Silicone scam

Industrial-grade silicon caused a global public-health scare – whose fault is it?

The recent public-health care scandal will no doubt have caught your eye – 300,000 women in 65 countries are concerned that their breast implants might leak or rupture following the discovery that French firm Poly Implant Prothese (PIP) filled their implants with industrial-grade silicon.

In 2009, French surgeons started reporting abnormally high rupture rates when using PIP’s breast implants – leading to a flood of legal complaints, the implants being banned and PIP going bankrupt. An investigation of the manufacturing site showed the company was filling implants with unapproved in-house manufactured industrial-grade silicon.

Their implants contained Baysilone, Silopren and Rhororsil – chemicals that cost a mere 10% of the approved substance, and are normally used as a fuel additive or in the manufacture of industrial rubber tubing.

But whose fault was it that these products made their way onto the market – the man who got away with it, or the authorities that may have played a role in letting him?

Yves Haddad, lawyer for PIP founder Jean-Claude Mas, said most of the implants sold by the firm since 1991 were produced using a silicone not approved by health authorities. He said the company created two products – a simple one made with the unapproved silicone, and a high-end version for wealthier clients using the approved silicone.

“There is a product made by PIP which did not formally receive the regulators’ approval and in this regard there was a violation of regulations,” Haddad said, adding the company did not ask the French medical device safety regulator to approve their in-house product because they presumed it would have been approved.

However, it looks like Mas knew the silicone wouldn’t have been approved – he is said to have told Police recently: “I gave the order to hide any document relating to non-approved PIP gel and the staff got rid of the containers. We did it for 13 years without any problem,” before adding: “The victims are psychologically fragile and complaining in order to receive money.”

It’s interesting that he uses the word ‘victim’ before saying they’re just after money – whether they had their surgery for medical or cosmetic reasons, there is bound to be some psychological fragility there, which I can only imagine has been exacerbated by this recent scare – I very much doubt money is their main concern at the moment.

The 30,000 French victims of PIP have been told to have their implants removed, as have many others. Although they are non-toxic, cancer has been found in 20 women with the allegedly faulty implants. The French health authorities – AFSSAPS – insist there is no proven link with the disease.

But before all medical devices are allowed onto the market, they have to be approved by the relevant authorities – in this country the Medicines and Healthcare products Regulatory Agency (MHRA).

Transform – a private cosmetic surgery group – place the blame squarely with the MRHA for the health scare in the UK. The group have reported a rupture rate of 7-8% – much higher than the industry standard of 1-2% – and its chief executive, Nigel Robertson, accused the agency of failing to monitor and routinely audit the use of the implants.

"The NHS and the cosmetic surgery industry used these products because they had been approved by the MHRA for medical use and carried a CE mark to that effect," he said, adding that the agency must bear responsibility for the current situation.

But were the MRHA really to blame? It might seem that they are as they failed in their duty of care to UK consumers, but we don’t know which batch of PIP implants they were sent to approve, or if they were duped by Mas – we will only know as more information about the scam is released.