IMPORTANT MESSAGE From Dr Beretta concerning the tests on PIP Implants:
In the following you will find a brief report in which I have combined the results from the studies conducted by myself (Chemist, Italy), Matteo Malacco (Surgeon, Italy) and Adrian Richards (Surgeon, England) and the first preliminary but relevant observations from the experimental/clinical survey done in collaboration with those of you that kindly agreed to send specimens to my lab at the Univ of Milan.
The first preliminary analyses done on PIP implants specimens provided by some donors (for reasons that you can understand, I will not reveal their number, identities and nationalities) shown features that may help understand the complicated picture of the health effects of PIPs.
I will go by points and try to be as brief and clear as possible.
1) In previous studies we have shown that PIP filler silicone is only scarcely cohesive (according to what found by the French ASNM in 2010 when they found PIP was using a mixture of industrial silicones instead of the approved components).
2) In a subsequent study, we have also shown that in case of silicone bleeding from the implant(s), this silicone is incorporated under the form of very small particles into a fluid called "late periprosthetic fluid", a serum fluid that sometimes (rarely) appears also with other implants brands as a response to a inflammatory body reaction. The main difference between PIP and other approved brands is that commonly the late periprosthetic fluid is a clear fluid, while in the case of PIP it appears as a turbid, viscous fluid (due to the presence of silicone with a yellow to orange colour (haemoglobin).
3) We proposed that if this fluid is absorbed by the breast lymphatic system, the silicone particles may move outside the breast, in first place to the axillary lymph nodes, that if involved become more swollen than in the cases of lymphadenopathy associated to other implants brands.
4) There is a question that still needs to be answered: Why some implants do not show any problem during many years of implantation while others are found ruptured or "exploded" after even few months of implantation ?!
5) We know half of the answer. PIP implants are not filled with cohesive silicone gel (at least many of them, the first PIP silicone we analysed was from a implant manufactured in 2001 and it was not cohesive gel). So we hypothesized that the other half of the answer was to be searched in the implants shells.
6) First indications from the evaluation of PIP shells from intact explanted prostheses sent to the lab. Originally, PIP was supposed to use a multilayer implant shells in which a anti-bleed barrier to limit the diffusion of silicones (a solution adopted by most of the manufacturer). Based on the microscopical analyses of the shells and on the informations provided by the patients, we have observed that when the shells were multilayer and thick enough (1.0-1.2 mm) there were no problems of silicone bleeding established observable by MRI, USS or at explantation (with disappearance of the toxic reactions or at least a significant improvement of the health status after explantation).
Silicone bleeding problems start to appear when the shell is not multilayer (single layer) or thinner than normal (with more problematic management of toxic signs and symptoms).
7) One observation: The EU group SCENIHR published the information the PIP removed the barrier layer in 2007. We have evidence of single layer shells implants manufactured in 2001.
A) We need more samples of intact implants to get a more clear picture of the situation (manufactured before/after 2007, you can get this information at the last two digits of the 5-digits serial number of the implants or of its ID card). (with attached information about serial numbers and clinical evolution since implantation)
We need specimens of shells from ruptured implants too (with attached information about serial numbers and clinical evolution since implantation). This is easier, a small piece that can be mailed in an envelope is enough.
I apology if some points are not clear or if I missed something in this brief.
We can improve it for sure.
Of course I am fully available to answer your questions (if am able to do it !) and to receive any comments or suggestions from you !
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