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TÜV sentenced to high compensation payment for poor quality breast implants
A new verdict was made in the scandal surrounding the defective silicone breast implants of the French manufacturer Poly Implant Prothèse (PIP). A court in France has ordered the German TÜV to pay 60 million euros for negligence. However, the latter does not want to accept the judgment.
3,000 euros each for 20,000 applicants
In a scandal involving defective breast implants from the French company PIP, TÜV Rheinland was sentenced by a commercial court in Toulon in southern France to pay 60 million euros in damages, reports the AFP news agency. The court therefore accused the TÜV of inadequate controls and awarded around 20,000 applicants each 3,000 euros. According to the information, the German testing company, which had certified the manufacturing process of the low-quality silicone implants, immediately announced an appeal.
A court in France has ordered TÜV Rheinland to pay damages of EUR 60 million. The test company is said to have insufficiently checked defective breast implants. (Image: Aarrttuurr / fotolia.com)
Health risks from breast implants
It was already known in 2010 that the French company Poly Implant Prothèse (PIP) had been filling its breast implants with cheap industrial silicone instead of special silicone for years. It was shown that the pillows can tear more easily and cause inflammation.
Even then, the health risks from breast implants from PIP had been pointed out.
It can be assumed that the risk of silicone escaping from the implant shell of PIP products is several times higher than that of high-quality implants and increases with increasing wearing time, wrote the Federal Institute for Drugs and Medical Devices (BfArM) years ago.
"Leaked silicone can lead to local tissue reactions as well as being distributed in the body and e.g. accumulate in the armpit lymph nodes, ”the experts explained. From the BfArM's point of view, “medium and long-term health risks in connection with PIP silicone-filled breast implants cannot be excluded”.
Scientists also reported that breast implants can cause cancer.
TÜV controlled silicone cushions not
According to the AFP report, tens of thousands of women have had PIP implants worldwide, and it has been estimated that around 6,000 women in Germany. Many are said to have had the implants removed by surgery.
The TÜV certified the manufacturing process at PIP, but did not check the silicone cushions itself.
The legal dispute has dragged on for years. In November 2013, the TÜV was ordered by the Commercial Court in Toulon to pay damages to 1,700 women affected and to several dealers for violating its "inspection and supervision obligations".
In 2015, this judgment was overturned by the court of appeal in Aix-en-Provence in southern France. According to the judges, the TÜV had fulfilled its inspection obligations and made "no mistake".
In Germany, affected women were only subject to a dispute over PIP breast implants last year. According to a ruling by the Higher Regional Court in Karlsruhe, neither the doctors nor the insurers of PIP have to be liable.
Fraud could have been "easily exposed"
The commercial court of Toulon now convicted the TÜV in a lawsuit with significantly more applicants. The exact amount of the payments is still to be determined on the basis of expertise, but the TÜV is to make preliminary payments totaling EUR 60 million.
According to the agency, the court argued that TÜV Rheinland had not checked the “compliance between the purchase of the various necessary components and the manufacture of the breast implants”. However, this is a "crucial and essential basis of controls", which is required by EU law.
In addition, some TÜV employees did not have the necessary approvals to participate in the annual inspection visits. Furthermore, the TÜV PIP did not make any unannounced inspection visits that "easily exposed the fraud".
Company founders sentenced to imprisonment
While plaintiffs' reaction to the decision was "extremely satisfied", TÜV lawyer Cécile Derycke criticized: "The Toulon Commercial Court misjudges and ignores the clear statements of the Court of Appeal (from Aix-en-Provence) in this case", according to which the TÜV carries out its duties "responsibly." and perceived in accordance with all applicable laws and norms ”.
"Against this background, it is irresponsible to award the provisional amounts and to declare the judgment enforceable for the time being. We will attack that before the appeals court. "
The TÜV repeatedly emphasized that the implant manufacturer himself had been deceived. We are talking about a "large-scale and complex fraud".
According to AFP, PIP founder Jean-Claude Mas was found guilty of fraud against the women concerned and the TÜV in two criminal cases and sentenced to four years in prison.
In Germany, a lawsuit even went to the Federal Court of Justice (BGH) in Karlsruhe, which brought the case to the European Court of Justice. This is intended to clarify how extensive the inspection requirements for the certification of medical devices are. (ad)