What is the PIP scandal?
PIP was a company founded in 1991 by Jean Claude MAS, specializing in the manufacture and sale of breast implants, and located in the town of La Seyne sur Mer, France.
PIP manufactured breast implants filled with silicone gel. In the companies design brief, PIP claimed to use a NUSIL medical silicone gel.
From the mid-2000s, a large number of women with PIP implants and their surgeons started to complain of an abnormal rate of rupture, (sometimes ruptures occurred just a few months after surgery) and for a number of victims, the appearance of lymphadenopathy (siliconosis) resulting from leaking PIP implants.
It was in this context that the French Health safety agency (AFFSAPS) in March 2010 made an unexpected inspection of the PIP factory.
During this inspection, the AFSSAPS discovered a terrible fraud: PIP were not using the medical grade gel NUSIL but a much cheaper industrial gel normally used for the sheathing of electrical wires.
Given the seriousness of the fraud, and the associated health risks, the AFSSAPS recommended that women with PIP implants around the world get emergency surgery and have these potentially dangerous implants removed.
The French Minister of Health decided to shut down the factory and ban the sale of PIP implants worldwide.
More than 400,000 women were involved.
What is known about the dangers of PIP implants?
In truth there is a great deal of uncertainty about the long-term toxic effects of PIP implants.
Very few scientific tests have been carried out on the dangers of industrial grade silicone in the body.
Nevertheless a French AFSSAPS inspector (now ANSM), Mr GUISLAIN, told the French judges that the PIP implants caused an unusually high proportion of inflammatory problems compared to other brands.
Rouen University Hospital Center (France) published a study in 2012 which indicated that out of 99 patients observed, 51 of them had had complications with PIP implants. And of these 51 patients:
– 17 of them had a rupture of their implants
– 28 adenopathies
– 8 had intra-mammary cysts and siliconomas
– 35 experienced chronic chest pain
Beyond physical injuries and illnesses, all victims have suffered and, in many cases, continue to suffer a great deal of anxiety. All will have to undergo unwanted surgery to remove PIP implants. The courts consider that this is an injury and suffering.
The damages are therefore:
– Financial (cost of successive interventions)
In this type of case, the courts award sums ranging from 8000 euros or more.
What injuries do PIP victims suffer?
Many different physical problems have been observed in thousands of victims including siliconomas, lymphadenopathies, night sweats, unexplained blood poisoning, inflammations, joint pain etc.
Pain under the arms, in the chest, unexplained fevers, multiple silliconomas, ganglia, are typical. Many women have had to stop breastfeeding their children.
Tragically, there have been fatalities from a newly recognised cancer, BIA-ALCL (breast implant associated anaplastic large cell lymphoma) also known as breast implant cancer that has been directly linked to textured silicone implants. The first recorded deaths from BIA-ALCL were women with ruptured PIP implants.
Who Is Responsible?
• PIP Implant Manufacturers
PIP executives have all been convicted. The President of the company PIP, Mr. Jean Claude MAS was sentenced to a prison term.
• CE Mark Regulators: TÜV RHEINLAND
TÜV RHEINLAND, a German company, was responsible for annually inspecting the PIP company and verifying that it manufactured the implants according to its design file. Between 1997 and 2010, TÜV RHEINLAND certified that PIP implants were safe and manufactured in accordance with the law (and their design file). It is thanks to this certification that the company PIP was entitled to affix the “CE” Mark on its implants. It is because there was a “CE” mark, PIP implants were sold all over the world.
Concerns have been raised that TÜV RHEINLAND did not carry out proper controls at PIP.
Several faults have been noted and highlighted by GAUDON & Associés:
– no unannounced/surprise checks (TÜV always gave PIP three months prior notice)
– no implant testing (TÜV argues it is not obliged to test)
– no taking into account the alarming figures of the number of ruptures and leaks reported to AFSSAPPS
– a class-action launched in Great Britain in 2006 did not alert TÜV Rheinland to potential problems at PIP
– an unannounced inspection at PIP in 2000, by the FDA (American health agency) had already highlighted the problems at PIP. The FDA issued a “warning letter”, an official document (published on the internet) in which it banned the importation of PIP breast implants in the USA.
– a lack of trained staff at PIP
– the audits at PIP were not carried out by TÜV RHEINLAND but by a French subsidiary which was authorized to audit electrical devices but not breast implants.
In November 2013, GAUDON & Associés obtained the condemnation of the company TÜV RHEINLAND to compensate 1,500 victims. (TUV I)
In 2017, GAUDON & Associés obtained the conviction of TÜV RHEINLAND on behalf of 6,500 additional victims. (TUV II)
The scale and enormity of the PIP fraud and the reluctance of the medical profession and the government health agencies to take action, let alone acknowledge the problem, is a scandal.
Laurent Gaudon and his team have fought tirelessly against the odds alongside PIP Action Campaign for over eight years to hold to account all those who allowed such a horrific medical fraud to happen.
The 10th October 2018 judgment against TÜV and their efforts to deny responsibility will finally allow the PIP victims to get both recognition and compensation for their suffering.
Your Claim With GAUDON & Associés
Today, GAUDON & Associés can claim to be the most competent, successful and specialised law firm in the PIP health scandal. GAUDON & Associés is recommended by PIP Action Campaign members on TUV I and TUV II.
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