German certifier back on trial over faulty breast implants

A Paris appeals court Tuesday began hearing a case against a German safety certifier accused of improperly approving breast implants that were at risk of rupturing, causing health scares for thousands of women around the world.

In a far-reaching scandal that emerged in 2010, implants from the French firm Poly Implant Prothese (PIP) were also later found to have been made with industrial-grade silicone gel, cheaper and more dangerous than medical-grade silicone.

The implants were used for some 400,000 women, most of them in Latin America, and thousands had to have them removed.

The German certification firm, TUV Rheinland, was originally cleared of any liability by a court in the southern French city of Aix-en-Provence in July 2015.

But in August 2018, France’s supreme court for criminal matters ordered a retrial, saying TUV was responsible for “testing the breast implants and checking the producer’s documentation on purchases of supplies.”

It sent the case back to the Paris court of appeal.

Prosecutors had claimed at TUV’s first trial that despite 13 checks carried out at PIP sites from 1997 to 2010, no regulatory violations were detected.

But TUV’s lawyers argued Tuesday that the German firm was also deceived by PIP’s founder Jean-Claude Mas, who was convicted of fraud and sentenced to four years in jail.

His company was shut down in 2010, and Mas died in 2019 while still fighting his conviction.

“PIP misled the national health authorities as well as TUV,” lawyer Christelle Coslin told the court. “The guilty party is notably absent from this trial.”

Laurent Gaudon, a lawyer representing French victims, said that while TUV “was without a doubt a victim of a fraud,” it should have detected the cover-up.

TUV has already been ordered by several French courts to compensate victims, including a 2017 ruling requiring a deposit of 60 million euros ($71 million) for potential compensation for 20,000 women.

TUV appealed that ruling, and a decision is expected in February.

The firm has some 20,000 employees worldwide, and generates annual sales of around two billion euros.