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BREAST IMPLANTS

German firm liable over faulty breast implants

A French court ruled on Thursday that German safety standards firm TUV was liable for a global health scare, after green-lighting French-made breast implants which were in fact defective.

German firm liable over faulty breast implants
French court rules German safety standards firm TUV was liable for a global health scare, after green-lighting defective French-made breast implants. File photo: Webhotographeer/Flickr

The court in the southern city of Toulon ruled that TUV Rheinland had "neglected its duties of checking and vigilance" after having certified that implants made by Poly Implant Prothese (PIP) conformed to European safety rules – even though they were subsequently found to have been made of substandard, industrial-grade silicone gel.

TUV Rheinland had certified that implants made by French firm Poly Implant Prothese (PIP), but the gel caused abnormally high implant rupture rates, sparking a global scare in 2011.

Six distributors of the faulty implants from Bulgaria, Brazil, Italy, Syria, Mexico and Romania are suing TUV for €28 million ($38 million), as are more than 1,600 women who were fitted with the implants – most of them from South America but also from France and Britain.

The victims are asking for €16,000 euros each, taking the total claims against TUV to €53 million euros.

An estimated 300,000 women in 65 countries are believed to have received the faulty PIP implants, and more than 16,000 women have had them removed.

However health officials in various countries have said they are not toxic and are not thought to increase the risk of breast cancer.

Proceedings against TUV began in March and Thursday's ruling in a court in the southern city of Toulon, was issued in the presence of some of the plaintiffs.

This civil trial had come on top of a high-profile criminal court case that took place in April and May in the nearby city of Marseille against PIP founder Jean-Claude Mas and four other executives.

All five are charged with aggravated fraud for using the industrial-grade silicone in implants, and a ruling on that case is expected on December 10th.

In the TUV case, lawyers for the distributors and victims had condemned the German firm for not ever having checked the implants despite all the means at their disposal, such as unexpected inspections or sample testing.

But lawyers for TUV had retorted that it was never the German firm's job to check the actual implants, and their task was only to inspect the manufacturing process.

The substandard gel was found in 75 percent of PIP breast implants, saving the company about €1 million annually, according to an ex-company executive.

The firm has since been liquidated.

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BREAST IMPLANTS

Faulty breast implants: French court orders German safety body to pay out €60 million

A French court on Friday ordered German safety certifier TUV to pay 60 million euros ($64 million) in compensation to 20,000 women who received defective breast implants that the group had approved.

Faulty breast implants: French court orders German safety body to pay out €60 million
Photo: AFP

A French court on Friday ordered German safety certifier TUV to pay 60 million euros ($64 million) in compensation to 20,000 women who received defective breast implants that the group had approved.

TUV Rhineland was ordered to make a provisional payment of 3,000 euros to each plaintiff for certifying that implants made by French firm Poly Implant Prothese (PIP) met safety standards.

In the far-reaching health scandal, the devices were later found to contain substandard, industrial-grade silicone gel that was seven times cheaper than medical-grade silicone.

“The final amount will be determined after an assessment, but (TUV) is required to make a provisional payment of 3,000 euros” per person, said lawyer Laurent Gaudon, representing 7,000 women.

Another lawyer Olivier Aumaitre, representing some 13,000 women, praised the commercial court in the southern port of Toulon for a ruling he said was inevitable given “TUV's glaring negligence”.

TUV's lawyer Cecile Derycke said the firm would appeal the latest ruling in a long-running saga.

The court “persists in ignoring very clear elements of the PIP dossier that establish that (TUV Rheinland) fulfilled its mission of a certifying body with diligence and full conformity with applicable regulations,” she said in a statement.

The Toulon court in 2013 ordered TUV to pay 53 million euros to six foreign distributors of the implants as well as 1,600 users.

But an appeals court later overturned that decision, saying that TUV had fulfilled its obligations as a certifying body and could not be held responsible for failing to detect PIP's cover-up.

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

The court said that if TUV staff had carried out “the slightest unannounced inspection… the fraud would have been easily detected.”

The scandal made global headlines in 2011, the year after doctors first noticed abnormally high rupture rates in the implants.

Some 300,000 women in 65 countries, most in Latin America, are believed to have received the faulty implants.

PIP's founder, Jean-Claude Mas, was convicted of fraud and sentenced to four years in jail in 2013, confirmed on appeal in 2016.

Toxicity ruled out

Mas was ordered to pay a fine of 75,000 euros and was banned from working in the health sector or running a business

He has appealed that ruling.

Two other pending legal cases are pending against Mas, one for involuntary manslaughter — the implants were suspected in several deaths from systemic toxicity — and another linked to the financial implications of the scandal.

He always denied the implants posed any health risks.

In a setback for the plaintiffs, a scientific panel mandated by the European Commission concluded in May 2014 that the implants could not be linked to toxicity and users did not have to remove them as a precaution.

Thousands of women have had the implants removed, even though health officials in several countries have said they are not toxic and are not thought to increase the risk of breast cancer.

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