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Human Adjuvant Disease Corp. , M.D.

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Human Adjuvant Disease Corp. Update

We are in the process of establishing Human Adjuvant Disease Corp.

chapters in all 50 states and in Canada. If you would like to become

involved in this project,please contact us.

The Human Adjuvant Disease Corp. is now accepting saline and silicone

implant recipients to participate in a 5 year research study. If you

are

a healthy patient with implants, a patient who is ill with implants,

or

if you had your implants removed, please contact us for more

information. Enrollment in this study will continue until July 2004.

INFORMATIVE LINKS

SILICONE/SALINE NEWS SPRING 2001

SILICONE/SALINE NEWS FALL 2001

SILICONE/SALINE NEWS 2002

DR. MYHILL- SILICONE DISEASES- UNITED KINGDOM

IMPLANT~INFO~NET

IMPLANT~INFO~NET FORUM

MILLENNIUM HEALTHCARE

TEMPLE OF HEALTH

INFO-IMPLANTS MAMMAIRES INC.

MEDWATCH-REPORT MEDICAL PROBLEMS FROM IMPLANTS

IMPLANT INFORMATION PROJECT

HUMANTICS FOUNDATION

TOXIC DISCOVERY NETWORK

BOOKS RELATING TO BREAST IMPLANTS

AMERICAN AUTOIMMUNE RELATED DISEASES ORGANIZATION

SURVIVORS OF SALINES

CHIN AUGMENTATION OPTIONS

CHEEK AUGMENTATION OPTIONS

SILICONE-RELATED DISEASES

What are silicone-related diseases?

Silicone-related disease is a term used to describe all illnesses

caused

by different types of silicone implants. Silicone Induced Immune

Dysfunction Syndrome and Human Adjuvant Disease are two disorders

that

occur in implant recipients.The following articles contain

information

on these illnesses.

SILICONE INDUCED IMMUNE DYSFUNCTION SYNDROME

W. , M.D. , Medical Director, Center for Immune,

Environmental, and Toxic Disorders, Houston, TX

Excerpt

Numerous patient case reports and controlled clinical trials have

discussed some of the many disorders and clinical syndromes

associated

with silicone implants, some of which resemble systemic lupus

erythematosus, rheumatoid arthritis, scleroderma, Sjogren's disease,

polymyositis, mixed connective tissue disease, multiple

sclerosis ,and

other neurological disorders. However, it is important to note that

silicone induced immune dysfunction syndrome is a multisystem

disorder,

which can affect any and all systems of the body.

The following is a list of the most common patient complaints

compiled

by us from over 4,000 patients with silicone prosthetic devices:

breast pain or tenderness

fatigue, usually made worse by exercise

cognitive function problems, such as

attention deficit disorder, calculation difficulties, memory

disturbance, spatial disorientation, frequently saying the wrong word

psychological problems such as depression, anxiety, personality

changes,

mood swings

sleep disturbance and non-restorative sleep

headaches of a greater intensity than before implantation

changes in vision

seizures

loss of balance

numbness and tingling

lightheadedness

paralysis

joint and muscle aches and pains

shortness of breath

lymph node enlargement

weight gain

low grade fevers

abnormal heart rhythm

hair loss

dry eyes and mouth

frequent canker sores in the mouth

low back pain

skin changes and/or rashes

severe muscular weakness

intolerance of bright lights

intolerance of alcohol

decreased libido

ringing in ears

muscle tremors

recurrent flu-like illnesses

severe allergies

irritable bowel syndrome

night sweats

uncomfortable urination

chest pain

cough

Raynaud's phenomenon

enlarged thyroid.

On physical examination, the common findings are:

hair loss

canker sores in the mouth

breast pain and tenderness

low back pain

thickening of the skin ,fingers, and hand

optic neuritis

enlarged thyroid

upper back pain

abdominal pain on palpation

muscle pain

photosensitive dermatitis :the skin is affected by exposure to the

sun

lymphadenopathy: enlarged lymph glands in the neck, under arm, and

groin

areas

diffuse petechiae on torso: small red spots on the chest and abdomen

positive schirmer's test, indicating deficiency of tear formation

reduced range of movement of extremities due to joint pain and

stiffness

Raynaud's phenomenon, with cold fingers or toes that can turn white

and/or ulcerate

malar or discoid rash :a rash over the cheeks of the face and upper

back

and chest

migration of the implant, usually laterally, and superiorly,

unilateral

or bilateral

capsule formation, unilateral or bilateral

asymmetrical breasts from unilateral rupture ,migration of implant,

capsule formation, post-surgical complications such as hematoma or

infection

livido reticularis :a lace-like pattern on the arms or legs caused by

abnormalities of the blood vessels

abnormal neurological examination with increased or decreased deep

tendon reflexes, and signs of nerve damage.

LABORATORY TESTING FOR SILICONE INDUCED IMMUNE DYSFUNCTION SYNDROME

SILICONE ANTIBODIES

The effects of silicone have been described in several studies. That

these effects are linked to Silicone Induced Immune Dysfunction

Syndrome

(S.I.I.D.S.) has also been established. Silicone antibodies in serum

confirms the exposure to silicone. We studied 520 women and published

these findings recently showing the significant relationship.It is

important to look for four types of silicone antibodies, IgA,

IgG ,IgM,

and IgE.

AUTOIMMUNE ANTIBODIES

Autoimmune like disease caused by silicone implanted medical devices

has

been described extensively in literature. Breast implants are not the

only implants that may lead to immune and autoimmune disease. All

silicone implants can cause autoimmune-like disease states .

IMMUNE SYSTEM

Certain tests,a subpopulation of lymphocytes and their function, have

been shown to be abnormal in patients with silicone implants.

Controlled

studies have shown a decrease in the function of Natural Killer Cell

Activity in patients with silicone implants and a return to normal

levels after explantation. Significant abnormalities in

T-Helper/T-Suppressor ratios have also been demonstrated indicating

an

immune dysregulation. All of the above contribute to confirming the

diagnosis of silicone induced immune dysfunction syndrome.

TREATMENT

Anyone suffering from Silicone Induced Immune Dysfunction Syndrome

should have their implant(s) removed.The surgery should also include

the

removal of the entire capsule surrounding the implant(s). This may

alleviate some symptoms, especially breast pain and tenderness. Care

should be taken from then on to allow the immune system to

recuperate by

avoiding the ingestions, absorptions, and inhalations of chemicals.

This

includes nicotine, caffeine, alcohol, artificial preservatives,

artificial food colorings, artificial sweeteners, artificial

flavorings,

household cleaning solvents, sprays, etc. Eating fresh foods,

preferably

organically grown, avoids pesticide contamination. In short, live and

eat like grandma and grandpa did. The medical treatment should focus

on

immune restoration.It is preferable to repair the damage done to the

immune system than to prescribe medication for every symptom. As

every

person's immune system is unique and different, there is no " boiler

plate " method.

HUMAN ADJUVANT DISEASE (H.A.D.)

" Disquisition on human adjuvant disease. "

Perspect, Biol. Med. 38(2): 274-290.

Human Adjuvant Disease (HAD) is an autoimmune condition associated

with

foreign materials in contact with the human body. HAD means the

disease

produced by the immune stimulation is caused by the effect of'

foreign

material(s). Therefore, this definition excludes all naturally

occurring

disorders merely worsened by the immune stimulation of the foreign

material. Such disorders should be classified as " worsened by

adjuvant

activity of. " For example system lupus that is believed to be

worsened

by adjuvant activity of' polyurethane and free siloxane in tissue

should

be classified as systemic lupus worsened by those adjuvants-and not

as

HAD.

DEFINITION BY DIVISION

Most cases of HAD would be expected to exhibit the following

characteristics.

1. Foreign material or materials in the body at some time prior to

the

development of the autoimmune disease.

2. Local reaction to the implanted material with any one or all of

these

things: encapsulation, pain, tenderness, heat, swelling, redness.

3. Some signs and symptoms generally associated with known autoimmune

conditions, including but not necessarily restricted to aches and

pains

in muscles and joints, stiffness, weakness, and easy fatigue.

4. At least one circulating autodirected antibody at some time after

installation of the foreign material. Such antibodies must be

detected

in amounts elevated above normal.

5. No other condition or disease explains the patient's illness,

including infection, malignancy, or naturally occurring autoimmune

disease.

6. Evidence is found for local immunological activation. This

commonly

consists of foreign body giant cells, but can be simply a chronic

inflammation with plasma cells, some lymphocytes, but mainly lots of

macrophages marginated on or near the foreign material or surrounding

the foreign material.

7. Improvement follows explanation when most if not all the foreign

material is removed. Time to improvement depends on the age of the

patient, the duration of illness, the severity of the autoimmunity,

and

many other influences and conditions not fully understood. In

general,

significant clinical and laboratory improvement in HAD occurs within

two

years of explantation. If improvement fails to occur within this time

frame, HAD probably was not the cause of the patient's condition.

These empiric defining criteria, like the criteria for rheumatic

diseases in general, derive from a dynamic area of research which at

present has an incomplete concept of the disease and an imperfect

diagnostic technology. In the years ahead, improved knowledge and

techniques will likely change refine and more accurately describe

these

characteristics.

Meanwhile, the seven divisions offer a standard against which

individual

cases or groups of patients can be identified, measured, and

compared.

COMPARISON

Similarities and differences among cases define HAD and help

distinguish

it from other conditions. Degree also indicates the type of illness

and

cause.

SIMILARITIES

Most HAD patients can be identified by the pattern distribution of

abnormalities in their cases and their similarity to others who have

had

comparable problems. The usual patient has had foreign material

installed within body tissues, followed sometime later by the

development of local difficulties around the site of implantation

and,

after that, systemic signs and symptoms of reaction to the material.

Local complications include pain, aching, heat, contracture, and

tenderness around the foreign material.

Prominent systemic symptoms include morning stiffness, aches and

pains

in muscles and joints, gel phenomena, memory loss for recent events,

dry

eyes, weakness and easy fatigue of skeletal muscle, regional

lymphadenopathy, and skin rash. Signs include local heat, redness,

induration, and irregularity around the implant, and generalized

weakness, glove and stocking sensory loss, and evidence of other

peripheral or central nervous system dysfunction or both. This

pattern

distribution of local complications near the foreign material

associated

constitutes a combination unique to HAD. Future studies may show it

the

sine qua non of this disease, a stereotype of abnormalities usually

not

seen in conditions other than HAD.

Incidentally, HAD does not occur exclusively in women. It happens in

men

in cases associated with ruptured pectoralis and testicular implants

[and facial implants].

Laboratory reports show a variety of abnormalities not unique to HAD

but

occurring in other autoimmune conditions.

All of the abnormalities probably reflect diffuse rather than focal

activation of the immune system. The ANA, rheumatoid factors,

positive

antibodies against human antigens, the antibodies against the major

ganglioside in the central nervous system, anti-GM, antibodies,

myelin

associated glycoprotein antibodies (anti-MAG), antisulfatide, and

anti-beta-tubulin antibodies do not mean the patient has lupus or

rheumatoid arthritis or the other relatively specific diseases

associated with those positive blood tests, and certainly do not mean

those diseases are present in the absence of clinical disease.

They are immune markers suggesting immune system activation by the

foreign material. Other tests show what organ systems are adversely

affected by the immune activation and by how much. So, when

indicated,

MRI, SPECT scan, EMG, and so forth can help define the extent of'

damage

already present in an individual patient and can help organize the

approach to treatment.

DIFFERENCES

Patients with HAD differ from other patients in a variety of ways,

including the obvious presence of foreign material in their bodies

and

also in the multiplicity of signs and symptoms. They usually have at

least 20 complaints and commonly circle over 50 percent of the lists

of

common symptoms of disease. Other patients who do not have HAD have a

much more circumscribed list of complaints. The large number of

complaints in HAD makes sense if one considers the disease is likely

due

to a diffuse activation of the immune system and not a circumscribed

focal activation of one part of the immune system. If the immune

system

is diffusely and globally activated, then there should be diffuse and

global complaints referable to virtually every level of the nervous

system, to the muscles and nerves, connective tissue, blood vessels,

and

skin.

DEGREE

As the severity of local problems increases, the systemic problems do

too, especially if the implant has ruptured or if the immunogenic

foreign material directly contacts the immune system by regional or

systemic spread. The presence of different time courses and clinical

degrees of affliction associated with different foreign materials

strongly suggests that the foreign material plays an etiological role

and may actually cause the disease.

With silicone gel implants, six years usually elapse from the time of

implantation to development of first systemic symptoms; silicone

implants surrounded by polyurethane have a shorter latency. Taken

together, the similarity of disease among patients exposed to the

same

agent, the differences that the induced disease bears to other

naturally

occurring diseases, and the fact that degrees of adversity depend on

degrees of exposure, as well as the time-linked nature of the

exposure

to the subsequent development of the disease, all argue that the

agents

named actually cause the condition.

RELATIONSHIP

The topic of relationship divides into three parts: cause and effect,

antecedent and consequent, and contraries and contradictories.

CAUSE AND EFFECT

To assign a cause and make it stick requires four elements. The cause

must be sufficient to produce the effect; it must be the most likely

among several possible causes; conditions must not inhibit the cause

from exerting its effect; and the cause must invariably produce the

effect. In the muddy waters of statecraft, real-life situations, the

legal arena, and medicine " invariably " has given way to " more likely

than not " or " with a reasonable degree of medical certainty. " In HAD,

all four elements apply to foreign materials that are associated with

local complications, such as the rupture of an implant and spill of

free

silicone into tissue. The rupture of the implant alone is sufficient

to

produce the spill of silicone into tissue and to provoke a local

inflammatory reaction.

Systemic complications require no small degree of circumspection, and

cases must be considered individually. It is not enough to show that

the

disease followed implantation. These things considered, most people

will

associate a ruptured implant with the systemic disease that follows,

because most individual cases have strong evidence for unique

activation

of the immune system.

ANTECEDENT AND CONSEQUENT

This less rigorous form of' cause and effect argument generally

applies

to implants and can be reduced to a rephrased syllogism:

(1) Foreign materials produce local and systemic reactions;

(2) an implant is a foreign material; therefore,

(3) an implant causes local and systemic reactions. Whether the

implant

has in fact done so in an individual case depends on the individual

evidence adduced.

One can make the same argument for the causation of systemic

complications.

Either implants cause systemic complications or they don't.

Silicone directly injected into tissue causes local and systemic

reactions; therefore, silicone indirectly injected into tissue after

a

silicone implant ruptures causes local and systemic complications.

Hence, if the implant has been associated with Sjogren's syndrome,

Raynaud's phenomena, scleroderma, memory loss, muscle weakness, and

what

have you in individual cases, then a patient who exhibits all of

those

afflictions can have a possible complication too.

--PATTEN,B.M. and OSTERMEYER SHOAIB, B. (1995).

This article has been condensed from the original publication.

Note- Intact silicone implants have also been associated with Human

Adjuvant

Disease. These devices do not have to rupture to elicit an autoimmune

response.

Certainly, patients with ruptured implants are more likely to

develop a

systemic disease than those without a rupture.

© 2004,Human Adjuvant Disease Corp.

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