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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New cancer fears over breast implants in France

The question of whether to ban breast implants in France has once again been raised after reports revealed a rise in the rate of a rare cancer that has been linked to the prosthetics.

New cancer fears over breast implants in France
New fears raised in France over the dangers of breast implants. Photo: Webphotographer/Flickr

France is once again asking itself the question about the dangers of breast implants and more specifically how likely they are to cause cancer and whether they should be banned.

France's national cancer institute said on Tuesday there was a "clearly established link" between a rare form of cancer and a certain type of breast implant, as the health minister sought to allay fears.

The national cancer institute (INCa) said there had been 18 cases of the rare disease — anaplastic large cell lymphoma — since 2011, linked to silicone breast implants.

Given the rarity of the cases, the INCa said there was no need to recommend the removal of the implants.

"This complication presents very infrequently," the body said.

Although the number of cases reported since 2011 are low given the fact around 400,000 women in France have implants. But they are rising year on year, to the concern of cancer experts.

French health authorities have said that they will take all the necessary steps if experts advise them to do so.

“If we need to take action to ban them then we will,” said François Hébert from France’s national drug and health agency (ANSM), which will meet in 10 days to discuss the reports.

In France around 400,000 women are believed to have had breast implants inserted, 83 percent for aesthetic reasons and 17 percent for reconstructive surgery.  

“It’s been decided that women who are intending to have breast implants put in should be warned of this new risk, even if it is fairly weak,” said Hébert.

Hebert said that out of the cases of cancer reported one person has died.

France's Health Minister Marisol Touraine has tried to ease fears saying it's not recommended that women start making appointments to have the implants removed and that the public should not fall victim to "unnecessary panic".

She added that no particular brand of implant had been placed under suspicion of causing the cancers. "We will remain absolutely vigilant," she said.

According to analysis by Le Parisien newspaper the cancer appears to be caused by inflammation which occurs around the surface of the implant.

France has long been concerned by the possible detrimental impact of breast implants on women’s health ever since the scandal broke that the firm PIP was saving millions of euros by using industrial-grade gel in 75 percent of the implants. 

It only came to light after an unusual number of ruptures.

PIP's founder Jean-Claude Masa, who was dubbed "the sorcerer's apprentice of implants" was jailed in 2013 for fraud.

In May last year the ANSM said that despite measures taken to avoid a repeat of the recent global healthcare sparked by faulty French implants, the industry could do a lot more to improve safety and inform women of the potential dangers. 

And it said it had ordered a French and a South Korean breast implant company to stop selling their products in France as they did not meet safety standards. 

The report, carried exclusively by Le Parisien newspaper, said that 2,169 women had since 2010 reported that their breast implants had ruptured. 

It said this figure was separate from the cases of women who had implants made by the French firm PIP.