the battle over breast implants: new research shows what we’ve known for decades — they can cause autoimmunity

HUGE STUDY LINKS BREAST IMPLANTS TO AUTOIMMUNITY
NOT SURPRISINGLY, FDA DENIES

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“There is no scientific evidence that breast implants and leakage of silicone has been the cause of any type of autoimmune disease.” Dr. David Song, president of the American Society of Plastic Surgeons, and vice chairman of the Department of Surgery at the University of Chicago Medicine as quoted by Roberta Alexander for the July 28, 2016 issue of Healthline (Should Women Have Their Breast Implants Removed?

“The FDA responded to claims from women who had scleroderma, lupus, fatigue, or other autoimmune diseases.  They looked for associations between the implants and the symptoms, and they found no difference.”  Dr. Daniel Mills, president of the American Society for Aesthetic Plastic Surgery.  Ibid

“By coincidence alone, thousands of women will have both breast implants and an immune disorder.”   Dr. Marcia Angell, executive editor of the New England Journal of Medicine and author of Science on Trial being quoted by Doug Bandow for his 1999 article for the Cato Institute (Breast Implant Myths)

“Judge Pointer formed a four member expert panel in 1996 to assess the scientific evidence on implants. Recently, it concluded: ‘No association was evident between breast implants and any of the individual connective tissue diseases, all definite connective diseases combined, or the other autoimmune/rheumatic conditions.’  A succession of peer-reviewed studies from researchers at such diverse institutions as Harvard University, Johns Hopkins University, the Mayo Clinic, and the University of Michigan had previously exonerated implants.  Nor is this only the opinion of American professionals. Earlier this year the European Committee on Quality Assurance and Medical Devices in Plastic Surgery, which included experts from Israel and South Africa, concluded that implants do not cause auto-immune or connective tissue diseases, and that ‘there is no scientific evidence that such things as silicone allergy, silicone intoxication, atypical disease, or a new silicone disease exist.’ Similarly, the British government’s Independent Review Group reported that it could find ‘no histopathological or conclusive immunological evidence’ and ‘no epidemiological evidence’ of implant-caused diseases. Nor did it discern any ‘good evidence’ of such conditions as silicone poisoning.  This succession of research is about as conclusive as one could imagine. Dr. Elizabeth Connell, who chaired two FDA hearings on implants, observes: The Pointer Panel report ‘might not be the end of it, but it will be extremely helpful in putting the controversy to rest.'”  Ibid

“Silicone gel breast implants were removed from the U.S. market for cosmetic use in 1992 owing to safety concerns. They were reintroduced in 2006, with a call for improved surveillance of clinical outcomes….  32 studies (in 58 publications) met eligibility criteria.  The evidence was most frequently not specific to silicone gel implants, and studies were rarely adequately adjusted for potential confounders.  The evidence remains inconclusive about any association between silicone gel implants and long-term health outcomes. Better evidence is needed from existing large studies, which can be reanalyzed to clarify the strength of associations between silicone gel implants and health outcomes.” From a study funded by the Plastic Surgery Foundation and published in a 2016 issue of the Annals of Medicine (Long-Term Health Outcomes in Women With Silicone Gel Breast Implants: A Systematic Review)

Even though the information above “proves” that breast augmentation surgery is safe (or as the last bullet point shows, just how poor and inconclusive much of the research has actually been), there is plenty of information showing otherwise.  For instance, the study above came to some of the same conclusions as the MD Anderson study I’ll show you momentarily.  Regardless, breast augmentation is big business in America, with 300,000 augmentation procedures and 100,000 reconstructions done annually, as well as 50,000 implant reversals (“explants”).  Reversals?  Why in the world would someone who went through the time, effort, pain, and expense of having breast augmentation in the first place be interested in having it reversed?

Since the late 1800’s, doctors have been experimenting with injecting or implanting a wide array of substances into breasts for the express purpose of making them larger or changing their shape.  The National Academies of Science, Engineering, and Medicine (Information for Women about the Safety of Silicone Breast Implants (2000) Chapter: A History of Implants) revealed that, “ivory, glass balls, ground rubber, ox cartilage, and sponges, sacs, and tapes made from various synthetic substances. Later came rubber, Teflon, and finally silicone” were all tried, before settling on the later.  For the record, when silicone was first used it was injected directly into the breast.

Although silicone breast implants have been around since 1961, they didn’t really take off until the 1980’s.  Throughout this time, Dow Corning, the original manufacturer, didn’t need to argue for their safety because the FDA had not made any safety requirements for them.  However, as the number of complaints and adverse events associated with the implants grew, in the early 1990’s the FDA issued a “voluntary moratorium” (key word being ‘voluntary‘) to slow things down while studies were being done.   A 1998 issue of the  Journal of American Medical Women’s Association put it this way in a study titled Silicone Breast Implants and Autoimmune Disease.

“In 1992, the Food and Drug Administration requested a voluntary moratorium on the scale and implantation of silicone-gel-filled breast implants because of growing concern over the lack of scientific and clinical data supporting their safety and effectiveness. Breast implants had been reported to cause serious local complications, and new questions about breast implants and increased risk for autoimmune disease, including the rare but sometimes fatal connective tissue disease scleroderma, were also raised.”

The legal fallout from this and similar admissions was brutal, with several well-known corporations (Bristol-Myers Squibb, Union Carbide, 3M, Baxter International, Inamed, and of course Dow) forced to cough up just under five billion in settlement fees.  The May 2010 issue of the AMA Journal of Ethics (Silicone Breast Implant Litigation) put an industry spin on this story by writing……

“In March of 1994, after Dow Corning filed for Chapter 11 bankruptcy, the remaining manufacturers agreed on a settlement that more than 90 percent of the class action plaintiffs accepted. At $3.4 billion, it was the largest class action settlement to date. Preliminary approval was obtained in March 1994, clearing the way for women to start applying for claims in the settlement. In June of 1994, the New England Journal of Medicine published a study by Mayo Clinic epidemiologists that found no increased risk of connective tissue disease in women with silicone gel breast implants. In 1995, the Journal followed with yet another study—this one larger and more refined—that found no association between implants and connective tissue disorders. As a result of the studies, the American College of Rheumatology issued a statement in 1995 asserting that the evidence was “compelling” that “silicone implants expose patients to no demonstrable risk for connective-tissue or rheumatic disease,” and that “anecdotal evidence should no longer be used to support this relationship in the courts or by the FDA”. In 1997, the American Academy of Neurology reviewed existing silicone gel breast implant studies and concluded that there was no link between the implants and neurological disorders. In the same year, the Journal of the National Cancer Institute published a review of studies and concluded that breast implants did not cause breast cancer.”

Despite years of haggling, disagreement, and debate as to the mechanism and severity of health problems associated with silicone implants (and actually, whether said implants had anything to do with autoimmunity whatsoever —-see the FDA’s Regulatory History of Breast Implants in the U.S.), in November of 2006,  “The FDA approved Allergan and Mentor’s premarket approval applications for silicone gel-filled breast implants.  This was the first time silicone gel-filled breast implants were available for augmentation, in addition to reconstruction and revision, since the moratorium was established in 1992.”  As you might imagine, women flocked to have the procedure.  However, this is not the end of the story.

Interestingly, a study was published just the other day (US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients) by the plastic surgery department of the famous cancer center, MD Anderson, in the journal Annals of Surgery.  Listen to the conclusions this elite team of researchers came to after looking at the long term results of 100,000 post-augmentation surgeries, in what is unarguably the largest study of it’s kind.

“Despite the number of patients with breast implants followed by United States Food and Drug Administration large postapproval studies, this database has not been thoroughly analyzed or reported.  Compared with normative data, silicone implants are associated with higher rates of Sjogren syndrome (814%), scleroderma (700%), rheumatoid arthritis (596%), stillbirth (450%), and melanoma (371%).  At 7 years, re-operation rate is 11.7% for primary augmentation, and 25% for primary/revision reconstruction. Capsular contracture occurs in 7.2% of primary augmentations, 12.7% primary reconstructions, and is the most common reason for re-operation among augmentations.”

Gulp!  Not only are these numbers dumbfounding, but the first sentence provided a hint at what was to come for the research team.  If you make accusations against the FDA (“their database has not been thoroughly analyzed or reported“) you had better be prepared for some backlash.  They received that backlash in the form of an editorial published in the same issue (Assessing the Risks of Breast Implants and FDA’s Vision for the National Breast Implant Registry) as well as a PRESS RELEASE (Statement From Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on Agency’s Commitment to Studying Breast Implant Safety), both authored by Dr. Binita Ashar, a surgeon, who is director of the FDA’s Division of Surgical Devices.

In as good as an example of governmental CYA as I’ve seen lately, Ashar essentially said that the government had done its due diligence, requiring that manufacturers do a series of studies on their implants.  Unfortunately, when it comes to the FDA, THE FOX ALWAYS SEEMS TO BE GUARDING THE HENHOUSE.  Maybe it’s why their results were so different.  Different?  You see, MD Anderson’s researchers looked at the very same raw data from the very same studies that the FDA had used to approve these devices, while coming to the almost unbelievable conclusions seen above.  This forced Ashar and the FDA into some admissions of their own.

We respectfully disagree with the author’s conclusions.  Because of these concerns, we urge the public and healthcare community to view this external assessment’s conclusions with caution. Breast implants are not lifetime devices and the longer they have the implants the more likely they are to experience local complications and adverse outcomes requiring implant removal.  Local complications and adverse outcomes include capsular contraction, re-operation, and implant rupture.  Many patients also experience breast pain, wrinkling, asymmetry, scarring and infection.  Breast implants are associated with BIA-ALCL, a cancer of the immune system….  At the present time there is not sufficient evidence to show an association between breast implants and rheumatologic or connective tissue diseases”

So, not only are there a veritable treasure trove of side effects, which according to Ashar, seem to be relatively common, but she argues that despite this there is not a link to AUTOIMMUNE DISEASES (“rheumatologic or connective tissue diseases“).  Why do you think that this kind of protection of industry goes on in the FDA, both with medical devices and pharmaceutical drugs?  Might it have something to do with THIS STUDY, essentially pulling back the curtain and revealing yet another of their many dirty little secrets — the revolving door between government and industry?  As a side note: if you are interested in seeing my post about SCARING OF BREAST TISSUE, simply follow the link.

The truth is that some of the previous ‘major’ studies from the big hitters in American medicine (the Mayo study, the Harvard study, and a famous study published in the New England Journal of Medicine) have been so dirty and conflicted that it’s virtually impossible to believe anything in them.  Although it’s certainly not peer-review, the Alexander Law Firm provided an excellent example of exposing some of these study’s significant “limitations” in an article titled  Breast Implants: Fact v. Fiction in the Harvard and Mayo Clinic Studies.  For starters, “Two of the authors of the study… admitted under threat of perjury that they were paid consultants of breast implant manufacturers.”  Isn’t that special considering what research has repeatedly shown us about FINANCIAL CONFLICTS OF INTEREST in academic medicine?

Although we could discuss a wide array of topics here, I want to tackle just one — ASIA.  While many of you may think of ASIA as a continent on the other side of the planet, for our purposes today think of it as Autoimmune/Inflammatory Syndrome Induced by Adjuvants.  What in the world is an adjuvant?  For now just understand that adjuvants create INFLAMMATION — the root cause of virtually all pain and disease.  Two major studies were published on this topic just last year, the first in BMJ’s Annals of Rheumatic Diseases (Prevalence and Autoimmune Rheumatic Disease in Patients with Autoimmune/Inflammatory Syndrome Induced by Adjuvants Associated to Silicone Breast Implant) saying that, “We found a prevalence of ASIA associated to silicone breast implants of 11%,” and the second, from Immunologic Research (Two Hundred Cases of ASIA Syndrome Following Silicone Implants: A Comparative Study of 30 Years and a Review of Current Literature), which came to similar conclusions…….

“Despite changes in the principal constituents of the silicone implants during the past fifty years, silicone remained an adjuvant that may ‘bleed’ and subsequently may be a chronic stimulus to the immune system resulting in similar clinical manifestations…  In conclusion, we report that there is a group of patients who develop complaints related to silicone breast implants. In the past thirty years, the character of silicone-related complaints has been similar.” 

It wasn’t, however, like this was new information last year.  Five years earlier, in 2012, SAGE Insight published a fascinating study titled Silicone Implants and Autoimmune Conditions (ASIA Syndrome).  The part about this study that caught my eye was not the information on the disease itself, but the way the process of its discovery unfolded, reminding me of the Larry Nasser molestation case, where the therapist for USA Gymnastics and Michigan State University was convicted of sexually abusing young female athletes for decades (plural) before finally being caught.  The dominoes did not start falling until one woman came forward publicly, opening the flood gates and eventually leading to dozens upon dozens of women coming forward to accuse Nasser of sexual improprieties.  Worse yet were the numerous complaints against Nasser since the 1990’s that had been covered up and buried — similar to what you will see industry doing momentarily —- HERE). 

Likewise, the women in the study below knew they had problems, but neither they nor their doctors had any idea what was causing them until someone figured it out and started talking about it publicly, subsequently starting an avalanche of cases (of course there was some cover-up in this tale as well).  It helps you understand why hundreds of studies on ADVERSE EVENTS have shown they are only reported to proper authorities slightly more than 1% of the time (see link, not a misprint).

“In 1976 researchers in Japan reported on 9 cases of systemic sclerosis in subjects with silicone implants. A further 100 similar cases were quickly then discovered followed by  hundreds of case reports and patient studies reporting the development of diverse clinical symptoms following the insertion of silicone implants, which especially when these implants had ruptured. However, even when not ruptured an increased incidence of autoantibodies was recorded in many of these subjects. We now know that an asymptomatic presence of autoantibodies in the serum may precede the eventual development of full blown autoimmune diseases by several years. This new syndrome has been called ASIA (Autoimmune syndrome induced by adjuvant). Silicone was selected for use within implants because of its consistency as well as the belief that it is inert and would not be targeted by the immune system, yet it has been found to act as an adjuvant, especially when invading neighboring tissues when an implant ruptures.”

A few years later the journal Medical Cases (Silicone Breast Implants as Predisposing Factor for Non-Hodgkin’s Lymphoma: An Additional Facet of Auto-Inflammatory Syndrome Induced by Adjuvant) reported that “Systemic lupus erythematosus (SLE), Sjogren’s syndrome (SS) and rheumatoid arthritis (RA) were previously reported as risk factors for subsequent emergence of non-Hodgkin’s B-cell lymphoma.  ASIA syndrome is an array of autoimmune responses considered to evolve after, and result from chronic immune stimulation by adjuvants.”  The study went on to link silicone breast implants to FIBROMYALGIA-LIKE symptoms, CHRONIC FATIGUE, muscle pain, joint pain, stiffness, RA, and a hodge-podge of other autoimmune symptoms and diseases, including MULTIPLE SCLEROSIS, many of which are risk factors for this cancer.

Writing for the Clinical Neurology News later in 2014 (Syndrome Induced by Adjuvants May be Precursor to Autoimmune Disease), Sharon Worcester explained how exposure to said “adjuvants” occurs (ADJUVANTS are chemicals that intentionally or inadvertently FIRE UP OR “BOOST” ONE’S IMMUNE SYSTEM, leading to INFLAMMATION).  She quoted noted researchers as showing that the number one “intentional” adjuvant people are being regularly exposed to is ALUMINUM, which is added to most VACCINES (including the FLU SHOT) for the express purpose of creating inflammation and intensified immune system responses because in most cases, germs alone won’t do this.  A major inadvertent adjuvant exposure is silicone.  I’m not going to go into details on this article concerning the work of physician and researcher, Dr. Yehuda Shoenfeld, but his latest book (Vaccines and Autoimmunity) should make you stop and think.

“Adjuvants were formerly thought to pose little or no independent threat, but animal models, and some human studies, have suggested otherwise. In his article and during his presentation, Dr. Shoenfeld reviewed the data on the role of infections, silicone, and aluminum salts commonly found in vaccines as they relate to the development of autoimmunity.  Activation of the autoimmune mechanisms by infectious agents is common, he explained in the article.”

Spot on, including his assertion that microbes (germs) have the propensity to themselves ignite autoimmune responses, SOMETHING I SHOWED MY READERS recently.  This is especially freaky after seeing information revealing that silicone implants have been shown to be breeding grounds for a potentially highly reactive microbe, continually releasing it back into the body — Aspergillus Niger, otherwise known as BLACK MOLD.  Take a look at this absolutely crazy three minute video clip from the Discovery Channel on the relationship between silicone implants, black mold, and autoimmune symptoms (MONSTERS INSIDE OF ME).

The silicone implant fiasco should lead us to ask other questions; namely what else might the FDA be lying about?  What about many of the DRUGS we take (at less than 5% of the world’s population, Americans use over 2/3 of all the world’s meds — HERE)?  What about vaccines, which researchers are unable to tell the truth about if they value their careers (HERE)?  After all, that’s where we almost exclusively see the terms “ASIA” and “adjuvant” used, and frequently together.  What about “PREVENTATIVE MEDICINE” that doesn’t remotely manifest the almost magical health-preserving powers ascribed to it?  The truth is, as I’ve shown you in my dozens of posts on EVIDENCE-BASED MEDICINE, healthcare is all too often about the same thing it’s always been about — money.  

Allow me to show you tidbits from a quarter century of studies showing in “CHERRY-PICKED” fashion why the FDA should have been doing a better job of protecting women from autoimmune-inducing silicone breast implants.  Believe me when I tell you that this is barely scratching the surface — I could have given you a book.

  •  “An association between crystalline silica and immune disease has long been recognized. Silicone has been shown to ‘bleed’ from the implants and can migrate to distant sites. There is evidence of cellular and humoral immune responses to silicone…. The implant population needs to be closely monitored; their clinical management should be based on a case by case evaluation.”  From a 1993 issue of Europe PMC (Autoimmune Disease and Silicone Breast Implants)

  • “The association between the use of silicone breast implants and the later development of connective tissue disease was reviewed. Data from case reports (only 40 in the world literature), case series, case-control studies, surveys of plastic surgeons, and cohort studies provided no evidence of an association. In many studies, the appropriate information was not collected to evaluate the association. The case-control and cohort studies were too small to detect even moderately increased risks should they exist.”  From a 1994 issue of Seminars in Arthritis and Rheumatism (Autoimmune Disease Following the Use of Silicone Gel-Filled Breast Implants: A Review of the Clinical Literature)

 

  • “As rheumatologists who have examined and evaluated a combined total of more than 3,000 symptomatic women with silicone breast implants, we feel compelled to point out the shortcomings of the study by Gabriel et al. (June 16 issue).  We, like many others, believe that many symptomatic women with silicone-gel implants have a new and unique rheumatic syndrome characterized by chronic fatigue, myalgia, polyarthralgia, cognitive dysfunction, symptoms similar to those of the sicca syndrome, rashes, and neurologic disturbances. This disease was first described 20 years ago by the Japanese as ‘human adjuvant disease’ and more recently has been labeled ‘atypical connective-tissue disease.’  Pending definitive studies, we believe that the FDA is justified in continuing the ban on silicone-gel implants. The burden of proof should be on implant manufacturers, to provide evidence of safety, not on physicians who treat symptomatic women, to provide proof of injury.”  A letter to the editor of the New England Journal of Medicine (Breast Implants and Connective-Tissue Diseases) written by rheumatologists from elite institutions around the nation

 

  • “As early as 1954 an in-house study by Dow Corning, a prime implant manufacturer, found that the silica in silicone has quite a high order of toxicity, according to recently released documentation of that previously suppressed study. In 1956, silicone fluid injected into laboratory dogs migrated to all the major organs; and in 1961, the year the first implants were released, Dow’s own internal medical research department reported that silicone leaking from implants is equivalent in toxic effect to direct injections of silicone into the body.  Prior to implants, that had been the preferred method of breast enhancement. But in the 1940s, Japan, for one, banned this procedure for its immunologically toxic effects, which included poisoning, infections, and the early development of cancer. Even so, it remained legal in the U.S. until the 1960s.”  From a 1996 article titled Scientific Evidence Proves that Silicone Breast Implants can Produce Autoimmune Illnesses

 

  • “In the last 2 decades, based mostly on anecdotal reports of association with certain phenomena, e.g. neoplasia and autoimmune disease, they have been subject to a wave of negative publicity so that the use of the silicone gel filled types has been banned in the USA except for special cases. They continue to be available in other parts of the world, including the UK. Nevertheless their usage is associated with some complications. Calcification of the capsules has been reported mostly as individual case reports but in a recent study it was noted to occur in 16% of explanted silicone gel implants and more so in the patients with long-term augmentation (greater than 10 years).  The etiology is unknown but suggested predisposing factors include postoperative infection and inflammation.”   From a 1997 issue of the British Journal of Plastic Surgery (Silicone Breast Implants: Complications)

 

  • “For decades, women who have undergone breast implant surgery have reported high implant failure rates and general, unidentifiable illness.  We do know that a very high number of women have been affected by breast implant-related complications. A Mayo Clinic study in the United States, for example, found that 25% of women with breast implants suffered local complications requiring additional surgery within five years. We also know that there were 103,343 adverse reaction reports associated with silicone breast implants and 23,454 reports involving saline implants received by the U.S. Food and Drug Administration between January 1, 1985 and September 17, 1996.  Systemic complications appear most frequently several years after breast implantation. These complications tend to present as a cluster of symptoms, including those associated with autoimmune diseases, connective tissue diseases, “human adjuvant disease” and/or fibrositis/fibromyalgia-like disorders. (The classic autoimmune and connective tissue diseases thought to be associated with silicone implants are scleroderma, systemic lupus erythematosus, mixed connective tissue disease, rheumatoid arthritis and Sjogren-Larsson syndrome.) Women with breast implants have also reported granulomas and lymph node involvement, chronic flu, respiratory problems and infections.”  From a 2003 article on the Canadian Women’s Health Network titled Health Complications from Breast Implant Surgery Common

 

  • “The immune system activation from silicone/silica causes a unique fibromyalgia syndrome. My peer reviewed paper in the Journal of Rheumatology entitled ‘Where There’s Smoke There is Fire’ was a plea to define the newly recognized and still controversial subject of a silicone breast implant (and any other silicone device in the body) syndrome. This opinion is not unfounded. It is based on my experience caring for 2,000 sick women over thirty years in Tampa at the University of South Florida College of Medicine and three years in Detroit at Wayne State University School of Medicine. We let people smoke and we know that kills them. I don’t think silicone kills people, but it can make you feel like the flu every day, which is a pretty miserable way to live. If you are sick and your doctor can only diagnose fibromyalgia, you steadily worsen with activity, feel like you need to urinate all the time and have in apparent insects crawling on your burning skin, consider removing and not replacing your silicone breast implants.”  Renowned rheumatologist, Frank Vasey, from an article he wrote for a 2007 issue of the New York Journal of Style and Medicine

 

  • “Today, breast implant augmentation remains the most common plastic surgery procedure in the United States; in 2009, 311,957 breast augmentations were performed, half were with silicone implants.  The possible association between silicone and systemic events has been suggested because as silicone degrades, its fragments, which are non-inert, are deposited around the capsule and scattered to other parts of the body potentially causing an interaction with the body’s defense systems leading to cancer or autoimmune phenomena.  Autoimmune reactions to presumably silicone shell breakdown in patients with saline-filled breast implants have been well documented. The amount of extracapsular silicone from implant rupture statistically correlates with systemic problems. Pain and symptoms of chronic fatigue were more frequently reported in patients with ruptured versus unruptured implants. Implant manufacturers changed to harder elastomer shells to decrease the chance of rupture because the adverse effects of silicone on immune function was becoming evident and well described. When silicone migrated outside the scar tissue capsule surrounding the implant, women were significantly more likely to be diagnosed with an autoimmune or connective tissue disease.  Oftentimes, symptomatic breast implant patients do not fit into a particular disease category. If their symptoms are never adequately defined or quantified, it will never be possible to conclusively prove, or disprove, any assumed link between silicone breast implants and systemic disease. A relationship between silicone implants and a particular constellation of symptoms, which did not fulfill any diagnostic criteria for any recognized connective tissue diseases has been documented in several studies and analyzed in a recent meta-analysis.  Whereas silicone-elicited inflammatory fibro-proliferative response is irrefutable and the presence of anti-silicone antibodies, non-related autoantibodies and nondefined silicone-associated autoimmune phenomena seems plausible.”   From a 2010 issue of the European Journal of Clinical Investigation (Silicone and Autoimmunity)

 

  • “Silicon is one of the most common chemicals on earth. Several compounds such as silica, asbestos, silicone or, nanoparticles are built from tetrahedral units with silicon as the central atom. Despite these, structural similarities, they have rarely been analyzed as a group. These compounds generate significant biological alterations that include immune hyperactivation, production of the reactive species of oxygen and tissue injury. These pathological processes may trigger autoimmune responses and lead to the development of rheumatoid arthritis. A recently denominated autoimmune / inflammatory syndrome induced by adjuvant (ASIA) was defined (for complete review see references). As it was described previously by Shoenfeld and Agmon-Levin this syndrome includes four particular medical conditions, defined by hyperactive immune responses. The major diagnostic criteria are the clinical manifestations such as arthralgia and/or arthritis, neurological manifestations, unrefreshing sleep or sleep disturbances, chronic fatigue, cognitive impairment and memory loss, myalgia, muscle weakness, myositis pyrexia, and dry mouth after a systemic exposure to external stimuli, for example, infections, vaccines, silicone, and adjuvants.  As an adjuvant, silicone is capable of inducing autoimmune-like conditions (e.g. Gulf war syndrome, siliconosis, postvaccination phenomena, and the macrophagic myofasciitis syndrome). This could be the case for symptoms such as arthralgia and myalgia that are more common in individuals exposed to silicone implants. Siliconosis is one of the most characteristic diseases because of its potential as an adjuvant in the immunization process.”  From a 2012 issue of the journal, Arthritis (Silicon, a Possible Link between Environmental Exposure and Autoimmune Diseases: The Case of Rheumatoid Arthritis)

 

  • “Despite changes in the principal constituents of the silicone implants during the past 50 years, silicone remained an adjuvant that may ‘bleed and subsequently may be a chronic stimulus to the immune system resulting in similar clinical manifestations as 50 years ago. Silicones are spread throughout the body and can be detected in tissues and the central nervous system. Autoimmune/inflammatory syndrome by adjuvants (ASIA), allergies, autoimmune diseases, immune deficiencies and lymphomas occur in patients with silicone breast implants. There is a need for adequately adjusted epidemiological studies to ascertain the frequency of these diseases. Removal of the breast implants, however, should be advised to patients with complaints, as 60–80% of patients show an amelioration of the signs and symptoms after explantation. Silicone breast implants are associated in a proportion of patients with complaints such as fatigue, cognitive impairment, arthralgias, myalgias, pyrexia, dry eyes and dry mouth. Silicone can migrate from the implant through the body and can induce a chronic inflammatory process.”  From the July 4, 2017 issue of Current Opinion in Rheumatology (Silicone Breast Implants and Autoimmune Rheumatic Diseases: Myth or Reality?)

 

  • “We included 24,651 SBI (silicone breast implant) recipients and 98,604 matched SBI-free women in our study. The association between SBIs and autoimmune disease was significant. The strongest association with SBIs was recorded for systemic sclerosis and sarcoidosis. Similar results were calculated when analysis was limited to cancer free women. Multivariable Cox regression model yielded…. being diagnosed with at least one autoimmune disease in women with SBI compared to those without.  SBIs seems to be associated with higher likelihood of auto-immune disease diagnosis.”  From the June, 2018 issue of the British Medical Journal (Silicone Breast Implants and the Risk of Autoimmune Diseases: Real World Analysis)

I sincerely hope that this has quenched any desire some of you may have had to have silicone surgically implanted into your body — especially after seeing statistics from Canada’s National Center for Health Research (What You Need to Know About Breast Implants).  “46% of women with silicone gel implants and 21% with saline implants underwent at least one re-operation within three years; 25% of silicone patients and 8% of saline patients had implants removed; and 6% of silicone patients and 16% of saline patients experienced breast pain.  A Danish study of ruptured silicone gel implants suggests that after 20 years the few that are still intact will break.”  The paper went on to talk extensively about the autoimmune consequences when this inevitably happens.  Ask yourself this ladies; is it really worth it?  “Jane” would argue vehemently that it’s not.

I well remember the first patient I saw this phenomenon in.  It was late 1993, and I hadn’t seen Jane for a few months.  When I did see her it was quite obvious that she had gotten implants.  However, within a year or so she was complaining about bone-crushing fatigue, chronic all-over pain and stiffness, and mental fog.  To make a long story short, although she eventually had them removed, the desire for larger breasts had essentially destroyed her life and career — something I’ve seen happen on more than one occasion, and with butt implants as well (HERE).   For information on natural approaches to reducing systemic inflammation and subsequent autoimmune symptoms, HERE is the post.  And if you know any women, be sure to do your part to see that today’s post makes the rounds on FACEBOOK!

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