Fw: Silicone Implant Disease by Dr. Ron Kennedy

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Subject: Silicone Implant Disease by Dr. Ron Kennedy

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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 ã DC 360 silicone fluid ã was once considered

worth following up for development by Dow Corning scientists as a potent

insecticide, one of the few known substances capable of killing

cockroaches.

Dow Corning researchers also studied silicone as a possible better

chemical warfare and riot control agent, according to a 1969 internal

memorandum obtained by the PSC (Public Safety Commission).

Silicone gel is not a single substance but a fluid comprised of numerous

different versions of silicone, and is better termed a " silicone chemical

soup. "

Research collected by the PSC shows that silicone has marked effects on

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)

ÝImplants Ýwill Ýlikely Ýrupture Ýand Ýleak Ýwithin Ýten Ýyears Ýof

Ýplacement.

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 Ýmigrates Ýfrom Ýthe Ýrupture ÝsiteÝthroughout Ýthe Ýbody.

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 Ýproduces Ýabnormalities Ýin Ýimmune system Ýfunctioning.

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)

ÝIn 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 Ýproduces Ýa ÝclassifiableÝ new Ýdisease Ýmarked Ýby Ýautoimmune

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 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 Ýsymptoms Ýgo Ýaway Ýwhen implants ÝareÝremoved.

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?Ý

Legal ÝAction

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.

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