Silicone Implant Disease

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Silicone Implant Disease

by Ron Kennedy, M.D., Santa , CA

Silicone breast implants were introduced in 1962 and have beensurgically implanted in an estimated 2.5 million American women sincethen and many more world-wide. Some women get them as part of breastreconstruction therapy following mastectomy for breast cancer, but themajority get them because they want larger breasts.

Now, 38 years later, it is clear that silicon enhancement of breastscan be hazardous to the health of the recipient. The real cost ofcosmetic breast enhancement may not be the $10,000 in surgical fees toimplant them, but a host of autoimmune symptoms and strange illnessesthat 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 inertand nontoxic, was based on a single one-week study of rats and guineaspigs. (In 1943, Dow Chemical Company and Corning Glassworks formed DowCorning Corporation to market silicone and silicone implants.)

The basic gel implant filler — DC 360 silicone fluid — was onceconsidered worth following up for development by Dow Corning scientistsas a potent insecticide, one of the few known substances capable ofkilling cockroaches.

Dow Corning researchers also studied silicone as a possible betterchemical warfare and riot control agent, according to a 1969 internalmemorandum obtained by the PSC (Public Safety Commission).

Silicone gel is not a single substance but a fluid comprised ofnumerous different versions of silicone, and is better termed a"silicone chemical soup."

Research collected by the PSC shows that silicone has marked effectson the adrenal glands and liver, induces chronic inflammation, anddegrades into smaller molecules, including silica. Silicone fed torabbits produced widespread toxic effects including kidney and spleendamage 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 ofRheumatology (W.B. Saunders Company, 1993).

Silicone degrades into silica, usually at the surface of the gelimplant, then fragments and subdivides into millions of microdropletscapable 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 theimmune system, killing cells, and producing silicosis.

Silicone and its contaminants which bleed through its surroundingimplant envelope into neighboring tissue have the potential forsignificant toxicity in the implant recipient.(Seminars in Arthritisand 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 DowCorning have been aware of the toxic effects of silicone and silicasince the 1950s, based on their own studies, but never published thedata. They knew these substances were bio-active, immunotoxic, andinflammatory 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 ofMedicine concluded in 1995: From a pathophysiological perspective,silicone should be expected to be a bio-active materials and thephysico-chemical and immunological data at the experimental level arecompelling. (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 thatthe rupture rate of silicone implants ranges between 5% and 51% andthat unfortunately we do not know with any confidence where within thatrange the real rupture rate lies." Even if it is 5% that is a risk toogreat to justify the use of silocone in human beings.

When 51 implants were removed, one to 17 years after implantation, 2were found to have ruptured, 7 were leaking, and only 17 were in goodcondition; 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 that63% 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 inCleveland, Ohio, in evidence presented to the PSC, 11% of implantswhich have been in the body less than seven years rupture, but of thosein the body more than seven years, 61% rupture.

Deformities such as holes or cracks were found in 40% of 1,717breast implants after six years of use and in 95% after 12 years ofuse. (Canadian Journal of Plastic Surgeons, Spring 1997)

When breast implants from 300 patients were examined, 71% had eitherrupture or silicone bleed, or both, and 63% of 592 implants, whenremoved, were found to have ruptures. This led researchers to conclude:We have found and predict that most implants have lost or will lose theintegrity of the silicone shell between eight and 14 years, leavingfree silicone [in and out of the capsule] in the breast. (ls ofPlastic Surgery 34:1 [January 1995], 1-6)

Based on an examination of 217 silicone implants removed during afour-year period, physicians concluded that, either from leakage orrupture, 40% failed within six years of implantation, and 95% within 12years. (Canadian Journal of Plastic Surgery 4:1 [1996], 55-58)

Using magnetic resonance spectroscopy, researchers found that among39 women with implants, 20 (51%) had ruptured implants and 27 (69%) hadevidence of silicone in their livers. (Radiology 201:3 [December 1996],777-783)

Complications of implants requiring further surgery are likelywithin five years, based on a study of 749 women with siliconeimplants. During a median span of 7.8 years after implantation, 27% ofthe women underwent 450 implant-related surgeries; 79% of thesesurgeries were needed to address a complication, most frequently amongwhich were capsular contraction (tightening of scar tissue around theimplant) and rupture. (New England Journal of Medicine 336:10 [March 6,1997], 677-682)

French researchers found that the well-described leakage occurringthrough the silicone envelope allows the silicone gel to diffuse tomultiple anatomic areas in the body, producing a cellular response thatincludes the formation of a capsule around the implant. (Revue deMedecine Interne 18:12 [1997], 955-966)

Silicone migrates from the rupture site throughout the body.

As early as 1956, Dow Chemical researchers knew that liquidsilicone, when injected into the body, migrates to all the majororgans, including the spleen, heart, lung, and brain. (PSC Record No.0006) Studies by both Dow Corning and Dow Chemical in 1970 confirmedthat silicone, after injection, migrates to the bone marrow of animalsand changes brain weight. They also showed that silicone particlesmigrate from a human finger joint into the lymph nodes. (PSC Record No.0018, 7038)

Researchers at Baylor College of Medicine in Texas found thatsilicone is widely distributed throughout the body of mice after asingle injection, migrating to ten different organs from the brain tothe uterus and persisting in these organs over time. (American Journalof Pathology 152:3 [March 1998], 645-649)

Researchers at the Medical College of Wisconsin in Milwaukee foundthat following silicone implant rupture, silicone gel migrated into thearm of a woman, where it produced nerve pain, dysfunction, andfibrosis. (Plastic Reconstructive Surgery 89:5 [May 1992], 949-952)

Physicians at Massachusetts General Hospital in town, usingmagnetic resonance imaging, found that a significant amount of freesilicone had migrated from an implant (not noticeably ruptured) intothe liver and spleen of a woman. (Magnetic Resonance Medicine 36:3[september 1996], 498-501. Researchers also found that silicone in theliver could be detected in the first three to four years after a womanreceived her implant. (Magnetic Resonance Medicine 33:1 [January 1995],8-17)

Of 39 women with silicone implants, 27 (69%) showed signs ofsilicone 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 theliver. (Radiology 201 [1996], 777-783; PSC Record No. 0050)

In 1989, studies by Dow Corning showed that silicone, given orallyto rats, increased liver size and weight by up to 45% and suggested theenlargement might be interpreted as a carcinogenic response. (PSCRecord 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 thanten years earlier. Among these women, 60% had an elevated ratio ofhelper T cells to suppressor T cells; 20% had a blockage in particularfunctions of T cells and natural killer cells. (Toxicology IndustrialHealth 8:6 [November/December 1992], 415-429)

Scientists at the University of California at reported thatevidence suggests that the degradation products of silicone inactivateCD8+ suppressor T cells (key immune cells) and thereby lead to aninflammatory state in the body. (Food and Chemical Toxicology 32:11[November 1994], 1089-1100)

The activity of natural killer cells is significantly suppressed inat least 50% of women with silicone implants observed in a study; thisputs the women at a higher risk of developing cancer. The same effectwas demonstrated in animals; it was reversed upon removal of thesilicone. (Toxicology and Industrial Health 10:3 [May/June 1994],149-154)

High levels of anti-nuclear antibodies (ANAs), immune markersassociated with lupus erythematosus, were observed in ten of 11 womenwith implants reporting autoimmune symptoms. (Lancet 340:8831 [November28, 1992], 1304-1307)

When 500 women with silicone implants were examined, 30% testedpositive for ANA levels; those women also had rheumatic symptoms. Theresults strongly suggested immune activation in women with siliconeimplants.(Current Topics in Microbiological Immunology 210 [1996],277-282)

Based on a study of 3,380 breast implant recipients, scientistsstate there is a sixfold increased likelihood that testing these womenwill show elevated ANAs; the longer the implant has been in place, thegreater the likelihood. (Current Topics in Microbiological Immunology210 [1996], 337-353)

In a study of 111 women (with and without implants), those withimplants had a statistically significant elevation of anti-siliconeantibodies (immune cells focused against silicone as a foreignsubstance in the body); the highest levels were observed in women withnoticeable implant rupture or leakage. (FASEB 7:13 [October 1993],1265-1268)

Researchers at the University of Wisconsin at Madison School ofMedicine reported that autoantibodies of unclear significance may befound in 5% to 30% of women with silicone breast implants.(Archives ofInternal 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 elevatedlevels of autoantibodies to collagen, in a manner highly similar towomen with lupus and rheumatoid arthritis. (Current Topics inMicrobiological Immunology 210 [1996], 307-316)

Among 310 symptomatic women with silicone implants, there wereelevated levels of novel auto-reactive antibodies to siliconeassociated antigens(a specific type of heightened immune response)compared to healthy women without implants. (Current Topics inMicrobiological Immunology 210 [1996], 327-336)

Scientists at the Technical University of Munich in Germany examined239 breast implant recipients and found the following immunologicalabnormalities: levels of complement C3 were elevated in 42% of thewomen; complement C4 was elevated in 21%; and anti-thyroglobulin (anantibody that attacks a substance in the thyroid gland) was higher in28%. (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 ofseverely disrupting the immune system. Silicone plays the role of anadjuvant, providing constant nonspecific stimulation of the immunesystem.(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 andimmunological effects, a variety of names for silicone-induced diseasehave been proposed: siliconosis, undifferentiated or atypicalconnective tissue disease, silicone related disease, silicone reactivedisorder, silicone disease syndrome, and silicone implant disease (SID).

Typical symptoms associated with silicone include cognitivedysfunction, short-term memory loss, Sjögren's syndrome (dryness inglands, such as the mouth, kidneys, eyes, and lungs), scleroderma,rheumatoid arthritis, dermatomyositis, severe joint and muscle pain,incapacitating fatigue, swollen lymph glands, skin problems, peripheralnumbness, multiple allergies, headaches, hair loss, sunlightsensitivity, central nervous system disorders (similar to multiplesclerosis), and others.

Among 176 breast implant patients examined by doctors at theHospital for Joint Diseases, 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 offatigue, 75% of generalized stiffness, 71% of poor sleep, and 78% ofjoint 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 (skinthickening which damages tissues) revealed that scleroderma symptomsdeveloped an average of nine years after implantation. Of these, 77%also had Raynaud's phenomenon (extreme skin pallor and coldness inhands and feet), 53% had swallowing difficulties, 47% had lungproblems, and 83% had antinuclear antibodies. (Current Topics inMicrobiological Immunology 210 [1996], 283-90)

Doctors at the Comprehensive Care Clinic in Houston, Texas, foundthat 26 women developed a systemic disease with central nervous systeminvolvement (resembling multiple sclerosis) an average of 5.7 yearsafter receiving silicone implants. (Southern Medical Journal 89:2[February 1996], 179-88)

Doctors at the Louisiana State University Medical Center at NewOrleans examined 300 women (average age, 44) with silicone implants andmusculoskeletal complaints. The symptoms developed an average of 6.8years after receiving the implants; 83% had symptoms highly suggestiveof an underlying connective tissue disorder; and 54% met the criteriafor a fibromyalgia (chronic muscle pain) diagnosis. (ClinicalRheumatology 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 directinjection [of silicone] and the effects of gel-filled devices[implants]."

In either case, the human body reacts to the presence of this aliensubstance" by forming granulomas which then produce a chronicinflammation. Direct injection of silicone into the breast forenlargement was outlawed because it produced serious, toxic effects inwomen; it is illogical, state Drs. Shanklin and Smalley, that thispractice is still permitted via ruptured leaking implants. (Science andMedicine 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 103of 142 women attributed a variety of symptoms to their implants andthat 50% of these women reported improvement in their health problemswhen the implants were removed. (ls of Plastic Surgery 34:1[January 1995], 1-6)

Of 33 women who underwent implant removal (average age 44), 24experienced significant improvement in numerous silicone-associatedsymptoms within 22 months. (Seminars in Arthritis and Rheumatology 24:1Suppl 1 [August 1994], 22-28)

Among 300 women with implants and musculoskeletal complaints, 70%who underwent implant removal reported improvement in their systemicsymptomatology. (Clinical Rheumatology 14:6 [November 1995], 667-672)

Dermatologists at the Medical University of South Carolina atton report that when a woman, 46, with scleroderma had herimplants removed, the scleroderma gradually resolved.(Archives ofDermatology 126:9 [september 1990], 1198-1202)

Doctors at the University of California, School of Medicinereport that for a woman with debilitating multisystem sarcoidosis(multi-organ granulomas), her clinical condition dramatically improved,after her silicone implants were removed. (International Archives ofAllergy and Immunology 105:4 [December 1994], 404-407)

Canadian researchers polled 100 women for health changes theyexperienced after having their silicone implants removed (mean age 41)after having had the implants for a mean of 12 years. After an averageof 2.7 years, 45% of 75 women in this group (those who had lost nipplesensitivity) believed, in retrospect, their implants had causedpermanent health problems and 43% were suing the implant manufacturers.

Those women who had no previous signs of autoimmune symptomsresponded most favorably to explanations 80% reported major improvementin their symptoms and 93% said they had a significantly improvedpsychological well-being.(ls of Plastic Surgery 39:1 [1997], 9-19)

Surely there is enough evidence to support the case that siliconebreast implants pose a serious potential health threat, if not forevery woman, at least for many. Isn't it therefore prudent to side withcaution–having the implants removed and residual silicone detoxifiedfrom the body–if the health ramifications of a procedure are thatuncertain?

Legal Action

Not everyone sees it this way of course. The subject of siliconebreast implants is clouded and controversial, marked by denial,cover-up, stonewalling, suppressed research, bankruptcy, and classaction lawsuits. There is also much suffering involved.

The manufacturers and most plastic surgeons strenuously insistsilicone breast implants pose no health danger; most women apparentlybelieve this because 87,704 more American women received implants in1996. Between 1992 and 1997, the number of breast augmentationsurgeries increased by 275%, according to the American Society ofPlastic and Reconstructive Surgeons.

The majority were saline implants in a silicone casing; the onlywomen until recently still getting silicone implants are those who optfor breast reconstruction following mastectomy and agreed to be part ofthe FDA's clinical trials on silicone implants. Now, tragically, theFDA has re-approved silicone implants. One can only guess the factorsbehind that shady deal. Many other countries have not banned siliconeimplants and millions of women are still regularly exposed to the fullforce of not only the silicone bag which is used with saline implantsbut also the silocone gel chemical soup inside. In fact, I was inspiredto post this article after a woman from Paraguay came to my office withsevere fatigue four years after receiving silicone implants. On LiveBlood Cell Analysis several bundles of foreign crystallized substancecould be seen in each high powered field, occupying at least 5% of herblood volume! She returned to Paraguay to have her implants removed.

Thousands of women who have had their implants for one or twodecades now are seeking medical help for mysterious symptoms whichresemble arthritis, fibromyalgia, scleroderma, connective tissuedisorders, and/or immune dysfunction and seem to be associated withtheir implants. Anyone skilled with a dark field microscope can showyou large numbers of mysterious chunks of foreign particles floatingaround in the blood of many women complaining of these symptoms.

In 1992, the FDA declared a moratorium on sales of silicone breastimplants, citing the lack of clinical studies proving their safety.However, the FDA did not say silicone implants were unsafe, hedging asusual on the side of manufacturers and against the public, callinglamely for more studies.

Treatment

Silicone will exit the body with time and this can be accelerated with the use of oral DMSA as a chelator of silicone.

http://www.medical-library.net/content/view/91/41/

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