Illegal breast prostheses: around 400,000 women will be compensated worldwide

The Paris Court of Appeal today confirmed the responsibility of the German certifier TÜV Rheinland in the case of fraudulent breast prostheses Poly Implant Prosthesis (PIP). With this failure, the French company will have to compensate the victims who, according to estimates, are around 400,000 in the world.

After more than a decade of proceedings and a series of contradictory judgments, the court ruled that the German company is responsible “for its shortcomings and abstentions in the respect of its missions and obligations in the control of the quality system” of the prostheses of the French . PIP company.

However, the court limited this liability to the period from September 1, 2006 to April 6, 2010. Thus, among the some 2,500 women who joined the proceedings, several hundred cases were deemed “inadmissible”, according to the AFP agency.

Between 2001 and 2010, a million fraudulent prostheses from the manufacturer Poly Implant Prosthesis (PIP) They were sold all over the world and, for the most part, in Latin America. The number of victims worldwide is estimated to reach 400,000 people.

The PIP breast prosthesis scandal became public in March 2010, when it was learned that the company was using silicone gel not approved for medical use instead of freezing Nusil authorized, which he claimed to use.

This adulteration – in order to reduce costs – caused a much higher rate of internal rupture in women who have had it, mainly in Latin America and to a lesser extent in Europe. The scandal led to its global ban and triggered alerts about failed health checks.

The cataract lawsuits brought by victims in different countries have led to jail time for the brand maker and a financial penalty for the German certifier who approved the implants.

“After 10 years of waiting and hard fights, the German certifier will have to fully compensate the victims. We are very satisfied with this decision, which definitively puts an end to the doubts about the responsibility of TÜV.“Said Dr Olivier Aumaître, lawyer for some 20,000 victims, in a press release.

The TÜV was found guilty in 2013 of “failure to fulfill its obligations of control and surveillance” and ordered to compensate six distributors and some 1,700 victims. However, two years later, the Aix-en-Provence Court of Appeal reversed this judgment and released the German certifier from all responsibility. In 2018, the Supreme Court overturned this decision and referred the case back to the Paris Court of Appeal..

What happened also involved a turning point in the controls of implants and medical devices that entered Argentina. Until then the country had been imported 13,500 defective PIP prostheses, according to data provided by the National Administration of Drugs, Food and Medical Technology (ANMAT).

“This is a high number. The entry into the local market for these prostheses was almost exclusive because they were inexpensive. Being very cheap and coming from France, many came», He explained to Infobae Virginia Luna, lawyer for 1,500 Argentinian victims within the framework of the collective trial initiated in our country and in France.

Until it was known that the PIPs contained adulterated silicone, ANMAT had only received two reports of ruptures, despite the fact that the rate of reported incidents worldwide was much higher. According to a report from the National Health Service, the British health service, PIP implants had a higher gel rupture and leakage rate – 2 to 6 times – than other implants within five years of implantation.

Finally, in February 2013, three years after the first alert, ANMAT published a new regulation – provision 727/13 – which established new controls and requirements to authorize implants and medical devices, including the adoption of Mercosur technical regulations for medical products.

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