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> > From: Kathynye@...

> Date: Sun, 8 May 2005 07:35:29 EDT

> Subject: POST:Silicone Implant Disease

> Kathynye@...

>

> Subj: Silicone Implant Disease

> Date: 5/7/2005 11:51:43 PM Eastern Standard Time

> From: toxicdiscovery@...

>

>

> 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

> moreworld-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 — DC 360 silicone

> fluid — 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 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 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 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

> 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-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 a

> reas 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

> 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 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 antibody

> that 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, Sjögren'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 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)

>

> 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

> fromParaguay 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.

>

>

> Toxic Discovery

> 601 W. Nifong

> Bldg. 3B. Suite P.

> Columbia, MO. 65203

>

> Phone: (573) 817-2090

> Fax: (573) 445-4700

> Email: kkjohnston@...

> Website: www.toxicdiscovery.com

>

>

>

>

>

>

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