Breast Implant Scandal in France - Industrial Silicone Used in Implants

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JeantheBigone

Quite Involved in Discussions
#42
How sure is everyone that the terms "industrial grade" vs "medical grade" are simply marketing terms and/ or indications of purity? There are indications that the silicone used contained additives not present in the medical grade and that furthermore these additives may have been causally related to the high rupture rate.

http://www.theaustralian.com.au/new...pturing-implants/story-e6frg6so-1226235271472

And for the record, when saline filled implants fail, those need to be explanted as well, it is not as if the saline is absorbed.
 
#43
I have just checked the web site of a reputable supplier of health-care silicones. They class their products as "Restricted" and "Unrestricted".

Restricted they say could be used for implantation up to 29 days; Unrestricted could be used for long term implantation. They maintain master-files and all supporting data that the FDA like to see.

They state that their products "exceed USP class VI and ISO 10993 requirements" but go on to say that the device manufacturer must ensure suitability. So there is no overall clearance.

In the PIP case the most alarming thing, in my view, was not that the materials had an "Industrial" label but that he was mixing up his own concoctions using a blend of silicones and oils to get what he thought was "about right". Who knows what ended up in the end result and how stable it is.
 
M

MIREGMGR

#44
There of course can be substantive differences between two substances, in which case it's certainly justifiable to affix descriptors to the two materials so that they can be told apart. If one of them is better suited for a particular use than the other, it's perfectly sensible to communicate that to possible purchasers.

It however has been very common for many years for general material suppliers to sell their products in a medical version for which medical-use-appropriate documentation exists and (sometimes) for which medical-use-required testing has been done, and an industrial version that is chemically and physically identical and comes from the same production process but is not so documented and tested. This is a straightforward way to (try to) apportion the extra costs of such documentation and testing only to those customers who need those added services, while keeping the product version for which such services are not needed at a more competitive pricepoint.

This, over time, has morphed in material marketing into a common practice of just offering a "medical grade" at a higher price, with no additional services provided on the basis that the buyer is expected to do the materials qualification and documentation.

In my experience, far more often than not, "medical grade" has no substantial meaning other than that the medical-device-maker purchaser is thought to be willing to pay more.

Of course, this has to be applied intelligently and knowledgably.
 
M

MIREGMGR

#45
when saline filled implants fail, those need to be explanted as well, it is not as if the saline is absorbed.
??

Except in a pathological circumstance i.e. such extreme calcification and encapsulation without vascularization that the saline is immobile, certainly freed saline will be absorbed. The explant would be of the failed shell.
 

JeantheBigone

Quite Involved in Discussions
#46
In the early 1980s I worked with an attorney who made himself the "go-to" guy for a class action lawsuit against a large manufacturer of saline filled breast implants. These implants were subject to leaking and what happened was that hard tissue formed around the leaking solution, in other words encapsulation, and the implants and the hard tissue had to be removed.

As I am not a biologist I can't give you the biological reasons as to why it happened, but I was personally involved with about 10 cases where it did.
 
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