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Assessing Autoimmune Disease Symptoms in Silicone Breast Implant Recipients

• By Charles Radis, DO

My nurse, Joanne, took me aside before I began my next consult. “Room No. 5, breast implant patient. Her lawyer organized the records.” She handed me a hefty three-ring notebook organized by color-coded tabs. “Her attorney called just now,” Joanne raised an eyebrow, “and told me to tell you that, to save time, he highlighted in yellow marker the most critical aspects of the case for you to review. The breast implant settlement agreement is on the last page.”

This would take some time. On my way to my office, I grabbed a fresh cup of coffee and caught a glimpse of my next patient through the half-open exam door. Middle-aged, razor-cut layered blond hair, ivory cheeks, white sweater, eye-catching silhouette, she was speaking to someone seated, hidden beyond the exam table. Just before I ducked into my office I heard her ask Joanne where the bathroom was located. I looked back and watched her scurry down the hallway. I had a few minutes.

I cracked open the notebook.

Breast Implants & Automimmune Disease

It is 1994, and each month I consult on two or three women with silicone breast implants who may or may not have autoimmune disease. Without exception, they are in diffuse, excruciating pain and wonder if—no, they’re convinced that—the implants are the reason. It is a dramatically different consult from what I am accustomed to. As a rule, I see patients in consultation to answer two basic questions: What is the diagnosis? And second, how can the disease best be treated?

This paradigm is completely turned around by my silicone breast implant evaluations.

The Case

Stokkete/shutterstock.com

Stokkete/shutterstock.com

Whitman, Connolly, and Favio, a New Orleans law firm representing thousands of breast implant sufferers, has kindly organized Mrs.—I flipped the page—Mrs. Hayden Morse’s medical file in minute detail and wants me to qualify her for the Dow Corning Breast Implant Settlement.

In the introductory letter, I am informed that I am worthy as a board-certified rheumatologist to verify that the claimant has scleroderma, systemic lupus erythematosus (SLE), mixed connective tissue disease, polymyositis, dermatomyositis, primary Sjögren’s syndrome or an atypical rheumatic syndrome. My job is to review the documents, particularly those aspects of her case highlighted in yellow marker, examine the patient and check off the appropriate box on the settlement page. Browsing through the trail of yellow highlights, it’s pretty clear that the law firm is convinced its client has SLE. Do I agree?

Comments

  1. great article, dr radis!
    i had much the same experience with the implant patients, and the same difficulties in dealing productively with them.
    thank you for clearing the air!

    • The author of this article, Charles Radis receives corporate funding from Big Pharma. Just between 2013-2015 he received $81,867 on research mostly from Pfizer but also from two other big pharmaceutical companies.

      Pfizer has financial interests in the breast implant manufacturers, recently trying to purchase Allergan in 2015.

      Some of the studies he listed were by scientists who were corporate funded, paid for by the breast implant manufacturers, and therefore are biased with conflicts of interest.

      This information can be found in the Integrity of Science Database that reveals the corporate funding of scientists.

      6. Silicone breast implants and the risk of connective-tissue diseases and symptoms.
      Authors:

      Two of the authors of the study, Dr. Graham A. Colditz and Dr. Matthew H. Liang, admitted under threat of perjury that they were paid consultants of breast implant manufacturers.

      Speizer FE received corporate funding on his research.

      7. Risk of connective tissue disease and related disorders among women with breast implants: a nation-wide retrospective cohort study in Sweden.
      Authors:

      McLaughlin JK was President of the for-profit International Epidemiology Institute, which has received funding from the Dow Corning Corp. and 3M Company.

      Blot WJ was Chief Executive Officer of the for-profit International Epidemiology Institute.

      Boice JD, Jr. was the Scientific Director of the for-profit International Epidemiology Institute.

      Josefsson S. has been a paid consultant.

      Adami HO has been found in the past to have been hired to conduct research and supported the industry he was hired by. He is referenced in the article “Secret Ties to Industry and Conflicting Interests in Cancer Research,” Am J Ind Med. 50:227-233 [2007].

      8. Self-reported breast implants and connective-tissue diseases in female health professionals. A retrospective cohort study.
      Authors:

      Hennekens CH is a paid consultant for AstraZeneca, Bristol-Myers Squibb/Sanofi (breast implant manufacturer), Novartis, Pfizer, and Reliant. Co-author of Pfizer funded study, “Absence of Interaction Between Atorvastatin or Other Statins and Clopidogrel.”
      Also serves as a paid consultant, including Chair or membership on Bristol-Myers Squibb (breast implant manufacturer), Data and Safety Monitoring Boards for AstraZeneca, Bayer, Chattem, Delaco, GlaxoSmithKline, McNeil, Novartis, Pfizer, and Reliant.

      Manson JE worked as a paid consultant.

      Unfortunately, this was quite common and the articles that were published in favor of no association were by scientists with conflicts of interest. This only touches the surface of the dirty business of breast implant manufacturers.

      See this article for more: http://www.reuters.com/article/us-implants-idUSTRE8090XI20120111

      • All studies are funded by somebody. Studies should be judged on their methodology, results, and data analysis. The results should be reproducible by others. To throw out a study simply because the researcher(s) is(are) funded by a manufacturer is to ignore the factual, or non-factual, information therein. If we did this to all studies, there would be few left. This author of this article struck me as an unusually thorough, compassionate physician. What he has received from “Big Pharma” is a pittance. I doubt he would sell himself out so cheaply. What, exactly, is wrong with the article, as written?

    • I am reading this, feeling so sad for my children who will grow up without a mother because of breast implants poisoning me.
      I am too weak to tell my story, but mine is very common….a young,active typeA personality decides to ‘improve” her figure…is fine for 10yrs. & then her body starts failing…all strange symptoms… Dr.s say are not related to each other- even though I was only 30 yrs. old- took 5 LONG yrs. of suffering ~~before is was figured out- not by Dr.s- but by friends, family, & me ? By the time they were finally removed, I was dying…& they were leaking and had a faulty valve. I have never tried to get any $- I just want my daughter to know that her mother missed her childhood because of toxic, poison balls-(please look up disgusting ingr. of implants) and not because I had a mental issue.
      I hope that all the will change and not ruin more families. It’s truly heartbreaking. ??

    • Dear Doctor,
      “Dealing productively with them” is a key indicator of precisely why these patients come to me to cope with the fallout of their implants. After doing a simple timeline, you may discover the obvious.

      Even if the implants are completely safe, there is always a risk of leakage because the implants have a time limit. I am dealing with one such client now. The depression that ensues leads them to see me, but I find myself frustrated by the sheer arrogance of the medical community to be so dismissive of their symptoms, relegating all such symptoms to being simply the product of hysteria. However, there is a simple way psychologists like me can assess whether symptoms are somatic or whether they are genuine: The reaction of the client to discovering their symptoms. When a client is genuinely mystified by their new found allergic response to foods and substances which had never been a problem before, this is a good indication as to whether they are somatic or genuine. Dr. Paul Ekman did extensive research on facial expressions and produced excellent criteria for monitoring such expressions. This is one tool I use to detect somatic symptoms. An individual in genuine pain makes another key expression on their face that I am confident you observe in patients without even recognizing what you are noticing. That could provide an additional clue for you to identify somatic symptomology versus genuine.

      While I would agree there is possible financial motivation for some patients, most people with this problem are not expecting to want an explantation procedure. It is not common human behavior to want to have breasts altered to look uglier. A young woman especially is highly motivated by vanity, so to seek your assistance to potentially identify a diagnosis which could result in further disfigurement is even less likely. Although it seems reasonable to be suspect of any patient who seeks a consult for litigation, I invite you to consider what brought them to you and set your bias aside. Having worked with the clients struggling with the depression of their reality; namely, their illness and potential disfigurement was self-inflicted out of vanity, compassion with make it far easier to “deal productively” with these patients than hostility.

      Just a thought. I hope my client is able to find a compassionate physician that can assist her in her hope of silicone explantation and recovery of her health. It would seem her complaints of finding only dismissive and callous physicians in this effort may be a common dilemma.

      • Thank you so much for this comment! We, as women with silicone or saline breast implants who have gotten so ill they stay in a recliner for 23 hours a day, and then looking at having their implants removed in a risky operation, are not just looking for money, they want their health back. I had silicone implants put in for breast reconstruction from breast cancer in 2013. Within two-and-a-half years I was diagnosed with sero positive rheumatoid arthritis. I lost my job, my friends, my whole way of life and am now trying to scrape by on disability. I didn’t choose to get implants due to wanting bigger breasts, my plastic surgeon assured me that they were perfectly safe, he never gave me the booklet that came with the implants because I’m sure somewhere in the small print was the risk of autoimmune disease. If I had seen this or been told of the risk, I would never have had implants put in. I was told by two of my sisters that possibility of my illness was due to breast implants. I ignored the advice for a year as I certainly didn’t want to think that it was my implants that were causing the disabling fatigue and pain I was having. It took me another six months of research to realize that it was indeed my implants as I had other symptoms totally unrelated to rheumatoid arthritis symptoms that matched perfectly to the list of breast implant illness symptoms. I we’ll be having the surgery to get these toxic silicone bags out at the end of January 2019, my chest will be concave and deformed with no breast tissue. I just need to stop feeling like I am dying everyday, I don’t I think that having them out will reverse the rheumatoid arthritis, but if I can just get back at least 20% of my energy and just have a few hours a day to do something normal, I will feel like I’m at least alive again and not just existing. That is really adding insult to injury to do this to a woman who had her breasts removed due to cancer. Greed is a horrible driver! As textured breast implants have recently been banned in Europe, hopefully it won’t be long until they are banned in the US and Canada as well. The truth WILL come out, we will no longer be victims of Big Pharma and parts of the medical community who only wish to get rich off of their specialties, and actually make more money when more patients are sick. It’s hard for me to understand how these people can sleep at night knowing the truth, and running full speed at wanting to put more implants in.

    • This article is infuriating and insulting. He is part of the problem, not solution. Of course, he suggests her complaints are from mental conditions, she’s a woman. What arrogance and sexism.
      I am one of the hundreds of thousands of women who have become incredibly sick due to implants. To suggest my symptoms are related to depression or unresolved trauma is negligent. I have been bedridden for 2.5 years and meet every criteria described across the board with Implant Illness. If my doctors said anything near of what the author suggests, I would have spoke my truth and left, never to return. It’s this lack of compassion, knowledge and belief in patients that leave us suffering.
      Shame on all of you if you follow this awful example.
      Patients, even women, deserve your attention, respect and willingness to assist.
      Be part of the solution and genuinely become familiar with this real complicaton of implants. It’s not just breast implants, but any forgein body. Ignorance does not excuse poor care.

  2. I am one of the 40 or so rheumatologists who became satisfied on the basis of their personal experience implants cause systemic disease still undefined. This was based on improvement in most patients post removal. Obviously not convincing to people who didn’t see those patients in large numbers. I saw 2-3 K over 30 years in Florida. I helped in the best outcome study of 100 pts followed over 2 yrs. It was not randomized or blinded, but the 1/2 pts who removed them improved on an appropriate Likert scale. The others worsened. Rejected by 3 rheum and one plastic J. Available at NYJSM on google silicone syndrome.

    • Thank you Dr Vasey for your contribution to our community. I was diagnosed with a series of autoimmune diseases and a heart condition (severe pulmonary hypertension) following the introduction of breast implants for reconstructive surgery at the age of 17. I was ill within months for a total of 9 years until both the implants and scar capsules were removed. I have recovered fully and have enjoyed my prior excellent health for the past 6 years largely thanks to doctors such as yourself and the women who have recovered before me.

    • Thank you, Dr. Vasey! Dr. Brawer is another rheumatologist that observed women and observed the real science behind silicone.

      Chronology of 300 symptomatic recipients of silicone gel-filled breast implants (1996). Brawer AE

      Clinical features of local breast phenomena in 300 symptomatic recipients of silicone gel-filled breast implants (1996). Brawer AE

      Silicon and matrix macromolecules: new research opportunities for old diseases from analysis of potential mechanisms of breast implant toxicity (1998). Brawer AE

      Amelioration of Systemic Disease after Removal of Silicone Gel-filled Breast Implants (2000). Brawer AE

      Bones, Groans, and Silicone (2012). Brawer AE

      Breast Implant Toxicity (2016). Brawer AE

  3. You missed an editorial we wrote on the subject:

    Sanchez Guerrero J, Schur PH, Sergent JS, and Liang MH: Silicone breast implants and rheumatic disease. Clinical, immunologic, and epidemiologic studies. Arthritis & Rheumatism 37:158 168, 1994.

    • Peter Schur, you were a paid consultant to lawyers representing Dow.

      Sergent JS was also a paid consultant and expert witness for Baxter Healthcare, Dow Corning, 3M, Bristol-Myer Squibb.

      Your study was part of the conflict of interest, junk science that was bought by corporate revenue, the manufacturers, to salvage them.

      This information can be found in the Integrity of Science Database that reveals the corporate funding of scientists.

      Unfortunately this was quite common, and the articles that were in favor of the no association of illness were published by scientists (such as yourself, Sergent JS, McLaughlin JK, Adami HO, Liang MH, and others) with a conflict of interest.

    • Another author of the study, Liang MH admitted under threat of perjury that he was a paid consultant of breast implant manufacturers. He received significant financial interest from them.

  4. Please see our papers:
    Zandman-Goddard G., Blank M., Ehrenfeld M., Gilburd B., Peter J., and Shoenfeld Y.
    A comparison of autoantibody production in asymptomatic and symptomatic women with silicone breast implants.
    J. Rheumtol. 26: 73-77,1999.
    ——————————————————————————————————————
    Rishpon A, Wohl Y, Barnea Y, Ehrenfeld M, Weiss J, Klaz I, Brenner S.
    Silicone implants and connective tissue disease: 5 cases.
    SKINmed.6: 30-34, 2007.
    ___________________________________________________________________________________
    Levy Y, Rotman-Pikielny P, Ehrenfeld M, Shoenfeld Y.
    Silicone breast implantation-induced scleroderma: description of four patients and a critical review of the literature.
    Lupus 18: 1226-1232, 2009.
    ____________________________________________________________________________________
    Bar-Meir E, Ehrenfeld M, and Shoenfeld Y.
    Silicone gel breast implants and connective tissue disease-a comprehensive review.
    Autoimmunity 36:193-197,2003.
    ______________________________________________________________________________________

  5. Dr. Radis‘s has constructed a narrative that was very typical of what our group saw in 1994-5, for awhile on a nearly daily basis. The solicitous companion (relative, husband, concerned friend) and litigious background were almost universal. Most were seeing us because previous rheumatologists had failed to discover autoimmune disease leaving many of these patients with the impression that their symptoms were “in their heads”. Most had not even addressed possible psychiatric disorder, probably fearing confrontation and a low “patient satisfaction rating.” While this approach may have been in the best interest of the doctor, it was not helpful to the patient.

    Back in those days we asked all of our patients to complete appropriate questionnaires after each visit. For silicone breast implant patients these included instruments to assess sleep, pain syndromes and depression. Almost all such patients turned out to have fibromyalgia and depression.

    Mrs Morse had diffuse pain, fatigue, sleep difficulty, fluctuating autonomic dysfunction (weakness) and both a history of and likely ongoing depression. The physical examination demonstrated non-articular tenderness without objective weakness or neurological signs. I suspect that if Mrs Morse had presented in our office, a new diagnosis of fibromyalgia associated with depression would have been made. What that meant is that her symptoms of pain, fatigue, poor sleep, weakness, etc could be explained, without recourse to an underlying mysterious autoimmune disease; and a treatment plan for those symptoms could be contemplated.

    When I/we saw these patients education was a primary task. “I don’t believe that you have Lupus. That’s a good thing. You didn’t tell me but I bet bright lights and loud noises bother you. You’ve had more trouble with constipation alternating with diarrhea……..”
    “How did you know?”
    “Because those are also symptoms of fibromyalgia which I know you have. And we can treat them”.
    I would then begin a discussion of distress, sleep and the physiological mechanisms that were responsible for her/his symptoms would have been offered.

    Were these visits always pleasant? Absolutely not. Were they often initially adversarial? You bet. Were they time and emotionally consuming? I did not want to see more than one silicone breast patient a day. (I saw patients nine half days each week). Did I get my letters? Plenty. The patient would vent her/his anger on two-four colorful pages with threats and sometimes prophecies about my future relationship to hell.
    Did they all get better? No but many did and became regular patients. They had many of the same symptoms, but would often volunteer that “They don’t bother me any more.”
    Maybe that was because I often told patients that “Pain is inevitable. Suffering is negotiable.”

    Contrary to the “popular belief”, popular because it gets the doctor off the Hippocratic hook, making the diagnosis of fibromyalgia does not harm the patient or lead to increased health care utilization (1,2). Quite the opposite happens. And this should have been expected. The scary unknown/mystery has been solved. So don’t rely on the “popular belief” as an excuse. And incidentally, “I am not a psychiatrist” doesn’t provide absolution either.

    I know that simply telling these patient that they didn’t have autoimmune disease; or even better, just writing a letter to the referring physician, was/is the Dr.-prudent thing to do. It also saves time ($$). But is it the brave thing to do? We all got into this profession to care for patients first.

    1) Sanchez RJ, et al: Current Medical Research & Opinion Vol. 27, No. 3, 2011, 663–671.
    2) White KP, et al: Arthritis & Rheumatism (Arthritis Care & Research) Vol. 47, No. 3, June 15, 2002, pp 260–265.

    William S Wilke MD. Orthopedic and Rheumatologic Institute, Cleveland Clinic, Cleveland, OH, USA (retired).
    Author; The Cleveland Clinic Guide to Fibromyalgia 2010; Kaplan Publishing. Liberty Plaza 24th Floor; New York, NY.

  6. I had reviewed many case records for the defense, hence I had to cease seeing patients with alleged problems much earlier–both due to my own apparent conflict of interest and anger at my stated position on the subject. One point often understated was the recruiting of women by large plaintiff firms for law suits. A very good story of some of these machinations was done by Kolata and Meier of the NY Times: http://www.nytimes.com/1995/09/18/us/doctors-lawyers-silicone-special-report-implant-lawsuits-create-medical-rush.html?pagewanted=all (“Doctors, Lawyers and Silicone: A special report.; Implant Lawsuits Create A Medical Rush to Cash In”)

  7. I think a lot depends of the HLA type of the patient, e.g., is the silicone breast implant recipient positive for the autoimmune haplotype HLA-DR1- HLA-B8, etc? There is presently no data on this subject, and such a study will never be done. My impression is that the vast majority of patients with silicone breast implants don’t have true autoimmune diseases and just fibromyalgia. However, it is quite conceivable that if you are born with the classic autoimmune haplotype, as above-mentioned that silicone breast implants may trigger autoimmune disorders, as certain vaccines, e.g., hepatitis B have been shown to induce in this autoimmune prone population,

  8. I thank God that you are not my doctor, Mr. Radis. I’m horrified at the thought of you teaching future medical professionals.

  9. This was mine but wasn’t approved:

    Breast implant “safety and effectiveness have not been established in patients with the following: • Autoimmune diseases (e.g., lupus and scleroderma)”. This is directly written in the product insert sheets. It should be a given that women are tested prior to implantation, but that is usually not the case.
    Breast implants have not been proven safe. The FDA “believes that approved breast implants have a reasonable assurance of safety and effectiveness when used as labeled”, not that they are 100% safe. They were put back on the market with the understanding that long term studies need to be completed. Many times women were discarded in studies when they had symptoms but no “defined” disease. According to Allergan on page 20 of their product insert sheet for NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants, “The study size needed to conclusively rule out a small risk of connective tissue disease among women with silicone gel-filled implants would need to be very large. The published studies taken together show that breast implants are not significantly associated with a risk of developing a typical or defined connective tissue disease.” It does not say that there is NO association. It says that the study size needs to be larger. According to the Mentor MemoryShape Product Insert Data Sheet on page 19, “The study size needed to conclusively rule out a smaller risk of connective tissue disease among women with silicone gel breast implants would need to be very large. The published studies taken together show that breast implants are not significantly associated with a risk of developing a typical or defined connective tissue disease.” Once again, they don’t rule it out, they only say that the small studies done don’t show a significant correlation. Even more trivial is the fact that many of these studies on these particular issues have been terminated – probably due to the fact that they have unrealistic numeric expectations to complete the study. Therefore, safety is not proven or disproven when addressing things like connective tissue disorders, neurological disease, brain cancer, cervical cancer, and lymphoma.
    Furthermore, the Allergan and Mentor labeling pamphlets actually list some of the symptoms that many women describe. “Literature reports have also been made associating silicone breast implants with various rheumatological signs and symptoms such as fatigue, exhaustion, joint pain and swelling, muscle pain and cramping, tingling, numbness, weakness, and skin rashes.” (same pages on both pamphlets). So even when a defined illness is not correlated, the patient can experience symptoms that correlate with autoimmune or connective tissue disorders.
    Then add on the fact that there is a direct correlation with Breast Implant-Associated Anaplastic Large Cell Lymphoma. It is a recognized diagnosis by the WHO, the FDA, the ASPS, the ASAPS, the UKAAPS, etc. Surgeons cannot deny the fact that implants can cause cancer. This disease is undertested and underreported.
    Surgeons need to stop telling their patients that these devices are 100% safe. Safety and efficacy has not been proven. France is questioning safety and threatening a ban. Women in the UK are asking for proof of safety. The TGA in Australia is being hit hard for proof of safety and efficacy. Women in the US are stepping forward and comparing stories. Canada is being hit for proof. A recent study comparing women in the Netherlands in 2014 who were sick from their breast implants to women at the Baylor College of Medicine 30 years ago showed that the symptoms were exactly the same. Despite innovation in breast implant manufacturing, the symptoms are still similar and still relevant. Explantation was the 10th most ranked cosmetic surgical procedure in the US in 2015 according to the ASAPS. We believe that 2016 will prove to be even more significant. It will eventually lead to a question as to why women are wanting their implants out. They are sick, frustrated, and tired of being ignored! We will not be ignored any longer. We are speaking out and we are making our voices heard.

    • I had my ruptured implants out in 1986 and never had others put back in after being so sick and after reading the FDA ingredient chart! Horrifying! They should be banned on the fact that “loose” silicone can’t be used or injected into the body.
      What do they think a rupture is?
      Every breast implant leaks. That is “loose” or liquid silicon. Against the law. My rupture came out of my nipples and breast and took 16 surgeries to scrape my chest and ribs to get the loose gel out! I had silicomas, psuedamonas, cellulitis and strepB blood infections from the implants!
      Doctors will sell anything- big money. Make sure you have the best!
      You are beautiful just like you are- healthy!

      • Hi Jill,

        I had my implants removed June 2013…and I am seeing a rheumatologist….I had no idea breast implants were NOT approved by the FDA.. I have axilla pain up to neck, groin pain and my flanks/obliques are painful all the time. I think I may have silicone in my body…My implants were 28 years old….I had no idea the implants had a life expectancy until one breast became painful….I did not have any patient teaching in 1988 when they were inserted….

        I need to have a list of appropriate questions to ask my rheumatologist when I see in April. Any advice on questions I should ask would be most appreciated….

  10. Alyssa posted these complete, accurate and unbiased scientific articles that show the harmful effects of breast implants.

    [1] Ostenmeyer B, Patten BM, Calkins DS. Adjuvant breast disease: a clinical evaluation of 100
    symptomatic women with silicone breast implants or silicone fuid injections into the breast. Keio Med
    J 1994; 43: 79-87.
    [2] Lappe, M. ‘Nonreactive’ Chemicals lack Adverse Efects in Chemical Deception. San Francisco:
    Sierra Club Books, 1991.
    [3] Kessler DA, Merkatz RB, Schapiro R. A call for higher standards for breasts implants. JAMA 1993;
    270: 2607-8.
    [4] Kessler DA. Te basis of the FDA’s decision of breast implants. N Engl J Med 1992; 326: 1713-15.
    [5] Kumagai Y, Shiokawa Y, Medsger TA, et al. Clinical spectrum of connective tissue disease afer
    cosmetic surgery. Arthrit Rheumat 1984; 27: 1-12.
    [6] Kossovsky N, Heggers JP, Robson MC. Te bioreactivity of silicone. Crit Rev Biocompat 1987; 3: 53-
    85.
    [7] Hausner R, Schoen FJ, Pierson KK. Foreign body reaction of silicone-gel in axillary lymph nodes
    afer augmentation mammoplasty. Plastic Reconstruct Surg 1978; 62: 381-3.
    [8] Hilts PJ. Maker of implants says silicone-gel poses health risks. Houston Chron 1993; 20 March: 1-2.
    [9] Cronin T, Gerow F. Augmentation mammoplasty, a new natural feel prosthesis. In: Transactions of
    the Tird International Congress of Plastic and Reconstructive Surgery. Amsterdam: Excerpta Medica,
    1964; 41-2.
    [10] Brozema SJ. Fenske NA, Cruse CW et al. Human adjuvant disease following augmentation
    mammoplasty. Arch Dermatol 1988; 124: 1383-6.
    [11] Cuellar M, et al. Silicone breast implants associated with musculo-skeletal manifestations. Clin
    Rheumat 1995; 14: 667-72.
    [12] Human Resources and Intergovernmental Relations Subcommittee of the Committee on
    Government Operations. Te FDA’s Regulation of Silicone Breast Implants. Washington, DC: US
    Government Printing Ofce, 1992.
    [13] Heggers JP. Kossovsky N, Parsons RW, et al. Biocompatability of silicone implants. Ann Plastic
    Surg 1983; 11: 3845.
    [14] Jenny H, Smahe L. Clinicopathological correlation in pseudocapsule formation afer breast
    augmentation. Aesth Plastic Surg 1981; 5: 63-8.
    [15] Kessel RWI, Monaco L, Marchisio MA. Te specifcity of the cytotoxic action of silica. A study in
    vitro. Br J Exp Pathol 1963; 44: 351-64.
    [16] Kaiser W, Beisenback W, Stuby U, et al. Human adjuvant disease: remission of silicone-induced
    autoimmune disease afer explantation of breast augmentation. Ann Rheumat Dis 1990; 49: 937-8.
    [17] Batich C, DePalma D. Materials used in breast implants: silicones and polyurethanes. J Long-Term
    Efects Med Implants 1992; 1: 25568.
    [18] Allison AC, Harrington JS, Birbeck M. An examination of the cytotoxic efects of silica on
    macrophages. J Exp Med 1966; 124: 141-53.
    [19] Argenta LC. Migration of silicone gel into breast parenchyma following mammary prosthesis
    rupture. Aesth Plastic Surg 1983; 7: 2534.
    [20] Baldwin CM, Kaplan EN. Silicone induced human adjuvant disease. Ann Plastic Surg 1983; 10:
    270-3.[21] Barker DE, Retsky MI, Schultz S. Bleeding of silicone from bag-gel breast implants and its clinical
    relation to fbrous capsule reaction. Plastic Reconstruct Surg 1978; 61: 836-41.
    [22] Batich C. Silicone degradation products. In: NIH Immunology of Silicones Workshop, 13-14
    March 1995.
    [23] Garrido L, Detection of Silicone Migration with NMR. In: NIH Immunology of Silicones
    Workshop, 13-14 March 1995.
    [24] Garrido L, Pfeiderer B, Papisow M. et al. In vivo degradation of silicones. NRM 1993; 29: 839-43.
    [25] Goldblum RM, Pelley RP, O’Donell AA, et al. Antibodies to silicone elastomers and reactions to
    ventriculoperitoneal shunts. Lancet 1992; 340: 51013.
    [26] Guthrie JL, McKinney RW. Determination of 2,4 and 2,6 diaminotoluene in fexible urethane
    foam. Anal Chem 1977; 49: 1676-80.
    [27] Harrison M. Adjuvancy and breast implants. Dow Corning Commun 1993; 4 March: 1-2.
    [28] Pernis B, Pametto F. Adjuvant efect of silica (tridymite) on antibody production. Proc Soc Exp
    Biol Med 1962; 110: 3902.
    [29] Lake RS, Radonovich H. Action of Polydimethylsiloxanes on the Reticuloendothelial System of
    Mice: Basic Cellular Interactions and Structure-Activity Relationship. Midland, MI: Dow Corning
    Corporation, Research Department, 1975.
    [30] Pfeiderer B, et al. Migration and biodegradation of free silicone from silicone gel-flled implants
    afer long-term implantation. Magnet Res Med 1993; 30: 534-43.
    [31] Uber CL, McReynold RA. Immunotoxicology of silica. CRC Crit Rev Toxicol 1982; 10: 303-19.
    [32] Picha GJ, Goldstein JA, Stohr E. Natural-Y meme polyurethane versus smooth silicone: analysis of
    the sof-time interaction from 3 days to year in the rat animal model. Plastic Reconstruct Surg 1990; 85:
    903-16.
    [33] Kossovsky N, Freiman S. Silicone breast implant pathology: clinical data and immunologic
    consequences. Arch Pathol Lab Med 1994; 118: 686-93.
    [34] Vodjani A, Campbell A, Brautbar N. Immune functional abnormalities in patients with clinical
    abnormalities and silicone breast implants. Toxicol Ind Health 1992; 8: 415-29.
    [35] Nain JO, Lanzafame RJ, van Oss CJ. Te adjuvant efect of silicone gel on antibody formation in
    rats. Immunol Invest 1991; 22: 151-61.
    [36] Black DL. 2,4-TDA analysis with regards to PUF breast implants. Aegis Anal Lab Commun 1991; 4
    June: 1-2 and 1993; August II: 3-4.
    [37] Kossovsky N, Heggers JP, Robson MC. Experimental demonstration of the immunogenecity of
    silicone-protein complexes. J Biomed Mater Res 1987; 21: 1125-33.
    [38] Wolf C, et al. Chemical analysis of explanted breast implants. In: NIH Immunology of Silicones
    Workshop. 1995.
    [39] Bergman RB, van der Ende AE. Exudation of silicone through the envelope of gel flled breast
    prostheses: an in-vitro study. Br J Plastic Surg 1979; 32: 314.
    [40] Lust JA. Te role of cytokines in the pathogenesis of monoclonal gammopathies. Mayo Clin Bull
    1994; 69: 691-7.
    [41] Rodnan GP, Bendek TG, Medsger TA, et al. Te association of progressive systemic sclerosis
    (scleroderma) with coal miners’ pneumoconiosis and other forms of silicosis. Ann Intern Med 1966;
    66: 323-8.
    [42] Swan S. Epidemiology of silicone-related disease. Sem Arthrit Rheumat 1994; 24 (Suppl 1): 38-43.
    [43] Tasher A, Broughton A. An ELISA method for detecting serum antibodies. Clin Chem 1993; 39:
    1247-9.
    [44] Sergott TJ, Limoli JP, Baldwin CM et al. Human adjuvant disease; possible autoimmune disease
    afer silicone implantation: a review of the literature, case studies and speculation for the future. PlasticReconstruct Surg 1984; 78: 104-14.
    [45] Sahn EE, Garen PD, Silver RM et al. Scleroderma following augmentation mammoplasty. Arch
    Dermatol 1990; 126: 1198-202.
    [46] Schmidt GH. Mammary implant shell failure. Ann Plastic Surg 1980; 5: 369-71.
    [47] Chan SC, Birdsell DC, Gradeen CY. Detection of toluenediamines in the urine of a patient with
    Polyurethane-covered breast implants. Clin Chem 1991; 37: 7568.
    [48] Gayou R, Rudolph R. Capsular contraction around silicone mammary prostheses. Ann Plastic
    Surg 1979; 2: 62-71.
    [49] Capozzi A, Du Bou R, Pennisi VR. Distant migration of silicone-gel from a ruptured breast
    implant. Plastic Reconstuct Surg 1978; 62: 302-3.
    [50] Cocke WM Jr, Sampsom HW. Silicone bleed associated with double-lumen breast prostheses. Ann
    Surg 1979; 18: 524-6.
    [51] Ostermeyer B, Patten BM. Abnormal laboratory and histopathological fndings in women with
    systemic disease and saline breast implants. Brain Pathol 1994; 15: 376-9.
    [52] Ostermeyer B, Patten BM. An atypical motor neuron disease syndrome in patients with breast
    implants. Can J Neurol Sci 1994; 1 (Suppl 2): 64-9.
    [53] Lee L, Ostermeyer B, Patten BM. An atypical chest pain syndrome in silicone breast implant
    patients. S Med J 1994; 87: 978-84.
    [54] Vargas A. Shedding of silicone particles form infated breast implants. Plastic Reconstruct Surg
    1979; 64: 252-3.
    [55] Travis WD, Balogh K, Abraham JJ. Silicone granulomas: report of three cases and review of the
    literature. Human Pathol 1985; 16: 19-26.
    [56] Miyoshi K, Miyamura T. Kobayashi Y. et al. Hypergammaglobulinemia by prolonged adjuvanticity
    in man. Disorders developed afer augmentation mammoplasty. Jpn Med J 1964; 2122: 9-14.
    [57] Van Nunen SA, Gatenby PA, Basten A. Post-mammoplasty connective tissue disease. Arthft
    Rheumat 1982; 25: 694-7.
    [58] Endo LP, Edwards NL, Longley G, et al. Silicone and rheumatic diseases. Sem Arthrit Rheumat
    1987; 47: 112-18.
    [59] Varga J, Schumacher HR, Jimenez SA. Systemic sclerosis afer augmentation mammoplasty with
    silicone implants. Ann Intern Med 1989; 149: 1194-6.
    [60] Varga J, Jimenez SA. Augmentation mammoplasty and scleroderma. Arch Dermatol 1990; 126:
    1220-2. [61] Ericsson AD, DeGeorge J. Te story of silicone. Explore 1996; 6: 13-16.
    [62] Fock KM, Feng PH, Tey BH. Autoimmune disease developing afer augmentation mammoplasty:
    report of 3 cases. J Rheumat 1984; 11: 98-100.
    [63] Gelfand EW. Intervention in autoimmune disorders. Clin Immunol Immunopathol 1989; 53: S1-6.
    [64] Package Insert. Arlington, TX: Dow Corning Wright 1991.
    [65] Trachman H. Ilowite N, Levine J. Increased urinary NO and NO excretion in children breast fed
    by mothers with silicone implants (SI). Arthrit Rheumatol 1994; 37: s422 (1-8).
    [66] Truong LD, Cartwright J, Goodman D, et al. Silicone lymphadenopathy associated with
    augmentation mammoplasty. Morphologic features of nine cases. Am J Surg Pathol 1988; 12: 484-91.
    [67] Uretsky BF, O’Brien JJ, Courtiss EH, et al. Augmentation mammoplasty associated with a severe
    systemic illness. Ann Plastic Surg 1979; 3: 445-7.
    [68] Walsh FW, Solomon DA, Espinosa LR, et al. Human adjuvant disease. A cause of chylous efusions.
    Arch Intern Med 1989; 149: 1194-6.
    [69] Celli B, Texter S, Kovnat DM. Case report: adult respiratory distress syndrome following
    mammary augmentation. Am J Med Sci 1978; 275: 81-5.
    [70] Washington University Neuromuscular Clinical Laboratory Evaluation Publication, 1996.[71] Rechlin S. Neuroendocrine-Immune interactions. N Eng J Med 1993; 329: 124652.
    [72] Broughton A, Trasher JD. Auto-antibodies associated with silicone breast implants. Clin Chem
    1993; 39: 113940.
    [73] Morse JH, Spiera H. Autoimmune disease immunoglobulin isotypes and lymphocyte subsets in 30
    females with breast augmentation mammoplasty Arthrit Rheumat 1992; 35: 65-7.
    [74] Mancino D, Vuotto ML, Minucci M. Efects of a crystalline silica on antibody production to tdependent and t-independent antigens in bald/c mice, Int Arch Allergy Appl Immunol 1984; 73: 10-13.
    [75] Bar-Meir E, Teuber SS, Lin HC, et al. Autoantibody profle of women with silicone breast implants.
    breast implants and symptoms of rh Rheumatic disease. Ann Intenn Med 1994; 37: s422 (9-12).
    [76] Bridges AJ, Conley C, Wang G, et al. A clinical immunological evaluation of women with silicone
    breast implants and symptoms of rheumatic disease. Ann Intern Med 1993; 118: 929-36.
    [77] Silver R Sahn EE, Allen JA. et al. Demonstration of silicon in slides of connective-tissue disease in
    patients with silicone-gel breast implants. Arch Dermatol 1993; 129: 63-8.
    [78] Silverman S, Mendoza M, Silver D, et al. Measurement of fatigue in patients with silicone breast
    implants (SBI) as compared to fbromyalgia (FM) and rheumatoid arthritis (RA). Arthrit Rheumat
    1994; 37: S271, 4-6.
    [79] Love LA, Weiner SR, Vasey FB, et al. Clinical and immunogenetic features of women who
    developed myositis afer silicone implants. Arthrit Rheumat 1992; 35: 46-8.
    [80] Freundlich B, Tomaszewski J, Callegari P. A Sjogren’s-like syndrome in women with silicone-gel
    breast implants. Arthrit Rheumat 1992; 35: 67-9.
    [81] Tenenbaum SA, Silveira LH, Martinez-Osuma P, et al. Identifcation of a novel auto-antigen
    recognized in silicone associated connective tissue disease. Arthrit Rheumat 1992; 35: 73-5.
    [82] Ostermeyer B, Patten BM. An MS-like syndrome in women with silicone breast implants or
    silicone fuid injections in breast. Neurology 1994; 44: A158: 37-4.
    [83] Ostermeyer B, and Patten BM. Human adjuvant disease presenting as multiple sclerosis-like
    syndrome. S Med J 1996; 89: 179-88.
    [84] Levine J, Ilowite N. Scleroderma-like esophageal disease in children breast-fed by mothers with
    silicone breast implants. JAMA 1994; 271: 213-16.
    [85] Gutierrez FJ, Espinosa LR. Progressive systemic sclerosis complicated by severe hypertension;
    reversal afer silicone implant removal. Am J Med 1990; 89: 390-2.
    [86] Young, V. et al. HLA typing in women with breast implants. Plastic Reconstruct Surg 1995; 96:
    1497-519.
    [87] Jekel J, et al, Epidemiology biostatistics and preventive medicine. Philadelphia, PA: W. B. Saunders,
    1996.
    [88] Rosenberg N. Te neuromythology of silicone breast implants. Neurology 1996; 310: 308-14.
    [89] Weisman MH, Vecchione TR, Albert D, et al. Connective tissue disease following breast
    augmentation: a preliminary test of the human adjuvant hypothesis. Plast Reconstr Surg 1988; 82: 626-
    30.
    [90] Bright RA, Jeng LL, Moore RM. National survey of self-reported breast implants; 1988 estimates. J
    Long-Term Efects Med Implants 1993; 3: 81-9.
    [91] Okano V, Nishikai M, Sato A. Scleroderma, primary biliary cirrhosis and Sjogren’s syndrome afer
    cosmetic breast augmentation with silicone injection: a case report of possible human adjuvant disease.
    Ann Rheumat Dis 1984; 43: 520-1.
    [92] Oxelius V. Immunoglobulin G subclasses and human disease. Am J Med 1984; 4: 7-18.
    [93Kumagai Y, Abe C, and Shiokawa Y. Scleroderma afer cosmetic surgery. Arthrit Rheumat 1979; 22:
    532-7.
    [94] Spiera H. Scleroderma afer silicone augmentation mammoplasty. JAMA 1988; 260: 2368.[95] DeCamara DL, Sheridan JM, Kammer BA. Rupture and aging of silicone gel breast implants.
    Plastic Reconstruct Surg 1993; 91: 828-34.
    [96] Cook RR, Delongchamp RR, Woodbury M. et al. Breast implant prevalence. Dow Corning
    Commun 1993; 17 March: 2-3.
    [97] Spiera H, Kerr L. Scleroderma following silicone implantation: a cumulative experience of twelve
    cases. Arch Rheumat 1992; 35: 68-72.
    [98] Koeger C, Alxaix D. Rozenberg S, et al. Silica-induced connective tissue diseases do still occur.
    Arthrit Rheumat 1993; 35: 34-7.
    [99] Jordan S. Intravenous gamma globulin therapy in systemic lupus erythematosis and immune
    complex disease. Clin Immunol Immunopathol 1989; 53: 164-9.
    [100] Dwyer JM. Intravenous therapy with gamma globulin. Adv Intern Med 1987; 32: 111-36.
    [101] Barrett J. Textbook of Immunology. St Louis: Mosby Company, 1988.

  12. Excellent article! It’s amazing to see that rheumatologists around the world face the same issues. Many patients with mass somatization/somatoform disorders or litigation issues continue to be wrongly diagnosed with fake rheumatic epidemics hype (autoimune or fibromyalgia), and thus they do not receive what they really need: self-assurance, social/emotional support and appropriate psychological/psychiatric treatment.

    • Educate yourself on the foreign body reaction to biomaterials.

      Breast implants are large foreign objects that overwhelm and weaken the immune system, eventually creating a cascade of dysregulation in the body that may include autoantibodies and autoimmune diseases, endocrine dysfunction, gut dysbiosis, and more. Essentially they are immune provoking foreign bodies that indwell and deteriorate in the body, therefore it is not a matter of if you will get sick, it is a matter of when you will get sick. An overburden of toxicity manifests itself in inflammation and other health issues.

      Leakage, ruptures, and shell degradation are associated with increased symptoms. Implants have 40+ toxic chemicals, various silicones of different molecular weights, and many heavy metals (such as mercury, arsenic, lead, cadmium, platinum, and more). Intact implants have semi-permeable shells and leak gel bleed of low molecular compounds from the time they are implanted, as written in FDA documents. Chemist, Dr. Pierre Blais, states “the devices act as time release systems for pharmacologically active compounds.” These induce silicone toxicity and heavy metal toxicity.

      In addition, polymeric biomaterials oxidize in the body and contribute to degradative oxidative stress.

      We are onto you and your nonsense, this article is trash.

    • This is a sham article. I have major demonstrated connective tissue disease and implanted in 1995. For this doctor to write such an article is a joke and it is very disturbing for women like me who are suffering from actual physical disease.

      • I also hav mixed connective tissue disease/lupus/scleroderma. Was explanted in 1993 after being implanted in 1985.a lot of toxic symptoms improved but hav suffered with illnesses above. Unfortunately the plastic surgeon didn’t believe they were the problem to me being so sick & no pseudo capsule was removed. Cheers Jennifer

  13. The recovery of a particular illness is going to begin with removing any interference with the body. That’s when reversal can occur, not from symptomatic treatment which treats the symptoms but not the source.

    Many women with breast implants have unknowingly developed various symptoms in response to the foreign body reaction, toxins, and oxidative stress from their breast implants. They began seeking help from their physician and specialists – adjusting their lifestyles to cleaner eating, less work, various health treatments – without resolve until connecting their symptoms to a systemic response to their breast implants regardless of make or model.

    Women recover after explant, this of itself establishes causation. Breast implant illness is a historically reoccurring inconvenient truth

  14. As a president of a Dutch foundation established in 1992 for women with illness and health issues due to breast implants I want to react to your article.
    The Netherlands has no claim culture. Nevertheless, without media attention here
    contributed, more than 4700 women reported health issues.
    We patients are dependent on science. honest, unbiased science. No fights between industry and independent scientists.
    We just want recognition and treatment.
    If there had been honest unbiased scientific research, then we as patients may be able to understand that there are new insights.
    But now, as a patient reading for instance the research of the IOM Safety of silicone implants, where still many, even the FDA, refer, know it’s outdated.

    How can you write such an article as it is now known that there is a breast implant-related anaplastic large cell lymphoma?
    How can you write such an article as it now appears that about 33% of all implants are contaminated with bacteria.

    Of course there are women who blame all their health complaints to implants, which is not always the case, but there are too many unanswered questions and too many sick women.
    Science has been poor in the case of breast implants.
    Would you still write this article if you knew:
    Most of the implants turn yellow after time: No studies took place to investigate this phenomenon. Studies from other implants explain the yellowing as degradation of the implants, hydrolysis. This could change the physical properties of the product. Also bodily fluids act as a plasticizer.
    No toxicologic studies have taken place on women. Although not all ingredients are (just) simple PDMS as plastic surgeons would like us to believe. In manufacturing the shell and patch they use some nasty chemicals like Di(2,4-dichlorobenzoyl)peroxide, 0.0.0.trixime dibutyltin and vm + p naphtha.
    During the moratorium in America science began investigating siloxanes. Although used in so many women. In the IOM study Safety of silicone breast implants it was written (personal communication with Thomas Lane Dow Corning: D4 (octamethylcyclotetrasiloxane 855 ppm for one 300cc implant. Same amounts for D5 and D6. Independent scientists already wrote about changes in the liver, ridiculed by COI’s scientists. Now it is known that these siloxanes are endocrine disrupting chemicals. With a silent drum manufacturers brought the amounts back to <60 ppm. Again women with breast implants with huge amounts are forgotten. Once ridiculed by many scientists.

    I could go on and on with facts, about science, about the conflicts of interest in epidemiology etc.
    One thing I hope for and that is justice. Justice in science not in court. Sadly enough apparently the court is needed because many scientists are biased.

  15. How do we recover? I don’t care what my breasts look like…I want my life back…Thoughts are most welcomed…

  16. I have implants due to being a breast cancer survivor. I was diagnosed with breast cancer at the age of 36 yrs after the loss of my 12 yrs old SON. I had a bilateral mystectomy. The 1st set were silicon, they ruptured, I replaced them with saline but I didn’t like the feeling so in 2002 I replaced them with silicone, but now I believe they’ve been licking for several years. I’ve been diagnosed with lupus, fibromyalgia, rheumatoid arthritis, constant head aches, fatigued w/some depression, spinal stenosis and bone on bone in my knees. I’ve complained of mild pain in my both breasts, especially the right and my breast doctor told me it was scar tissue and I trusted him. Now the pain had increased, I’ve changed doctors, thanks to my primary doctor. I believe my breasts have been licking fir several years. My breasts are in pain especially the right one with a burning sensation. I’m removing my implants in the next two weeks, hopefully it’s not too late. I’m praying that GOD WILL BE WITH ME and spare my life for a few more years. I’m 69 hrs old, but I have a family and I want to live a few more years with better health. I’m terrified.

    • Kris,
      I pray your surgery provided you the relief you sought. I work with Medicare patients suffering with the same difficulty. It is disheartening to think someone who endured so much is fighting for quality of life. I pray God grants you many more pain-free days with your family. He does love you and hears your prayers.

  17. I have excruciating pains from my ruptured silicone gel implants (1980) Dow Corning. I am 72 yrs old. I only collect SS. I cannot afford explant surgeon. My OBGY & rheumatologist misdiagnosed me. Please help me have them remove.

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