Breast Implant Scandal in France - Industrial Silicone Used in Implants

Marcelo

Inactive Registered Visitor
#21
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 knowledge 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 completely investigated by competent authorities and that the responsible persons are blamed for what they have done.
Just to add more spice to the discussion, in my opinion, one real problem with all the discussions of "this system is better than the other" or "this works and the other not" is a misunderstanding of what regulatory systems really are and the role of regulatory authorities.

Medical devices regulatory systems are created to ensure safety and efficacy (and whatever else) and they are usually created with the premise that the companies will be following them (they are usually laws). In this way, they are created for the "right" manufacturers, the ones which are going to comply.

It's primarily the responsibilities of the manufacturer to comply. It's also the primarily responsibility of the manufacturer to perform the conformity assessment of his compliance.

There may be an additional conformity assessment by regulators, but this is usually related to an "sample" audit or inspection, or inspection of a summary technical documentation, or another "general" review. I mean "general" here in the sense that, as the manufacturers already have to comply and assess conformity, an inspection, audit or review by a regulator is trying to determine if it "seems" that the manufacturer is really complying (and people can begin saying that, for example, the FDA or whatever inspection is more detailed or whatever, however even theirs is a sample).

Note, again, that it's expected that the manufacturer "wants" to comply (because they have to). So, if a manufacturer does not want to comply, they can simply mask what they are doing for example.

Do regulatory systems prevent that bad manufacturers (the ones which do not want to comply) exist? No, the systemas are created to the good ones. The way to deal with bad manufacturers is really the police (I'm saying this in a broader view).

Anyway, the only way that I know of, of a regulator really making sure that things are going to be followed (which, again, is not the responsibility of the regulator) is to put regulator staff on each manufacturing plant, 24 x 7. Even this would not really guarantee that things are followed :)
 
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Elsmar Forum Sponsor
#22
For those interested there is a guidance document on conformity assessment of these implants at www.team-nb.org under the 'Public Documents' link. The document is dated 11/2007 and titled 'G.C.A. Breast Implants according Dir.. 93/42/ECC relating to M.D.07-1998'

From that document:
Evaluation of biocompatibility should cover the shell, the filling material and the bleed materials as well as all other materials which could be in contact with the tissues in case of rupture of the envelope, as identified in the risk analysis
It has a detailed annex with the required comparability tests, which are extensive (and expensive). But not justification for what is clearly becoming criminal acts rather than slips of a quality system.
 
M

MIREGMGR

#23
For those interested there is a guidance document on conformity assessment of these implants at www.team-nb.org under the 'Public Documents' link. The document is dated 11/2007 and titled 'G.C.A. Breast Implants according Dir.. 93/42/ECC relating to M.D.07-1998'.
Thanks for pointing this out. I hadn't been aware of it.

The particular document you referenced is obsolete, and was superceded by the MedDev document http://ec.europa.eu/health/medical-devices/files/meddev/2_5-7____07-1998_en.pdf.

Note that this guidance calls for information that (I believe) is not obtainable in the real world. Theoretical studies of human device lifetime to rupture by means of animal models are not realistic because rupture in humans often is associated with external-force and device-stressing events, not just with biological effects and materials aging. My understanding is that post-market studies of the available data support this conclusion, i.e. there's no good way to tell how long an implant will last. It's inherent to a prediction of device lifetime that the variability of any such prediction is very large...so much so that for any given patient and doctor, the theoretical lifetime is a useless number.
 
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M

MIREGMGR

#24
i) (...) 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?
Yes, that would be the normal requirement of the medical device process. The problem in the instance of silicone filled breast implants is that there is no such thing as biocompatible silicone fluid/gel filler material. Such silicone material is fundamentally non-biocompatible, not because it is directly toxic (assuming that it is chemically pure, sterile and suitably "clean", which may or may not have been the case with PIP), but because it is inherently migratory and cannot be located so as to remove it; it cannot be sequestered and broken down by the body's normal cleanup processes and immune system which causes those systems to go into permanent overdrive, resulting in sustained inflammation and damage to adjacent necessary tissues, much like lupus or other generalized autoimmune diseases; and it "plugs up" critical biological processes, which results in critical secondary effects that can include severe multiple-organ damage and death.

For some kinds of medical devices, severe risk is acceptable because the alternative is worse. Society hasn't formulated a coherent stance yet on the underlying legal logic of a device class that has severe risk when the immediate benefit is aesthetic and psychological, and customers value the benefit so much that they choose to ignore the risk.
 
P

pldey42

#26
Here is the UK position, revised after a hasty review:

BBC summary:
http://www.bbc.co.uk/news/health-16444162

Government official position:
http://www.dh.gov.uk/health/2012/01/pip-implants-interim-report/

The following relates to the CE mark scheme and TuV's role, from the Guardian, a newspaper that's generally well-respected in the UK and tends to get its facts right:

http://www.guardian.co.uk/world/2012/jan/06/medical-devices-toys-safety-checks

Quote …

When it comes to devices such as hip joints and breast implants, a manufacturer is not required to win a licence based on evidence of safety and efficacy from clinical trials. Instead, they must get a CE mark which certifies the product reaches a certain European quality standard. It is the same mark that a Chinese toy company, for example, would have to obtain to sell yo-yos in Europe.

[..]

The trouble began after PIP had obtained its CE mark. TÜV Rheinland, which has a good reputation in Germany, did send in inspectors on occasion. But PIP knew they were coming. A defiant Jean Claude Mas, the owner of the company, admits he was buying cheap industrial-grade silicone to fill the implants, costing €5 a litre, instead of medical-grade which cost €35.
"TÜV would announce its visits 10 days beforehand," he told French journalists. "That was the routine. I would give the order to hide all the documents regarding the non-authorised PIP gel and as far as the containers were concerned, the staff would organise themselves to make them disappear."

Thierry Brinon, technical director of the company, who said he was recruited from "a small ad", told investigators that "for as long as organisations give us systematic notice of inspection, any kind of malpractice can be hidden".

[..]

Many think the system is tougher in the US than in Europe. Britain's only breast implant manufacturer, Nagor, which has an exemplary record, is still struggling through the regulatory hoops to win approval. Regulation is through the centralised Food and Drug Administration, which also licenses drugs.

End quote
 
M

MIREGMGR

#27
...non-authorised...
...malpractice...
Noting that the Guardian apparently is quoting reports by unnamed French journalists rather than directly from the French individuals, and also noting that presumably the original comments were in French and on occasion subtle shifts in meaning can occur in translation to English...

If these two specific terms were used, that's quite extraordinary. Most people accused of making bad medical devices tailor their public comments to defend what occurred as allowed by the rules, or at least to deny ill intent.
 

Ajit Basrur

Staff member
Admin
#28
China Daily - No PIP breast implant rupture reported in China


China's top drug safety watchdog said Friday that it has not found evidence of any ruptures in 743 French-made breast implants sold in the country.

The implants, produced by Poly Implant Prothese (PIP), caused a global health scare after French authorities recently advised women in France who carry PIP implants to have them removed over potential rupture risks.

The French medical regulatory agency said on December 30 that 20 cancer cases had been found in women wearing PIP implants, but added that a link between the cancer cases and the implants had not been confirmed.

The implants were banned in March 2010 after an official inspection found that industrial-grade silicone was used in some of PIP's products without approval from health authorities.

China's State Food and Drug Administration (SFDA), in a probe of a China-based PIP implant sales agent, found that the company imported 912 such products in question after gaining import approval from the SFDA in April 2009.

As of Thursday, 743 PIP implants that were sold by the Chinese company had been traced with no reports of ruptures, according to the administration, which has urged further efforts to trace the products.

The administration warns those who have purchased PIP implants in China to be wary of potential ruptures.

.
 
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