THE TRUTH ABOUT SILICONE BREAST IMPLANTS
(Interview by Joseph G. Hattersley, Washington on Dr. Edelson)
In his Rule of Law column in the Wall Street Journal, Tort Lawyers Gear up for More Silicone Silliness, October 4, 1995, Max Boot wrote, Evidence continues to pour in that there is no basis for breast-implant plaintiffs [engaged in a pending $4.7 billion settlement] collecting any damages at all. He points out abuses by certain doctors and lawyers attempting to collect for symptoms that may be unrelated to silicone.
Indeed, a 1990 survey by the American Society of Plastic and Reconstructive Surgeons reported that 93% of women with implants who were queried were satisfied with the results1 (reference #6 throws some doubt on that conclusion). A Harvard epidemiological study of 87,501 women over a 4-year period endorsed such implants.2 And a study published in 1995 detected no immune-system effects among a sample of 1,183 women who had such implants.3 No doubt abuses exist. But authorities on the subject question the accuracy and objectivity of the denial of any grounds for damages. My two-hour survey of 1993-1994 technical and medical literature in Index Medicus easily accessible in any medical library suggests that people such as Max Boot examined only evidence that supports their already-formed (politically correct?) conclusions. Looking into 1991 for an hour, the adverse findings are even more numerous.
In fact, articles listed in Index Medicus are probably but the tip of the iceberg. Thousands of scholarly, carefully documented medical journals, not indexed there, are undoubtedly loaded with confirmatory evidence. One example appeared in the Townsend Letter for Doctors. (In that letter, which does not mention silicone, Dr. Edelson tells of a patient with ADHD (attention deficit hyperactivity disorder) who had 12 listed allergies of which none had been detected by a conventional allergist).
Stephen B. Edelson, MD, FAAFP, FAAEM, of the Environmental Preventive Health Center, Atlanta, Georgia,5 is regarded as the leading authority on the subject. His interpretations are fully supported by scientific and medical documentation some of which is cited herein. Dr. Edelson was
interviewed by Jeffrey S. Bland, PhD, on Preventive Medicine Update for December 1994. Even if the implant doesn¹t rupture6 slowly and at different rates the silicone oil molecules leak through the semipermeable membrane (itself made of silicone!) surrounding the implant and are carried by cells of the immune system (macrophages, large scavenger white blood cells) to fat cells in all the organs. A wide variety of symptoms appear to have resulted from silicone implants. In some cases leakage causes metaplasia,7 which Webster1s defines as 3 abnormal conversion of one type of adult tissue into another, as of cartilage into bone.2 Studies being published at Mayo Clinic and elsewhere are trying to relate this silicone disaster only to autoimmune diseases already known about such as Lupus, rheumatoid diseases, and scleroderma. 3 In fact, 2 writes Dr. Edelson, they will never be able to link this problem to those diseases because we have this new disease, The Silicone Immune Dysfunction
and Toxicity Syndrome,2 as Dr. Edelson named it; and they are not looking at it in that way.
What you have to do is look at 100 patients who have had silicone breast implants for 15 years, and see how many of these patients have evidence of this new syndrome.8 Some women do not develop symptoms until after a latent period of 15 to 20 years; in others, they can begin as soon as months after implantation. Silicone Immune Dysfunction and Toxicity Syndrome has become a major new medical illness because nearly two million women received these implants since 1962.
Many experience a continuing downhill course of worsening health, until the implants are removed and a healing process is begun. The problems, which go well beyond the traditional definition of silicosis, are much more widespread than three or four decades ago. How could such a catastrophe have occurred? America has failed at many levels to protect the well-being of its citizens. Silicone (the molecules of which are built around silicon atoms), had long been assumed without evidence to be biologically inert. In the 1950s-1960s, it was simply injected into women¹s breasts, causing widely recognized problems. But the substance was assumed (again without investigation) to be safe when enclosed in a semipermeable silicone capsule.
The U.S. Patent Office, which approved silicone breast implants in 1966, was not legally required to, and did not, test their safety. And because the implants were considered a device and not a drug, they did not have to pass rigorous reviews as do pharmaceutical products although both are absorbed into the human body. Clearly, regulation needs to be radically revised. Dr. Edelson¹s list of Silicone Immune Dysfunction and Toxicity Syndrome symptoms includes fatigue, malaise; memory loss, confusion, difficulty sorting information, lack of concentration; weight gain/weight loss, joint pain, muscle pain, hair loss, dry eyes and mouth, flu-like symptoms, burning skin, constipation, dizziness, blurred vision, sweating, diarrhea, spacey feeling, enlarged lymph nodes; anxiety and depression, thyroid problems especially hypothyroidism; night sweats, fibromyalgia, bladder problems, irritable bowel syndrome and abdominal pain; hyperactivity; elevated blood pressure or cholesterol. Gingival-dental problems, dysphagia, conjunctivitis; emotional instability, multiple chemical sensitivity, food and inhalant sensitivity; shortness of breath, myositis; heart irregularities; infertility; peripheral neuropathy, central neurotoxic neuropathy, cervical and axillary lymphadenopathy, pulmonary hypersensitivity with dyspnea; muscle burning, twitching, weakness; numbness and tingling; viral reactivation, joint and tendon pain, skin problems, anorexia and hypoglycemia.
All these symptoms result from the dysregulation and damage to the immune system and by damage occurring both directly and indirectly from the free radicals produced by our bodies in response to the chemical, silicone as well as free radicals from other sources. Silicone tetramer is a man-made organic (carbon-containing) polymer technically known as polydimethylsiloxane. A polymer consists of giant molecules formed from smaller molecules of the same substance and often having a definite arrangement of the components of those giant molecules.9 Those of silicone are lipid-soluble and hygrophobic (moisture-repelling). And so they lodge in fat stores of a variety of organs including the fat-laden brain, rather than in plasma, the fluid part of blood.
Silicone must be carefully distinguished from the atomic element silicon, the commonest element of the earth¹s crust as silica (silicon dioxide, SiO2, or quartz). Silica is also one of the most abundant elements in the human body, being found mostly in bones. Inadequate body content of silica can promote both osteoporosis and cardiovascular disease10; in excess, silicon can sometimes cause immune system dysfunction. 11
Toxins come from silicone breast, penile, jaw and tempero-mandibular joint (TMJ) implants; from shunts, replacement joints, metatarso-phalangeal structures,12 intraocular lenses,13 and more.14 Silicone leaking out of implants, Dr. Edelson and others have found, can cause arthropathies (diseases affecting the joints) throughout the body.16-21 And that is only the beginning. Many believe silicone is responsible only for immune system dysfunction,22,23,24 which at least in some cases is reversible on removal of the silicone.25,26 Reversing the other problems is not simple.
To the contrary, by mechanisms that are not yet well understood, this xenobiotic causes a variety of non-immunity related organ diseases. These molecules leached from implants are picked up by macrophages and carried from the lymphatic system (the body¹s natural garbage-disposal system) into the bloodstream and deposited at distant body sites. There, Dr. Edelson explains, silicone molecules can combine with proteins to form haptenes (molecules which, when coupled with a protein or other molecule, can cause the formation of antibodies). The haptenes combine with complement, heat-sensitive proteins in the blood plasma that act with specific antibodies to destroy corresponding antigens, such as bacteria or foreign proteins.27 Besides this weakening of immunity, an oxidant storm is created, secondary to inflammatory reactions. This oxidant storm releases free radicals: molecules carrying unpaired electrons in the outer shell. These very dangerous Jack the Ripper-Type molecules of all kinds and from all sources, external as well as internal, can flourish with these chemicals in a very destructive manner circulating throughout the body. External sources of free radicals include dentist-installed root canals,28,29 and mercury primarily from dental amalgams.30-32
The multifaceted symptoms of Silicone Immune Dysfunction and Toxicity Syndrome include pancreatic exocrine malfunction without any sign of autoimmunity. Exocrine function enables secretion of substances, either directly or through a duct, onto an epithelial surface. Such cellular tissues cover surfaces, form glands and line most cavities of the body; they consist of one or more layers of cells with only little intercellular material. The implication, Dr. Edelson says, is that these problems result from free-radical damage to the pancreas much like that in cystic fibrosis, but in much milder form.
Pain syndromes in the chest or breasts are related to the inflammatory reaction that occurs with secondary oxidant release. Very common fatigue in women with silicone breast implants suggests mitochondrial damage (the mitochondria are the power plants of cells) as with mercury and many other xenobiotics.33 A persistent flu-like illness, which appears in some, is most likely related to secondary elevations of lymphokines secondary to the immune system dysregulation that is occurring with this silicone toxicity. Lymphokines are soluble substances, released by sensitized lymphocytes on contact with specific antigens, which promote cellular immunity by stimulating activity of monocytes and macrophages. (Lymphocytes are a variety of leukocytes, white blood cells; they are formed in lymphatic tissue and are important in synthesis of antibodies.)
The neurocognitive difficulties that other patients develop without any sign of immune system involvement, can result only from free radicals. Penile implants, others report,34 can be associated with local infections; and Dr. Edelson stated that people with silicone shunts have shown increases in autoantibody production. Dr. Edelson35 and others have found suspicions of cancer promotion36,37 or mimicking,38 or thrombotic complications.39,40 And silicone toxicity symptoms have been observed in many other countries.41 Patients with such a myriad of complaints (polysymptomatic) are commonly sent by conventional internists to a psychiatrist. But talk therapy is unlikely to help much; neuroleptic and nonsteroidal anti-inflammatory drugs may simply worsen problems by adding to the body burden of toxins to be detoxified.42 As with some plastics, Dr. Edelson explains, humans possess no hepatic detoxication mechanism for silicone. And so the only way the substance can exit the body is through the sebaceous glands, which secrete a greasy substance called sebum. Silicone, which may have damaged the brain and other organs for five to 25 years, escapes only gradually over a period of decades.
And among those tens of thousands who said they were satisfied with their silicone breast implants43 how many had the sorts of problems here discussed, caused by the silicone implants without knowing the source of their ailments? The only helpful treatment consists in trying to repair whatever organs have been damaged.44 It is important, says Dr. Edelson, to treat the whole patient. Analysis requires knowledge of environmental medicine, clinical-nutritional biochemistry, free radicals medicine and an understanding of thorough evaluations at the molecular level. A battery of sophisticated tests are needed. A patient suffering from the above type symptomology who also has a history of breast implants, needs a thorough evaluation. First, one must rule out other problems such as Lyme disease and rare infections. After an exhaustive interview and history, the next step is to discover which organs have been damaged.
Studies of the immune system include T-cell silicone immune study, silicone antibodies, gastric analysis, complete autoimmunity studies, immunoglobulin investigation, immune complex studies, biochemical profiles, fungal and bacteriological studies and skin testing; evaluation of liver Phase 1 P-450 and Phase 2 enzyme conjugation detoxification systems. In addition, more complex studies might include PET, SPECT, beam and EMG studies of the nervous system, as well as pulmonary function tests, MRIs and mammograms of the breasts, and comprehensive digestive and pancreatic studies, etc. Silicone itself may even interfere with tests.45 Silicone immune toxicity syndrome is a very complicated illness and should be taken care of only by people with a comprehensive background in dealing with toxic environmental materials and their effects on the human organism. With this knowledge these patients can be helped greatly in achieving a normal life again. This requires a long time, patience, hard work and much cooperation of the patient to gradually strengthen the damaged organs. The body can then begin to heal itself, in what Russell Jaffe, MD, PhD, calls the human healing response.51
The treatment for these patients needs to be directed at the flaws that are found in their biochemistry and immune systems. Therapies to be considered include dietary management; intravenous nutritional therapy for detoxification; immunotherapy to chemicals, foods, inhalants, and silicone. Oral nutritional supplementation for example, ascorbate (vitamin C), among others, helps against superoxide anion radical and hydroxyl radicals; vitamin E (alpha-tocopherol), among others, helps against singlet oxygen and polyunsaturated fatty acid (PUFA) radicals. The vitamins are used in quantities far exceeding the grossly inadequate Recommended Dietary Allowances (RDAs). Glutathione peroxidase, among others, fights hydrogen peroxide, organic/fatty acid hydroperoxides and oxidized protein. (All these oxidized molecules also elevate cardiac risk,52 particularly in women after menopause as well as men of all ages.) Anti-oxidation, exercise advice; environmental and chemical controls of the home and place of business; homeopathics, psychological counseling, drugs. Varied immune modulation techniques including: bio-oxidative therapy using hydrogen peroxide to improve immune function by up-regulating the mitochondrial systems and destroying old immune system cells; DMSO (dimethyl sulfoxide), thymus therapy, intravenous gamma globulin, DHEA (dehydroepiandrosterone, a very important hormone whose synthesis in the body drops sharply in older people), and transfer factor, depending on the individual¹s specific problems.
Also, silicone has had ill effects on some babies of mothers with breast implants. In a recent study, 11 children (ages 1-1/2 to 13 years; 6 boys, 5 girls) of such mothers had been referred for abdominal pain. They were compared to 17 patients (mean age 10.7 years) with abdominal pain who had not been exposed to silicone. The silicone-exposed children had a scleroderma-like autoimmune disorder, which was related to abnormal esophageal motility. (Scleroderma is a chronic disease in which the skin becomes hard and rigid; motility is the ability to start spontaneous movement; the esophagus is the gullet.) These problems could be traced back to an autoimmune activation due to potential silicone exposure either in utero or through breast milk.62,63 This is a very good example of sensitivity that can be transmitted from mother to child through an environmental exposure in this case, contamination due to breast implants.64 In that study, expression of autoantibodies was not demonstrated; studies evaluating larger numbers of children are needed to determine the extent of the risk.
1. Source, 1990-91. I have written to the Society for the reference, which I couldn¹t find in IM.
2. Sanchez-Guerrero J et al. Silicone breast implants and the risk of connective-tissue diseases and symptoms. New Eng J Med 1995 (June.22);332(25): 1666-1670.
3. Wall St J 1995; June 22.
4. Edelson SB. A real life story of environmental illness. Can a poisoned environment play a major role in the ability of a child to learn? Townsend Ltr Doc 1995; Apr: 106-109.
5. Stephen Edelson, M.D., Environmental and Preventive Health Center of Atlanta, 3833 Roswell Rd, Suite 110, Atlanta, GA 30342-4432. (404) 841-0088; FAX (404) 841-6416.
6. Caffee HH et al. Detection of breast implant rupture with aspiration cytology. Plast Reconstr Surg 1995 (June); 95(7): 1145-1149.
7. Rosario AD et al. True synovial metaplasia of breast implant capsules: A light and electron microscopic study. Ultrastruc Pathol 1995 (Mar-Apr); 19(2):83-93.
8. Edelson SE. Personal communication, 1995.
9. Webster Œs New World Dictionary, Second College Edition, 1982.
10. Silicon takes its place among the essential nutrients. Health Counselor 1995 (Aug/Sept);7:39-40.
11. Edelson interview.
12. Friedlander GN et al. Silicone elastomer microshards in fluid from a painfill metatarso phalangeal implant site: A case report. Arch Cytol 1995 (May-June);39(3):586-588.
13. Newland TJ et al. Neodymium: YAG laser damage on silicone intraocular lenses. * of lesions on explanted lenses and experimentally produced lesions. J Cataract Refract Surg 1994; 20:527-533.
14. Gard ZR, Brown EJ. Silicone breast implants and immunological disease. Townsend Ltr Doc. 1993; June:570-573.
15. Holten IW et al. Intraductal migration of silicone from intake gel breast prostheses. Plast Reconstr Surg 1995;95:563-566; discussion, 567-568.
16. Brauthar N et al. Silicone breast implants and autoimmunity: Causation or myth? Arch Env Hlth 1994;49(3):151-153.
17. Sanger JR et al. Tissue humeral response to intake and restored silicone gel-filled prostheses. Plast Reconstr Surg 1995;95: 1033-1038.
18. Goldman JA et al. Breast implanted rheumatoid arthritis and connective tissue disease in a clinical practice. J Clin Epidemiol 1995;48:571-582.
19. Patel DC et al. Synovitis secondary to silicone elastomeric joint implant. J Foot Ankle Surg 1994;33:628-632.
20. Borenstein D. Siliconosis: A spectrum of illness. Semin Arthritis Rheum 1994;24(1 suppl 1):1-7.
21. Freundlich B et al. Profile of symptomatic patients with silicone breast implants: A Sjogrenslike syndrome. Semin Arth Rheum 1994; 24(1 suppl 1):44-53.
22. Walland MJ et al. The effect of silicone intubation and infection rates after dacryocystorhinostomy. Opthalmic Surg 1994;25:597-600.
23. Bradley SG et al. Subchronic 10-day immunotoxicity of silicone fluid gell elastomer and polyurethane disks in female B6C3F1 mice. Drug Chem Toxicol 1994;17:175-220.
24. Teuber SS et al. Immunopathologic effects of silicone breast implants. West J Med 1995 (May);162(5):418-425 (83 ref).
25. Campbell A et al. Suppressed natural killer cell activity in patients with silicone breast implants: Reversal upon explantation. Toxicol &Indus Health 1994;10:149-154.
26. Slavin SA et al. Silicone gel implant explantation: Reasons, results, and admonitions. Plast Reconstr Surg 1995;95:63-69.
28. Price WA (nd). The Price… of Root Canals. La Mesa, CA: Price-Pottenger Nutr Foundation.
29. Meinig G. Root Canal Cover-up Exposed! Ojai, CA: Bion Publ, 1993.
30. Hattersley JG. Mercury and root canals toxicity. Unpublished manuscript. 124 ref.
31. Huggins H. It¹s All in Your Head. Diseases Caused by Silver-Mercury Fillings. 4th ed, 1990 (800) 331-2303.
32. Edelson SB. Mercury toxicity, unpublished memo.
33. Rogers, S.A. Tired or Toxic? Syracuse, NY: Prestige Publ, 1990.
34. Edelson interview.
35. Edelson SB. Silicone immune dysfunction syndrome. N.p., n.d.
36. Horstra J et al. [Breast carcinoma following primary augmentation surgery of the breast]. Ned Tidschr Geneeskd 1990 (Nov 10);134(45):2169-2170. [Dutch; English abstract].
37. Fajardo LL et al. Breast cancer diagnosis in women with sub glandular silicone gel-filled implants. Radiology 1995;194;859 862.
38. Warner E et al. Silicone mastopathy mimicking malignant disease of the breast in East Asian women. Can Med Assoc J 1991 (Mar 1); 144(5):569-571.
39. Haire WP et al. Thrombotic complications of silicone rubber catheters during autologous marrow and peripheral stem cell transplantation: Prospective * of Hickman and Groshong catheters. Bone Marrow Transplantation 1991 (Jan);7(1):57-59.
40. Pippus KG et al. Thrombotic complications of saphenous central venous lines. J Pediatr Surg 1994;29:1218-1219.
– Jiang Y et al. [Silicone removal in 3 l cases] .Chung Hua Yen Ko Tsa Chih 1995 (Jan);31 (1): 36-38 [Chinese; English abstract].
– Guthoff R et al. [Prevention of postnucleation syndrome: Hydroxylapatite silicone implants. Preliminary experimental studies and initial clinical experiences. Opthalmologe 1995 (Apr); 92(2) 198-205 [German; English abstract].
– Akuginova ZD et al. [Immunity and resistance in experimental tuberculosis in mice exposed to various environmental factors.] Probl Tuberk 1995;(1):40-43 [Russian; English abstract].
– Liao SG et al [Experience in the treatment of complications following liquid silicone rubber augmentation rhinoplasty] . Chung Hua Cheng Hsing Shao Shang Wai Ko Tsa Chih. 1990 (Dec); 6(4):252-253.
– Gondo G et al [Posterior fossa hemorrhage 11 years after the use of silastic dural substitute: Case report]. No Shinkei Gekar 1991 (June);19(1):59-62 (8 ref). [Jap; Eng. Abstract].
– Gervais P. [Report of experts on possible adverse effects of breast implants with silicone gel.] Ann Chir Plast Esthet 1994; 38:819-822 (French).
42. Rogers, S.A. Tired or Toxic? Syracuse, NY: Prestige Publ, 1 9 90 .
43. Source, 1990-91.
44. Edelson S. Interview in Bland JS, Prev Med Update 1994; Dec.
45. Harms SE et al. Silicone-suppressed 3D MRI of the breast using rotating delivery of off resonance excitation. J Comput Assist Tomogr 1995 (May-June);19(3):394-399.
46. Rogers SA. Tired or Toxic?
47. Wilkes, MS et al. Pharmaceutical advertisements in leading medical journals. Ann Int Med 1992;116:912-919.
48. Medical Dissent (Health Care Reform Group, Australia), 1992; Spring/Summer:1-12.
49. Council Against Fraudulent Medical Research. The Pharmaceutical Drug Racket, 1993.
50. Mullins, E. Murder by Injection. The Medical Conspiracy Against America. Staunton, VA 24401: Natl Council for Medical Research, 1988.
51. Jaffe R. Lecture to Well Mind Association, Seattle, 1990.
52. Hattersley JG. Vitamin B6: The overlooked key to avoiding heart attacks. J Applied Nutr 1995;47:24-31
53. Hattersley JG. The importance of vitamin C and vitamin B6 in prevention and reversal of acquired atherosclerosis. J Orth Med (in press).
54. Altman N. Oxygen Healing Therapies for Optimum Health & Vitality. Rochester, VT: Healing Arts Press, 1995.
55. McCabe, E. Ask Mr. Oxygen with Ed McCabe. Family News 1994;5(2): 14-16.
56. Rogers, S.A. Tired or Toxic?
57. McCabe E. Radio interview, 1992.
58. McCabe E. Radio interview, 1992.
59. Sunnen, G. Ozone in Medicine. Townsend Ltr Doc. 1994; Feb/Mar:182-187.
60. Latino, JS. Personal communication, 1994.
61. Horwitz, N. Oxygen plus ozone mixture can inactivate HIV in vitro. Med Tribune 1994; Jan 20: 12.
62. Levine JJ, Ilowite NT. Sclerodemalike esophageal disease in children breast-fed by mothers with silicone breast implants. JAMA 1994;271 :213-316.
63. Flick JA. Silicone implants and esophageal dysmotility. Are breast-fed infants at risk? JAMA 1994;271 :240-241 ( editorial.)
64. Bland JS . Prev Med Update 1994; Apr.
65. Siddiqui WH et al. Reproductive and developmental toxicity study in rats and rabbits. Fundam Appl Toxicol 1994;23:370-376.
Joseph G. Hattersley
7031 Glen Terra Court S.E.
Olympia, Washington 98503-7119 USA