PIP: One Bad Apple?

It was fairly predictable that this would happen wasn’t it? How likely was it really that the PIP story would end with France and UK adopting different strategies based on different stats? So like an elaborate game of Cluedo we must try to piece together the likely chain of events and responsibilities and look to how things could be done differently to prevent a recurrence.

The Government(s)

In our article in December we observed that it was unlikely that French operations were in some way 5 times worse than UK ops and that the likely reason for the discrepancy was down to reporting. Little surprise then that when the numbers were scrutinised more closely and by different centres we now have reports of significantly higher numbers (up to 7%) of women having problems in UK. This story isn’t going away any time soon and the government seem to acknowledge that, wheeling out Health Minister Andrew Lansley to demonstrate the ongoing level of attention it’s being given.

Former PIP Executive 

Prediction number two was that the former executives of PIP would have a case to answer and that seems to have been borne out with reports that the French health minister has called for the arrest of CEO and founder Jean-Claude Mas. Mas has denied manslaughter(he is facing criminal proceedings following the death of one French woman who was fitted with the implants). In a vitriol-filled article the Mail online aims both barrels at Mas with damning claims that he has a reputation for being an ex-butcher, delicatessen proprietor and rep before turning into “a businessman with an uncompromising sales patter — ‘a faker, a crook’ who ‘wanted to succeed at all costs’.”

As events unfold, PIP’s founder, Jean-Claude Mas, is said to be ‘unwell’ and his family claim that, under ‘French privacy laws’, he doesn’t have to explain what happened. The article claims that Mas this week remains in his luxury villa on the Riviera, while “concerns are growing that the 72-year-old multimillionaire is making moves to protect his fortune from those trying to bring him to account.” Mas is facing criminal proceedings with regard to a series of offences, including manslaughter (resulting from the death of one French woman who was fitted with the implants).

Regulatory Authority

Our third prediction involved the regulatory bodies who had seemingly either missed something or been deliberately hoodwinked. It is now reported that TUV Rheinland, one of the most respected notified bodies and the one responsible for approving PIP and its products, has issued legal proceedings against PIP, claiming the French company ‘continued to mislead’ it when its staff made regular inspections at the site. A spokesman says inspectors were shown the approved silicone, which was then replaced by ‘another silicone’ in the manufacturing process when the inspectors left.

So what does all this mean and where’s it leading?

UK MHRA is still not recommending routine removal of implants, citing the lack of evidential support for undertaking surgery, with its attendant risks.  We’ll see where that ends up, but the other open issues relate to how easy it is to pull the wool over the regulatory body’s eyes and then of course, who should pay if it comes to implant removal? Sadly for the tax payer it is likely that would be you, because the product was approved by an Eu notified body, meaning it was on the market legally.  Even if it turns out the manufacturer was guilty of a deception it’s difficult to see who else would foot the bill.  The healthcare providers (usually private) who supplied the original treatment certainly won’t because they acted in good faith using an approved product.

Whoever pays, there’s no doubt therefore that regulatory bodies will be under huge pressure from now on to operate in a much more aggressive manner towards their commercial clients if their “approval” is to remain a credible rubber stamp to commercial use. This entire sorry tale demonstrates just how easy it is for an allegedly unscrupulous manufacturer to make money from medical devices.  It must be mind-blowing for the woman in the street who puts faith in healthcare provider, clinician and device maker to be doing so in a way that is in her interest. It’s no doubt equally mind-blowing for most clinicians who again rely on regulatory authorities to control the products they use every day. Put it this way, if you’re a clinician and a company rep offers you something that looks too cheap to be true, but claims “it’s CE marked so what’s to worry about?”… you might just think “plenty” at the moment.

Dermal fillers next?

Source; medlatest staff, mailonline