The National Medicines Safety Agency (ANSM) defends itself accusations made by the news site Mediapartwho reproached him, Tuesday, October 1, for not having reacted in time to the first reports of ruptures of PIP prostheses, in 2006. Marketing was interrupted in 2010 when it could have been suspended in 2007 or 2008, according to an internal Afssaps (formerly ANSM) report never published, cited by Mediapart.
In an interview with Figaro, the deputy director general of the ANSM, François Hébert, explains: “In this area, we regularly receive reports of ruptured prostheses. But how can we identify, in the midst of these reports, a particular problem relating to the use? of this prosthesis? In 2008, we had very few reports. ” He also believes that “if the agency had made this observation at the time, it would never have left this file as it is.”
Among the charges, Mediapart accuses the ANSM of having omitted elements “which pointed to the major shortcomings of the management by Afssaps” in the report submitted in February 2012 to Minister of Health Xavier Bertrand. On this point, François Hébert answers in the columns of the Figaro that “this note was given to us on April 9, two months after the publication of our report, and I spontaneously forwarded it to the courts, during a search of our offices on April 12.”
Today, 7,400 women have lodged a complaint in this case, including Jean-Claude Mas, manager of the company PIP, is the main accused. The trial judgment is expected on December 10, 2013.