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Faulty breast implants TÜV should pay about 60 million euros in damages
In the scandal around the faulty silicone breast implants of the French manufacturer Poly Implant Prothèse (PIP), a new verdict has been made. A court in France has the German TÜV for negligence for the payment of 60 million euros. However, he does not want to accept the verdict.
3,000 euros each for 20,000 applicants
The TÜV Rheinland has been convicted in the scandal of defective breast implants of the French company PIP by a commercial court in Toulon, southern France, for the payment of 60 million euros in damages, reports the AFP news agency. The court therefore accused the TÜV of insufficient controls and awarded around 20,000 claimants 3,000 euros each. According to the information, the German testing company, which had certified the manufacturing process of the inferior silicone implants, announced an immediate appeal.
Health risks due to breast implants
Already in 2010 it became known that the French company Poly Implant Prothèse (PIP) filled its breast implants for years with cheap industrial silicone instead of special silicone. It turned out that the pillows are easier to tear and cause inflammation.
Even then, the health risks of breast implants from PIP had been pointed out.
It is "to assume that the risk of silicone leakage from the implant case for PIP products compared to high-quality implants is increased many times and increases with increasing wearing time," wrote the Federal Institute for Drugs and Medical Devices (BfArM) years ago.
"Leakage of silicone can lead to both local tissue reactions as well as being spread throughout the body and can occur e.g. accumulate in the lymph nodes of the armpit ", explained the experts. According to the BfArM, "medium and long-term health risks associated with PIP silicone-filled breast implants can not be ruled out".
Scientists also reported that breast implants can cause cancer.
TÜV controlled silicone pad not
According to the AFP report, tens of thousands of women were implanted worldwide with PIP implants; in Germany, it was estimated that around 6,000 women were women. It is said that many opted for surgical removal of the implants.
The TÜV certified the manufacturing process at PIP, but did not control the silicone pads themselves.
The lawsuit has dragged on for years. In November 2013, TÜV was ordered by the Commercial Court in Toulon to pay compensation to 1,700 affected women and to several traders for violating its "control and oversight responsibilities".
In 2015, this judgment was set aside by the Appeal Court in Aix-en-Provence, southern France. According to the judges, the TÜV met its inspection obligations and committed "no mistake".
In Germany affected women only in the last year in the dispute over PIP breast implants. According to a ruling of the Higher Regional Court of Karlsruhe, neither the physicians nor the insurer of PIP have to be liable.
Fraud could have been "easily revealed"
The Commercial Court of Toulon now condemned the TÜV in a process with significantly more applicants. Although the exact amount of payments should still be determined on the basis of expert opinions, the TÜV should make provisional payments totaling 60 million euros.
According to the agency, the court argues that TÜV Rheinland did not verify the "compliance of the purchase of the various necessary components and the manufacture of the breast implants". However, this is a "crucial and indispensable basis of controls" required by EU law.
In addition, some TÜV employees would not have had the necessary approvals to attend the annual inspection visits. Furthermore, the TÜV PIP had not carried out unannounced inspections that "would have easily exposed the fraud".
Founder sentenced to imprisonment
While plaintiff lawyers responded to the decision "extremely satisfied", TÜV lawyer Cécile Derycke criticized: "The Commercial Court Toulon misjudges and ignores the clear findings of the Court of Appeals (of Aix-en-Provence) in this case," according to which the TÜV "responsibilities and in accordance with all applicable laws and standards.
"Against this background, it is irresponsible to award the payment of provisional amounts and declare the judgment provisionally enforceable. We will attack that in the appellate court. "
The TÜV has repeatedly stressed that it has even been deceived by the implant manufacturer. There is talk of a "large-scale and complex fraud".
According to AFP, PIP founder Jean-Claude Mas was convicted in two criminal cases of fraud against the women and the TÜV and sentenced to four years in prison.
In Germany, a complaint even went to the Federal Court of Justice (BGH) in Karlsruhe, which has submitted the case to the European Court of Justice. This should clarify how extensive the testing obligations in the certification of medical devices. (Ad)