In july 2012 A. U. Daniels, Faculty of Medicine, University of Basel, Switzerland published an article about silicone breast implant materials. He gives a clear explanation on the chemistry of silicone breast implants and his opinion.
Quote from his article:
"It is certainly conservative and appropriate to minimise the dispersion of foreign materials into the body from implants of any kind – except drug delivery devices. Also specific concerns have been voiced that low molecular weight PDMS – especially cyclic molecules – might mimic estrogens or CNS-active drugs.
In addition platinum can evoke toxic responses. For example, cisplatin (cis-PtCl2(NH3)2), used in tumor chemotherapy, damages numerous types of non-tumorous cells."
Another important quote from his article about PDMS:
"In any case it is not possible to give exact physical or chemical properties for PDMS silicone rubber because there is no such thing as just 'plain' PDMS silicone rubber.
Here is why:
First, the liquid PDMS starting material can have a range of molecular weights. Then, a selected amount of “nano-particles” of amorphous 'fumed' silica (SiO2) filler is added to liquid PDMS to make higher-performance silicone rubber – e.g., for medical use. This filler increases strength, tear-resistance and the amount the rubber can be stretched under tension before failure. After adding the particles, a PDMS silicone rubber is then formed by chemically cross-linking the formulation to various extents and in various ways. Thus PDMS silicone rubbers can have a wide range of structures and properties. Finally, while it is possible to buy finished PDMS silicone rubber stock (e.g., sheets) and make things from it, that is not how breast implant shells are made. The cross-linked, finished PDMS rubber in breast implants is created from liquid components during formation of the shell. So the only meaningful way to determine composition, structure and properties of breast implant silicone rubber is to use specimens taken from a finished shell. Even then, the results only apply to that particular type of shell. And finally, the structure and properties may well differ from one part of the shell to another part due to differences in forming temperature, pressure, etc.". This is a must read! You can read his article here.
Daniels wrote finally: "Up until the PIP incident, the question of breast implant material biocompatibility seems to have become resolved."
It is never resolved, it is denied. Illnesses due to implants are denied.
On our other website, here, you can read about all chemicals used in the production of silicone breast implants.
Questions remainingBesides all chemicals used in the production and their controversial outcomes, there remain questions unanswered, like:
Why do most implants turn yellow in time?
Allthough implants are used for so many years, there is no answer to this question, only guesses.
Quote from the SCENIHR report: In a clinical study, one-third of the not-ruptured implants were found to be yellow . This is explained by the presumable uptake of substances from the serum (Chummun & McLean, 2013). Similar results have been reported (Nakamura et. al., 1991) for silicone implanted in the eyes of rabbits. This indicates that besides leakage of silicone components across the shell there is also uptake of lipophilic molecules from the body into the implant. The relevance of these observations for the health risks of the silicone breast implants are yet unknown and needs further investigations.
Our opinion: First the word 'presumable' and second the sentence 'The relevance of these oberservation for the health risks are yet unknown and needs further investigations.' Strange... meanwhile they say; "they are safe".... allthough the health risks are yet unknown.
If there were no or a few reported health issues it would be logical to say despite the change in color they are reasonable safe.
Our research and possible explanations:
Polymers undergo degradation. What is observed, among other things, is discoloration. In this investigation of PDMS page 21: A color change was also
observed to accompany this in-growth process and over time the sample changed from clear to a deep orange-yellow color, which is consistent with the presence of Pt(II) or Pt(IV) complexes.
One of their conclusions was: "This study has also shown that network formation processes in these systems are not solely governed by functional group concentration, species diffusion and mobility – but by a complex and not fully understood series of interactions between the platinum catalyst and the vinyl groups of the polymer system itself."
Kaali et al, published in 2011 an article about degradation of silicone materials and biofilms. This image from their research explains the process of degradation
Also they descibed color change as a sign of degradation.
Birkefeld AB et al, wrote in 2003; It was possible to detect lipids (mainly phospholipids) as well as silicone oligomer species in explanted envelopes and gels. Silicone oligomers were also found in connective tissue capsules, indicating that cyclic polysiloxanes can migrate from intact implants to adjacent and distant sites. Furthermore, lipids can permeate the implant and modify its chemical composition. On our SVS-site you can find more articles about this subject.
PlatinumWe already described in 'When science fails' that there is little known about platinum and breast implants. Allthough known for its toxicity also described by A.U. Daniels, Cisplatin, and known as an allergen, in case of breast implants nobody seems to care.
What women hear, when they see their doctor, is most of the time; you cannot be allergic to breast implants. As far as we know, from >4000 women in our database, no one got tested for a platinum and/or allergy.
S.Maharaj, a scientist who did several investigations on platinum, wrote in 2008: A recent report by the U.S. Food and Drug Administration reviewed the literature on the subject of platinum in silicone gel-filled breast implants. In this study the author evaluates the FDA report for scientific accuracy and impartiality, and provides relevant discussions on financial conflicts of interest, an Institute of Medicine report, and public health policy. The study suggests that the FDA used discredited scientific practices in compiling its report. Reports by regulatory agencies should be scientifically accurate, with no partiality to industry. The current policy of one-way information flow from the FDA directly to those being informed needs to be revised. Greater importance should be placed on studies in which authors have no financial conflicts of interest.
Amorphous silicaIn the past there was also a discussion about silica used in breast implants.
Silica has been associated with respiratory diseases, such as chronic obstructive pulmonary disease (including bronchitis and emphysema), as well as kidney and immune system diseases. According the industry, silica used in breast implants is in an harmless amorphous form. But is it really harmless?
The last years more and more research is published.
Here we quote Toshimasa Kusaka et al (2014)
To assess the health effects of silica particles more precisely, toxicokinetic studies would also be required. A previous study demonstrated that in mice injected intravenously (i.v.) with gold particles, nanoparticles spread widely to various organs, suggesting that nanoparticles may cause multi-organ failure. In this regard, Nabeshi et al. recently reported that nanosilica can penetrate the skin barrier, and that mice injected i.v. with smaller silica particles show higher mortality. In this study, we chose an i.t. injection route because in the workplace, the risk of aspiration is much higher than the possibility of silica particles directly entering the blood stream. Consistent with a study using i.v. injection, we observed that many mice were moribund six hours after i.t. injection of 30 nm silica, but not 3000 nm silica (data not shown). It remains unclear whether 30 nm silica-induced lung inflammation is associated with the lethality. Thus, in addition to high inflammatory activity, smaller particles, including nanosilica, may be harmful in terms of their toxicokinetics. When bioparticles such as bacteria and apoptotic cells are internalized by macrophages, in which these particles are digested, and cleared from our bodies. In contrast to bioparticles, silica particles cannot be digested. Notably, even after phagocytosed by macrophages, intact silica particles would be eventually released from live and/or dying macrophages and likely stimulate neighboring macrophages. Presumably, forms of silica particles that cannot be excreted remain in the lung for an extended period of time, and may continually stimulate and disrupt macrophages, leading to chronic inflammation. Thus, highly inflammatory and unexcretable forms of silica would be most harmful. Overall, extensive studies of inflammation and toxicokinetics would be required for an assessment of the health risks of silica particles. They also wrote Submicron silica particles cause substantial lysosomal damage leading to IL-1β secretion.
J. O. Naim et al wrote in 2000:,
Over the past several years our laboratory has shown that certain forms of silicone are immunologically active. Silicone gel is a potent humoral adjuvant and a weak adjuvant for cell-mediated immunity (CMI). Low-molecular-weight (low-MW) silicone oils are weak adjuvants, whereas the highest-MW and most viscous oil tested showed significant humoral adjuvant properties. Silicone gel when mixed with bovine type II collagen is arithritogenic in female DA rats. Silicone elastomer, preadsorbed with plasma proteins, activates human monocytes/macrophages in vitro to secrete interleukin-1β (IL-1β), IL-6, and tumor necrosis factor alpha (TNF-α). Also, recent work by McDonald et al. has demonstrated that silicone gel enhances the development of autoimmune disease in NZB mice and has little effect on BALB/c mice. Thus, there is substantial evidence that silicones have an effect on immune cells.
These are just a few featured examples, we found thousands of reports on less known chemicals used in the manufacturing of breast implants
When you want to know more visit our site www.siliconebreastimplants.org.