German safety firm held liable over French breast implant scandal

·2-min read
The faulty implants were used for hundreds of thousands of women

A Paris appeals court ruled Thursday that the German safety certification firm TUV Rheinland was liable for improperly approving faulty breast implants and ordered it to pay damages to hundreds of victims.

The latest decision in a 10-year legal battle over implants made by French company Poly Implant Prothese potentially opens the door for tens of thousands of women worldwide to receive compensation.

The implants were used for some 400,000 women, most of them in Latin America. Ruptures caused severe lymph node inflammation, and thousands of patients had to have them removed.

TUV was held responsible "due to its negligent failures and inaction in its missions and obligations in carrying out the supervision of quality systems" at PIP, the court said in its ruling, seen by AFP.

But the court dismissed a couple hundred of the cases lodged by the 2,500 plaintiffs in the case, in particular women who had the implants before September 2006.

"We are thrilled at this outcome, which puts a definitive end to any doubts about TUV's responsibility," a lawyer for the PIPA victims' association that represents around 20,000 women in various lawsuits, said in a statement.

"After 10 years of waiting and a hard fight, the German certification firm will have to fully compensate victims," he said.

TUV has faced multiple lawsuits since the scandal erupted in 2010, when French regulators discovered that implants made by Poly Implant Prothese (PIP) had been made with industrial-grade silicone gel, cheaper and more dangerous than medical-grade silicone.

- 13 inspections -

The certifier has denied any wrongdoing, with a lawyer telling the Paris court in November that PIP "did everything it could to deceive patients as well as the health authorities and TUV."

Other courts have cleared TUV of any responsibility despite its finding no causes for concern even after 13 inspections of PIP between 1997 and 2010, most recently an appeals court in the Paris suburb of Versailles.

In a statement after the ruling Thursday, TUV contested the court's decision that "some pieces of evidence could have led (the company) to take additional measures as of September 2006."

"The evidence in this case clearly shows that TUV Rheinland acted diligently, in compliance with applicable regulations, and it was not its role to track down the fraud pursuant to regulation," the company said.

A spokeswoman said TUV was studying the ruling before deciding if it will try to appeal.

Another case is ongoing in the southern French city of Toulon involving 1,500 patients, with a court expected to issue its ruling on June 11.

As a result, legal experts say any definitive ruling will most likely be decided by France's highest court, the Cour de Cassation.


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