The past five years have witnessed a recurrent public health debacle encompassing illness caused by silicone gel-filled breast implants. In an attempt to explain this epidemiologic reality, researchers from many institutions have resurrected the faulty device-related autoimmune theories of the early 1990's. These researchers are genuinely convinced that breast implants initiate a novel disease, but their methodology utilized to prove this premise is unsound. The inability to consider mechanisms of widespread biochemical disruptions caused by in vivo exposure to organosilicon molecules is coexisting with multiple deficiencies in detecting the voluminous clinical manifestations of ailing implant recipients. Chief among the latter are the use of truncated data bases to record symptoms and signs, coupled with the lack of appreciation that silicone-induced disease evolves chronologically in a manner simulating a dose-response curve. This failure to correlate the diverse clinical features present in toxic breast implant recipients with logical mechanisms of disease causation provides a clear understanding of why the silicone breast implant chaos of the early 1990's was inevitably destined to repeat itself.
Background Twenty-five years ago attorneys representing ailing women in class action litigation against silicone breast implant manufacturers made the procedural error of defining silicone-induced toxicity in the courtroom before it was properly studied in the exam room. This aberrant methodology perverted the proper research process, rendered verification of any real disease elusive, and cemented the groundwork for a repeat public health crisis potentially affecting two million women in the USA who possess new silicone gel devices inserted over the past 10 years. Patients and methods Six women, previously well, aged 27 to 53 (mean 42), were recipients of the new generations of cohesive silicone gel-filled breast implants approved for general use by the Food and Drug Administration (FDA) since December of 2006. They averaged seven years of total implantation time, and none experienced implant rupture. Results All six became ill on average 3.5 years from the time of implantation. By seven years the women manifested multiple types of skin rashes, polyarthritis, fatigue, protracted AM stiffness, myalgias, headaches, photosensitivity, hair loss, paresthesias, tinnitus, lymphadenopathy, chest pain, cognitive dysfunction, dry eyes, skin pigment changes, itching, muscle twitching, dizziness, nausea, easy bruising, and odor and smell sensitivity. Three of the four who were explanted noted improvement and/or resolution of at least 50% of their total disease manifestations. Conclusions These six women are representative of over 70,000 other breast implant recipients who, over the past three years, have had their new silicone devices permanently removed because of alleged gel-induced toxicity. The recurrence of this public health crisis has been fueled by manufacturers' research fraud, FDA ineptness, faulty informed consent, patient abandonment, proprietary manufacturing secrecy, misleading advertising, physician indifference, aberrant research methodology, and lax Congressional oversight.
In humans the element silicon is essential for normal growth and development. It is extensively biointegrated into a wide variety of matrix macromolecules that display endless variations of complex overlapping interactions. When living organisms are confronted with artificial man-made organosilicon and organosiloxane compounds there is a finite limit of adaptive mechanisms by which normal cells and tissues can dispose of these molecules. Exposure to silicone gel-filled breast implants is particularly harmful due to biochemical chaos caused by in vivo degradation of an exceedingly excessive polymer presence. The worldwide proliferation of 60,000 other man-made siliconcontaining compounds permeates all aspects of everyday living and has created generalized environmental exposure via inhalation, dermal absorption, and ingestion. These exposures are producing heightened public health concerns because prior assertions that organosiloxanes are chemically and biologically inert are no longer tenable. It is proposed that vague syndromes, such as fibromyalgia and chronic fatigue syndrome, are disorders caused by insidious slowpaced toxicity mechanisms similar to the more rapid and profound biochemical disruptions occurring in sick breast implant recipients.
BackgroundRheumatoid arthritis (RA) is known to have many predisposing factors.ObjectiveWe studied individuals whose RA was initiated by physical injuries.Patients and methodsSixty patients (43 females), previously well, developed RA following trauma. No other known environmental or familial influences were present. Fourteen sustained a fracture; of the 46 who did not, 36 sustained multiple injuries that in part involved the axial skeleton. Subsequent unremitting daily pain, stiffness, limited motion, pain on motion, and/or swelling in the injured areas were mandatory for inclusion.ResultsNine months after injuries (span: 2 weeks–36 months), more obvious signs of inflammation (IM) appeared in multiple other joints that were previously not affected by the original trauma. In those with laboratory tests done prior to the spread of IM (30/60), 22 (73%) were normal until an average 8 months after the spread of IM. Of the entire cohort of 60, only 23% had a positive rheumatoid factor, but 43% had a positive antinuclear antibody.ConclusionIt seems apparent that any severe trauma to a joint may precipitate an ongoing localized chronic inflammatory disorder for an indefinite period of time, which may then lead to the spread of IM to multiple other joints. The initiation of RA following trauma warrants consideration as a legitimate entity.
Vaccination-induced disorders are a genuine reality that continue to generate intense controversy. Although the majority of immunization recipients have little or no safety issues, that does not detract from the occurrences of multiple systemic diseases initiated by a wide variety of parenteral vaccine exposures. Over the past four decades case reports of chronic vaccination-induced disorders have generally segregated into two main categories: (a) autoimmune and autoinflammatory diseases; and (b) neuro-psychiatric diseases, characterized by overlapping clinical features of the various neurologic fatiguing syndromes [1][2][3][4][5]. Afflicted individuals in category "b" are typically Gardasil vaccine recipients. They manifest widespread generalized pain, fatigue, muscle weakness, and small fiber neuropathy, along with mood and sleep disturbances, lethargy, headaches, dizziness, vertigo, reduced alertness, tinnitus, hearing loss, motor neuron dysfunction, abnormal gait, adverse cardiovascular events (e.g., orthostatic fainting, postural tachycardia, other arrhythmias, heart block), gastrointestinal complaints (e.g., cramps, nausea, vomiting, diarrhoea), cognitive dysfunction (e.g., memory lapses, learning impairment), tremors, seizures, metabolic disturbances (e.g., menstrual irregularities), and even sudden death [3][4][5][6][7][8][9]. The published reports of category "b" phenomena begin after either Gardasil 4 and/or Gardasil 9 immunizations, regardless of whether any single individual had received one, two, or three separate parenteral doses designed to protect against human papillomavirus induced cancers [10][11][12]. Within category "b" there also exists considerable diversity regarding the types of clinical features manifested by any single patient, as well as considerable heterogeneity in their time to onset, severity and persistence. Complicating all of this is the lack of specific nomenclature for category "b" events, in part because multiple investigators have identified a variety of autoantibodies and cytokines in ailing Gardasil recipients, and others have grossly oversimplified disease features to resemble patterns seen in fibromyalgia, chronic fatigue syndrome, neuroinflammation, dysautonomia, postural orthostatic tachycardia syndrome, Gulf war illness, macrophage myofasciitis, small fiber neuropathy, and complex regional pain syndrome [9,[13][14][15][16][17][18]. In essence, mechanisms of disease causation put forth by these researchers to account for category "b" events are superficial, overly simplistic, disjointed, and at times inherently contradictory [19,20]. All of these confounding factors have added considerable fuel to the Gardasil controversy, and questions continue to persist regarding definitive identification of those at risk for this bizarre syndrome.
The vast majority of immunization recipients have no safety issues, but that does not detract from the reality of numerous peer reviewed publications reporting on a wide variety of new onset vaccination-induced disorders
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.