French Hip Replacement Scandal: Could It Happen in Packaging?
Still reeling from the PIP breast implant scandal, France is once again facing international scrutiny for allowing 630 people to be fitted with hip implants without European safety certification.
While health officials insist that the non-certified implants pose no health risk, according to the Telegraph they have:
- Launched an investigation into Ceraver, France's second-biggest manufacturer of artificial joints
- Confiscated 1,000 of its artificial hips
- Asked surgeons to carry out checks, including scans, on the patients concerned
And while Daniel Blanquaert, chairman and CEO of Ceraver, told Le Parisien, he admits that there are "irregularities" and that Ceraver "was wrong," he also said, "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."
Are you hearing what I am? The certification process would take too long and was therefore ignored.
I believe that arrogant MDMs don't get to decide what modifications are "minor" and what aren't. That's the point of certification, so we know that the devices are following current guidelines and standards.
What do you think? Is this attitude that some changes are "too minor" justifiable because the certification process is perceived as too cumbersome?
With the changes in regulation currently taking place, especially in labelling requirements, could this type of scandal happen in packaging?
Stephanie Wiseman, Community Editor, UBM