Two days ago, Jean-Claude Mas, founder of the notorious Poly Implant Prothèse (PIP) breast implants, was sentenced to 4 years imprisonment and a €75,000 fine*, with four former PIP exectuives also being given lesser, suspended sentences. This follows the compensation bill given to TUV Rheinland in November.
The question now remains; how do we prevent such a case from happening again? Many point to regulation as an answer, and while this certainly plays a role, there is no guarantee that another faulty product couldn’t slip through the net and reach consumers. Equally, while the case has been rumbling on for a number of years, lawmakers (in the UK, at least) haven’t seemed so keen to address the issue head on. We’ve had reviews and evidence panels, but the status quo remains. Perhaps we’re too scared to challenge and try to make a difference, despite figures such as Sir Bruce Keogh labelling the cosmetic surgery market a ‘crisis waiting to happen’.
I say to the lawmakers and regulators that it is a ‘crisis’ of their own making. Long before the deregulation of laser devices for cosmetic treatments were there concerns of non-qualified personnel carrying out medical treatments such as laser hair removal or injections of botulinum toxin, coupled with UK government bodies advising that the aesthetic industry should ‘self-regulate’.
If other countries have followed the same course of self-regulation, then it’s clearly not working. The French breast implants firm was warned by American health officials in 2010 that its products were ‘adulterated’ — 10 years before Afssaps found that the implants were filled with a different gel from that declared by the company during marketing and in the manufacturing files, and following reports of ruptures in the previous year.
As a result of the PIP case and subsequent rulings, the European Commission has proposed new rules on the regulation of medical devices, including those in the aesthetic industry. It certainly sounds promising in theory, but could leave patients waiting longer for treatments and a longer time to market for innovative companies. Again, whether it works in practice — and to the benefit of patients and their physicians — is a different matter.
Let’s also not forget the hundreds of thousands of women affected by the PIP scandal; I suspect that suspended sentences and relatively small fines won’t instil a sense of justice in many. Nor will the promise of better regulation.