Guest guest Posted January 23, 2006 Report Share Posted January 23, 2006 1997 Silicone Implants Are Dangerous For many years, Dow Corning conducted experiments on silicone breast implants. Dow found that the implants leak and rupture, spreading silicone throughout the body (1). They learned that the silicone in the implants kills roaches (2), is not biologically inert (3), and stimulates a human immune response (4). Tragically. Dow kept this science hidden. In recent years, however, a host of articles have been published in scientific journals pointing to the negative health effects of silicone breast implants. A Canadian study found that 40% of implants leak or rupture after six years. And 95% leak or rupture after 12 years (5). Other studies are finding a rupture rate after 10 years of 70% (6). A Mayo Clinic study found that 25% of women require surgery within five years after implantation (7). A report in the Archives of Dermatology shows the unmistakable link between local pain, numbness and deformity and deposits of silicone that had migrated from a ruptured implant (8). It has also been documented that silicone leaks from women's nipples (9). A 1996 Harvard study found a 24% increase in connective tissue disease, both classical and atypical, for women with breast implants (10). A 1997 report in The Lancet found an abnormal immune response in women with silicone implants (11). A University of Michigan study found women with implants had three times the risk of developing an unusual connective tissue disease (12). Other studies have documented that silicone provokes an immune reaction in humans and animals (13).The Dow public relations machine has led many people to believe that implants have been proven safe. Nothing could be further from the truth. There is abundant scientific evidence confirming that thousands of women are suffering the effects of faulty, broken, dangerous silicone implants. For many years Dow Corning conductedexperiments on silicone breast implants. Dow found that the implants leak and rupture, spreading silicone throughout the body. They learned that the silicone in the implants kills roaches, is not biologically inert, and stimulates a human immune response. Tragically, Dow kept this science hidden. _______________ (1) " If enclosed within a silicone bag, the fluids would tend to diffuse out...and be absorbed into the tissues. " Dow internal document written by Ethel Mullison, PhD at the Dow Corning Center for Aid to Medical Research to Dr. Cronin, January 24, 1961. Page75 " The results of this study indicate that dimethylpolysiloxane fluid is deposited in the spleen, liver, adrenals, pancreas, ovaries, abdominal lymph nodes, and kidneys of mice... " " Silicone in Mice, " a study by Dr. Rees, Dow Corning, 1966. " Milt, as you know, we have discussed the rupture problem twice in the past month, and as of this date, the problem is still recurring at an inordinate rate. " " Mammary Prosthesis Ruptures, " memo from to Milt Hinsch, December 15, 1977. (2) " cockroaches went into the silicone fluid...never got more than a few inches from the dish before dying. " Dow study IV (1968): Effects of Silicone Oils on Cockroaches (DCC--16001147). (3) " The preponderance of available animal data also suggests a potential for silicone materials to be involved in immunologically mediated disease states. " " Investigation of the Effects of Silicone Fluids, Gels, and Particles on the Immune System, " Boley, Malczewski, and , Health Care Group Research, February 19, 1985. (4) " Some possible applications of the immunological enhancing agnets...the production of high quality and expensive experimental antibodies. " " Organosilicon Immunopotentiators: Patent Memorandum No. 4320, " Boley, Lake, and LeVier, Dow Corning Corporation, January 31, 1975. (5) " Failure Properties of 352 Explanted Silicone-Gel Breast Implants, " s, et al. Canadian Journal of Plastic Surgery, Spring 1996. (6) " Reported Complications of Silicone Gel Breast Implants: An Epidemiologic Review, " Kessler, et al. ls of Internal Medicine, April 15, 1996. (7) " Complications Leading to Surgery after Breast Implantation, " , et al. New England Journal of Medicine, March 6, 1997. (8) " We report the unique occurrence of significant overlying scarring and ulceration following silicone gel migration down the affected arm. " " Silicone Breast Implant--Associated Scarring Dystrophy of the Arm, " Gershwin, et al. Archives of Dermatology, Jan 1995; vol 131. (9) " She reported being able to express a substance that was like 'hair gel' from both nipples. " " Intraductal Migration of Silicone from Intact Gel Breast Prostheses, " Barnet, et al. Plastic and Reconstructive Surgery, March 1995. (10) " ...increased risks of connective-tissue disease among women with breast implants. " " Self-Reported Breast Implants and Connective-Tissue Disease in Female Health, " Hennekens, et al. Journal of American Medical Association, Feb 28, 1996. (11) " ...some individuals may mount a specific antipolymer immune response after exposure to silicone from SBI [silicone breast implants]. " " Use of Antipolymer Antibody Assay in Recipients of Silicone Breast Implants, " Garry, et al. The Lancet, Feb 15, 1997; vol 349. (12) " These results suggest that self-reported occupational exposure to silicone and the presence of implanted medical devices, particularly those that contain silicone, increase the risk of developing UCTD [undifferentiated Connective Tissue Disease]. " The Page 76 Association Between Silicone Exposure and Undifferentiated Connective Tissue Disease Among Women in Michigan and Ohio, " Schottenfeld, et al. University of Michigan. Abstract presented at American College of Rheumatology Meeting, October 1996. (13) " In summary, we have shown that chemical comonents used in the manufacture of a silicone implant, when considered individually or as an extract, are not inert, as reflected by the rat's granulomatous response and induction of cells derived from the immune system. " " Analysis of the Soft-Tissue Response to Components used in the Manufacture of Breast Implants: Rat Animal Model, " Goldstein, et al. Plastic and Reconstructive Surgery, March 1991; 87(3). " It can be seen by the studies reviewed here that silicones are neither biologically or chemically inert and that there is clinical and theoretical reason for concern. " " Immunopathologic Effects of Silicone Breast Implants, " Gershwin, et al. Western Journal of Medicine, May 1995. " ...silicone implantation may result in autoantibodies against silicone-bound proteins... " " The Influence of Silicone Implantation on Type II Collagen-Induced Arthritis in Mice, " Schaefer, etal. Arthritis & Rheumatism, June 1997;40(6). " ...the effects of silicone breast implantation on immune stimulation to self appear to be long-lasting. " " Cellular Immune Reactivities in Women with Silicone Breast Implants: A Preliminary Investigation, " Atkinson, et al. ls of Allergy, Asthma, and Immunology, 1997; 79 Page 77 \http://www.howdyneighbor.com/JusticeDenied/page31.html MEMOIR OF A JUNK SCIENTIST BY BERNARD M. PATTEN, MD, FACP, FRSM The former President of the American Society of Plastic and Reconstructive Surgery called me a junk scientist. My lame, but honest, reply is that I am a junk scientist because I have, for the last fifteen years, been studying a piece of junk. That's what the silicone breast implant was and is. Let me explain: It all started years ago, never mind how many, when I decided to switch my program at Columbia College from American History to premed. My career seemed to go pretty well for a time. I graduated from Columbia College summa cum laude and second in my class of 725 students. Thence I went to Columbia's College of Physician and Surgeons where I also graduated second in my class. They elected me to AOA, the national medical honor society in my junior year, and I took the Mosby Prize for Scholarship at graduation. After internship at Cornell Medical Center - The New York Hospital, I returned to Columbia for residency in neurology and eventually, by unanimous vote of the faculty was elected Chief Resident in Neurology at the Neurological Institute of New York. After a fellowship year in human memory at Columbia, I went to NIH where I became the assistant chief of Medical Neurology and did neurological consultations for the clinical center and many times for the United States Senate. So far so good. Not a bad start for a junk scientist, wouldn't you say? Along the way I published over 100 papers in peer reviewed journals, gave over 500 lectures to national and international audiences and received many prizes and awards for research in Parkinson's Disease (I was there with Dr. C. Cotzias when the first dose of DOPA was given) and Myasthenia Gravis (I was there with Dr. King Engel when we pioneered the immune suppressive treatments) as well as a listing in the usual places such as Who's Who in America, Who's Who in the World, Who's Who in Health and Medical Education, Who's Who in Science and Engineering and so forth. I had a loving wife who was also a physician and two children and four cats and, yes, as unfashionable as it may be to admit, I was happy. Happy, that is until that fatal day when I decided to leave the sacred groves of NIG to take a job as Chief of Neuromuscular Diseases and eventually Vice Chairman of Neurology at the Baylor College of Medicine in Houston, Texas. Soon after that mistake my troubles began. At Baylor I made friends with Dr. Gerow, one of the two inventors of the silicone breast implant. explained that he and Cronin wanted to do something with plastic surgery that would match the artificial heart the Dr. Debakey was working on, something that would draw national attention to themselves the way NASA, situated only 40 miles south of Baylor, got national attention. First, they tried direct injections of silicone into tissues to make bigger breasts and the results were, of course, a disaster. I saw lots of these women in consultation. They were by and large the wives of medical students who had volunteered for the experiments. The silicone caused marked fibrosis, hard, painful, disgusting looking breasts which the women were ashamed to show. All Page 78 others who tried to directly inject silicone into human tissue have gotten the same terrible local complications proving that silicone is not inert but is biologically active enough to cause severe local inflammatory reactions. The interesting thing that escaped my attention at the time was that most of these wives also had weird neuromuscular and rheumatologic diseases including myasthenia gravis, polymyositis, small fiber sensory neuropathy and Sjogren's syndrome. In many cases, the autoimmune diseases required treatment and I applied the treatments the best I could without thinking that there might be a connection between the silicone and the autoimmunity. Because direct injection gave awful results, Gerow and Cronin decided to enclose the silicone in a elastomer bag and put the bag into the breast area to make big breasts. A lot of people thought the idea absurd, almost obscene, but it did give the promise of what some women wanted and it was quick giving immediate results. Of course, there ware lots of problems with the surgery including infections and herniation of the implant through the incisions and multiple redos because the implant had ruptured or shifted or had developed a baseball hard capsule or the woman wanted still larger and larger breasts and so forth. But the local complications Gerow and Cronin could handle. Besides whether you put implants in or you took them out or you changed them, the surgeon still got paid. Eventually, Baylor accumulated the first and the largest series of implanted women in the world and as the neurologist that Gerow knew and presumably trusted, I got the referrals of the women who had complaints referable to muscles, nerves, spinal cord, or brain. And there were many of them, a superabundance. Probably from 1986 to 1993 I personally saw and examined over 2000 such women. Their stories were all quite similar: Sometime after the implantation, they felt weak and tired, developed morning stiffness, excessive fatigue, dry mouth, dry eyes and dry vagina. Most also had hot painful tender breasts with contractures. I made it my business to examine the breasts of all these women and got pretty good at detecting ruptures, spills, and enlarged local lymph nodes. There were many women with amazingly anesthetic nipples which Gerow told me was because T4, the nerve to the nipple, had been cut on insertion of the larger implants through the axillary approach. Quite a few women had severe sharp shooting chest pains simulating heart attacks. Gerow had an answer for that too: On insertion the implant forms a physical barrier to the regrowth of severed nerves causing neuroma formation. We even biopsied a few cases and proved the neuromas were present and published two papers on chest pain in implanted women. One paper appeared in Emergency Medicine and one appeared in the Southern Medical journal. But the thing that impressed me the most about the local situation was that the implant, in this selected group of women that I saw, had failed miserably to deliver what it had promised. Beautiful breasts they were not. In fact, the opposite was true: The implant had made satisfactory breasts horribly deformed and ugly. I did complete physical examinations on each of the women and found that they all seemed to show much the same general pattern; they had skin rashes, cold fingers and toes, dry eyes and dry mouths, and they were weak. We weren't sure how strong a woman should be so I sent out a medical student to get pinchometer and gripometer measurements in Page 78 normal and hospitalized women. The results confirmed that implanted women, the ones referred to me at any rate, were, in relation to their peers matched for age and sex, objectively weak, usually scoring less that 50% of the controls on the dynamometer measurements. On neurological examination I found that ladies had more than the usual trouble with simple mental status tests such as proverbs, subtractions, serial sevens, naming the presidents and so forth. That could have been because they came from poor education backgrounds, which they did by and large. Except, even some high powered women who had completed graduate school, Judges in Houston courts for instance, or the former assistant postmaster general and other women of achievement in journalism and science, also did poorly on these tests. Gait and station testing showed most couldn't do a push up or a sit up and most had glove and stocking sensory loss suggesting they had neuropathy. Laboratory tests confirmed that the women seemed to have something autoimmune though just what that was we couldn't say. There were lots of abnormal autodirected antibodies including ANA and rheumatoid factors and antinerve antibodies but none of the ladies actually fit into the currently accepted diagnostic criteria for the diseases usually associated with those antibodies. Almost all the women who had cognitive complaints had decreased cerebral flood flows as measured by research physicians as part of the NIG approved Baylor- Methodist Cerebral vascular research center grant. Almost all had positive tear tests proving the ladies really did have dry eyes. Most of the patients had surgical indications for implant removal and I followed them during and after the surgery. I personally reviewed the slides on all tissues removed and gradually learned to identify free silicone in tissue, polyurethane, and the dense inflammation with foreign body giant cells that surrounds the implant. We documented with pictures the gross appearance of massive silicomas larger than softballs and capsules thicker than magazines. We kept track of the relations of examination results before to what happened after surgery. In general, women with polyurethane implants did lousy and got worse after explantation. Women who had massive spills of silicone had teams of surgeons laboring over nine hours fail to get all the silicone out. That group also did poorly. Women with high titers of antiGM1 antibodies got progressively worse and sent down hill often dying of a weird neuromuscular disease that resembled a combination of dermatomyositis, lupus, rheumatoid arthritis, motor sensory neuropathy, Sjogren's syndrome, and amyotrophic lateral sclerosis with, believe it or not, signs and symptoms of multiple sclerosis! Women who had minor spills that surgeons could remove and those with intact implants did the best. Most in that group recovered within two years. Three of these who had had complete remissions of well documented diseases got tired of living with small tits and made the mistake of getting reimplanted. The diseases, as predicted, roared back thus fulfilling Koch's postulates. We found that the incidence of ruptured implant correlated with the severity of autoimmune disease. The proven rupture rate for our series of severely ill women with the Multiple sclerosis, for instance, exceeded 70%. We published our results in eight papers covering everything we could think of from the local to systemic problems. Under separate cover, I will send some reprints of those to Page 79 you. The citations of all papers appear in Medline. My fellows, Britta and Glen, and I presented our data at national and international meetings including the World Federation of Neurology and the American Neurological Association and the American Academy of Neurology. The Southern Medical Society and the Texas Neurological Society gave us several awards for clinical research and encouraged us to dig further. In many cases, our reports hit the front pages of USA Today, The New York Times, The Wall Street Journal and so forth. Little did I realize that that publicity would hurt us. Nor did I realize, until it was too late, how much it would hurt. About 1986 Dow-Corning paid me $4,800 to consult with them about their product. I told them what we were finding and I told them especially about my concern about the rupture rate (50% ruptures in ten years on average) and the severe local complications we had seen due to ruptures. I urged them to set up some form of free clinic to care for the injured women and to make cowardly amends for what they had done. Some months later they told me I was wrong and that the implant caused no such problems. We went back to the drawing boards and redid much of the research only to discover the same things we had discovered before. I estimate the pause caused by the misinformation received from the company delayed our progress for two years. As it was misinformation, because to my chagrin, I learned on my way to Washington to testify before the expert panel of the FDA, while reviewing the secret company documents supplied to me by the FDA, that the company clearly knew as far back as 1976 that silicone spread, caused local inflammation, and in some animals resulted in autoimmune diseases. I appeared before the panel a shaken man. The people who had hired me as a consultant had deceived me. How naive I had been. The rest as they say is history. FDA took implants off the market for cosmetic augmentation. TV began to do shows about how bad a scientist I was. Gerow staggered under the weight of over 13,000 malpractice suits against him and Baylor. Trustees called Doctor , the President of Baylor, about a program about me put on by CNN. Frontline even said in a voice over that I was under investigation by the FBI for Medicare fraud. I was not, not then, not ever. But multiple investigations were conducted on the basis on anonymous complaints to the Texas Board of Medical Examiners. Seven so far have been dismissed after years of investigation and reinvestigation. Every slide I ever showed in any scientific meeting was seized and investigated as possible evidence against me. Criminals broke into my office and stole research data related to implants. The biopsy laboratory was broken into and slides and reports on implanted patients looked into. A man posing as my fellow copied the brain scans and charts of over 200 patients, a theft of medical records never solved. Death threats arrived in the mail. People phoned in threats. One plastic surgeon said I was part of a communist conspiracy to deprive American women of their implants. And, yes, a dead decapitated animal, a rabbit not a horse, arrived at the doorstep, just like in the movies. Baylor restricted my teaching saying that they couldn't prevent my research but they sure could stop me from talking to students, interns, and residents about implants. They were careful to mention that they were not restricting my research because they recognized the Page 80 rights of a tenured associate professor to publish what he wished. And they affirmed that they wished me to continue my teaching in every other aspect just as before. However, the chairman of the department soon came upon the idea that he could stop my seeing implanted women. I protested but Baylor administration remained intransigent. So realizing the futility of trying to make further progress, I bowed out. Meanwhile, Cronin started to make rounds in the nude and was discovered to be demented and Gerow, drinking a lot, refused to have his protime checked. He had an artificial aortic valve for which he took Coumadin. His subsequent death from a cerebral hemorrhage prompted me to formulate the following epigram: The silicone implant was: Bad for those who made them Bad for those who put them in Bad for those who got them in And bad for those who did research on them. God rest his soul. Before he died Gerow predicted what subsequently came true: " The silicone implant, born in Houston, will die in Houston. " And so it is with a kind of wispy regret that I make some suggestions to future scientists who might consider doing implant research. First of all, consider carefully, you men and women of the future, and if you take my advice, don't do it. It isn't worth it. More than one career has been ruined in this field and others are sure to follow. The companies have massive amounts of money to defame even the most sincere and diligent researcher. The chance that you will escape the same fate as me is slim. But if the compulsion to do research that will have a significant impact on the health of women for our time and for all time is unavoidable, I suggest you consider the following: ·Set up special free clinics to study women with implants. These ladies have genuine medical problems, which are not being addressed. Regardless of the cause of their physical and mental diseases they need help which they are not able to get at present because for various reasons they are locked out of the medical system. ·Repeat the epidemiological studies. Most of those studies, by their own admission, are flawed. The Mayo study more than the others. In fact, the Mayo study was reported in the same section at the annual meeting of the American Society of Plastic and Reconstructive Surgery that I reported the complication of giving a transfusion into an implant. At that meeting the version was that there was a high incidence of autoimmune disease in the implanted patients compared to controls particularly Hashimoto's thyroiditis. For some reason, partial deselection of evidence I presume, that item never found its way into the Mayo final report. ·Even forgetting about possible causation for the moment, why not study intensively the mechanisms of autoimmunity in patients with implants? At the time of my retirement I had collected 51 cases of ruptured implants in patients with multifocal brain infarctions associated with antiphospolipid antibodies. Could that be an accident? ·Follow all women with implants in a national registry. Require that all have yearly screening examinations for local and systemic Page 81 complications. History and physical examinations is all that is needed for effective screening.Career researchers not connected with the companies in anyway and not connected with the business of installing or removing implants in anyway should do the screening. The companies have spent 26 million dollars on spin to make themselves look good. Why not spend a similar amount on some real unbiased research? ·Do animal studies injecting silicone mixed with blood proteins into animals. The results, I predict, will show that the animals develop autoimmune diseases. " Medical Debate Over Implants Has a Dark Side Science: Regardless of results, researchers studying the safety of silicone gel implants have been targets of harassment. The Los Angeles Times Los Angeles, Calif. May 17, 1995 ----------------------------------------------------------------- Authors: DAVID R. OLMOS Authors: HENRY WEINSTEIN Abstract: [bernard M.] Patten says there was no mistaking the message behind the rabbit-which had been decapitated. The Baylor College of Medicine professor says he has been the victim of constant harassment since publishing a research paper last year that found a possible link between silicone gel breast implants and unusual chest pain in women. His laboratory at a Houston hospital was broken into, he says, and documents were stolen from his university office. Police have no suspects. But Patten says the cloak-and-dagger goings-on are part of an unseemly behind-the-scenes backdrop to the impassioned debate over breast-implant safety. Scientists stand accused of allowing money to skew their research results. Attorneys on all sides trade accusations of harassment. The skirmishes are evidence of disagreement over some fundamental questions: Do breast implants really pose a medical risk, as hundreds of thousands of implant recipients and their attorneys contend? Or have the dangers been overblown by plaintiffs' attorneys in pursuit of million-dollar damage awards, as implant suppliers and their attorneys contend? " Page 82 http://www.the-scientist.com/yr1989/sep/spurgeon_p7_890904.html The Scientist 3[17]:7, Sep. 4, 1989 NEWS Chemist Gets Fired After Calling Breast Implant Unsafe Canadian scientist appeals his dismissal, charges the agency that employed him with trying to stifle his criticism of the product By DAVID SPURGEON OTTAWA—Research chemist J.J.B. Pierre Blais joined the health protection branch of Canada’s Department of National Health and Welfare in 1976 in the midst of a productive career in the federal science bureaucracy. He had spent seven years at the National Research Council, and looked forward to many more satisfying years with his new agency. For a while it was just that. An expert in the biocompatibility of implant materials, Blais has worked on projects that have led to amendments in Canada’s Medical Devices Regulations and served as section head within the department. “He’s a brilliant scientist who is always searching for the truth,” says one of his superiors, Agit Das Gupta. Blais also built a reputation as an innovative and productive investigator, with some 180 published articles, book chapters, patents, and monographs. But six weeks ago Blais, at the age of 49, was fired from his job. And he blames that same bureaucracy that had employed him for 20 years for trying to stifle his scientific criticism of a product that he and others believe is unsafe. That product is a polyurethane-coated breast implant known as Même. Blais first became interested in it in 1979, and the more he learned about M~me, the more concerned he became about its potential harmful effects on the women who had received it as part of reconstructive or cosmetic surgery. Blais is not the only scientist to hold such views. All silicone gel-filled breast implants are unsafe, says Teisch of the Health Research Group, a Washington, D.C.-based consumer advisory body, and polyurethane-covered types are “a particularly noxious” variety. Laval University’s Guidoin, whose laboratory of experimental surgery conducts research on breast, heart, and cardiovascular implant designs, believes the implant should be removed from the Canadian market. And the U.S. Food and Drug Administration last spring warned the parent company of the current manufacturer of the implant that the manufacturer has failed to report at least 11 prosthesis failures that probably caused serious injuries. Page 83 Spokesmen for Canada’s Department of Health and Welfare refuse to comment on any details of the Blais case, noting that his dismissal is being appealed by the labor union to which Blais belongs, the Professional Institute of the Public Service. Blais says he was persuaded by the institute to lodge the appeal, which is not expected to be heard for several months, “in order to protect the professional and scientific reputation of the department.” The department,. which carries out a range of scientific, regulatory, and social welfare functions, has some 9,000 employees and oversees expenditures of $36 billion. Another government scientist, who is also a former executive for the union’s scientific research group, says that Blais “has enormous backbone, considerable personal and technical integrity, and a conscience.” Citing a stream of budget cuts and previous cases in which the advice of government scientists on various health issues was ignored, the scientist called Blais’ dismissal “another blow to the morale of the scientific community in the Canadian public service” and “a sign of general malaise” in the government. The events that led to Blais’ firing go back a decade, when he first learned about the implant. By 1985 Blais had collected a spate of journal articles that cited difficulties stemming from its use. The following year other medical product manufacturers started to complain to the health minister about the practices of the product’s Canadian distributor, Real Laperriere Inc., of Montreal, (The U.S. distributor is Surgitek Medical Inc., of Racine, Wis., a subsidiary of Bristol Myers Pharmaceuticals. Since January, the manufacturer has been Surgitek’s Aesthetec Division of Paso Robles, Calif.) Soon surgeons began to ask Blais to identify material from implants removed from patients. In November 1988, the Canadian health minister received a letter asking him if he would agree to have Blais appear as an expert witness in a lawsuit involving the prosthesis. It was at that point, Blais says, that the government lowered the boom on him. “I was ordered not to commumcate with anyone connected with this type of implant,” he says. “I was given no reason. It was the first time I had seen such a thing happen.” Blais says that he has been told that the department fought subpoenas from the court requesting that he tes tify. “They initiated a series of procedures that blocked or reduced the probability I would be compelled to appear,” he says. Although the government’s attempts failed, Blais has yet to testify because the trial has been postponed. By this time, Blais had written a number of memos asking for further investigation of the implant and calling for a voluntary halt to its sale until the work was completed. He believes thatthose memos made him a target of on-the-job harassment. At first Blais was bewildered by the logistical roadblocks thrown in his way, but eventually he was told that his professional activities were being restricted for purposes of “policy coordination.” Finally, on July 17 Blais received a letter of dismissal, citing his official “misconduct.” He was accused of leaking confidential information on the Même implant to the press, contrary to departmental regulations, and of having failed to return all his laboratory samples page 84 and files. Given only a few hours to clean out his desk, he was escorted from his office. Weeks later, Blais is still trying to figure out why. He admits to having become increasingly convinced that the Même implant was unsafe, and he’s made no secret of his views within the department. But, he declares;,, I am not a whistle-blower. I have never gone public with this type of information. I’ve always held [to] the confidentiality of the department—in fact more so, perhaps, than I should have in retrospect, because many situations involve the public good. I remained within the terms of reference given to me by the department, but I fought tooth arid nail within the department to get this stuff off the market.” What apparently caused the health and welfare department to clamp down on Blais were reports earlier this year in the Montreal Gazette that quoted his confidential memos. Says Blais, “It was a time when much of this information [about the implant] was already surfacing in different ways, and because the department is very small and there’s only a few plastic specialists, everyone inferred that [the person responsible for the leaks] was me. I’d published before on this subject for the scientific literature. I’d given lectures and so on.” Blais says that the government is wrong in its assumption. “The department leaks like a sieve,” he says. And he says that he wouldn’t be surprised if the leaks continued. In the meantime, Blais is still reeling from the shock of being fired. “It’s one of the most distressing episodes in my career,”he says. “It’s not just that I have been dismissed. I fought within the department to have the product at least sidetracked until we knew more about it, but they refused to withdraw it.” He says that many scientists have called him and the union to express their support for his appeal. “They feel,” he says, “that the whole integray of the scientific arm of the public service is at stake.” Spurgeon is a freelance science writer based in Ottawa. ----------------------------------------------------------------- The Scientist 3[17]:7, Sep. 4, 1989 Page 85 FDA Testimony Oct 2003: Ed Brent...PJ Brent's Husband ~ High Platinum levels... CDC said.. No wonder she committee suicide ED BRENT: Good morning. My name is Ed Brent and I have received no funds nor do I have a sponsor that has helped me to fund this trip. Three years ago, my wife stood before you and did her best to convince you, the FDA, not to allow saline breast implants on the market. My wife had double-lumen implants, my daughter, , leg braces, and that was because of the silicone implants, {} carried one of my wife's implants to your table showing the black fungus growing inside of it. My wife was P.J. Brent. You may have seen her on CNN or other t.v. networks discussing breast implants. She was distraught after being here and learning that everything that she had said was anecdotal evidence and not to be considered by the panel. We were here March 1, 2000. On May 29, 2000, my wife committed suicide. She left behind seven children and I am here on behalf of my wife and children to urge you not to allow silicone breast implants on the market. There are three studies showing that women that breast implants are more likely to commit suicide compared to other women. Some experts think that these suicides mean that women with breast implants have lower self esteem before they got their implants as well as after. But the National Cancer Institute study, which compares implant patients to other plastic surgery patients, shows that the problem is more likely to be from the implants. My wife was not a woman with low self esteem. She was a vibrant, loving wife and mother. P.J. loved the way she looked the first few years after the implants. Then she started to get sick. Her joints hurt. Her fingers would swell so she could not wear her rings. She did not know what was happening and sought medical help. She had lupus-like symptoms and was diagnosed with fibromyalgia. She was explanted in 1992. P.J. breast-fed the two daughters she had after the implants. was born in 1985 and was diagnosed with chronic inflammatory demyelating polyneuropathy, CIDP, as well as esophageal-motility disorder. She spent years in leg braces to allow her to walk. Now, the braces are gone and have been replaced with a wheel chair and she has a special car with hand controls to help her drive. was born in 1986 and also had esophageal- motility disorder and signs of the neurological disorder. After P.J. committed suicide, an autopsy was performed from her. Samples were extracted. Large amounts of platinum were found in her body. This came from the silicone. The high platinum levels, a doctor at CDC saw them and said, " No wonder she committed suicide. She could not have been in her right mind. " Hair, nail and tissue samples were taken from our daughters who breast Page 86 fed and it was found that they, too, had elevated platinum levels. You have an awesome responsibility before you, a responsibility of conscience and doing what is right for the women and yet unborn children of these women who may be forever affected. Don't let this be a money issue, but a moral issue. Thank you. http://www.fda.gov/ohrms/dockets/ac/03/transcripts/3989T1.DOC (page 71) Page 87 From: dee allison <Recipient List Suppressed:> Date: 6/1/2001 11:41:44 AM Subject: calcified organs-FULL BODY SCAN--thanks, Ilena Thanks, Ilena, Dear, for posting this to the group.... Hi, All. First of all, I wanted to let everyone know I did the now famous " Full Body Scan " you are now hearing much about, and wonder if I may be able to answer any questions you have re that, so feel free. Secondly, has anyone ever heard of different organs calcifying or shrivelling up and disappearing altogether? I will search these things myself, but I am interested in your replies, so much, as they may put me on the right trail faster. My liver, adrenal glands, coronary arteries, etc. etc.....are showing calcification, the coronary artery part being a separate and apparently serious condition, though this is not really news and am not freaked. Yet. I'd just like everyone to answer if they know the various causes of calcified organs or have had same diagnosed... Love and light and thanks immensely! D Page 88 Original Message] From: Jussta <jussta@...> <Recipient List Suppressed:> Date: 4/12/2001 12:26:13 PM Subject: ~~~ Jussta Update ~~~ I was praying to die! I begged God to put me out of all this excruciating misery. God had other plans, so I am still here! None of my doctors or the specialists or Nuclear technicians can believe I am still alive, let alone functioning. I was injected with Radiation on Monday, March 26 and had a Gallium Scan of my lungs the next day and then the following day another Gallium Scan was done of my lungs. The monitor screen is supposed to look like a television that is turned off with very dim static (if the radiation is not clinging to any foreign matter such as infection, inflammation, tumors, etc.) The monitor during my first Gallium Scan of my lungs was brilliant white showing every part of my lungs with very intense 'hot' white areas. It looked like Las Vegas at night! The second day, there should be almost no static or any white areas. When they scanned my lungs, they were even 'hotter' and had bigger clumps of white areas that looked like quartz lamps turned on high. They kept changing Nuclear technicians on me - each one had many more years of experience and wanted to see THIS. We all knew it was the silicone. I urged the technicians to do a scan of my entire torso, just out of curiosity. It took them about a second to agree. Not only were my lungs totally outlined and brilliant white from the radiation sticking to the silicone in my lungs, on the Gallium Scan of the remainder of my torso - my liver was brilliant white, my entire stomach, my intestines - both upper and lower, my gall bladder, my bladder. Every organ in my torso is totally inflamed with Silicone. One of the Nuclear Technicians asked me to autograph my miracle Flaming Aura photograph from Australia - so I did, he was the one who injected me with the radiation. So I wrote on it, " To , who gave me a whole different glow. " I could not miss the irony of a Firewalker dying of inflammation I told that I could 'feel' the radiation in my body and that I could not have a bowel movement. He said he had never heard of radiation making you constipated. Within moments of completing the second day of Gallium Scans, the head Radiologist at Eisenhower came at a fast walk - almost running, shook my hand, introduced himself, and went into the reading room. The head Nuclear Technician asked me to wait to make certain the Scan was complete. Within two or three minutes, I was told I could leave and that Dr. Mohammed Mojarad, my Pulmonary Disease Specialist would have the report early the next morning. Something horrid had happened to my vocal chords and my ability to speak. I absolutely could not breathe. Was constantly coughing and losing bladder control. Several friends urged me to go to the emergency room later the next day, concerned because I could barely speak and could not breathe. I called 911 and the paramedics took me to Eisenhower by page 89 ambulance. Instead of taking me into the ER - I was put in a chair in the waiting room. Left unattended, except for other people in the waiting room. I was having major constant coughing fits, could hardly breathe, was urinating on myself every time I coughed which was constantly. I was there for 3 HOURS sitting in that chair. During that time, I was taken to the restroom, where I was left alone - it was all I could do to not faint. I rang the emergency bell and no one came for over twenty minutes. A woman waiting for someone in the ER came and put me in a wheel chair - someone wheeled me over to the courtesy phone and I telephoned Dr. Mojarad's service and told them what was happening and they could not believe it and called Dr.. Mojarad - but another half-hour had passed, I still had not been seen, nor acknowledged. I was soaking wet from sweating, freezing cold with chills, my fever was 102.7 and the nurse at the desk would not give me a blanket! I wheeled myself outside and saw someone with a cell phone and had them call me a taxi. I went home so exhausted and angry - burning up with fever which was now 104.5 and crawled into bed, covered myself with a ton of blankets. That night, I was almost with my head on my pillow when I had a major " brain storm " - (not the idea kind). Since 1978, I have had a buzzing in my brain that sounds like an electrical short. This buzzing usually only lasts several seconds - up to a minute and is coupled with total paralysis. This night, the buzzing (electrical short) was the most severe ever, coupled with the total paralysis, but this time there was a major light show - I was really in awe over the exploding colored lights and patterns until I felt like I was being choked and this time the 'brain storm' lasted 37 minutes. This time, I was pretty sure I was not going to survive. I did - weak, shaking, and totally drained. About a week before this, I suffered major spasms in my bronchial and larynx and could barely speak - and sounded like no one I have ever heard. I felt that my speech would not return. After this 'brain storm', my speech returned - so there was a blessing in it. Greg McGee and other friends urged me to go to the ER. This time I drove myself and told the Triage Nurse that a friend had driven me. I had a 'brain storm' and did not know if it was a stroke or what. I was immediately seen and taken into the ER. My temperature was 103.1 and I was sweating profusely, shaking and experiencing frequent 'buzzing (electrical shorts) in my brain'. The ER doctor was very concerned. He consulted with Dr. Mojarad and they decided to do a Cat scan of my brain and took x-rays of my right hip which I was unable to lift my right leg because of sitting in the damn chair for 3 hours the night before. Five hours later, after the Cat Scan and the x-ray and numerous blood tests, the doctor prescribed a Nebulizer with Albuterol. He said I did not suffer a stroke, nor did I throw an embolism and there was no brain tumor. I told him it's the silicone moving around in my brain and he agreed. I drove myself home and Greg came to stay later. We got the Nebulizer and the Albuterol the next day which helped me to be able to breathe. That night I had another 'brain attack' - for almost five minutes. Greg was sleeping on the sofa bed in the living room - and because I am totally paralyzed, I could not call out to him or move my arms to hit anything to get his attention. After the episode, I could call for Greg - and Greg wanted me to call 911 - I told him no way. I am dying and I have spent the last time in ER's, in doctor's offices and having tests. The Gallium Scan would be the proof I wanted of the devastating effects of silicone. Within a couple of days of being injected with the radiation, I looked Page 90 like I was 20 months pregnant and the next day, my bowel was bulging through the wall of the skin on my abdomen so that it was perfectly outlined. had told me that the radiation is eliminated through the feces. As it turned out, the radiation had grabbed onto the silicone everywhere in my body and was NOT coming out. I did enemas, suppositories, drank Magnesium Citrate, made up an old gypsy remedy for intestinal blocks of tomatoes simmered in olive oil and ate a large bowel of that - and NOTHING... Nothing but a little brown water and my abdomen and stomach protruding the size of a large medicine ball. I had absolutely no peristaltic action, no gas, nothing would come out. This went on from the day I was injected with the radiation! Every thing I eat makes me nauseous and gives me an instant smashing headache and it feels like my eyes are going to explode. I wrote a new holographic will. Sat on the sofa with the Nebulizer and sorted and organized my papers for Greg to be able to find everything and act as executor. Greg was packing - all of these health challenges and having to move because I had sold my mobile home. I wanted to complete the deal on Monday, April 2nd so I would have the money to set up the foundation and to pay to have the autopsy done and have it videotaped. At this point, I was begging God to not let me die in Rancho Mirage - in the god-forsaken desert that had nearly killed me. The next morning, Dr. Mojarad telephoned me with the results of the Gallium Scan. The purpose of a Gallium Scan of any part of the body is to specifically identify the location of infection, tumors, cancer, growths, whatever - to be able to do a biopsy of the foreign matter so it eliminates exploratory surgery and poking around trying to find the right spot. My pulmonary disease specialist, Dr. Mohammed Mojarad told me I am untreatable. He cannot do a biopsy, since every organ in my body is totally major inflamed with Silicone and there are large hot areas of siliconoma. He cannot prescribe Prednisone for the pulmonary fibrosis because of the serious side effects of infection (I already have auto-immune deficiency), bone loss (I already have five Sequestra (bone dying and breaking away from my jaw). He also said that I cannot have any of the cancer treatments which have worse side effects than the Prednisone. He suggested I find an internist immediately at Scripp's. I told him all I want to do is to not suffer with the seizure like muscle spasms that twist my liver, stomach, diaphragm, and the large muscles in the back of my thighs into rope in an instant and I want to be able to breathe. The Nebulizer helped me to breathe - staying at Greg's at the beach has immensely helped my breathing. The muscle spasms are diminishing, but when they hit it is sheer agony. I am having frequent 'buzzing' in my brain - Driving is very difficult because it must be the motion which starts the buzzing and makes my eyes close and I am unable to open them or stay alert. I have had major 'brain storms' two nights in a row - and yesterday afternoon when I took a nap on the sofa. I can only call Greg when they are over - I know how helpless he must feel and he always asks if he should call 911, I refuse. Enough is enough. I have canceled all medical (allopathic) doctor appointments and am seeing a really gifted Chiropractor here in Oceanside who acknowledges silicone poisoning. I first saw him on Monday, April 9th, and that afternoon for the first time, I had a small bowel movement. This was two weeks with an intestinal block. I have stopped all medication - stopped the Lescol, Paxil, Premarin, Zyrtec, anti-inflammatory that I was allergic to anyway - stopped all Page 91 vitamins and supplements and only take Vicodin for the constant, excruciating pain. I do not take any Vicodin at night. Miracles abound. I wanted a little cottage by the ocean. I went for coffee down by the harbor - Spirit totally guiding me. Someone had left a newspaper with the classified section on top. I skimmed through houses for rent in Oceanside and there was an ad for a 1 bedroom - 1 bath with garage. The pay phone was a couple of steps from the outdoor table and I called the number. I reached the landlady and we met. I knew it was mine. She agreed. I move in on Saturday, April 14th. It is one block from the beach, it is about an 80 year old house with a large fenced yard with a lawn and trees. It has a garage with an area for a work bench or potting shed. It has a laundry room. It is exactly what I asked for. The landlady is going to tear it down next year, so I can paint it or do anything to it, she doesn't care. There is a chimney already in place, so I am going to put in a Swedish Fireplace that I can take with me - or Greg can... The Universe truly provides so many blessings for me. I can walk to the grocery store and to the Pacific Coast Highway so the 'brain storms' affecting my driving, will not interfere. I do have a mission. I am going to set-up a non-profit Foundation called The Jussta Trust. The mission will be to disseminate the truth about Silicone. To inform, educate the medical profession and the public, to prevent any use of silicone or saline implants, the use of silicone in or on any product or prosthesis used on or in the human body, including coating syringe needles, and acupuncture needles with silicone to make the insertion less painful. To document the devastating effects of silicone poisoning on the human body through collection of medical records, testimonials, audio, video, and the world-wide web. To gather a team of pathologists and coroners to perform autopsies focused on documenting the effects of silicone in the human body. Gathering documentation, medical records, photographs, and other materials in a central library. To force corporations, manufacturers, and medical doctors to be totally accountable for their participation, manufacture, or use of silicone in any form. If you or any of your friends or associates wish to participate and join this mission, I welcome your assistance. We need a lawyer to form the non-profit organization. We need volunteers who are experts at writing grants, and volunteers to begin collecting the data world-wide. We need documentarians, videographers, photographers, web hosting. We need medical doctors that acknowledge Silicone Poisoning to agree to share their medical records and to give testimonials on their experience with the devastating effects of silicone. Greg McGee is an award winning documentarian and has graciously offered to do a documentary on my experience which will include my medical records and the Gallium Scan. This is only the beginning. Time is of the essence because of my tenuous health. Doctors, and even I, do not know how I can possibly be alive - of myself, I can do nothing, it is Spirit within me that is carrying me to do this. I have stopped praying to die. I am not praying to live - I have totally surrendered - Not my will, Father, but Thy will be done. I will be offline again until Friday of next week, April 20th. Your prayers are appreciated. Bless each and everyone of you! Love, Light, & Blessings, Jussta I have updated my website: http://www.jump.to/jussta Page 92 PLAINTIFFS' SUBMISSION AND PROPOSED FINDINGS TO THE NATIONAL SCIENCE PANEL ON SILICONE GEL BREAST IMPLANTS July 21-23, 1997 VI. TOXICOLOGY " That silicone is toxic in both animals and man is well proven. From the earliest studies which found silicone toxicity in animals to findings that silicone suppresses natural killer cell activity, causes an activation of complement, generates a specific immune response, causes extensive fibrosis with chronic and granulomatous inflammation, causes immunogenic delayed hypersensitivity granulomas to form, leads to increased liver weight, and demonstrates parental toxicity by a reduction in mean live litter size and reduction in pup viability in Sprague-Dawley rats, the research collectively supports Dr. Sergent's statement in the Textbook of Rheumatology that silicone is, indeed, toxic to animals and humans. In this section analyzing the toxicity of silicones, it is difficult and ultimately quite arbitrary to draw lines between the scientific evidence on toxicity with that of its immunological and pathologic effects. Much of that evidence has already been presented in previous sections and will not be repeated here. Much like the Dow Corning Medtox analysis, the toxicology analysis here will focus on the following progression of events: GEL BLEED, LEAKAGE, RUPTURE SYSTEMIC MIGRATION SUBDIVISION OF THE GEL/PARTICULIZATION OF THE ELASTOMER METABOLISM AND DEGRADATION INTO SILICA AND SILANOLS ADVERSE FINDINGS OF TOXICITY Among the adverse toxicity findings are the following: Page 93 Pathologic evidence of gel bleed and migration; calcification and mineralization; severe, painful capsular contracture; extensive - sometimes massive - angiofibrosis; chronic and granulomatous inflammation characterized by the presence of lymphocytes, eosinophils, mast cells, plasma cells, and giant cells; immunogenic delayed hypersensitivity granulomas; macrophage activation with secretion of cytokines; fat and tissue necrosis; ulcerated skin and skin atrophy; silicone lymphadenopathy; and silicone implant-related synovitis. Immunologic evidence that silicone is an adjuvant and is immunogenic, findings of abnormal biomarkers including elevated AnA and IgG, suppression of natural killer cell activity, modulation of serum corticosterone levels causing thymic atrophy, and evidence suggestive of plasmacytomas and immune-mediated cancers such as multiple myeloma. Other toxicity evidence related to silicone breast implants including metabolism and degradation of silicone to silica in vivo, an increase in liver weights, cytotoxicity data, parental toxicity data, and effects on cholesterol levels. Other toxicity analogies: Plaintiffs submit that the evidence of toxicity of silicones comes from a variety of diverse yet prolific areas of research which, when viewed collectively, demonstrate that in some women implanted with silicone breast implants there is credible evidence for scientists to reasonably conclude that silicone is not inert and indeed can cause physiological effects within the body. 1. HISTORICAL OVERVIEW OF THE TOXICOLOGIC LITERATURE The Dow Chemical Company conducted the first major research on the toxicological properties of silicone in the 1940s. The results of their research were published in the seminal article on silicone toxicity by Rowe, Spencer and Bass They studied two silicone fluid materials of low molecular weight and one of high molecular weight administered orally to rats and guinea pigs over a one-week period. While the low molecular weight silicone caused a mild inebriation and central nervous system depression, the authors claimed that this one-week study showed that DC 200 fluid is " exceedingly low in oral toxicity " and that silicones are " inert. " Dow Corning's Center For Aid To Medical Research extensively promoted the Rowe study and claims of silicone's inertness to the medical community throughout the 1960s and 1970s. Dow Corning first manufactured and sold silicone breast implants in the mid 1960s. The published literature, at the time, including numerous references to the Rowe article and to Dow Corning (which cited Rowe) for the proposition that silicones are inert. The myth of silicone's inertness flourished in the medical community without any serious consideration of the reported findings in the literature on silicone gel breast implants until the early 1980s. Unfortunately, overlooked by most persons - although Dow was aware of it, it was the 1952 Cutting article in the Stanford Medical Bulletin reporting " widespread " toxic manifestations in rabbits fed a high cholesterol diet containing DC 200 silicone fluid. In Cutting's study, nearly all of the 10 rabbits showed renal tubular damage and lesions in the kidneys in varying degrees when fed DC 200 silicone in concentrations of one percent for three to four months. Microscopically, he observed capsular thickening in the spleens with deposits of DC Antifoam A silicone, and, in the kidneys, there was distension of tubular cells and large masses of macrophages between the tubules with a clear amorphous substance. Despite Cutting's findings of toxicity, further long-term toxicological research on silicones and silicone breast implants by the manufacturers was non-existent for some and very limited for others. Dow Corning was the only manufacturer to have a formal toxicology department, and that was not established until the late 1960s. The early studies, performed by outside laboratories in the 1960s including understaffing, lack of facilities and persons with expertise to interpret findings, inadequate resources to conduct studies, Dow Corning's Toxicology Department Continued to experience serious problems through the 1980s including understaffing, lack of facilities and persons with expertise to interpret findings, inadequate resources to conduct studies, and failure to follow GLP's. For example, in 1989, an independent Page 94 consulting toxicologist audited Dow Corning's toxicology program. The audit revealed serious problems including lack of competent management, lack of familiarity with GLP's, documentation which was " extremely poor, " a general feeling within the lab ....of chaos, " a department that had " little depth " and no system to " assure either that bad science or poorly thought out procedures...do not get put into place, " " wrong people [who] are making decisions (in some cases the WRONG decision) which impact upon the science being performed, " and a " Dow Corning management style [that] is not conducive to running even an adequate toxicology laboratory. " The consultant recommended a " complete overhaul " of the department including the hiring of qualified, trained toxicologists and staff to bring the department up to industry standards. The problems, however, were not corrected and another outside audit in 1994-95 uncovered instances of data falsification in several internal Dow Corning studies. Understanding that these issues do not directly assist the Panel in completing its charge, plaintiffs nonetheless note these problems in this submission for several reasons: 1) with the exception of the research conducted by Dr. 's Bioscience Research Department in the mid 1960s to mid 1970s, much of the internal industry research on which Dr. Brent and the manufacturers rely is of questionable value; 2) very little toxicological research was conducted on silicones for many years because of the myth that Dow Corning propagated to the medical and scientific community that silicone was inert; and 3) the other manufacturers relied on Dow Corning, as the supplier of the silicone materials used in breast implants, for virtually all safety testing. Because of the many deficiencies in the internal studies uncovered by outside audits, reliance on many of Dow Corning's early studies for claims of biocompatibility, such as those made by Dr. Brent before this Panel, is misplaced. 2. SUMMARY OF ADVERSE FINDINGS WHICH HAVE TOXICOLOGICAL IMPLICATIONS 1. Chronic and Granulomatous Inflammation Can Stimulate the Immune System, Causing Systemic Symptoms, Signs and Symptoms of Disease, and Immune Dysfunction. The adverse and immunopathologic reactions to silicone within the body and their clinical significance are documented extensively in the pathology and immunopathology sections. Many of the studies that the industry conducted in the 1960s and 1970s are also found chronic inflammation and granuloma formation. Because of the earlier extensive discussions, both in the Historical section and in the Pathology, the evidence will not be repeated here. 2. Immunologic Evidence Demonstrates That Silicone Is Immunogenic. The immunologic evidence, also previously discussed, is convincing and substantial. It forms a credible basis for physicians and researchers to conclude that silicone is immunogenic and acts as an adjuvant in the body, which results in immune system dysfunction and clinical signs and symptoms. 3. OTHER EVIDENCE ON SILICONE BREAST IMPLANT TOXICITY PROVIDES FURTHER SUPPORT FOR THIS PANEL Additional evidence of silicone's toxicity in animals and humans is found in studies on the effect of low molecular weight cyclics on liver weight, the data from animal teratology studies supported by data showing that silicone can have cytotoxic and cytopathic effects. 1. Low Molecular Weight Cyclics Affect Liver Weight In 1989, several Dow Corning studies showed that low molecular weight silicones specifically, D3, D4 and D5 resulted in toxic changes in various animal models. Mehendale evaluated D5 via oral administration in female rats at 2000 mg/kg body weight/day at 24 hours and 4, 8 and 12 days, followed by a period of recovery of 24 days. He found that D5 induced: [h]epatomegaly with recovery after cessation of dosing. The enlargement appeared to be due to a net enlargement in the liver mass. D5 was found to be an inducer of drug metabolizing microsomal enzymes and to resemble phenobarbital in this regard. However, D5 differed from phenobarbital in that it decreased the P-450 hemoprotein content of the microsomes. Page 95 Silicone Implant Disease By Ron Kennedy, M.D., Santa , California Silicone breast implants were introduced in 1962 and have been surgically implanted in an estimated 2.5 million American women since then and many more world-wide. Some women get them as part of breast reconstruction therapy following mastectomy for breast cancer, but the majority get them because they want larger breasts. Now, 38 years later, it is clear that silicon enhancement of breasts can be hazardous to the health of the recipient. The real cost of cosmetic breast enhancement may not be the $10,000 in surgical fees to implant them, but a host of autoimmune symptoms and strange illnesses that can crop up, typically within about seven years of implantation. Silicone Is A Biologically Active And Toxic Substance The original statement by the Dow Chemical Company in the 1940s (repeated hundreds of times since) that silicone is biologically inert and nontoxic, was based on a single one-week study of rats and guineas pigs. (In 1943, Dow Chemical Company and Corning Glassworks formed Dow Corning Corporation to market silicone and silicone implants.) The basic gel implant filler ã DC 360 silicone fluid ã was once considered worth following up for development by Dow Corning scientists as a potent insecticide, one of the few known substances capable of killing cockroaches. Dow Corning researchers also studied silicone as a possible better chemical warfare and riot control agent, according to a 1969 internal memorandum obtained by the PSC (Public Safety Commission). Silicone gel is not a single substance but a fluid comprised of numerous different versions of silicone, and is better termed a " silicone chemical soup. " Research collected by the PSC shows that silicone has marked effects on into smaller molecules, including silica. Silicone fed to rabbits produced widespread toxic effects including kidney and spleen damage within four months. (Stanford Medical Bulletin, 10:1 [1952], 23-26) That silicone is toxic in both animals and man is well proven, states S. Sergent, M.D., and colleagues in The Textbook of Rheumatology (W.B. Saunders Company, 1993). Silicone degrades into silica, usually at the surface of the gel implant, then fragments and subdivides into millions of microdroplets capable of migrating throughout the body (PSC Records No. 1352, 7017). These are documents produced by Dow Corning in national litigation). Silica in the body is a toxic, carcinogenic substance, damaging the immune system, killing cells, and producing silicosis. Silicone and its contaminants which bleed through its surrounding implant envelope into neighboring tissue have the potential for significant toxicity in the implant recipient.(Seminars in Arthritis and Rheumatology 24:1 Suppl 1[August 1994], 11-17) According to research gathered by attorney , of the Law Firm in San , California, Dow Chemical and Dow Corning have been aware of the Page 96 toxic effects of silicone and silica since the 1950s, based on their own studies, but never published the data. They knew these substances were bio-active, immunotoxic, and inflammatory when introduced into the human body, according to . (Update on Breast Implants, January 1998, website: http://www.consumerlawpage.com/article/dow.shtml Researchers at the University of California at Los Angeles School of Medicine concluded in 1995: From a pathophysiological perspective, silicone should be expected to be a bio-active materials and the physico-chemical and immunological data at the experimental level are compelling. (Journal of Biomaterials Science, Polymer Edition7:2 [1995], 101-13) Implants Will Likely Rupture And Leak Within Ten Years Of Placement In 1995, then FDA Commissioner A. Kessler, M.D., stated that the rupture rate of silicone implants ranges between 5% and 51% and that unfortunately we do not know with any confidence where within that range the real rupture rate lies. " Even if it is 5% that is a risk too great to justify the use of silocone in human beings. When 51 implants were removed, one to 17 years after implantation, 2 were condition; all implants older than ten years were leaking or ruptured. (Plastic Reconstructive Surgery 91:5 [April 1993], 828-834) Based on an examination of 350 silicone implants, doctors found that 63% of those implants in place for 12 years or more were not intact. (Plastic and Reconstructive Surgery 99:6 [1997], 1597-1601) According to Lu-Feng, M.D., of Mt. Sinai Medical Center in Cleveland, Ohio, in evidence presented to the PSC, 11% of implants which have been in the body less than seven years rupture, but of those in the body more than seven years, 61% rupture. Deformities such as holes or cracks were found in 40% of 1,717 breast implants after six years of use and in 95% after 12 years of use. (Canadian Journal of Plastic Surgeons, Spring 1997) When breast implants from 300 patients were examined, 71% had either rupture or silicone bleed, or both, and 63% of 592 implants, when removed, were found to have ruptures. This led researchers to conclude: We have found and predict that most implants have lost or will lose the integrity of the silicone shell between eight and 14 years, leaving free silicone [in and out of the capsule] in the breast. (ls of Plastic Surgery 34:1 [January 1995], 1-6) Based on an examination of 217 silicone implants removed during a four-year period, physicians concluded that, either from leakage or rupture, 40% failed within six years of implantation, and 95% within 12 years. (Canadian Journal of Plastic Surgery 4:1 [1996], 55-58) Using magnetic resonance spectroscopy, researchers found that among 39 women with implants, 20 (51%) had ruptured implants and 27 (69%) had evidence of silicone in their livers. (Radiology 201:3 [December 1996], 777-783) Complications of implants requiring further surgery are likely within five years, based on a study of 749 women with silicone implants. During a median span of 7.8 years after implantation, 27% of the women underwent 450 implant-related surgeries; 79% of these surgeries were needed to address a complication, most frequently among which were capsular contraction (tightening of scar tissue around the implant) and rupture. (New England Journal of Medicine 336:10 [March 6, 1997], 677-682) French researchers found that the well-described leakage occurring through the silicone envelope allows the silicone gel to diffuse to multiple anatomic areas in the body, producing a cellular response that includes the formation of a capsule around the implant. (Revue de Medecine Interne 18:12 [1997], 955-966) Page 97 Silicone Migrates From The Rupture Site Throughout the Body As early as 1956, Dow Chemical researchers knew that liquid silicone, when injected into the body, migrates to all the major organs, including the spleen, heart, lung, and brain. (PSC Record No. 0006) Studies by both Dow Corning and Dow Chemical in 1970 confirmed that silicone, after injection, migrates to the bone marrow of animals and changes brain weight. They also showed that silicone particles migrate from a human finger joint into the lymph nodes. (PSC Record No. 0018, 7038) Researchers at Baylor College of Medicine in Texas found that silicone is widely distributed throughout the body of mice after a single injection, migrating to ten different organs from the brain to the uterus and persisting in these organs over time. (American Journal of Pathology 152:3 [March 1998], 645-649) Researchers at the Medical College of Wisconsin in Milwaukee found that following silicone implant rupture, silicone gel migrated into the arm of a woman, where it produced nerve pain, dysfunction, and fibrosis. (Plastic Reconstructive Surgery 89:5 [May 1992], 949-952) Physicians at Massachusetts General Hospital in town, using magnetic resonance imaging, found that a significant amount of free silicone had migrated from an implant (not noticeably ruptured) into the liver and spleen of a woman. (Magnetic Resonance Medicine 36:3 [september 1996], 498-501. Researchers also found that silicone in the liver could be detected in the first three to four years after a woman received her implant. (Magnetic Resonance Medicine 33:1 [January 1995], 8-17) Of 39 women with silicone implants, 27 (69%) showed signs of silicone in their livers, and of the 20 whose implants had ruptured, silicone was detected in the livers of 17 (85%). In other words, whether the implants rupture or not, silicone leaks and migrates to the liver. (Radiology 201 [1996], 777-783; PSC Record No. 0050) In 1989, studies by Dow Corning showed that silicone, given orally to rats, increased liver size and weight by up to 45% and suggested the enlargement might be interpreted as a carcinogenic response. (PSC Record No. 0482) Silicone Produces Abnormalities In Immune System Functioning Silicone elicits antibody responses and immunological abnormalities, according to a study of 40 women who had received implants more than ten years earlier. Among these women, 60% had an elevated ratio of helper T cells to suppressor T cells; 20% had a blockage in particular functions of T cells and natural killer cells. (Toxicology Industrial Health 8:6 [November/December 1992], 415-429) Scientists at the University of California at reported that evidence suggests that the degradation products of silicone inactivate CD8+ suppressor T cells (key immune cells) and thereby lead to an inflammatory state in the body. (Food and Chemical Toxicology 32:11 [November 1994], 1089-1100) The activity of natural killer cells is significantly suppressed in at least 50% of women with silicone implants observed in a study; this puts the women at a higher risk of developing cancer. The same effect was demonstrated in animals; it was reversed upon removal of the silicone. (Toxicology and Industrial Health 10:3 [May/June 1994], 149-154) High levels of anti-nuclear antibodies (ANAs), immune markers associated with lupus erythematosus, were observed in ten of 11 women with implants reporting autoimmune symptoms. (Lancet 340:8831 [November 28, 1992], 1304-1307) When 500 women with silicone implants were examined, 30% tested positive for ANA levels; those women also had rheumatic symptoms. The results strongly suggested Page 98 immune activation in women with silicone implants.(Current Topics in Microbiological Immunology 210 [1996], 277-282) Based on a study of 3,380 breast implant recipients, scientists state there is a sixfold increased likelihood that testing these women will show elevated ANAs; the longer the implant has been in place, the greater the likelihood. (Current Topics in Microbiological Immunology 210 [1996], 337-353) In a Study of 111 Women (with and without implants), those with implants had a statistically significant elevation of anti-silicone antibodies (immune cells focused against silicone as a foreign substance in the body); the highest levels were observed in women with noticeable implant rupture or leakage. (FASEB 7:13 [October 1993], 1265-1268) Researchers at the University of Wisconsin at Madison School of Medicine reported that autoantibodies of unclear significance may be found in 5% to 30% of women with silicone breast implants.(Archives of Internal Medicine 153:23 [December 1993], 2638-2644) Researchers at Monash University in Clayton, , in Australia, found that women with silicone implants (70 were studied) have elevated levels of autoantibodies to collagen, in a manner highly similar to women with lupus and rheumatoid arthritis. (Current Topics in Microbiological Immunology 210 [1996], 307-316) Among 310 symptomatic women with silicone implants, there were elevated levels of novel auto-reactive antibodies to silicone associated antigens(a specific type of heightened immune response) compared to healthy women without implants. (Current Topics in Microbiological Immunology 210 [1996], 327-336) Scientists at the Technical University of Munich in Germany examined 239 breast implant recipients and found the following immunological abnormalities: levels of complement C3 were elevated in 42% of the women; complement C4 was elevated in 21%; and anti-thyroglobulin (an antibodythat attacks a substance in the thyroid gland) was higher in 28%. (ls of Plastic Surgery 36:5 [May 1996], 512-518) When silicone leaks from implants, immune cells form granulomas (microscopic lumps) around the droplets; the granulomas are capable of severely disrupting the immune system. Silicone plays the role of an adjuvant, providing constant nonspecific stimulation of the immune system.(Journal of Investigative Surgery 9:1 [January/February 1996], 1-12) Silicone Produces A Classifiable New Disease Marked By Autoimmune Symptoms Among physicians willing to credit silicone with toxicological and immunological effects, a variety of names for silicone-induced disease have been proposed: siliconosis, undifferentiated or atypical connective tissue disease, silicone related disease, silicone reactive disorder, silicone disease syndrome, and silicone implant disease (SID). Typical symptoms associated with silicone include cognitive dysfunction, short-term memory loss, Sj–gren's syndrome (dryness in glands, such as the mouth, kidneys, eyes, and lungs), scleroderma, rheumatoid arthritis, dermatomyositis, severe joint and muscle pain, incapacitating fatigue, swollen lymph glands, skin problems, peripheral numbness, multiple allergies, headaches, hair loss, sunlight sensitivity, central nervous system disorders (similar to multiple sclerosis), and others. Among 176 breast implant patients examined by doctors at the Hospital for Joint Diseases: Page 99 Orthopaedic Institute, in New York City, the most frequently reported symptoms were chronic fatigue (77%), cognitive dysfunction (65%), severe joint pain (56%), dry mouth (53%), dry eye (50%), hair loss (40%), and difficulty in swallowing (35%). (Seminars in Arthritis and Rheumatology 24:1 Suppl 1 [August 1994], 29-37) A study of 50 women with implants revealed that 89% complained of fatigue, 75% of generalized stiffness, 71% of poor sleep, and 78% of joint pain. Positive ANAs were found in 38% of these patients. (Seminars in Arthritis and Rheumatology 24:1 Suppl 1 [August 1994], 44-53) A study of 56 women with silicone implants and scleroderma (skin thickening which damages tissues) revealed that scleroderma symptoms developed an average of nine years after implantation. Of these, 77% also had Raynaud's phenomenon (extreme skin pallor and coldness in hands and feet), 53% had swallowing difficulties, 47% had lung problems, and 83% had antinuclear antibodies. (Current Topics in Microbiological Immunology 210 [1996], 283-90) Doctors at the Comprehensive Care Clinic in Houston, Texas, found that 26 women developed a systemic disease with central nervous system involvement (resembling multiple sclerosis) an average of 5.7 years after receiving silicone implants. (Southern Medical Journal 89:2 [February 1996], 179-88) Doctors at the Louisiana State University Medical Center at New Orleans examined 300 women (average age, 44) with silicone implants and musculoskeletal complaints. The symptoms developed an average of 6.8 years after receiving the implants; 83% had symptoms highly suggestive of an underlying connective tissue disorder; and 54% met the criteria for a fibromyalgia (chronic muscle pain) diagnosis. (Clinical Rheumatology 14:6 [November 1995], 667-672) According to R. Shanklin, M.D., and L. Smalley, M.D., both professors of pathology at the University of Tennessee at Memphis, there is little if any difference between the effects of direct injection [of silicone] and the effects of gel-filled devices [implants]. " In either case, the human body reacts to the presence of this alien substance " by forming granulomas which then produce a chronic inflammation. Direct injection of silicone into the breast for enlargement was outlawed because it produced serious, toxic effects in women; it is illogical, state Drs. Shanklin and Smalley, that this practice is still permitted via ruptured leaking implants. (Science and Medicine 3:5 [september/October 1996], 22-31) Silicone-associated Symptoms Go Away When Implants Are Removed Doctors at the University of Alabama at Birmingham observed that 103 of 142 women attributed a variety of symptoms to their implants and that 50% of these women reported improvement in their health problems when the implants were removed. (ls of Plastic Surgery 34:1 [January 1995], 1-6) Of 33 women who underwent implant removal (average age 44), 24 experienced significant improvement in numerous silicone-associated symptoms within 22 months. (Seminars in Arthritis and Rheumatology 24:1 Suppl 1 [August 1994], 22-28) Among 300 women with implants and musculoskeletal complaints, 70% who underwent implant removal reported improvement in their systemic symptomatology. (Clinical Rheumatology 14:6 [November 1995], 667-672) Dermatologists at the Medical University of South Carolina at ton report that when a woman, 46, with scleroderma had her implants removed, the scleroderma gradually resolved.(Archives of Dermatology 126:9 [september 1990], 1198-1202) Page 100 Doctors at the University of California, School of Medicine report that for a woman with debilitating multisystem sarcoidosis (multi-organ granulomas), her clinical condition dramatically improved, after her silicone implants were removed. (International Archives of Allergy and Immunology 105:4 [December 1994], 404-407) Canadian researchers polled 100 women for health changes they experienced after having their silicone implants removed (mean age 41) after having had the implants for a mean of 12 years. After an average of 2.7 years, 45% of 75 women in this group (those who had lost nipple sensitivity) believed, in retrospect, their implants had caused permanent health problems and 43% were suing the implant manufacturers. Those women who had no previous signs of autoimmune symptoms responded most favorably to explanations 80% reported major improvement in their symptoms and 93% said they had a significantly improved psychological well-being.(ls of Plastic Surgery 39:1 [1997], 9-19) Surely there is enough evidence to support the case that silicone breast implants pose a serious potential health threat, if not for every woman, at least for many. Isn't it therefore prudent to side with caution‚having the implants removed and residual silicone detoxified from the body‚if the health ramifications of a procedure are that uncertain? Legal Action Not everyone sees it this way of course. The subject of silicone breast implants is clouded and controversial, marked by denial, cover-up, stonewalling, suppressed research, bankruptcy, and class action lawsuits. There is also much suffering involved. The manufacturers and most plastic surgeons strenuously insist silicone breast implants pose no health danger; most women apparently believe this because 87,704 more American women received implants in 1996. Between 1992 and 1997, the number of breast augmentation surgeries increased by 275%, according to the American Society of Plastic and Reconstructive Surgeons. The majority were saline implants in a silicone casing; the only women still getting silicone implants are those who opt for breast reconstruction following mastectomy and agree to be part of the FDA's clinical trials on silicone implants. However, many other countries have not banned silicone implants and millions of women are still regularly exposed to the full force of not only the silicone bag which is used with saline implants but also the silocone gel chemical soup inside. In fact, I was inspired to post this article after a woman from Paraguay came to my office with severe fatigue four years after receiving silicone implants. On Live Blood Cell Analysis several bundles of foreign crystallized substance could be seen in each high powered field, occupying at least 5% of her blood volume! She returned to Paraguay to have her implants removed. Thousands of women who have had their implants for one or two decades now are seeking medical help for mysterious symptoms which resemble arthritis, fibromyalgia, scleroderma, connective tissue disorders, and/or immune dysfunction and seem to be associated with their implants. Anyone skilled with a dark field microscope can show you large numbers of mysterious chunks of foreign particles floating around in the blood of many women complaining of these symptoms. In 1992, the FDA declared a moratorium on sales of silicone breast implants, citing the lack of clinical studies proving their safety. However, the FDA did not say silicone implants were unsafe, hedging as usual on the side of manufacturers and against the public, calling lamely for more studies. Page 101 Quote Link to comment Share on other sites More sharing options...
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