Re: Way to go Dr Kennedy ! ! ! .......Silicone Implant Disease......

[Guest guest]

That is a wonderful article. Finally the negative exposure that

implants deserve by a real doctor! I wish they would have went into

a little more detail on the saline implants because in my opinion

they are still viewed as safe becuase all the contoversary is around

silicone but it is definetly a start. Thanks for sharing Dede.

>

>

> _The Doctors' Medical Library - Silicone Implant Disease_

> (http://www.med-library.net/content/view/91/41/)

> _http://www.med-library.net/content/view/91/41/_

> (http://www.med-library.net/content/view/91/41/)

> Silicone Implant Disease (javascript:void

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le=yes,width=400,height=275,directories=no,location=no')

> _by Ron Kennedy, M.D., Santa , CA_

> (http://www.med-library.net/content/view/343/39)

>

> (http://www.med-library.net/content/view/343/39) 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

> 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 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 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.

>

> (javascript:history.go(-1))

> _Ask Dr. Kennedy_

> (http://www.med-

library.net/component/option,com_registration/task,register)

>

>

>

>

> **************Start the year off right. Easy ways to stay in

shape.

> http://body.aol.com/fitness/winter-exercise?

NCID=aolcmp00300000002489

>

[Guest guest]

That is a wonderful article. Finally the negative exposure that

implants deserve by a real doctor! I wish they would have went into

a little more detail on the saline implants because in my opinion

they are still viewed as safe becuase all the contoversary is around

silicone but it is definetly a start. Thanks for sharing Dede.

>

>

> _The Doctors' Medical Library - Silicone Implant Disease_

> (http://www.med-library.net/content/view/91/41/)

> _http://www.med-library.net/content/view/91/41/_

> (http://www.med-library.net/content/view/91/41/)

> Silicone Implant Disease (javascript:void

> window.open('http://www.med-library.net/index2.php?

option=com_content & task=view & id=91 & Itemid=41 & pop=1 & page=0'

> , 'win2',

> 'status=no,toolbar=no,scrollbars=yes,titlebar=no,menubar=no,resizab

le=yes,width=640,height=480,directories=no,location=no')

(javascript:void

> window.open('http://www.med-library.net/index2.php?

option=com_content & task=emai

> lform & id=91', 'win2',

> 'status=no,toolbar=no,scrollbars=yes,titlebar=no,menubar=no,resizab

le=yes,width=400,height=275,directories=no,location=no')

> _by Ron Kennedy, M.D., Santa , CA_

> (http://www.med-library.net/content/view/343/39)

>

> (http://www.med-library.net/content/view/343/39) 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

> 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 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 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.

>

> (javascript:history.go(-1))

> _Ask Dr. Kennedy_

> (http://www.med-

library.net/component/option,com_registration/task,register)

>

>

>

>

> **************Start the year off right. Easy ways to stay in

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