R. Shanklin M.D. Departments of Pathology, Obstetrics, Gynecology - from the evidentiary files of breast implant litigation

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DCC017003147

R. Shanklin, M.D.

Departments of Pathology and Obstetrics and Gynecology

University of Tennessee, Memphis

Definition

The natural history of a disease includes the events,

agents, body defenses, modalities, and organisms which

lead to the presence of the lesions of and the

manifestations of that disease in living things,

including human beings. Lesions are those changes in

the various tissues which are the markers of the

disease and which, by their very presence, reduce or

interfere with the function of that tissue or organ,

leading to the clinical manifestations of the disease

in question. Lesions can be overt structural changes,

such as a tumor of the liver, or errors in enzymes

secreted by the stomach, or changes in any of the

thousands of chemical molecules found in biological

systems. One of the most fundamental lesions is found

in the human defensive system known variously as the

reticulo-endothelial system, the macrophage system, or

the immunological tissues.

The macrophage system

Unlike specified organs such as brain, liver, or

stomach, this system is dispersed throughout the body,

incorporating such tissues as the thymus,lymph nodes

(comparable lymphoid structures are found in many

other organs), spleen, and bone marrow. The essential

role of the immunological system is to produce protein

substances which then recognize other substances

foreign to the normal economy of the body.

The first step in this process is cellular.

Macrophages, large wandering cells from the immune

system, attack and engulf foreign material, beginning

the process of production of these proteins, known as

antibodies. The steps of immunologic processing are

complex. Basically, other cells, known as lymphocytes,

become programmed to react to specific antigens (the

active part of the foreign material). There are other

aspects of this body defense system which respond to

living organisms such as bacteria or to foci of dead

tissue within an organ; this is called the acute

inflammatory reaction. The acute reaction often

dominates in the early hours or days after a foreign

substance enters the body (e.g., a dirty splinter in

one's hand); nevertheless, the immune processing

system is called into action as well. Most

immunological mechanisms require weeks to months to

reach fulfillment.

The Elemental Basis of Human Biology

Biological beings, including humans, are based on

carbon biochemistry and carbon structural substances.

Carbon is the sixth element in the periodic table with

an approximate atomic weight of 12; silicon is the

14th element with an approximate atomic weight of 28.

Of interest is the fact that both are members of

atomic class 4-A (carbon is the first member, silicon

is the second), a group which is unlike most other

groups of atoms in that each member is very different

from the others with respect to physical and chemical

properties. Carbon, the most versatile of the atomic

elements, accounts for only about 0.2% of the earth's

crust by weight but 94% of all known compounds,

numbering about 4 million in all. Free carbon is found

in nature.

Silicon

Silicon, the element, is important to some living

organisms. Deep sea diatoms extract silica from sea

water, using the material to strengthen their cell

walls. Some silica is found in plants and in

vertebrate bones, including human bones. Silicon is

widely found in the universe and accounts for about

25% of the crust of the earth. It is the second most

abundant element, next to oxygen. Silicon has not been

found free in nature. It appears as silicon dioxide in

such forms as sand, quartz, and rock crystal, or as

silicates in forms as granite, asbestos, clay, and

mica. It is a relatively inert element with a valence

(combining attribute) of four subject to interaction

with halogens (chlorine, fluorine, etc.) and dilute

alkalis (bleaches, lye, etc.). The semiconductor role

of silicon in the electronic and computer industries

is well known. Talc is a complex hydrated magnesium

silicate; it is a soft mineral with a soapy feel, and

is widely used in industry and commerce. Corborundum,

silicon carbide, is amongst the hardest of substances,

and is a well known abrasive.

Silicones

Silicones are not biological or natural substances.

They are complex molecules with silicon as their base,

even though some carbon is present in the polymer.

Silicones are complex polymers of organosilicone

chlorides, made from dimethylsilyl chloride. They have

a wide range of physical properties depending on the

polymer length, side chains, and viscosity.

The silicones are the basis for certain medical

replacement implants used as lenses in the eye, for

small joint surfaces, to replace deviated nasal

septums, to enhance contours of skin (e.g., after

facial trauma), and most recently and widely, as

mammary replacement or enhancement prostheses. It has

been estimated that over 2,000,000 American women have

had mammary prosthesis insertions. The number used per

year since their introduction in the 1960s has not

been released to the medical profession - or the

public at large so that the trend of future

complications remains unpredictable.

Polyurethane foam

Polyurethanes are an entirely different class of

complex molecules. They are mentioned here only

because some mammary implants are coated with a foam

made of polyurethane, a complex polymer containing

carbon and nitrogen, but no silicon. Two of the

breakdown products of polyurethane, 2,4 -

diaminotoluene and 2,4 - dinitrotoluene, are well

known as carcinogens (cancer producing agents) and

have been banned from cosmetic products for that

reason.

The natural history of silicone associated diseases

Early infection is actually uncommon after mammary

silicone prosthetic placement, and is usually due to

surgical error. Large scale reports come mostly from

the use of silastic materials in joints; infection is

a minor risk, except for the person who develops it.

The first signs and symptoms of silicone reaction

often occurs three to twelve months after

implantation. This consists morbilliform

(measles-like) skin rashes, often migratory,

unexplained fever, weakness, and in some women,

swelling in the axilla (arm pit). Shooting pain down

the arms is more common at this time than elsewhere in

the body. The breast(s) may feel hard, even

hypersensitive. In a few women, small nodules may

appear under the skin (for physicians, this is

somewhat like a Weber-Christian syndrome). While these

are most likely across the upper trunk, upper arms, or

in the lower neck? they may appear on the abdomen.

These are most likely early silicone granulomas but

biopsies have not been reported so far. These acute

events usually subside.

Experience has indicated that when silicone mammary

prostheses are removed at this stage, many women

experience a progressive reduction in their symptoms

and signs.

Further progress in the disease takes several

pathways. One is local with he development of heavy

fibrous capsules about the implants. The laying own of

such scar tissue is a natural aspect of body defense,

but it is also he first phase of immunologic

processing. All silicone prostheses bleed or leak some

material into the surrounding tissue. Saline filled

implants still have a silicone envelope in direct

contact with living tissue. Silicone associated

disease does occur in such women and it can be just as

severe. The relative risk is not known with any

certainty, due to lack of published detailed surveys

of complications. Attempts to break the dense scar by

what is referred to as " closed capsulotomy " can

rupture the prosthesis, apparently more easily than

trying to break one held in the hand. This clearly

leads to the bulk spread of silicone into the body

along various lanes of tissue. It may be that several

months to years of exposure to body fluid weakens the

envelope but it is also true that the scar more

effectively " holds " the implant than one can in the

hands, focusing the force toward the weakest part of

the envelope.

Surgical tears on the implant have occurred at time of

insertion, weakening the envelope with delayed

rupture. Either of these circumstances puts the woman

in the same situation as those that received silicone

by injection, larger amounts of foreign silicone in

direct contact with the macrophage system. Silicone is

taken up by macrophages, usually as very small

droplets. Since these are normally wandering cells,

some will pass to other sites in the body. Low

viscosity silicones diffuse independently of this

mechanism, and this may well account or excretion of

small amounts in urine or stool.

This local reaction often produces deformity of the

breast, leading to additional surgery. Each such added

surgical procedure carries the further risk of any of

the complications known to follow cutting into the

skin and manipulating the soft tissues of the chest.

The original scar alters the blood supply to the area,

and hematoma seems to be more common after secondary

procedures. Once again, precise figures are unknown

due to lack of large scale reports. In the compiler's

current records, one woman had 15 different operations

on one or both breasts, with several replacements of

implants (the maximum in this database so far is six)

and multiple revisions of form.

The systemic reactions are numerous. The most common

so far is a form of rheumatoid arthritis which has

been debilitating to an advanced degree, with shoulder

involvement more prominent than hip or knee although

all forms have occurred. Laboratory tests for

rheumatoid

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