” Implant Files “, the new investigation by the international consortium of investigative journalists (ICIJ), reveals the failures of medical implants. Unlike drugs, which are the subject of extensive studies, the prostheses of the hip, shoulder or knee, yet implanted in the body, are simply the object of a validation by a private agency competitors. But sometimes, implants can be used without any certification. Radio France, which is part of the cell investigations, like The World, and Cash investigation, reveals how the company has decided to spend in addition to the regulation for the implantation of prostheses and orthopaedic.
The revelations begin, thanks to a whistleblower. “I can not stand to endorse the operation of the business,” he wrote to the MSNA (national security Agency of the drug). He speaks of Ceraver, a French laboratory, which manufactures prosthetic joints.
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“I wanted to mark my territory on the intellectual property aspect”
In June 2011, professors Alain Lortat-Jacob and Philippe Hardy, surgeons in the public hospital Ambroise-Paré in Boulogne-Billancourt, have, according to Radio France, operated on four patients without giving them a vital piece of information : the prosthesis they are to receive is not approved, explains Radio France. Worse, it is still in the testing phase on animals. As soon as the output of the block, two of them feel pain and will know of the complications.
How such an implementation has taken place ? According to Radio France, this is the CEO of Ceraver, Daniel Blanquaert, which has asked its department heads to provide the prostheses, non-certified surgeons. He wishes to have the paternity of Actisurf, an outstanding process that is used to limit the risk of infections. “I wanted to mark my territory on the intellectual property aspect “, then explain Daniel Blanquaert to investigators. In a congress, it displays this panel : “Actisurf coating anti-adhesion bacterial. Research CNRS – Inserm – Ceraver. 2011 : first settlements by A. Lortat-Jacob, Ph. Hardy, T. Bauer “, to suggest a certification. This has never been the case.
In all, 1 885 implants without a valid certificate would have been passed and the case could cost 1 140 209 euros to the company Ceraver. The head of the company and the professor Alain Lortat-Jacob will be judged in September 2019. Daniel Blanquaert has stated on Radio France that “the assessment of [the] society in these cases of non-compliance is still pending before the courts “and that” the absence of risk to the health of the patients has been emphasized by health authorities as early as 2013 “.
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