Unfit For Purpose:

PIP Breast Implants and the Medical Regulators.

Both the British and French regulators of medicines were well aware of the company’s unsavoury history of non-compliance with this type of product, but they made no attempt to monitor the quality of the product. Both regulators were instrumental in having breast implants re-classified as ‘high risk’ devices in 2003, and this should have forced them to reassess the data on which this product’s CE mark relied for registration. But since all inspections were notified to the manufacturer 15 days in advance, the implants easily slipped past them, even though they contained 80% of an illegal industrial grade silicone filler. Neither Agency carried out any spot tests to ensure that women were not at risk. In this article, the I examine the progression of this extraordinary fiasco, and show how the public is being deliberately misdirected by the government in order to protect an Agency that is now entirely out of control and unfit for purpose.

Now the spotlight has turned on national regulators of medical devices around the world, as evidence emerges of just how easily the PIP management was able to deceive the French regulator and its inspection company. Many overseas governments have immediately ordered the removal of all defective implants, in some cases at State expense. The safety of women is ranked far higher than mere concerns over who should pay, and the Precautionary Principle is at least recognised and rapidly implemented in some more responsible States. But in the UK the regulator of medicines and medical devices, the Medicines and Healthcare Products Regulatory Agency (MHRA - an executive agency of the Department of Health) fights a rear-guard action, stubbornly attempting to persuade an
increasingly skeptical public that there is no need to be alarmed. It claims that there is ‘No evidence’ that these implants need to be removed, because they are no more liable to rupture than any other implant - a deliberate lie - and that they are not toxic and don’t cause cancer. The British public, all too familiar with such platitudes from this disreputable quango, remain unconvinced, so it is interesting to look at the wider picture to understand what all the fuss is about, and who is responsible for what appears to be a very serious failure to protect women from a potentially dangerous medical device.

Are PIP implants really dangerous?
In its damage limitation exercise the MHRA is now assuring both the medical sector and women concerned over their implants that, on the basis of its Risk Assessment, it considers that there is no need for alarm. It is particularly insistent that there is ‘no evidence’ - a favourite expression of this Agency - that the filler may cause cancer. Predictably, this instantly inflamed media speculation and public alarm over that very same issue.

Damage limitation
The response of the MHRA.
Despite the scientific uncertainty about the safety of this product, on 1st September 2010, and only five months after it first became aware of the problem, the MHRA issued the remarkably reassuring public statement that it had received encouraging results of UK testing on the silicone gel breast implants manufactured by the French company Poly Implant Prosthese (PIP). The tests found no evidence of genotoxicity (potential for cancer) or chemical toxicity of the filler material in the implants.But it admitted that its own testing, carried out in an astonishingly short period, and almost certainly less reliable, were
not as extensive as those being carried out in France. [. . .] MHRA Director of Devices Clinical [sic], Dr Susanne Ludgate said, “It’s reassuring that our test results have shown no evidence of any associated risks with the filler material.” Reassuring? Well, not really. 
The forensic principle that ‘Absence of evidence is not evidence of absence!’ needs to be held firmly in mind in cases such as this. Following its initial study 17 AFFSAPS stated that since starting its inquiries in March 2010 it had found no evidence of any increase in cancers amongst women with PIP implants, However, it did then confirm that these implants are not of acceptable quality: The observed rate of rupture is higher than the rate of rupture observed with prosthesis of other manufacturers on the same implantation period and that, since the first years of implantation. (Cases recorded to date, show a high rate of rupture at 5 years) Clinical observations relate a sweating aspect of the explants, even without rupture.
Cases of adenomegaly (enlargement of lymph gland due to accumulation of silicon without rupture of the prosthesis were also noted for some women. At this stage, we can ’t determine if their frequency is higher than for other prosthesis on the market.The actual clinical and toxicological risks associated with these implants are couched in such arcane and abstruse technical language, and so carefully downplayed, that they are generally incomprehensible to the average woman concerned about her breast implants. But the MHRA appears to be unconcerned that, regardless of, the psychological effects of the revelation of this scandal in themselves present a very significant medical problem amongst women who already had these implants. In its latest Press Releases the Agency merely advises distressed women that If women have any concerns, they should speak to their implanting surgeon.and repeatedly insists that removal of these implants is not necessary unless they experience ‘a problem’. Read more 

The MHRA’s panic reaction.
When things go wrong, the Dept of Health and the MHRA have a disturbing history of instantly engaging in nifty damage limitation exercises - interested readers will be familiar with the phenomenon of initial institutional paralysis followed by frantic ducking and weaving as they attempt to divert the blame towards others. Their catastrophic mishandling of incidents such as the Camelford poisoning, the MMR vaccine fiasco, and its controversial decisions over the regulation of medicinal products such as Seroxat, Vioxx, Actonel and fluorosilicic acid. Now once again they are once again trying to cover their own corporate heads, by trying to divert public outrage blame over this latest fiasco onto the end users of these defective implants - the private clinics and surgeons - rather than admit that they alone are responsible for ensuring that such products are fit for purpose.
The MHRA issues Press Releases purporting to show that the rupture rate of these implants is extremely low. This is directly challenged by the AFFSAPS’s September 2010 statement quoted above (Ref 17), admitting that PIP implants are more prone to rupture than other makes. When challenged over the potentially huge costs to the public purse of removing potentially defective implants, the government instantly stepped in and agreed to pay to remove those implants supplied under the NHS - around 5% of all those used in the UK.
But then, conveniently ignoring the fact that these low-cost implants have also been widely used extensively in reconstructive surgery within the NHS, it quickly moves to the attack the private sector and arrogantly announced that private clinics have a "moral duty" to remove banned PIP breast implants from women they operated on 21 It accuses these clinics as having engaged in disreputable commercial ‘cost-cutting’ (presumably cost was not also a consideration within the NHS) - when the differences between the cost of PIP implants and those of other manufacturers are a very small part of the cost of the surgical operations to implant (and of course, to remove) the devices. This seems to have been conveniently overlooked by the bean-counters in the Dept of Health.
" And very significantly, it must never be forgotten that it was the Dept of Health and the MHRA themselves that took the unusual step in 2003 of requesting the European Commission to reclassify all breast implants as high risk Class III implantable medical device. As such, regulators have a clear duty to monitor their compliance far more rigorously than lower risk products. It is totally unacceptable that a national regulator should be able to adopt such a negligent approach to the mandatory surveillance of the use of such a product, especially under such circumstances as are associated with this rogue manufacturer."
The buck stops here.

If such devices are unfit for purpose, then the MHRA as regulator, and ultimately Mr Lansley as Secretary of State, are both fully responsible. As Mr Andrew Lansley angrily told Mr Paul Flynn MP recently in the House of Commons,
The MHRA operates, in scientific and expert terms, in an independent fashion. In so far as it it is accountable, it is accountable to me as Secretary of State and to this house. It is not accountable to the pharmaceutical industry. 22 Since the entire income of the MHRA is derived directly from that same industry, Mr Lansley’s confidence in the ‘Independence’ of the scientific expertise of the MHRA might appear to be somewhat questionable. Certainly its competence in interpreting and implementing the regulatory framework, especially that of European law, under which it operates is a matter of profound concern. The buck stops with the Secretary of State, not the clinical end-users or the unfortunate women who now fear for their own health and personal safety. The MHRA is manifestly unfit for purpose, and the time is long overdue for Parliament to subject this rogue Agency to the rigorous investigation and restructuring for which many MPs and concerned medical groups
have so long been calling.

 The full story here 

** Would personally like to thank Douglass Cross for an excellent piece on the Pip Implant Scandal .Very well written and straight to the bone ;-) Best Regards Pipsleak