
Legal dispute over defective breast implants
TÜV Rheinland has not sufficiently fulfilled its duty of inspection and due diligence
CC – 06/2023
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.