Fw: Silicone Implant Disease by Ron Kennedy, M.D., Santa , California

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From: " Kathi " <pureheart@...>

Sent: Saturday, July 13, 2002 10:06 PM

Subject: Silicone Implant Disease by Ron Kennedy, M.D., Santa ,

California

> from Lea

>

> Silicone Implant Disease by Ron Kennedy, M.D., Santa ,

> California

> >

> >

>

http://www.medical-library.net/sites/framer.html?/sites/_silicone_implant_di

>

> seas

> > e.html

> >

> > 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 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.

> > 6,849,810 Network hits since January 15, 1999. © 2002 The

> Doctors'

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> >

> > ===========================================e R. Wahl, Ph.D.,

> > C.N.C.Int'l. Resource Center for Chemically Induced Immune

> DisordersPh.

> > (847) 678-5934 e-mail: allenew@... cause of immune

> > epidemic: http://members.tripod.com/immune_disorders/index.html

> >

> >

>

>

>