Poly Implant Prothèse (PIP): the scandal of defective breast implants

The death of a woman recipient of PIP defective breast implant in November 2011 revived the debate over this problem in which Poly Implant Prothèse (PIP), a French company specializing in breast implants, is incriminated.
Article updated on 27/02/2019

Photo credit: US Gov.Founded in 1991 by Jean-Claude Mas, this company, number three on the international market, manufactured up to 100 000 implants a year, 84% of which designed for export, especially to Latin American countries.

As of 1996, the company’s practices have draw the attention of the French health authorities. Numerous anomalies have been picked up: non compliance with some regulations, huge non-conformities, high risk of implant rupture, inadequate guaranties. On three occasions between 1996 and 2001, the French agency of health safety for health products (Afssaps) had to suspend the marketing of PIP products.

Ever since, no other inspection of the factory premises followed on part of Afssaps. Until its bankruptcy in 2010, PIP had been controlled by the German certifying agent TÜV Rheinland which, upon each visit, granted PIP the CE label enabling the firm to sell its products. On each inspection, Poly Implant Prothèse’s proprietor, Jean-Claude Mas induced TÜV Rheinland to believe he had been using certified gel, clearing away, with the help of its staff members, any sign of non standard products.

PIP breast implants scandal: extremely harmful breast protheses

It was following an unannounced check carried out in March 2010, that Afssaps succeeded in unveiling the fraud and decided to withdraw definitively PIP breast implants from the markets. Six months later, the French health ministry asked the 30 000 French women to have the devices removed. By the end of January 2012, roughly 1 400 cases of implant rupture and 900 inflammatory reactions have been reported in France.

Used with permission from MicrosoftFor more than 20 years, PIP has managed to by-pass controls, manufacturing breast implants that are extremely harmful to health. Between 400 000 and 500 000 women scattered around 65 countries may have received this kind of implants.
Jean-Claude Mas has acknowledged having knowingly concealed the existence of “in-house” gel from TÜV Rheinland, a sub-standard industrial silicone which costs one tenth as much as medical gel. This deceitful practice has enabled the company to make savings of approximately 1 million EUR (1.3 million USD) a year.

PIP breast implants: lawsuits

A series of lawsuits targeting the different actors involved in the defective breast implants PIP scandal have ensued. The Poly Implant Prothèse company owner sued for "aggravated tort of deceit" and "bodily harm and manslaughter" was placed on probation against the payment of 100 000 EUR (132 266 USD) bail which will be used to indemnify some of the victims.

On 2 May 2016, Jean-Claude Mas was sentenced to four years in prison, fined 75 000 EUR (85 903 USD) and disqualified to practice in the field of health and management of any company.

Additional charges are also currently pressed against: the German certifying agency TÜV Rheinland and French agency Afssaps for breach of duty, surgeons and clinics for information gaps.

On January 20, 2017, the Commercial Court of Toulon ordered TÜV Rheinland to pay, as a provision, 60 million euros to the 20 000 victims of PIP prostheses.

PIP breast implants: victims’ compensation

The indemnification of the PIP implants' victims sounds complicated as Poly Implant Prothèse was placed under judicial winding-up in March 2010, making it unable to intervene to provide redress. The patients will not be able to benefit from PIP’s third party liability insurance, either, as the company has recognized having knowingly used sub-standard products. Non-compliance with the requirement of the legal standards in force stands as a guarantee exclusion for insurance.

Accordingly, Allianz, the insurer of PIP between 2005 and 2010, claimed that the insurance contract with the incriminated company is null and void, blaming the defective breast implants manufacturer for having acted deceitfully and knowingly concealing the risks related to these implants.

PIP breast implants: victims' compensation in France

The French health authorities recommend that PIP breast implants be removed from all women concerned, as a precautionary measure.
A special fund is likely to be established by the Office National d’Indemnisation des Accidents Medicaux (ONIAM). The latter can only compensate women who underwent remedial surgery (following cancer for instance), that is, 20% of the patients.
The cases pertaining to implant devices for aesthetic purposes (80% of overall cases) shall be examined by the Commission d’Indemnisation des Victimes d’Infractions (CIVI).
The State is to intervene also by setting up a public fund for the compensation of victims, similar to the one established for the case of the Mediator, a hazardous antibiotic which has been marketed for 35 years claiming the lives of 500 to 2 000 people.

PIP breast implants: victims' compensation worldwide

Image provided to Microsoft by iStockphoto. Used with permission from MicrosoftFor the other regions affected by the PIP implants, the recommendations and provisions, considered by the health authorities, differ from one country to another.
Nonetheless, victims worldwide are concerned about their health, especially about the cost of the surgeries required to remove and replace the implants.

As health care institutions, practitioners and distributers have denied responsibility in this scandal, victims will have their respective health authorities to blame for having authorized the implants on their markets.
A pool of 500 Argentine victims, and as many Venezuelans, have already pressed charges in the case of the flawed implants. These complaints should be added to another 2500 cases filed at Marseille’s district attorney general.
Furthermore, many South American women pooled up into an association with a view to claiming repair while an indemnification fund for foreign victims could be set up by the French and European authorities.

PIP breast implants: huge damages

Given the number of the women victims of the defeactive PIP breast implants case, the financial damage will be enormous.

The damage of “aggravated tort of deceit” will be indemnified at 10 000 EUR (13 226 USD) per patient. With over 300 000 victims worldwide, damages could easily amount to more than 3 billion EUR (3.9 billion USD).
As to "manslaughter", bodily injury will be assessed on the case per case basis.

PIP breast implants: main affected countries

CountryvictimsRecommendations and official reactions
United Kingdom
42 000
Surgeon consultation and medical monitoring but not recommendation for implant removal.
33 000
Free removal of defective PIP implants in public hospitals, implant resetting will not be covered.
30 000
Implant removal recommendation. Coverage will apply only to plastic surgery.
25 000
Tightening medical check-ups. Coverage of check-ups and surgery for ruptured implants.
15 000
The government will cover implant removal. Reimplantation will apply only to women having had cancer.
15 000
Medical control of implants
12 300
No evidence regarding abnormal rupture risk of PIP implants. No removal recommended.
10 000
Recommendation for PIP implants removal.
5 000
Health authorities will cover surgical procedures deemed necessary.
5 000
Free removal if need be in public hospitals and free replacement implant for women having had cancer.
4 500
Recommended medical monitoring
Czech Rep.
2 000
Recommendation for the removal of all implants.
1 500
Coverage only in case of implantation in a public hospital and for plastic surgery.
1 100
Tightened medical check-up
1 000
Recommendation for the removal of all implants.
Recommended medical monitoring
Coverage of removal and reimplantation in the event of complications and if the initial implant has been reimbursed.
Surgeon consultation and tightening medical monitoring
Semi-yearly check-ups recommended and removal in the event of rupture or risk of PIP implant rupture.
Regular check-up and no removal
Implant removal and replacement will be covered by the Caisse Sociale Monégasque” (Monaco’s social fund).
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