French breast implant manufacturer PIP used a fuel additive in its now-banned implants which the company knew were defective as early as 2005, it was revealed yesterday.
The growing litany of accusations against now-defunct Poly Implant Prothese has triggered a worldwide scare with several countries, including France, advising thousands of women to have the implants removed.
France’s RTL radio said it obtained an exact breakdown of the materials used in the faulty implants, including Baysilone, Silopren and Rhodorsil, all of which are industrial products never tested or approved for clinical use.
The products, used in the oil or rubber industries, allegedly contributed to the silicone gel implants having a high rupture rate.
French authorities including health safety agency AFSSAPS already knew that the implants contained industrial rather than medical quality silicone, but this is the first time the use of petroleum industry additives has been reported.
“According to the AFSSAPS, it was known that this was an unsuitable gel, usually used in food manufacturing or for computers,” a doctor advising implant wearers, Dominique-Michel Courtois, said.
But “there was no way of knowing that the gel contained an additive for fuel. That’s why we want implants removed from patients to be analysed themselves,” added a lawyer for implant wearers, Philippe Courtois.
AFSSAPS previously carried out tests on implants seized at PIP’s factory in the south of France in March 2010.
A lawyer for PIP’s 72-year-old founder Jean-Claude Mas sought to play down the importance of the use of oil and rubber additives.
“These are food products, used to make beauty products, bought from (chemical giant) Rhone-Poulenc and its competitors,” Yves Haddad said.
Mr Mas met with AFSSAPS representatives yesterday for the first time since the scandal broke, Mr Haddad later said.
“He met with AFSSAPS representatives for three hours without police,” Haddad said, calling it “an event that should calm people down.” He did not provide details.
Implant wearers’ lawyer Courtois called for tests to be carried out on implants sold abroad, after British media revealed that rupture rates on the PIP products were seven times higher than previously thought.
“The mix (of ingredients) could vary depending on the deliveries,” he said.