Breast Implant Scandal in France - Industrial Silicone Used in Implants

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pldey42

#31
Heh. I read that twice. Did it actually say anything useful? :)
The European Union is said to be planning to strengthen regulation as a result of the PIP incidents. At the moment regulation is done at national level. If the EU produces a directive that applies to all member nations, it will presumably be as a result of consultations. Eucomed claims to represent medical technolgy industry in Europe and this statement appears to me to be an opening gambit for negotiations that will lead to the new Directive.
 
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Ronen E

Problem Solver
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#32
Heh. I read that twice. Did it actually say anything useful? :)
Couldn't have said it better!

A lot of words to cover a very simple truth: A proper risk management process on PIP's behalf should have eliminated silicone gel filled implants from the market altogether, or at least would have ensured implant receivers are very aware of the associated risk(s) prior to consenting implantation; apparently both the manufacturer and the overseeing NB failed in this case with regards to the implementation of this very basic and essential component of EC medical devices regulatory clearance.
 

Ronen E

Problem Solver
Staff member
Moderator
#33
The European Union is said to be planning to strengthen regulation as a result of the PIP incidents. At the moment regulation is done at national level. If the EU produces a directive that applies to all member nations, it will presumably be as a result of consultations. Eucomed claims to represent medical technolgy industry in Europe and this statement appears to me to be an opening gambit for negotiations that will lead to the new Directive.
I think that in this specific instance there's nothing wrong with the existing directive(s). The relevant provisions are all there; it's just that (apparently) the basics were not followed.
 
P

pldey42

#34
Which directives? CE marking is not an EU directive. EU directives are something like federal laws, binding upon nations that comprise the EU, but each nation does its own thing within the limits of the Directive. Thus far there are none relating to breast implants, and if one is written it will be a first - and not without its challenges: the UK government might find itself resisting sane regulation because there are elements within the Conservative party (which dominates the Coalition) that want less, not more European harmony. Not right, not wrong, but a political reality that will probably cause any EU directive serious problems.

http://www.independent.co.uk/news/u...es-will-create-dilemma-for-no-10-6286782.html

CE marking seems to be a scheme whereby, as someone remarked earlier in this thread, as long as everyone tries to do the right thing, it works. TuV are arguing that, since PIP lied, they (TuV) are off the hook. It seems that CE auditors do not feel obliged to sniff out fraudulent reporting. Let's be clear: PIP behaved fraudulently and TuV didn't spot it.

By the way, is nobody but me shocked that clinics regard a 1.3% rupture rate as okay? I think that's fraudulent reliance on the faith we place in the medical profession, which surely goes for better general success rates in surgery, drug treatments and medical devices.

http://www.bbc.co.uk/news/health-16466918

UK breast implant providers are claiming that it's not their fault that their supplier evaluations were inadequate, but the Government's:

http://www.guardian.co.uk/world/2012/jan/09/breast-implants-refusal-free-replacement

They're scared they'll go out of business; no thought for their patients, who might face rather worse prospects.

The system of CE marking, government oversight and for-profit clinics with pathetic expectations of success (100 - 1.3 = 98.7%) failed to protect vulnerable women from fraud. If it can't do that, what's it for?

I think that this is a criminally immature industry learning that if you screw up in your supplier evaluations and mess up the lives of your patients, they will blame you. The only result for clinics from this sad state of affairs is a marked reduction in business caused by a loss of faith in clinics and their commitment to their patients. Clinics need to expect more of independent audit schemes and do their own evaluations as well, and not be seduced into undue indilligence by low prices. They also need to insure themselves properly against failure, rather than plead that they'll go out of business should they do the morally right thing and fix things at their expense for their anxious patients.

There's a lot wrong.
 

Ronen E

Problem Solver
Staff member
Moderator
#35
Let's be clear: PIP behaved fraudulently and TuV didn't spot it.
I think that's the core problem. If the entire system / method was completely wrong, you would have heard of similar occurrences much more often.

By the way, is nobody but me shocked that clinics regard a 1.3% rupture rate as okay?
In my opinion rupture rate is only one part of the big picture. If a saline-filled breast implant ruptured, it'd be a whole different story. The question is why the combination of a known harmful filler with a higher-than-absolutely-negligible rupture rate allowed.

There's a lot wrong.
I didn't claim that the system is perfect, I'm sure it can and should be improved in many ways. I wrote that in my opinion, with regards to this specific failure of the system, the blame is not on the directive's provisions (which directive? I'm referring to the MDD); Had just one of the manufacturer and the overseeing NB done their job properly in putting the MDD's provisions into practice, all of this wouldn't have happened.
 
P

pldey42

#36
It's not a question of "if" they rupture. They do, some 1.3% or more.

Nor is it a question of the combination being allowed. It wasn't.

PIP staff were instructed to hide the use of non-authorized silcone from inspectors. They did it for 13 years, and were able to do so because all visits were notified in advance - is that not part of the CE scheme?

http://www.guardian.co.uk/world/2012/jan/06/french-breast-implant-firm-boss-unrepentant?intcmp=239

My question stands: if schemes and audits can't detect simple fraud (this was not complicated, it was just buying cheap stuff, telling the staff to hide the fraud, and falsifying the records) what do they do? Why didn't audits of document and records control expose the fraud?

I think that one of the many problems here is that, like Enron's auditors (Arthur Anderson, remember them?) auditors become so accustomed to people trying (or pretending to) do the right thing, they forget that one reason for their existence is that, sometimes, companies are wilfully deceptive in their efforts to make a profit.
 

Ronen E

Problem Solver
Staff member
Moderator
#37
It's not a question of "if" they rupture. They do, some 1.3% or more.
It is. When 1.3% rupture, 98.7% don't. Even if that's actually 5%, the make up is 95%. I'm not saying that one figure or the other is "OK", just trying to stay accurate.

Nor is it a question of the combination being allowed. It wasn't.
Are you sure about that? I wasn't talking about "an industrial grade" vs. "a medical grade" (which is in fact, as already explained by others on this thread, and countless times before on these forums, just a meaningless market-speak that the mass media seems to be overly-joyed to adopt). I was referring to the combination of a non-negligible rupture rate (which IMHO, for that matter, could have been 0.5% or even just 0.1%), with a silicone-gel filler, which is, as MIREGMGR explained above, generically non-biocompatible for permanent implantation. *Any grade* of it. The debate over specific grades only highlights the fact that *some* silicone-gel grade was allowed, while it shouldn't have. That's the real failure. Given MIREGMGR's explanation above, I can't see how a silicone-gel filled breast implant (by any manufacturer, with any specific grade of filler) could be considered safe. That's basic in MDD terms, because it doesn't go anywhere beyond ER #1.

They did it for 13 years, and were able to do so because all visits were notified in advance - is that not part of the CE scheme?
Honestly, I can't recall a MDD clause or official guidance that I've seen, that bans NBs of holding unannounced or very-shortly-announced visits / inspections. If you could provide a reference, I'd appreciate it. Either way, as I noted before, it doesn't really matter what grade they've used; the generic material selection was already flawed, and a proper biocompatibility review on the NB's part could have spotted that.
 
G

Gert Sorensen

#38
Heh. I read that twice. Did it actually say anything useful? :)
:topic: Depends on what you are looking for. I think that there is an interesting statement regarding Eucomeds position on Standards, Guidelines and the quality of NB's in general.

Combine that with the proposed EU roadmap to revamping of the Device Directives and a pattern slowly starts to emerge :)
 
D

Dudes

#39
Heh. I read that twice. Did it actually say anything useful? :)
Nothing useful in the statement itself...

:topic: Depends on what you are looking for. I think that there is an interesting statement regarding Eucomeds position on Standards, Guidelines and the quality of NB's in general.

Combine that with the proposed EU roadmap to revamping of the Device Directives and a pattern slowly starts to emerge :)
... but insights in what Eucomed is advocating for and what "could" be ahead of us...
 
D

Dudes

#40
I think that this is a criminally immature industry learning that if you screw up in your supplier evaluations and mess up the lives of your patients, they will blame you. The only result for clinics from this sad state of affairs is a marked reduction in business caused by a loss of faith in clinics and their commitment to their patients. Clinics need to expect more of independent audit schemes and do their own evaluations as well, and not be seduced into undue indilligence by low prices. They also need to insure themselves properly against failure, rather than plead that they'll go out of business should they do the morally right thing and fix things at their expense for their anxious patients.

There's a lot wrong.
The sad truth is, that there is no system which is 100% safe. If someone REALLY wants to infringe, he'll find a way. The basic aim of the system is to ensure that the products landing on the market are safe. I think it does (more or less) works well with regard to this.

However, no system will ever be 100% safe against abusers. As long as a human factor is involved somewhere in the process (and I'm glad there is), there will be ways to abuse it. The system should be built in such a way that it is reasonably difficult (now try to define that one!) to abuse...

:2cents:
 
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