Riched20 5.40.11.2210;  Silicone Implant Disease

by Ron Kennedy, M.D., Santa Rosa, California

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.

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 the adrenal glands and liver, induces chronic inflammation, and degrades 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 John 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 Richard Alexander, of the Alexander Law Firm in San Jose, California, Dow Chemical and Dow Corning have been aware of the 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 Alexander. (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 David 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 silicone in human beings.

When 51 implants were removed, one to 17 years after implantation, 2 were found to have ruptured, 7 were leaking, and only 17 were in good 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-Jean 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. (Annals of Plastic Surgery 34:1 [January 1995], 1-6)

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)

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 Charlestown, 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 Davis 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)

277-282)

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 auto antibodies 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, Victoria, 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 antibody that attacks a substance in the thyroid gland) was higher in 28%. (Annals 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, 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 Douglas R. Shanklin, M.D., and David 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. (Annals 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 Charleston 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)

Doctors at the University of California, Davis 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. (Annals 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 silicone 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

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