The UK’s Telegraph has published an article by its medical editor which suggests that the PIP breast implant problem was first expressed to the MHRA in 2006, some four years before they were taken off the market. The article, which can be found here, talks of surgeons contacting the agency, reporting that PIP implants were splitting more frequently than other types of implant.
This has all come to light as a result of the publication of a report by Lord Howe in light of the potentially serious health implications resulting from the implantation of these devices, now known to have been filled with industrial silicone.
The report revolve around MHRA’s handling of the situation, which it concludes was appropriate, stating that “the MHRA had acted properly and promptly on information available at the time”.
That doesn’t quite gel with the early reports of problems, which are dealt with in the report by stating that “the MHRA could not be expected to act on the concerns raised by individual surgeons without corroborating evidence.”
Yet offers by surgeons, who were not named in the report, to carry out audits of their own records were not taken up by the regulator.
So what does Lord Howe recommend?
Well, two points characterise the output, both of which rather sing our tune. Firstly Consultant plastic surgeon and president of the British Association of Aesthetic Plastic Surgeons, Fazel Fatah, said: “Poor post-marketing surveillance of medical devices lies at the root of the PIP crisis.”
So, a recommendation that vigilance reporting measures are beefed up, which is good.
But what about tighter regulatory control in other areas?
The report states that; “It must be emphasised that this case was one of deliberate fraud by the PIP manufacturer which purposefully misled European regulators. Regulation alone cannot prevent fraudulent activity such as this.”
So it all looks like a rather sensible and pragmatic set of conclusions. There is little doubt in our minds that more draconian measures and over-regulation is not the answer, as we’ve said on many occasions, and that tighter and more extensive post-marketing surveillance is likely to be both preferred by suppliers and crucially far more progressive a measure than ever higher barriers to entry which would stifle innovation and restrict access to new technologies.
What’s really interesting is that the headline grabbing “scandal” of a four year delay looks like just that… headline grabbing, because the report broadly expresses the view that the MHRA acted appropriately and within the constraints existant at the time. So its just a matter of making sure the new regulatory regime is better, which as usual is easier said than done.
Source: Telegraph Health