where the PIP factory now lies empty.
In June, Nicolas and his sister Peggy, 24, set up a company called France Implant Technology — part of a plan to relaunch a company to manufacture implants.
Mas is listed as ‘technical promotion consultant’. The company, set up eight months after PIP closed, plans to produce 400 implants every day, selling them worldwide to countries including China.
‘It’s an absurd situation,’ said a source close to the criminal investigation into Mas’s business affairs. ‘He has shut down his company because he is being sued by women across the world. Yet his family are mysteriously still trading, and doing very well.
‘Then we learn Mas is no longer with his partner and their children, with them claiming that their business affairs have nothing to do with his. It’s all far too convenient.’
Such evasiveness will not impress Mark Harvey, the head of litigation at Hugh James Solicitors in Cardiff, who represents more than 350 women who have spent between 2,500 and 6,000 for implants made by Mas’s firm.
He says the women are livid that Mas cannot be pursued in the courts because his company is in liquidation.
‘We simply can’t go after the directors. Even the insurance company behind PIP is claiming they are the victims of fraud because they did not know that PIP was using a non-medical silicone, and they can’t indemnify people outside of France,’ he says.
Instead, a group action has been launched against as many as 20 UK clinics which, it is claimed, made guarantees to the women about the provenance and safety of the implants.
Mr Harvey adds: ‘Up to three-quarters of those women I represent have had ruptures and leaks from the implants and have had them removed. The rest fear that a leak will see industrial, rather medical, silicone seep out. Mas has made money from cutting corners and provided substandard and dangerous procedures.’
However, Tim Goodacre, president of the British Association Of Plastic Reconstructive And Aesthetic Surgeons, says none of the British surgeons who used the French implants was aware that industrial silicone had been used in their manufacture.
Closed: The locked entrance of French company Poly Implant Prothese near Toulon
Mr Goodacre, a surgeon with 25 years’ experience who has used only British implants and never known one to rupture, said some UK companies that chose cheaper implants may have been motivated by cost-cutting so as to attract customers.
He backed calls by Stephen Dorrell, the former Tory Health Secretary, for implant companies to register every patient who is given one of their products. He said: ‘This is a product being put into a human body — it should have a proper audit trail for where and when it is used.’
Meanwhile, according to his lawyer, Mas will keep silent over the scandal ‘out of decency and discretion’ and says he will eventually give his side of the story when his case for aggravated fraud and manslaughter comes to court next year.
The whole affair has raised profound questions about how the breast implant industry is regulated.
Some women have lost contact with the surgeons who fitted their prosthesis and therefore do not know if their implant was made by PIP.
Who is responsible if the implant goes wrong and who should foot the bill for corrective surgery appears to be new territory for an industry where there is a scandalous lack of regulation with no proper clarity between beauty salon treatment and surgery.
Regardless of whether it involves women needing corrective surgery after a mastectomy, or those who simply want cosmetic changes to their breast size, it is vital that more is done to reform an industry in which patients’ welfare comes second to the pursuit of profits.