Dear Dr. Kaczor,
Your article on autoinflammatory syndrome induced by adjuvants (ASIA) in the February 2017 issue of Natural Medicine Journal was unfortunately lacking a clear understanding of the breadth of silicone toxicity and the misguided nature of ASIA. I have written several papers that explain why the breast implant chaos of the 1990s was inevitably destined to repeat itself. If the ASIA criteria proliferate to the point where the medical community routinely uses it to “prove” silicone toxicity in any cohorts, then the truth about silicone breast implant disease will once again be negated by scientific panels, will be doomed to wind up being buried forever, and its victims will never have the satisfaction of being vindicated.
Women with silicone gel-filled breast implants are being deluged with numerous requests to participate in surveys. Virtually all of these surveys have glaring deficiencies that parallel the failed research initiatives of the 1990s. As an example, the criteria for ASIA (a.k.a. Schoenfeld’s syndrome) tries to tie together a number of disparate entities that actually have nothing to do with one another. One of these entities is vaccination-induced autoimmune illness.
Please be advised that as of December 2015, the ASIA criteria have been discredited by the special masters (judges) in vaccine court in Washington, D.C., and they will no longer allow it to be referenced by any experts testifying on behalf of vaccine injury claimants. Investigators who utilize the ASIA criteria to define and/or report on silicone toxicity are well-meaning in their desire to verify the existence of silicone-induced disease, but the ASIA criteria will never withstand the white hot lights of scrutiny by scientific panels or court litigation against implant manufacturers.
There are at least two dozen mechanisms causing silicone toxicity, virtually all of which disrupt the body’s biochemistry, and virtually all of which have nothing to do with autoimmunity. The ASIA criteria, like all other currently promoted surveys, are a gross oversimplification of what is clearly a much more complicated problem.
Silicone recipients might want to read the peer-reviewed manuscript on the topic published in 1998 in the journal Medical Hypotheses.1 As an example, at least 75% of symptomatic silicone recipients have markedly dry eyes and dry mouth, and Schirmer tests are quite abnormal in these patients. However, biopsies of their salivary tissues are completely normal, because this ailment is likely due to dysfunction of the receptor for acetylcholine (the neurotransmitter that normally stimulates these glands).
As another example, silicic acid (a breakdown product of silicone) can cross the blood-brain barrier and chelate neurotransmitters such as dopamine—hence cognitive dysfunction occurs, but MRI scans are normal.
As a third example, the element silicon forms 4 bonds like carbon, but silicon is capable of behaving like a metal at times. Phosphorus, the key to energy production and energy utilization, is metal-ion bound in energy systems. Therefore, the presence of excess silicon in mitochondria and the interior of cells causes interference with energy production and energy utilization. Hence, weakness and fatigue occur, but muscle biopsies are normal.
As for joint pain and arthritis in silicone recipients, any synovial fluid analyses reveal fewer than 1,000 cells (non-inflammatory). Think of substance P in nerve endings, and also think of the matrix macromolecules in cartilage. I encourage you to read my two papers published in the journal Lupus: “Destiny Rides Again: The Reappearance of Silicone Gel-filled Breast Implant Toxicity” and “Bones, Groans, and Silicone.2,3 After reading these, you will probably appreciate that (1) silicone gel-filled breast implants are indeed quite toxic to the body; (2) survey solicitations by other investigators are superficial at best and do not adequately assess the full extent of silicone-induced disease; and (3) scientists with a PhD in biochemistry need to get involved with the research.
Arthur E. Brawer, MD
Associate Clinical Professor of Medicine
Drexel University School of Medicine, Philadelphia
Editor’s note: Letters to the editor are edited for length, style, and clarity.
Dear Dr. Brawer,
Thank you for your letter to the editor. You bring up many good points regarding complications from silicone breast implants that go far beyond the criteria for ASIA. The myriad of possible mechanisms for toxic reactions is not surprising to those of us steeped in naturopathic, integrative or environmental medicines. I’m not a toxicologist, nor a specialist in this area. It was never my intent to “pigeon-hole” all reactions to silicone breast implants as being defined solely by the criteria for ASIA. As put forth in the original text, silicone breast implant reactions is one of the original conditions that led to the criteria for ASIA. That said, I would like to give the three points you bring up due attention.
1. “ASIA has been discredited in late 2015 by the special masters (judges) in vaccine court in Washington, D.C., and they will no longer allow it to be referenced by any experts testifying on behalf of vaccine injury claimants.”4
The legal aspect of silicone toxicity, and the botched means of defining “silicone toxicity” from the fiasco of the 1990s has merit, and I was not aware of details of the courtroom maneuvers that led the FDA to allow them back onto the market. In my review of ASIA, it was not a plaintiff, but a patient I was attempting to serve. If in extending ASIA as a possible explanation for clinicians seeing patients with disparate symptoms is damaging to future legal battles, I regret having been complicit in this.
2. “Silicone breast implant toxicity is a genuine illness that is orchestrated by at least two dozen fundamental disruptions of the body’s biochemistry, which in turn have virtually nothing to do with autoimmunity…. If the ASIA criteria become the standard by which silicone toxicity is defined, it is likely that future scientific panels will negate this methodology.”
If I gave the impression that all silicone reactions only fit into an autoimmune reaction, that was not the intent. I do not believe that clinicians would use ASIA as an exclusionary criteria in seeing patients with silicone implants. Rather, if the criteria is met, the clinician would have the wherewithal to address underlying immune dysregulation. The defining of ASIA to the reader does not mean that other reactions are not possible, and the average reader of NMJ is holistically minded and quite aware that deposition of silicon particles in or around cells may elicit biological aberrations not consistent with any immune reaction.
3. “Breast implant toxicity is not rare”
There appears to be little to no data on the actual numbers regarding the prevalence, likely due to the lack of defining criteria for breast implant toxicity as a diagnosable entity. Reference to its “rarity” was due to the millions of women who currently live with implants in the US without complication. From a population-based perspective there does not appear to be a large number of women suffering. As you have stated elsewhere, this may be due to the inadequate tracking of symptoms over time, with average systemic toxicities occurring at 3.5 years, and “safety” studies designed to stop at 3 years.5
Dr. Brawer, in summary your passion and dedication to helping women suffering from silicone toxicity find a voice in the legal realm is admirable. In writing my review of ASIA as a new entity, it was never my intent to more narrowly define the many possible reactions that can be due to a foreign substance such as silicon in the body. ASIA may not “hold up” in vaccine court, however I do think it's a useful clinical tool for us in recognizing when the immune system is being engaged and may exacerbate a patient’s symptoms. It is but a sliver of the possible ways of defining systemic ill health, be it in those with breast implants or without.
- Brawer AE. Silicon and matrix macromolecules: new research opportunities for old diseases from analysis of potential mechanisms of breast implant toxicity. Med Hypotheses. 1998;51(1):27-35.
- Brawer AE. Destiny rides again: the reappearance of silicone gel-filled breast implant toxicity. Lupus. 2017:961203317690241. doi: 10.1177/0961203317690241. [Epub ahead of print]
- Brawer AE. Bones, groans, and silicone. Lupus. 2012;21(11):1155-1157.