Scientific controversy
"Since the nineties, women with complaints about their breast implants have often been ridiculed, labeled hysterical or psychologically unstable. We knew what we felt. How shocking is it, then, that we discovered that a crucial aspect of . . . . . . the toxicity of the substance present in breast implants . . . has hardly been investigated? Only as real all You can call us neurotic. But if it turns out that substances such as biocidal products, which were known to be toxic before 1980 and are linked to fibrosis and autoimmune diseases, are implants, then not our mind, but the science of plastic surgery fails."
As a patient organisation Stichting SVS / Meldpunt Complaints Silicone we have been fighting for years for women with health problems due to silicone breast implants, also called Breast Implant Illness (BII) or ASIA. We've made a shocking discovery. And the site is frankly astonishing: In the report of the Institute of Medicine (IOM) Safety of Silicone Breast Implants of 1999.
A toxic risk known since 1981
The IOM report itself refers to ASTM STP 732 (1981), a study that shows that pyrogenic amorphic silica . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
This was not an isolated signal: studies such as Picha & Goldstein (1991) and other indications from the years .70, .80 and .90 pointed to similar risks, but were ignored or considered unreliable.
Brautbar et al (1994/1996) already wrote that through migration and degradation of implants women are exposed to pyrogenic amorphic silica, which can cause complaints such as hairdressing, Breast Implant Illness, and even BIA-ALCL (a rare form of lymph node cancer).
Recent literature, such as Zhang et al (2012), even confirms that pyrogenic silica in nanoform can be even more toxic.
Structural negligence in research
The IOM report acknowledged that pyrogenic amorphic silica was not toxicologically investigated because it was thought that women were not exposed to it and was not crystalline.
This is incorrect: silicone degradation over time, and studies have shown that silica migrates to tissues, where it causes immune reactions. However, shockingly little research has been done.
In the PubMed database, the search term "break implants" yielded more than 12,200 results, but if you are looking for "break implants AND fumed silica," you will find only 2 studies. This lack of research is unacceptable, especially given the seriousness of the complaints experienced by women.
(click here) This was written by the researchers of these 2 studies Picha and Goldstein in 1991:
The intensity of the cellular and capsular response was lower for the silicone oil and increased as the material hindered weight increased and material compliance. Fumed silica elicited the most highly reactive cellular response. From this study It is appropriate that the polymer . Further, the silicone extract distillate elicited a highly intense cellular response with pronounced lymphocyte invasion. The human response of this work awaits further correlation with implant retrieval and in vivo performance.*
What does this mean for women?
Pyrogenic amorphic silica is a known inflammatory agent, and the EU classifies this form (trimethylsilyl treated) even as a biocidal product It is a substance harmful to living organisms. This underlines how dangerous this substance can be. According to the current Medical Device Regulation (MDR) substances contained in medical devices must not be toxic, a rule clearly violated by the lack of toxicological research into pyrogenic silica in implants.
Some scientists claim that silica is firmly bound to the silicone matrix and does not come into contact with the body, but women were also once told that silicone would last a lifetime, and it turned out not to be true.
Our call
It is unacceptable that, as a patient organisation, we had to track down these decades of old warnings. Pyrogenic amorphic silica has been a hidden danger to women for 45 years, and it is time that this was seriously investigated.
While plastic surgeons have been looking for the cause of hairstyle formation for 50 years, we as patients may have found the crucial puzzle piece: pyrogenic amorphic silica.'
Disclaimer:
The information on this website is intended for informational purposes and is based on carefully collected scientific research. The topics and hypotheses discussed have not yet been widely recognised within the medical community. We are not doctors and do not give medical or legal advice. No rights can be derived from the content of this website. Stichting SVS accepts no liability for any consequences, damage, complaints or legal proceedings arising from the use of this information.
