OK, playing the Blame Game might be counter-productive. Getting help for PIP ladies is No. 1 priority, no matter where that help comes from. But victims of this PIP crisis are angry – and so are the general public! – understandably people want to know who is at fault for this; how things can have gone so spectacularly wrong. Since the start, everybody seems to have passed the buck of responsibility for PIP implants. Let’s take a look at the key players involved and how they might have prevented this situation becoming out of control:
Regulatory Agencies – Do You Know How they Work?
The regulatory bodies are the obvious choice when it comes to pointing fingers over PIP implants. There are, however, lots of misconceptions about who was responsible at each stage of the regulation process. The UK regulatory body (the Medicines and Healthcare products Regulatory Agency), has received much criticism yet their involvement came quite far along the chain of events.
- It was actually a German company called TUV Rheinland who approved PIP silicone implants for trade within the EU and awarded the CE (Kite) Mark. This is because UK breast implants fall under EU Medical Devices Directive rules. At this stage, the MHRA had nothing to do with it
- The fact that PIP selected a small Notified Body like TUV to award their CE Mark is perhaps unsurprising: there are ways and means around Notified Bodies, with some being notoriously more lenient than others. The manufacturer is essentially able to ‘pick and choose’ who they approach. So perhaps the system itself is to blame here?
- The company and product then should undergo ongoing checks by National Regulators. Whilst still in France, this was the Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS). But neither the AFSSAPS or TUV seem to have taken any real responsibility for monitoring PIPs: both passed it onto the other. The AFSSAPS – who technically could have had the product taken off the market there and then – told Reuters that the manufacturer holds responsibility for checking medical devices like breast implants. As for regulation? That was TUV’s problem, said the AFSSAPS. TUV, meanwhile, said it was only responsible for monitoring PIP’s manufacturing process. Any issues with the actual product or changes to the materials being used, relied on disclosure by the manufacturer. A marvelous system.
- The MHRA got involved once PIPs entered UK soil. It then became their responsibility to approve for UK-specific use, investigate claims, report on them and decide whether to allow the product to continue trading here. Because the product was already supposedly approved and regulated for EU trade, the MHRA may not have been so stringent about this although they claim that they were. Only fairly recently the MHRA took over in the UK from the previous MDA. Both could be found guilty of ignoring earlier tip-offs about issues with PIP implants from UK surgeons. As surgeon Brook Berry reported “they never seemed to care”. Once the French authorities and UK solicitors reported problems, however, the MHRA did act.
- The American FDA, meanwhile did repeatedly recognize problems early on with PIP as a company in general, not just in relation to silicone implants. They thank their insistence on refusing to grant FDA approval to PIP for the low numbers of effected women in the USA. That’s nice for them: whilst publicizing their thoughts on their own website, the FDA could also be criticized for not making more active efforts to bring their concerns to the attention of the regulatory bodies of the other countries involved.
Click here for a fantastic article about the background of regulatory bodies in the PIP implants crisis and for further discussion of the CE Mark system
The Government & PIP Implants
The UK Government and their Department of Health has been criticised throughout PIPgate for slow reactions and often inconsistent or ineffectual statements. Despite being well aware of the colossal numbers involved with PIP implants (approximately 40,000 UK women) the UK Government have always taken a toned down “Keep Calm and Carry On” Image Attached approach to the situation.
All along, their DoH has maintained that there is not enough evidence of health risks to advise precautionary removal of PIP implants…even when this advice directly contradicted statements released by the French authorities. Initially, the UK Government also claimed there was no increased rupture rate with PIP Implants; a statement which – though not officially revoked – has been made ever less as more surgeons release their removal statistics link to removal statistics spreadsheet.
Although the Government did ban PIP Implants in the UK, on the advice of the MHRA (taking lead from France) in 2010, critics allege that this was not communicated clearly enough to surgeons in the private sector, so PIP usage may still have continued. Many PIP victims feel that the Government has both refused to ‘see the wood for the trees’ – ignoring the multitude of symptoms and case studies right in front of them – and been guilty of refusing to err on the side of caution with a situation too serious to take such a risk. Click here for a recent Daily Mail article on the Government’s role in the PIP situation
Fraudulent PIP Staff
The Government, clinics and surgeons who used PIP implants of course say the blame really lies with the PIP company themselves for committing an act of fraud.
The CE Mark approval which TUV granted was for medical-grade silicone implants, not potentially inflammatory mattress filler! In fact, TUV Rheinland have filed a criminal complaint against PIP stating that they actively misled their inspectors…so it’s pretty obvious that they are trying to pass the blame firmly back to PIP. In fairness, there was definite evidence of covering tracks. The Telegraph have reported how PIP’s bosses would clear away all industrial materials before the inspectors came so they only ever saw the medical-grade filler in use; kept the substandard gel in hidden warehouses away from the majority of their staff and told the manufacturers that it was being used for hand creams! The fact still remains, however, that it was an EU system giving 15 days’ notice of every inspection which allowed all this track-covering to take place. (read the full article here ).
Senior PIP managers were aware what was going on. They claim that they did not realize the silicone was potentially toxic, only cheap. The lower employees – due to the elaborate web of deceit – were probably blissfully unaware.
PIP Implant Buyers – Surgeons, Clinics … and Patients!
Some blame surely has to be placed with those who were prepared to buy inferior quality products at a lower price?
By far the largest Private Sector units to have used PIP implants were The Harley Medical Group and Transform cosmetic surgery groups. Their PIP usage was so large that they have been given their own statistical analysis within DoH press releases. According to numbers on their sites and media reports, Harley Medical accounts for approximately 14,000 PIPettes and Transform about 5021. These groups still charged prices for breast enlargement roughly equivalent to the mainstream ‘norm’ yet were using implants containing gel five times cheaper. Interestingly, even now after this PIP crisis, Harley and Transform both offer lower-end implants (Allergan CUI range) as standard to their PIP implant R&R patients. If ladies want the better quality Allergan Natrelle Inspira range, they have to pay extra. Similarly, PIP apparently did have a higher budget range using medical-grade silicone (according to their lawyer Yves Haddad) but the substandard version was the cheap alternative.
Many of the good surgeons and groups who, to this day, refuse to use budget varieties of implant brands can hold their heads high and state they never used PIP implants: an interesting correlation. The NHS only used 791 PIP implants (according to current statistics) but even this number is alarming. All parties who used PIPs defend themselves on the grounds that these implants had been given CE Mark approval and there was no reason to suspect that anything was wrong with them. Although many surgeons are now reporting early suspicions due to abnormalities when PIPs were removed – tendencies to rupture, strange pus-like substances and ladies complaining of swelling – unless a surgeon or clinic actually experienced this firsthand, they might have no reason to question PIP implants.
As for patients? Many say they were told the implants were the “best of the best”. Although some PIPettes did pay slightly cheaper rates for ops with PIPs (in the same way a breast enlargement with CUI might cost less than with Natrelle), in most cases they actually paid full whack…not happy bunnies. If you bought a car and it constantly leaked petrol, you’d expect a refund or exchange, wouldn’t you? And that’s if it didn’t cause you any damage in the process.
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