It was one of the biggest trials in French legal history. The boss of a French company which distributed defective breast implants around the world has been sentenced to four years in prison for fraud.
Jean-Claude MAS, the founder of the PIP company, was also fined 75,000 euros (£63,000) by a court in Marseille.
The company’s sale of faulty implants caused a global health scare with an estimated 300,000 women in 65 countries affected.
The company used sub-standard silicone gel, causing many implants to rupture.
Four other former PIP executives were also convicted and given lesser sentences.
About 300,000 women in 65 countries are believed to have received PIP implants. Europe was a major market but more than half went to Latin America. They were not sold in the United States. 42,000 British, 30,000 French, 25,000 Brazilian, 15,000 Colombian and 16,000 Venezuelan women received PIP implants.
With more than 5,000 women registered as plaintiffs in the case, the trial was considered one of the biggest in French legal history.
The health scare came to public attention in 2011 when the French government recommended that women have PIP implants removed due to an abnormally high rupture rate.
There was confusion as British health authorities said there was no need for routine removal – though they later agreed to replace the implants to put women’s minds at rest.
The issue of whether the sub-standard silicone used in the implants posed any danger was not resolved by the trial, AFP news agency notes.
MAS, 74, showed no sign of emotion as sentence was passed. His defence lawyer, Yves Haddad, said he planned to appeal.
He and the others had all admitted to fraud.
PIP’s director-general was sentenced to three years in prison, two of which were suspended.
The company’s head of quality control received two years, one of them suspended, and the head of research and development was sentenced to 18 months, suspended.
Throughout the trial, MAS had denied the silicone used was harmful while all but one of the other defendants said they had not been aware of the risks.
When an implant ruptures, the silicone gel filling can leak into the body. Some women will not notice anything at all, and there is no evidence of an increased cancer risk.
However, it can result in the formation of scar tissue that can change the shape and feel of the breast. The gel can be an irritant, causing pain and inflammation. It can also be more difficult to remove an implant once it has ruptured.
France’s Health Products Agency (ANSM) has to date registered more than 7,500 implant ruptures and 3,000 cases of undesirable effects, mainly inflammations, among the 30,000 women using PIP products in France.
In a report released in June, the ANSM noted: “Taking into account the known under-reporting of medical device incidents, the number of women actually explanted may be greater than the number of cases reported to the agency.”
Isabelle Traeger, who received a PIP implant and attended the trial, said earlier that four years would be too little for what Mas had done.
“They explained what was in them [the implants],” she told Reuters news agency.
“Inflammable substances, substances to make your car work, and that at a certain point they said to the engineer who made them, ‘How did you make them? How did you mix together these substances?’ And he said, ‘You use your best guess’.
“And then they asked him, ‘Could you repeat what you just said?’. ‘You use your best guess’. Which explains why there were women in the room who had been much more seriously affected, as well as others who actually are coping quite well.
“Can you imagine? It’s a matter of chance. A dollop more, a bit more, a bit less. And he’ll get four years for that? For what is put in your body using one’s best guess. We don’t even give horses their food according to a ‘best guess’.”
BBC