Court clears German safety body in breast implant scare

A French appeals court on Thursday cleared German safety standards body TUV of liability in a faulty breast implant scandal, meaning hundreds of women will have to pay back damages they received.

The ruling overturns a decision by a lower French court in 2013 which had found TUV liable and ordered it to pay millions of euros in compensation to victims and distributors.

TUV certified that implants made by French firm Poly Implant Prothese (PIP) conformed to safety rules—even though they were subsequently found to contain substandard, industrial-grade silicone gel.

The agency has maintained it was never its job to check the actual implants, and their task was only to inspect the manufacturing process.

The appeals court in the southern city of Toulon found that TUV and its French subsidiary had "fulfilled the obligations incumbent upon them as a certifying body (and) committed no error engaging their criminal responsiblity."

"This decision absolves TUV of any responsibility and confirms that the decision of the Toulon commercial court in 2013 was unfounded," said Cecile Derycke, a lawyer for the body.

The scandal first erupted in 2010 after doctors noticed abnormally high rupture rates in PIP implants. The affair made global headlines in 2011, with some 300,000 women in 65 countries believed to have received the faulty implants.

Six distributors of the implants from Bulgaria, Brazil, Italy, Syria, Mexico and Romania sued TUV for a total of 28 million euros ($38 million).

Nearly 1,700 women who were fitted with the implants—most of them from South America but also from France and Britain—also asked the German firm for 16,000 euros each, taking the total claims against TUV to 53 million euros.

The German body was ordered to compensate "the damage (done to) importers and victims".

The lower French court ordered the German body to pay the women 3,000 euros ($3,300) each in compensation while waiting for individual medical or financial assessments to be conducted on each plaintiff.

TUV paid out a total of 5.8 million euros.

"With this decision the victims find themselves among the accused and will have to pay the money back to the certifier which, according to the appeals court, has done its job perfectly over the past 15 years," said Laurent Gaudon, a lawyer for the victims.

The women "will technically have to pay back this money but no decision has been taken on a request for reimbursement," said a source close to the safety body.

PIP's founder, Jean-Claude Mas, was convicted of fraud and sentenced to four years in jail in 2013 over his company's use of cheaper industrial-grade rather than medically approved silicone in its breast implants.

He denied the implants posed any health risks.

More than 16,000 women have had the implants removed since they were revealed to be faulty, despite health officials in several countries saying they are not toxic and are not thought to increase the risk of breast cancer.