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Implants scandal: Europe ignored French warnings

media A PIP breast implant REUTERS/Eric Gaillard

France, which was hit by a breast-implants scandal in 2010-11, has called for tighter controls of medical prostheses at European level. But other states opposed the move, which has been shown to have been desperately necessary by an investigation published in media around the world this week.

The "Implant Files", researched by over 250 journalists from the international consortium of investigative journalists, has revealed that implants including insulin pumps, pacemakers and breast implants are getting European safety certification with virtually no oversight.

A group of Dutch journalists managed to get a mandarin net passed as a vaginal net, while an increase in cancer among French women has been attributed to breast implants.

European certification lax

Companies who intend to market prostheses must seek safety certification at European level.

And that is incredibly easy, according to Emeline Cazi, who worked on the Implant Files for France's Le Monde newspaper.

"Sometimes just a letter was enough to get an implant onto the market," she told RFI. “A simple letter is enough or a mandarin net. All of this international investigation began with an experiment carried out by a Dutch journalist which got confirmation that a mandarin net could get the CE certification from a notified organism.”

France's PIP scandal

In France such scandals are not new.

In 2011 Frenchman Jean-Claude Mas went on the run after it was found that his breast implant company, Poly Implant Prothèse (PIP), was endangering the health of tens of thousands of women around the world by using unauthorised silicone gel.

He was tracked down and jailed in 2012.

France has tried to get European legislation tightened up but to no avail.

“Getting European certification for implants is completely different from medicine and drugs," Cazi says. "For drugs you need authorisation to put them on the market, controlled by medical authorities in each country, and to get this authorisation the manufacturer has to show that clinical trials have been carried out on humans.

The procedure is much more lax where medical implants are concerned.

"A manufacturer just needs this CE certificate so you pay a private company, a notified organism, you show them your requirements specification and explain that your product is produced in the way you’ve explained it in your specifications," Cazi explains. "So It’s really, basically, just documentation about technical documentation and at no moment is the product itself quality-controlled. “

French system not used

If there is a problem after that there is, in theory, a reporting system in France but Cazi says it is not working properly.

Health professionals are supposed to notify the the national medical products watchdog, ANSM, when there is a problem with a medicine or device.

"But, whereas for drugs the failure to report an incident is approximately 10 percent, for medical devices only one percent of health professionals respect the law and declare these incidents,” she says.

This is parly because the medical profession still is not accustomed to using the warning system.

"It takes time. After a busy day you don't necessarily want to fill in that form. And the surgeons are often in contact with the manufacturers. They'll call them and say 'Listen, these prostheses, some burst. Can you change the batch.' So things can be arranged between the manufacturer and the surgeon without anyone knowing about it and without the incident being notified officially."

In July 2018 Implant Files reporters gained access to the ANSM's database.

It had 181,853 incident reports but more than 28,000 of them gave no explanation of what had gone wrong. More than 125,000 led to no decision from the ANSM.

“We imagined there would be a sophisticated peace of software in France which would provide a system of alert. That’s not at all the case,” another Le Monde journalist, Chloé Hecketsweiler, told France Télévisions.

"The exercise has is limits. Clearly France doesn't yet have a perfect warning system,” ANSM implants specialist Jean-Claude Ghislain admitted.

But more resources have been provided, he says. "If you look at the number of alerts each year, they’re increasing. That suggests things are already improving.”

When things go wrong

In a programme called Implants, all guinea-pigs France 2 TV’s Cash Investigation shows how bad things can be when implants go wrong and can’t be removed.

The programme talks to a woman who had a Prolift vaginal implant. Her life has been ruined. The implant can’t be removed, she’s now totally dependent on painkillers.

Prolift, which was invented by French doctors and commercialised by an American laboratory, is meant to stop organs slipping. But, after a deluge of complaints, it is now banned in France and the US.

“I was surprised that the problems with all these implants did not lead to more research on animals, to go a bit further, before being rolled out on a big scale," comments gynaecologist-obstetrician Loïc Marpeau, who wrote a report in 2006 for France's top health authority about this type of implant.

"That’s why we concluded, already in 2006, that such implants should probably be reserved to certain researchers, with limited authorisations, so that before they’re widely used we can control how well these implants are tolerated.”

But there is pressure to use new products, Marpeau admits.

“We’re interested in all these new products so there’s some competition between us to use new techniques, to make a name by using new techniques. And, because it’s all less controlled than with molecules, drugs and so on, when the labs come and propose new products, we test them and there’s no one to stop us from doing that.”

Obstruction in Europe

Health Minister Agnes Buzyn on Monday declared that the rules are not “robust enough”.

“What’s interesting is that health minister Agnes Buzyn has told us that the medical devices were a source of anxiety for all health ministers," Le Monde's Cazi says. "It’s not new, we saw with the PIP case in 2010-11 it’s a problem of devices. Why hasn’t it been taken into account? It’s a good question.

"To modify the system it needs to be modified at the European level, that’s in Brussels. All member states have to agree. There is a huge manufacturing lobby which doesn’t necessarily want things to change and doesn’t want to introduce authorisation for launching products on the market, contrary to what France has been asking for several years now. But France has never had support.”

A European database, called Eudamed, is being prepared.

Like the ANSM register, it may be confidential.

Brussels will make the decision by the end of 2019.

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