Medical device manufacturer Ceraver has sold artificial hip replacements that had not been properly certified, French newspaper Le Parisien reported yesterday. The noncertified hips were sold to about 60 hospitals in France, and over 1000 artificial hips have been confiscated, according to the Telegraph. The scandal unraveled after a tip from a whistle blower led to an inspection at Ceraver’s two production facilities in France last month. The company reportedly made modifications to a device that was already certified by regulatory authorities without filing for the required certification.
The Ceraver scandal most likely will led to more calls for stricter medical device regulations in Europe, although the medical device industry (and the editors of this blog) has continued to stress that this type of fraud would not have been prevented with stricter regulations. It is likely that it also will influence the revision of the European medical device regulations, although probably to a less extent than the Pip scandal did, since the draft regulations have already been published. The Pip implant scandal is one reason European medical device regulations are moving towards a centralised premarket approval system.
The Ceraver scandal shares similarities with the Pip implant scandal; however, CEO Daniel Blanquaert was much quicker than Pip’s Jean-Claude Mas to admit his mistakes. In an interview with Le Parisien, Blanquaert said: “We are in the wrong. But for us the modifications we made to the joints were minor and did not justify going through the whole certification process again, which would have taken one to two years.” It took Mas over a year after the scandal broke to admit wrongs, but he finally asked for forgiveness during the trial for fraud, which is currently taking place in Marseilles, France.
From medtechinsider: Sorry Is No Longer Hardest Word for Pip Implants’ Mas
From medtechinsider: Draft Report on New Device Regulations Calls for PMA System for Innovative Devices
From EMDT: Faulty Medical Devices Back in News