Breast Implant Scandal in France - Industrial Silicone Used in Implants
M
MIREGMGR
I'm not intending to defend bad actors and apparently US FDA reached such a conclusion about PIP's general operations, manufacturing cleanliness and sterility characterization as of ten years ago, but just to be devil's advocate for purposes of improving the discussion: what standard or rule was not conformed to in the specific current instance?
Assuming no rupture of the silicone shell, the silicone filler-gel/fluid has no patient contact. My view is that this precludes applicability of ISO 10993 to the filler material. ISO 10993 of course does apply to the shell material, but in this instance my understanding is that the shell material conforms appropriately to that standard.
All silicone fluids/gels are generally considered to be life-threatening if released into the body in large quantities. This is a known risk of all silicone-gel/fluid-filled implants. Whether the filler material is "industrial" or "medical" makes no difference in this regard. It's fundamentally the case that there is no rule in any regulatory system that only "medical grade" materials may be used. In all regulatory systems, the device maker--not that company's material suppliers--has responsibility for whether the materials it uses are safe and effective. It's entirely legal for those materials to be of any origin, as long as the device maker appropriately qualifies and controls them and has suitable documentation of that qualification and control. "Medical grade" generally is a marketing term without legal meaning.
To the best of my knowledge, there is no evidence or technically knowledgable allegation--notwithstanding the various assumptions made in unknowledgable press reports--that the "industrial" silicone filler material has a deleterious effect on functional lifetime of the silicone shell material, relative to the lifetime that could be expected from a "medical" silicone filler.
I'm not aware that there is any standard for working lifetime of an implant of this kind in the human body.
It of course could be argued that this episode reinforces the legal argument that such products cannot be shown to be safe because their eventual failure rate is relatively high and sometimes such failure results in death or permanent adverse effects. In the US, that view informs the current law, but such implants are very widely used anyway because doctors are responsive to the public demand. Basically the public chooses to ignore the long term risks to obtain the more immediate benefits. In the US, this broad medical use of silicone filled implants in other-than-reconstructive instances is a legal gray area. Mentor and Allegan, the two dominant US makers, produce and sell far more units than the plausible reconstructive demand. My understanding is that no other country has adopted even a US-comparable degree of regulation of such products, again because of public demand.
So, given this legal context and the applicable rules and guidances: what standard or rule was not conformed to in the specific current instance?
Assuming no rupture of the silicone shell, the silicone filler-gel/fluid has no patient contact. My view is that this precludes applicability of ISO 10993 to the filler material. ISO 10993 of course does apply to the shell material, but in this instance my understanding is that the shell material conforms appropriately to that standard.
All silicone fluids/gels are generally considered to be life-threatening if released into the body in large quantities. This is a known risk of all silicone-gel/fluid-filled implants. Whether the filler material is "industrial" or "medical" makes no difference in this regard. It's fundamentally the case that there is no rule in any regulatory system that only "medical grade" materials may be used. In all regulatory systems, the device maker--not that company's material suppliers--has responsibility for whether the materials it uses are safe and effective. It's entirely legal for those materials to be of any origin, as long as the device maker appropriately qualifies and controls them and has suitable documentation of that qualification and control. "Medical grade" generally is a marketing term without legal meaning.
To the best of my knowledge, there is no evidence or technically knowledgable allegation--notwithstanding the various assumptions made in unknowledgable press reports--that the "industrial" silicone filler material has a deleterious effect on functional lifetime of the silicone shell material, relative to the lifetime that could be expected from a "medical" silicone filler.
I'm not aware that there is any standard for working lifetime of an implant of this kind in the human body.
It of course could be argued that this episode reinforces the legal argument that such products cannot be shown to be safe because their eventual failure rate is relatively high and sometimes such failure results in death or permanent adverse effects. In the US, that view informs the current law, but such implants are very widely used anyway because doctors are responsive to the public demand. Basically the public chooses to ignore the long term risks to obtain the more immediate benefits. In the US, this broad medical use of silicone filled implants in other-than-reconstructive instances is a legal gray area. Mentor and Allegan, the two dominant US makers, produce and sell far more units than the plausible reconstructive demand. My understanding is that no other country has adopted even a US-comparable degree of regulation of such products, again because of public demand.
So, given this legal context and the applicable rules and guidances: what standard or rule was not conformed to in the specific current instance?
Thanks MIREGMGR for pointing this out. The problem with these implants is any increased rate of rupture not the actual material, but I doubt whether this fact will feature much in the popular press. I did see that at the same time as the manufacturer changed silicone they also removed an outer layer from the design which may have made rupture more likely.
I have had some experience with implants (not breast) and know that "industrial" silicones have been used for many many problem free years. They were used when specific medical grades simply did not exist.
Some issues that the story raises are of concern.
i) Why did the NB not find problems? They claim it was an unauthorised design change but should they have spotted something at annual audit.
ii) Implant registries are needed.
iii) Why were the French authorities unaware of the FDA warning letter and 483 from ten years ago?
I have had some experience with implants (not breast) and know that "industrial" silicones have been used for many many problem free years. They were used when specific medical grades simply did not exist.
Some issues that the story raises are of concern.
i) Why did the NB not find problems? They claim it was an unauthorised design change but should they have spotted something at annual audit.
ii) Implant registries are needed.
iii) Why were the French authorities unaware of the FDA warning letter and 483 from ten years ago?
JeantheBigone
Quite Involved in Discussions
Speaking as someone not involved with quality, but who investigated faulty breast implants 30 years ago in connection with a planned class-action lawsuit, I would think that the issue is related to what the internal manufacturer specifications say.
If the drawing says to fabricate the component from material x and material y is used instead, this is a non-conformance, no? Heck I am aware of device manufacturers who have decided that if material y is more suitable, they simply use material y in place fo material x rather than change the drawing (requiring a modification) and hope no one will notice.
If the drawing says to fabricate the component from material x and material y is used instead, this is a non-conformance, no? Heck I am aware of device manufacturers who have decided that if material y is more suitable, they simply use material y in place fo material x rather than change the drawing (requiring a modification) and hope no one will notice.
Without knowing all the details and with a few assumptions
1. annex II 4.4 (assuming that route of conformity assessment) - requires notification of change to the notified body (evidenced by the legal action being taken by TUV)
2. Essential requirement 2: The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art.
Although the shell shouldn't rupture, you cannot assume that it won't, you should in fact assume that it will rupture in a number of cases (I'm unaware of the percentage) and that you should therefore use a material that is safe. I don't think it is an unreasonable step to use a material which complies with ISO 10993
True, however I think we will find in the case of PIP, they did not validate the material appropriately to determine that it is safe and effective. In light of the legal action TUV are taking I would also assume that they did not have the material reviewed by their notified body
M
MIREGMGR
Yes, I'm not arguing that PIP had a good overall stance. My concern is only with rules and standards compliance. If in fact that's PIP's conformance path and they did not so notify, that would be a nonconformance. If that can be shown to a court's satisfaction, TUV's case might prevail. The general "feel" of the TUV action to me, though, is that it's a desperate attempt to salvage as much of their reputation as possible, given the tremendous secondary legal exposure they may eventually have.
We all know that "generally acknowledged" cannot be legally defined other than by reference to consensus industry practice. In this instance, every worldwide maker of such implants primarily offers a silicone shell, silicone filled model, even though such products are universally known to have an unknown, widely varying time-to-shell-failure in the body, and silicone filler fluids/gels are universally known to have harmful effects when released in large quantities in the body. So, the generally acknowledged state of the art is to provide a known-unsafe product.
In my opinion, the European regulatory approach fails with regard to products like this. The US approach fails as well, but not quite as badly.
No silicone filler fluid/gel can be either safe or conformant by that standard, but that's the material of choice for the market because of its unique aesthetic characteristics. Only the FDA has tried to restrict silicone filler availability, and they've been unsuccessful in that regard.
D
Dudes
i) The NB claims hey wee deceived and presented with "conform" implants and manufacturing during the audits. In short, the company would have worked with double standards. They also claim the documentation was falsified to make "as if" they were using the allowed components and processes. This is based on the information I could gather from the general press (so I don't consider this to be very reliable...)
iii) That is the funny part. The French authorities say they didn't receive any information from the FDA. They also claim that they cannot possibly track the hundreds of such letters being published each week (I found 326 for the whole of 2011...) It is true that you can't search for warning letters issued per country. But still, it's not that difficult to keep an eye on them.
Lots of strange things going on there...
And to answer MIREGMGR question, given the fact that there is a non-negligible risk that the implants will leak, wouldn't you be required to perform some testing to ensure a minimum safety of the filler? One would need to have a look at their risk analysis (given it exists...) to understand the reasoning and see if yes or no, testing was required...
P
phloQS
This Information was given by the NB itself. You can have a look at here (German language):
http://www.tuv.com/news/de/deutschl...de_83092.jsp/TÜV Rheinland zu Medienberichten
For me this shows that the conformity assessment in europe is just save, if the companies want to be safe. There is always the possibility to show correct things and act false, if you want to.
But what else can be done? The only "full safety solution" would be a part to part control, made by government or other third parties with all the knockledge which is necessary t0o prove safety of such product. But I hope, this will never happen. The most important thing now is, that this case is competely investigated by competent authorities and that the responsible persons are blamed for what they have done.
Regards
phloQS
The plastic surgeons do not appear to listen to each other either:
http://www.telegraph.co.uk/health/healthnews/8986746/Breast-implant-scandal-the-whistleblowers.html
It can be legally defined; that is what court and expert witnesses are for.
This is an over simplification but:
I know that there are no definitions of medical and industrial grade (that is just for the press/marketing and ease of understanding) however, lets assume the following:
medical grade is that same as industrial grade, with additional manufacturing requirements resulting in a cleaner and purer product. It additionally undergoes additional testing to demonstrate biocompatibility and compliance with the original specification
Now line up a couple of experts in the field and get them to say which they would use in a court. The judge makes a decision and this is "generally acknowledged"
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