Concerning latest media articles concerning Silicone-filled breast implants
Cologne, 30 December 2011. Concerning latest media articles about PIP, Hartmut Müller-Gerbes, Head of Media Relations TÜV Rheinland, says:
TÜV Rheinland has in February initiated proceedings against Poly Implant Prothèse with the French prosecution service in Marseille. PIP continued to mislead TÜV Rheinland as the experts were shown the conforming silicone and the correct documents during the inspections that were regularly performed at PIP production site. Therefore, the TÜV Rheinland auditors must have the impression that the production was operated correctly.
When the TÜV Rheinland inspectors had left the production plant the conforming silicone was replaced by another silicone. On Wednesday, 28 December 2011 the former Managing Director of PIP, M. Jean-Claude Mas has confirmed this statement through his lawyer.
The conformity evaluation for the implant carried out by TÜV Rheinland in accordance with the European Directive on medical products, includes not a product test on the implant itself. The verification of the product documents also the audit of the quality management system at the companies' facilities were carried out by TÜV Rheinland in compliance with the legal regulations. The audits had been properly carried out by TÜV Rheinland (and one of the requirements says that audits must be announced to the factories' management.)
Following the applicable European approval procedure TÜV Rheinland has verified the product documents of the implants and has neither carried out product tests on the implants nor was the silicone tested that was used for the implant production.
As part of the conformity evaluation, the manufacturer was obligated to report any changes to the approved product design. However, no such changes were ever reported to TÜV Rheinland. Nevertheless, Poly Implant Prothèse did make changes to the silicone-filled breast implants, which involved the use of a type of silicone which was the subject of a complaint by the French supervisory bodies in 2010 and which had not been approved for this application by TÜV Rheinland. These non-conformities in production came to the knowledge of TÜV Rheinland in spring 2010. We immediately annulled the certificate we had granted as soon as we heard of the discrepancies on 26 March 2010. As a result, TÜV Rheinland has lodged a criminal complaint against PIP. TÜV Rheinland also informed the German Federal Institute for Drugs and Medical Devices (BfArM) at the same time of the situation in France.
TÜV Rheinland, Hartmut Müller-Gerbes, Head of Communication, Tel.: +49 2 21/8 06-4355