TÜV Rheinland has not sufficiently fulfilled its duty of inspection and due diligence

On 25 May, the French Supreme Court confirmed the responsibility of TÜV Rheinland in the affair concerning the defective breast implants of the French manufacturer Poly Implant Prothèse (PIP). The judges of the French Court of Cassation declared in their judgement that TÜV Rheinland had not fulfilled its duties of inspection, due diligence and vigilance when testing the implants.

The Court of Cassation dealt with four rulings by French Courts of Appeal on compensation for victims of the scandal. Among other things, a ruling by the Versailles Court of Appeal, which had seen no liability on the part of TÜV Rheinland, was overturned. Another is partially reviewed again. The cases were sent back to the Lyon Court of Appeal. The ruling by the Court of Final Appeal is a step on the way to compensation for tens of thousands of affected women.

Review

The health scandal involving defective breast implants was uncovered by French health authorities in March 2010. The implants of the now insolvent manufacturer PIP were filled with cheap industrial silicone instead of a prescribed silicone gel. The implants are more prone to tearing and the silicone gel being more fluid is more obvious and can penetrate the surrounding tissue. Thousands of women had to be re-operated.

As product certifier, TÜV Rheinland was responsible for certifying PIP's quality assurance process. The number of women with PIP implants is estimated at 400,000 worldwide. Thousands of women around the world have been affected by the fraud perpetrated by the PIP company.

Medical Device Regulation

In response to the defective breast implant scandal, the Medical Device Regulation (MDR) was adopted in 2017. It represents fundamental changes in the approval process for medical devices. The aim is to improve the quality, safety and performance of medical devices. Around 20,000 instruments, devices and aids need to be (re)certified. In spring 2023, the MDR transition periods were extended to avoid bottlenecks.