Various studies on capsules from implants

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ANALYSIS OF SILICONE LEVELS IN CAPSULES OF GEL

AND

SALINE BREAST IMPLANTS AND PENILE

PROSTHESES

Authors: s W.; D.; Lugowski S.; McHugh A.; Keresteci A.;

Baines C.

Address: Division of Plastic Surgery, Wellesley Hospital, Toronto,

Ontario,

Canada.

Source: ls Plastic Surgery, June, 1995, 34:6, 578-

84

Abstract: Although a potential link between silicone-gel breast

implants and

autoimmune connective tissue disease has been suggested, none has

been proven.

The potential role of silicone as an immune adjuvant remains very

controversial. Currently available techniques do not allow precise

measurements of silicone in tissues. However, all compounds

containing silicon

(including silicone) can be measured

accurately.

The present study was designed to measure silicon levels in the

fibrous

capsules of patients with silicone-gel breast implants, saline

breast

implants, and silicone inflatable penile prostheses. Baseline

control silicon

levels were obtained from the breast tissue of patients undergoing

breast

reduction, who had no exposure to breast implants. All silicon

measurements

were carried out using atomic absorption spectrometry with a

graphite furnace.

Silicon was measured in a normal heptane extract of silicone from

dried

tissue.

The mean silicon levels in 16 breast tissue control samples from 8

patients

undergoing breast reduction varied from 0.025 to 0.742

micrograms/gm with the

median mean being 0.0927. The median silicon level in capsules from

six

patients with saline implants was 7.7 micrograms/gm (range; 1.9-

36.6

micrograms/gm; averages 8,300% or 83 times more than those without

a silicone

implant). The median silicon level in capsules from five

patients with

silicone inflatable penile prostheses was 19.5 micrograms/gm

(range; 1.9-34.8

micrograms/gm; .0927 divided by 19.5 = 21,000% more than those

without any

type silicone implant). Although the levels of silicon in capsules

of patients

with saline breast prostheses and penile implants were higher than

in control

samples, they were much lower than those from the capsules of the

58 gel

implants (median; 9,979 micrograms/gm; range, 371-152,000

micrograms/gm;

almost 108,000 times as much silicone in capsules Vs those without

any type

silicone implant).

BREAST CAPSULE PERSISTENCE AFTER

BREAST IMPLANT REMOVAL

Authors: W. Bradford Rockwell, M.D., Holly D. Casey, M.D., and

A.

Cheng, M.D., Salt Lake City,

Utah

Source: Plastic and Reconstructive Surgery Journal, 101: 1085,

1998

Breast implant capsules are a foreign body immune response to breast

implants.

It has been proposed that capsulectomy after breast implant removal

was

unnecessary, as the body resorbs the capsule when the implant, the

impetus for

the foreign body response, is removed. We report eight women with

persistent

capsules 10 months to 17 years after silicone breast implant

removal.

COMPLICATIONS RELATED TO RETAINED

BREAST IMPLANT CAPSULES

Author: Hardt, N. S.; Yu, L.; LaTorre, G.; Steinbach,

B.

Address: Dept. Pathology, University of Florida College of Medicine,

Gainesville,

FL.

Source: Plastic and Reconstructive Surgery Journal, Feb., 1995,

95:2, 364-71

Abstract: Citing evidence that breast implant-related capsules

resolve

uneventfully, surgeons have elected to leave the capsules in place

when

implants are removed because capsulectomy adds both morbidity and

expense to

the procedure. However, recent clinical and histopathologic

evidence suggests

that uneventful resolution is not always the case, and several

potential

problems may arise from retained capsules after removal of the

implant.

Retained implant capsules may result in a spiculated mass suspicious

for

carcinoma, dense calcifications that obscure neighboring breast

tissue on

subsequent imaging studies, and cystic masses due to persistent

serous

effusion, expansile hematoma, or encapsulated silicone filled

cysts.

Furthermore, retained capsules are a reservoir of implant-related

foreign

material in the case of silicone gel-filled implants and textured

implants

promoting tissue ingrowth. To avoid complications from retained

capsules,

total capsulectomy or postoperative surveillance should be offered

to

patients.

LETTER BY DR. SHANKLIN TO AN INSURANCE COMPANY REGARDING NECESSITY

OF A TOTAL

CAPSULECTOMY

September 16, 1996

To Whom It May

Concern:

This communication is prompted by a form letter received by one

of my

patients from Florida which advised her that silicone implant

removal would be

covered as medically necessary but not device capsulectomy. It has

been said,

if you stay in medical practice long enough, just about everything

will occur:

in this case, a health insurer unbundling their own coverage!

(Letter Dated

August ,1995 from Aetna says, " Based on a review of the submitted

data, we are

unable to allow benefits for bilateral capsulectomies. Charges for

removal of

silicone gel-filled implants are covered when medically necessary. "

Hopefully,

my suit has cured them of this! The interesting part starts; read

on!):

Let me start with the last sentence of the letter, an attribution

of the

American College of Rheumatology (from Aetna's letter; " The

American College

of Rheumatology advises there is no evidence to support an

association between

systemic disease and the implants. " ) A statement was made to that

effect at

their annual meeting in San Francisco last October but it was not a

policy

statement. It was an unauthorized press release by the outgoing

president

which has since been retracted. In addition, the special study

group of the

ACR for silicone diseases is now ready to report. We are told

criteria have

been developed which permit a differential diagnosis of silicone

disease

(Siliconosis) from other connective tissue

diseases.

There is a remarkably large body of medical and scientific

literature on

these matters which emphatically shows the capsule is the site of

the illness.

It is one thing to debunk the patient of silicone load by

explantation but

unless the capsules come out at the same time the immunopathic

process will

continue unabated. The standard is not whether something is usual

our

customary, but whether it is the correct and logical thing to

do.

Please reexamine your policy on this matter. In the long run, the

better

health of these patients will be well served by doing the right

thing:

explantation with capsulectomy, a continuous and coherent procedure

appropriate to the underlying pathology. A rational policy of this

sort will

also serve the financial fiduciary requirements of your firm over

time. Such

has been the experience of this

clinic.

Sincerely Yours,

DOUGLAS R. SHANKLIN, M. D.,

F.R.S.M.

Professor of Pathology and

of

Obstetrics and

Gynecology

Dr. Shanklin: 1-901-227-

7695

YEAH FOR DR. SHANKLIN!

RESIDUAL CAPSULE AND INTERCAPSULAR DEBRIS

AS LONG-TERM RISK FACTORS

By: Dr. Pierre Blais, PhD

Contamination of the space between the capsule and the

implants by

micro- organisms, silicone oils, degradation products and gel

impurities

constitutes a major problem which potentates the risk of implants.

Such

problems include inflammation, infection, deposition of mineral

debris, as

well as certain autoimmune phenomena. These problems can be

present when

implants are in situ (in the body) and are often attributable to

the implant.

The logical expectation is that, upon removal of the implants,

adverse

effects will cease. This is an unjustifiably optimistic view. It

is well

documented from case histories that removal and or replacement of

implants

without exhaustive debridement of the prosthetic site leads to

failure and

post surgical

complications.

Plastic surgery procedure lead to favor speed and immediate

cosmetic

results. For these reasons, leaving or " reusing " tissue from an

existing

capsule may seem more " gratifying " . However, adverse effects

resulting from

the practice are widespread but have not been well documented.

Typically,

patients who require removal of faulty implants and undergo

immediate re-

implantation in the same prosthetic site habitually relapse with

the same

problem which motivated the previous surgery; the most common

example is

exchange of implants and/or sectorizing or bisecting the capsule

without

removing it

completely.

Such patients rarely achieve a significant capsular

correction and

habitually return for more similar surgery. A more illustrative

situation is

that where patients do not receive replacement implants. They form

the basis

of knowledge for evaluating the risks that arise from remaining

capsules. An

example is described in a paper published in 1993 (Copeland, M.,

Kessel, A.,

Spiera, H., Hermann, G., Bleiweiss, I. J.; Systemic Inflammatory

Disorder

Related To Fibrous Breast Capsules After Silicone Implant Removal;

Plastic

and Reconstructive Surgery: 92 (6), 1179-1181, 1993): reported

problems

derived primarily from immune phenomena and inflammatory syndromes

with pain,

swelling, serologic abnormalities and alarming radiologic

presentation.

Numerous similar cases have been noted amongst implant

patients but

have not been the object of publications. Some are cited in FDA

Reaction

Reports. Others appear in the US Pharmacopoeia Reporting

Programs.

A residual capsule is not a stable entity. It may collapse

upon

completion of surgery and remain asymptomatic for some time,

however, it will

fill with extracellular fluid and remain as a fluid-filled space

with added

blood and prosthetic debris. As the wall matures and the breast

remodels to

accommodate the loss of the prostheses, the capsular tissue

shrinks. Water as

well as electrolytes are expelled gradually from the pocket or else

the

mixture is concentrated from leakage of water from the semi-

permeable capsular

membrane

wall.

In most cases, calcium salts precipitate during that stage and

may render the

capsule visible as a radiodense and speckled zone in radiographic

projections.

Prosthetic debris is also radiodense and may be imaged to further

complicate

the presentation. The average size of the residual capsules after

6-12 months

is in the 2-7 cm range: most are compact, comparatively small and

dense.

Surgical removal should present no difficulty for most patients if

adequate

radiographic information is

available.

Later stages of maturation include the thickening of the

capsule wall,

sometimes reaching 0.5-1cm. Compression of the debris into a

cluster of

nodules which actually become calcifies follows for some patients.

A few

mimic malignancies. Others appear as small " prostheses " during

mammographic

studies. They are alarming to oncologists and are habitually

signaled for

further studies or biopsies by oncologic

radiologists.

In light of the present knowledge and considering the

probable content

of the residual closed capsules, an open or needle biopsy is not

advisable.

The risks of releasing significant amounts of hazardous

contamination and

possibly spreading infective entities outweighs the advantage of

the

diagnostic. At any rate, such a capsule requires removal for

mitigation of

symptoms and a more direct surgical approach appears more

economical and less

risky.

In summary, a capsule with a dense fibro-collagenous wall

behaves as a

bioreactor. Worse yet, it is fitted with a semi-permeable wall

that may

periodically open to release its content to the breast. The

probability of

finding the space colonized with atypical microorganisms is

elevated and the

control of infective processes by classic pharmacologic approaches

is

difficult if not

impossible.

Such closed capsular spaces may be comparable to " artificial

organs "

of unpredictable functions. Their behavior will depend on the

content and the

age of the structure, its maturity and the history of the patient.

There is a

high probability that these capsules will continue to evolve for

many years,

adding more layers of fibro-collagenous tissue and possibly

granulomatous

material. If bacterial entities are present within the capsule

space, they

can culminate in large breast abscesses

with

will resist conservative

treatments.

Even with less active capsules containing mostly oily and

calcitic

debris, the thickening of the wall leads eventually to solid " tumor-

like

structures " and are, by themselves, alarming on auscultation and

self

examination. At best, such structures are unique environments for

protein

denaturation and aberrant biochemical reactions with unknown long

term

consequences.

Pierre Blais,

PhD

Innoval, 496 Westminster Ave., Ottawa, Ontario, Canada KeA

2V1

613.728-8688, Fax: 613.728-

0687

Pierre Blais, PhD received his undergraduate and graduate degrees in

physical-

organic polymer chemistry from McGill University in Montreal,

Canada, and a

Postdoctorate Fellowship in biomaterials engineering at Case

Western

University in Cleveland, Ohio. In 1976 he became one of the first

scientists

to join the medical devices and radiological health program of the

Department

of Health and Welfare in Canada. He left the department in 1989 as

Senior

Scientific Advisor and formed Innoval Consultants, a firm engaged

in the

design, testing and failure analysis of high risk medical systems.

He has

authored over 250 publications on medical materials and their

interactions

with living tissues.

SPECTRUM OF HISTOLOGICAL CHANGES REACTIVE TO PROSTHETIC BREAST

IMPLANTS: A

CLINOPATHOLOGICAL STUDY OF 84 PATIENTS

Author: Yeoh G; P; E

Address: Hampson Pathology, Westmead, NSW.

Source: Pathology, August, 1996, 28:3, 232-

5

Abstract: A wide range of host reactions can be produced in response

to

prosthetic breast implants. Although the spectrum of histological

changes is

well described in the literature, the chronology and relative

occurrence of

these changes are not well documented. Examination of 161

capsulectomy

specimens from 84 women suggested the following chronological

sequence of

tissue response: fibrous scar tissue; histiocyte response; foreign

body giant

cell reaction to extruded or exposed material including

polyurethane and

Dacron patch; synovial-like metaplasia; and

calcification.

Fibrous scar tissue was seen in all implants. Histiocytic

response was noted

in 107/161 of the specimens and a foreign body giant cell reaction

to

polyurethane was seen only in the two Meme implants. Synovial-like

metaplasia

was less common than previously reported, occurring in 45/161 of

specimens

after a mean in situ duration of 11.7 years. This peculiar process

was seen

only in association with a prominent histiocytic response and was

not

associated with calcification. Dystrophic calcification, which has

been

reported as occurring rarely in implant capsules, was seen in

15/161 of our

specimens after a mean in situ duration of 17.7

years.

PATHOLOGICAL AND BIOPHYSCIAL FINDINGS ASSOCIATED WITH SILICONE

BREAST

IMPLANTS: A STUDY OF CAPSULAR TISSUES FROM 86

CASES

Author: Luke JL; Kalasinsky VF; Turnicky RP; Centeno JA; FB;

Mullick

FG

Address: Department of Environmental and Toxicologic Pathology,

Armed Forces

Institute of Pathology, Washington, D.C. 20306-6000,

USA.

Source: Plast Reconstr Surg, November, 1997, 100:6, 1558-

65

Abstract: Breast implant capsular tissues from 86 cases were studied

to

characterize the relationship between capsular findings and the

type of

implant used. Tissues were examined by light microscopy,

immunohistochemistry,

scanning electron microscopy/energy dispersive x-ray analysis and

Fourier

transform infrared, and Raman microspectroscopy. Capsular pathology

was

influenced by the structure and composition of the

implant.

A pseudoepithelium at the inner capsular surface (synovial

metaplasia) was

noted with silicone gel-filled, saline-filled, and polyurethane-

coated

implants, and disproportionately with textured surface implants.

Immunohistochemical studies of pseudoepithelium supported a

macrophage/histiocyte cellular origin. Talc was identified

intracellularly

within macrophages in 42 cases. Capsular calcification was strongly

associated

with the presence of implant stabilization patch material. Infrared

spectra

were used to identify silicone, talc, Dacron, and two different

types of

polyurethane in capsular tissues. Micropapillary structures

identified at the

pseudoepithelial surface have, to the authors' knowledge, not been

previously

described.

PHYSIOLOGIC AND PATHOLOGIC PATTERNS OF REACTION TO SILICONE BREAST

IMPLANTS

Author: Friemann J; Bauer M; Golz B; Rombeck N; Höhr D; Erbs G;

Steinau HU;

Olbrisch RR

Address: Abteilung fÂur Umweltpathologie des Medizinischen Instituts

fÂur

Umwelthygiene, Heinrich-Heine-UniversitÂat

DÂusseldorf.

Source: Zentralbl Chir, 1997, 122:7, 551-64

Abstract: Local morphological reaction patterns on breast implants

can be of

high significance as possible starting point for controversely

discussed

systemic immune response triggered by silicon or silicone.

Therefore, the

collagenous capsules of 149 explanted mammoplasty prostheses were

examined

macroscopically, under a scanning electron microscope and light-

microscopically using antibodies to the macrophage antigen CD68,

vimentin,

muscle actin, and the proliferation antigen MIB1, and were then

correlated

with anamnestic data (implanted type of prosthesis, indication for

im- or

explantation). According to our examinations, the in-vivo

durability of the

prostheses' shells is considerably decreasing with the expansion of

their

surfaces.

Regardless of the type of the prostheses' surface regularly a

chronic-

proliferating inflammation pattern could be identified in the

periprosthetic

capsulectomy specimens starting with a synovial metaplasia of

proliferating

CD-68-negative and vimentin-positive mesenchymal cells in the area

surrounding

the implants and ending by its transformation into a stage of dense

hyaline

collagenous fibrous tissue after an advanced implantation period (>

2 years).

By this, the texturing of the prosthesis surface modifies only the

course, but

not the quality of the chronically fibrosing inflammation. Bleeding

of

prosthesis as well as the incorporation of the polyurethane-foam

coating of

different prosthesis types into the periprosthetic breast capsule

lead to a

significant lymphoplasmacytic infiltration, partly with

participation of local

vessels as defined in a " silicone vasculitis " .

Morphological signs of an at least local immune response are

detectable in

8.3% of the examined fibrotic capsules even without a

morphologically

identifiable foreign-body embedding. They can be possibly referred

to- as well

as the complete absence of hyaline collagenous fibrous tissue in

30% of the

cases-a yet not causally clarified, inter-individually different

susceptibility of the implant bearers. Only the systematic

registration of the

above-mentioned morphological reaction patterns in a " prosthesis-

passport "

together with the additional clinical observation of the patients

can ensure

in future the realistic estimation of potential health risks caused

by

silicone breast implants.

HISTOLOGIC FEATURES OF BREAST CAPSULES REFLECT SURFACE CONFIGURATION

AND

COMPOSITION OF SILICONE BAG IMPLANTS

Author: Kasper CS

Address: Baylor University Medical Center, Department of Pathology,

Dallas,

Texas.

Source: Am J Clin Pathol, November, 1994, 102:5, 655-9

Abstract: The fibrous capsules that develop around silicone gel

breast

implants may become excessively thickened and result in painful

hardened

breasts. This article examines the microscopic anatomy of 80

periprosthetic

breast capsules removed during a 2-year period (1990-1992), and

describes the

histopathologic characteristics of capsules adjacent to the more

recently

modified implant types. Capsules were examined by routine light

microscopy,

with and without polarization. Several distinctive histologic

patterns were

recognized, and these unique patterns could be correlated with the

implant

type used.

All capsules were lined by a cellular membrane resembling

synovium. Capsules

adjacent to smooth-surfaced implants were lined by an intact

histiocytic

membrane of uniform thickness. In contrast, the membrane adjacent

to textured

implants varied in thickness, and was disrupted along its length.

In addition,

the inner surface of capsules adjacent to textured implants was

conspicuously

festooned with small (.25 to .5 mm) knob-like projections that were

not seen

in capsules adjacent to smooth-surfaced implants. A variety of

foreign

materials also were observed either within or adjacent to the

capsules, and

included droplets of liquid silicone, irregular solid fragments of

the bag

envelope, geometric crystalline fragments of polyurethane, and

talc. Thus, the

microanatomic features of periprosthetic breast capsules reflect

the

composition and surface configuration of the corresponding silicone

bag type.

CAPSULE QUALITY SALINE-FILLED SMOOTH SILICONE, TEXTURED SILICONE,

AND

POLYURETHANE IMPLANT SIN RABBITS: A LONG-TERM STUDY

Author: Bucky LP; Ehrlich HP; Sohoni S; May JW Jr

Address: Massachusetts General Hospital, Boston.

Source: Plast Reconstr Surg, May, 1994, 93:6, 1123-31; discussion

1132-3

Abstract: Recently, there have been many new designs in both the

surface

texture and chemical composition of breast implants that claim

reduced

constrictive capsular formation. The purpose of this study was to

utilize a

quantitative method to determine the firmness of capsules formed

around

saline-filled smooth silicone, textured silicone, and polyurethane

implants in

an experimental rabbit model 1 year after implantation. Our

objective was to

analyze the histologic, biologic, and biochemical content of the

respective

capsules to account for any differences in physical behavior. Forty-

five

smooth silicone, textured silicone, and polyurethane implants were

placed in

one of three positions beneath the panniculus carnosus muscle of

New Zealand

White rabbits.

After 1 year, all capsules were palpated and classified according

to

firmness. Intracapsular static and dynamic pressure measurements

were obtained

by placing a pressure monitor (Stryker) in an injector port

attached to the

individual implants. Capsular firmness was significantly greater in

the

textured silicone implants than in the smooth silicone or

polyurethane

implants after 1 year. The dynamic qualities of the periprosthetic

soft

tissues were measured while saline was injected into the

implants.

The capsules around the textured silicone implants generated

significantly

higher pressures than the smooth silicone or polyurethane

counterparts. The

capsules around the polyurethane implants were the softest and most

compliant

in all categories. Histologically, there is a significant

inflammatory

response surrounding the textured silicone implants that does not

exist in the

capsules around the smooth silicone implants. The capsules around

the

polyurethane implants have the least fibrous tissue deposition.

There is a

decrease in the proportion of type III collagen in the capsules

around the

textured silicone implants versus smooth silicone or polyurethane

implants.

The in vitro contraction patterns of the fibroblast-populated

collagen

lattices do not reveal the contraction differences observed in vivo

in

rabbits. However, there are many components that determine

contractility. This

area deserves further investigation.

[Guest guest]

ANALYSIS OF SILICONE LEVELS IN CAPSULES OF GEL AND SALINE BREAST IMPLANTS AND PENILE PROSTHESES Authors: s W.; D.; Lugowski S.; McHugh A.; Keresteci A.; Baines C. Address: Division of Plastic Surgery, Wellesley Hospital, Toronto, Ontario, Canada. Source: ls Plastic Surgery, June, 1995, 34:6, 578- 84 Abstract: Although a potential link between silicone-gel breast implants and autoimmune connective tissue disease has been suggested, none has been proven. The potential role of silicone as an immune adjuvant remains very controversial. Currently available techniques do not allow precise measurements of silicone in tissues. However, all compounds containing silicon (including silicone) can be measured

accurately. The present study was designed to measure silicon levels in the fibrous capsules of patients with silicone-gel breast implants, saline breast implants, and silicone inflatable penile prostheses. Baseline control silicon levels were obtained from the breast tissue of patients undergoing breast reduction, who had no exposure to breast implants. All silicon measurements were carried out using atomic absorption spectrometry with a graphite furnace. Silicon was measured in a normal heptane extract of silicone from dried tissue. The mean silicon levels in 16 breast tissue control samples from 8 patients undergoing breast reduction varied from 0.025 to 0.742 micrograms/gm with the median mean being 0.0927. The median silicon level in capsules from six patients with saline implants was 7.7 micrograms/gm (range; 1.9- 36.6 micrograms/gm; averages 8,300% or 83 times more than those without a silicone implant). The median silicon level in capsules from five patients with silicone inflatable penile prostheses was 19.5 micrograms/gm (range; 1.9-34.8 micrograms/gm; .0927 divided by 19.5 = 21,000% more than those

without any type silicone implant). Although the levels of silicon in capsules of patients with saline breast prostheses and penile implants were higher than in control samples, they were much lower than those from the capsules of the 58 gel implants (median; 9,979 micrograms/gm; range, 371-152,000 micrograms/gm; almost 108,000 times as much silicone in capsules Vs those without any type silicone implant). BREAST CAPSULE PERSISTENCE AFTER BREAST IMPLANT REMOVAL Authors: W. Bradford Rockwell, M.D., Holly D. Casey, M.D., and A. Cheng, M.D., Salt Lake City,

Utah Source: Plastic and Reconstructive Surgery Journal, 101: 1085, 1998 Breast implant capsules are a foreign body immune response to breast implants. It has been proposed that capsulectomy after breast implant removal was unnecessary, as the body resorbs the capsule when the implant, the impetus for the foreign body response, is removed. We report eight women with persistent capsules 10 months to 17 years after silicone breast implant removal. COMPLICATIONS RELATED TO RETAINED BREAST

IMPLANT CAPSULES Author: Hardt, N. S.; Yu, L.; LaTorre, G.; Steinbach, B. Address: Dept. Pathology, University of Florida College of Medicine, Gainesville, FL. Source: Plastic and Reconstructive Surgery Journal, Feb., 1995, 95:2, 364-71 Abstract: Citing evidence that breast implant-related capsules resolve uneventfully, surgeons have elected to leave the capsules in place when implants are removed because capsulectomy adds

both morbidity and expense to the procedure. However, recent clinical and histopathologic evidence suggests that uneventful resolution is not always the case, and several potential problems may arise from retained capsules after removal of the implant. Retained implant capsules may result in a spiculated mass suspicious for carcinoma, dense calcifications that obscure neighboring breast tissue on subsequent imaging studies, and cystic masses due to persistent serous effusion, expansile hematoma, or encapsulated silicone filled cysts. Furthermore, retained capsules are a reservoir of implant-related foreign material in the case of silicone gel-filled implants and textured implants promoting tissue ingrowth. To avoid complications from retained capsules, total capsulectomy or postoperative surveillance should be

offered to patients. LETTER BY DR. SHANKLIN TO AN INSURANCE COMPANY REGARDING NECESSITY OF A TOTAL CAPSULECTOMY September 16, 1996 To Whom It May

Concern: This communication is prompted by a form letter received by one of my patients from Florida which advised her that silicone implant removal would be covered as medically necessary but not device capsulectomy. It has been said, if you stay in medical practice long enough, just about everything will occur: in this case, a health insurer unbundling their own coverage! (Letter Dated August ,1995 from Aetna says, "Based on a review of the submitted data, we are unable to allow benefits for bilateral capsulectomies. Charges for removal of silicone gel-filled implants are covered when

medically necessary." Hopefully, my suit has cured them of this! The interesting part starts; read on!): Let me start with the last sentence of the letter, an attribution of the American College of Rheumatology (from Aetna's letter; "The American College of Rheumatology advises there is no evidence to support an association between systemic disease and the implants.") A statement was made to that effect at their annual meeting in San Francisco last October but it was not a policy statement. It was an unauthorized press release by the outgoing president which has since been retracted. In addition, the special study group of the ACR for silicone diseases is now ready to report. We are told criteria have been developed which permit a differential diagnosis of silicone disease (Siliconosis) from other

connective tissue diseases. There is a remarkably large body of medical and scientific literature on these matters which emphatically shows the capsule is the site of the illness. It is one thing to debunk the patient of silicone load by explantation but unless the capsules come out at the same time the immunopathic process will continue unabated. The standard is not whether something is usual our customary, but whether it is the correct and logical thing to do. Please reexamine your policy on this matter. In the long run, the better health of these patients will be well served by doing the right thing: explantation with capsulectomy, a continuous and coherent procedure appropriate to the underlying pathology. A rational policy of this sort will also serve the financial fiduciary requirements of your firm over time. Such has been the experience of this clinic. Sincerely Yours, DOUGLAS R. SHANKLIN, M. D.,

F.R.S.M. Professor of Pathology and of Obstetrics and Gynecology Dr. Shanklin: 1-901-227-

7695 YEAH FOR DR. SHANKLIN! RESIDUAL CAPSULE AND INTERCAPSULAR DEBRIS AS LONG-TERM RISK FACTORS By: Dr. Pierre Blais, PhD Contamination of the space between the capsule and the implants by micro- organisms, silicone oils, degradation products and gel impurities constitutes a major problem

which potentates the risk of implants. Such problems include inflammation, infection, deposition of mineral debris, as well as certain autoimmune phenomena. These problems can be present when implants are in situ (in the body) and are often attributable to the implant. The logical expectation is that, upon removal of the implants, adverse effects will cease. This is an unjustifiably optimistic view. It is well documented from case histories that removal and or replacement of implants without exhaustive debridement of the prosthetic site leads to failure and post surgical

complications. Plastic surgery procedure lead to favor speed and immediate cosmetic results. For these reasons, leaving or "reusing" tissue from an existing capsule may seem more "gratifying". However, adverse effects resulting from the practice are widespread but have not been well documented. Typically, patients who require removal of faulty implants and undergo immediate re- implantation in the same prosthetic site habitually relapse with the same problem which motivated the previous surgery; the most common example is exchange of implants and/or sectorizing or bisecting the capsule without removing it completely. Such patients rarely achieve a significant capsular correction and habitually return for more similar surgery. A more illustrative situation is that where patients do not receive replacement implants. They form the basis of knowledge for evaluating the risks that arise from remaining capsules. An example is described in a paper published in 1993 (Copeland, M., Kessel, A., Spiera, H., Hermann, G., Bleiweiss, I. J.;

Systemic Inflammatory Disorder Related To Fibrous Breast Capsules After Silicone Implant Removal; Plastic and Reconstructive Surgery: 92 (6), 1179-1181, 1993): reported problems derived primarily from immune phenomena and inflammatory syndromes with pain, swelling, serologic abnormalities and alarming radiologic presentation. Numerous similar cases have been noted amongst implant patients but have not been the object of publications. Some are cited in FDA Reaction Reports. Others appear in the US Pharmacopoeia Reporting Programs. A residual capsule is not a stable entity. It may collapse upon completion of surgery and remain asymptomatic for some

time, however, it will fill with extracellular fluid and remain as a fluid-filled space with added blood and prosthetic debris. As the wall matures and the breast remodels to accommodate the loss of the prostheses, the capsular tissue shrinks. Water as well as electrolytes are expelled gradually from the pocket or else the mixture is concentrated from leakage of water from the semi- permeable capsular membrane wall. In most cases, calcium salts precipitate during that stage and may render the capsule visible as a radiodense and

speckled zone in radiographic projections. Prosthetic debris is also radiodense and may be imaged to further complicate the presentation. The average size of the residual capsules after 6-12 months is in the 2-7 cm range: most are compact, comparatively small and dense. Surgical removal should present no difficulty for most patients if adequate radiographic information is available. Later stages of maturation include the thickening of the capsule wall, sometimes reaching 0.5-1cm. Compression of the debris into a cluster of nodules which actually become calcifies follows for some

patients. A few mimic malignancies. Others appear as small "prostheses" during mammographic studies. They are alarming to oncologists and are habitually signaled for further studies or biopsies by oncologic radiologists. In light of the present knowledge and considering the probable content of the residual closed capsules, an open or needle biopsy is not advisable. The risks of releasing significant amounts of hazardous contamination and possibly spreading infective entities outweighs the advantage of the diagnostic. At any rate, such a capsule requires removal for mitigation of symptoms and a more direct surgical approach appears more economical and less

risky. In summary, a capsule with a dense fibro-collagenous wall behaves as a bioreactor. Worse yet, it is fitted with a semi-permeable wall that may periodically open to release its content to the breast. The probability of finding the space colonized with atypical microorganisms is elevated and the control of infective processes by classic pharmacologic approaches is difficult if not

impossible. Such closed capsular spaces may be comparable to "artificial organs" of unpredictable functions. Their behavior will depend on the content and the age of the structure, its maturity and the history of the patient. There is a high probability that these capsules will continue to evolve for many years, adding more layers of fibro-collagenous tissue and possibly granulomatous material. If bacterial entities are present within the capsule space, they can culminate in large breast abscesses

with will resist conservative treatments. Even with less active capsules containing mostly oily and calcitic debris, the thickening of the wall leads eventually to solid "tumor- like structures" and are, by themselves, alarming on auscultation and self examination. At best, such structures are unique environments for protein denaturation and aberrant biochemical reactions with unknown long term

consequences. Pierre Blais, PhD Innoval, 496 Westminster Ave., Ottawa, Ontario, Canada KeA 2V1 613.728-8688,

Fax: 613.728- 0687 Pierre Blais, PhD received his undergraduate and graduate degrees in physical- organic polymer chemistry from McGill University in Montreal, Canada, and a Postdoctorate Fellowship in biomaterials engineering at Case Western University in Cleveland, Ohio. In 1976 he became one of the first scientists to join the medical devices and radiological health program of the Department of Health and Welfare in Canada. He left the department in 1989 as Senior Scientific Advisor and formed Innoval Consultants, a firm engaged in the design, testing and failure analysis of high risk medical

systems. He has authored over 250 publications on medical materials and their interactions with living tissues. SPECTRUM OF HISTOLOGICAL CHANGES REACTIVE TO PROSTHETIC BREAST IMPLANTS: A CLINOPATHOLOGICAL STUDY OF 84 PATIENTS Author: Yeoh G; P; E Address: Hampson Pathology, Westmead, NSW. Source: Pathology, August,

1996, 28:3, 232- 5 Abstract: A wide range of host reactions can be produced in response to prosthetic breast implants. Although the spectrum of histological changes is well described in the literature, the chronology and relative occurrence of these changes are not well documented. Examination of 161 capsulectomy specimens from 84 women suggested the following chronological sequence of tissue response: fibrous scar tissue; histiocyte response; foreign body giant cell reaction to extruded or exposed material including polyurethane and Dacron patch; synovial-like metaplasia; and calcification.

Fibrous scar tissue was seen in all implants. Histiocytic response was noted in 107/161 of the specimens and a foreign body giant cell reaction to polyurethane was seen only in the two Meme implants. Synovial-like metaplasia was less common than previously reported, occurring in 45/161 of specimens after a mean in situ duration of 11.7 years. This peculiar process was seen only in association with a prominent histiocytic response and was not associated with calcification. Dystrophic calcification, which has been reported as occurring rarely in implant capsules, was seen in 15/161 of our specimens after a mean in situ duration of 17.7 years. PATHOLOGICAL AND BIOPHYSCIAL FINDINGS ASSOCIATED WITH SILICONE

BREAST IMPLANTS: A STUDY OF CAPSULAR TISSUES FROM 86 CASES Author: Luke JL; Kalasinsky VF; Turnicky RP; Centeno JA; FB; Mullick FG Address: Department of Environmental and Toxicologic Pathology, Armed Forces Institute of Pathology, Washington, D.C. 20306-6000, USA. Source: Plast Reconstr Surg, November, 1997, 100:6, 1558- 65 Abstract: Breast implant capsular tissues from 86 cases were studied to characterize the

relationship between capsular findings and the type of implant used. Tissues were examined by light microscopy, immunohistochemistry, scanning electron microscopy/energy dispersive x-ray analysis and Fourier transform infrared, and Raman microspectroscopy. Capsular pathology was influenced by the structure and composition of the implant. A pseudoepithelium at the inner capsular surface (synovial metaplasia) was noted with silicone gel-filled, saline-filled, and polyurethane- coated implants, and disproportionately with textured surface implants. Immunohistochemical studies of pseudoepithelium supported a macrophage/histiocyte cellular origin. Talc was identified intracellularly within macrophages in 42 cases. Capsular calcification was strongly

associated with the presence of implant stabilization patch material. Infrared spectra were used to identify silicone, talc, Dacron, and two different types of polyurethane in capsular tissues. Micropapillary structures identified at the pseudoepithelial surface have, to the authors' knowledge, not been previously described. PHYSIOLOGIC AND PATHOLOGIC PATTERNS OF REACTION TO SILICONE BREAST IMPLANTS Author: Friemann J; Bauer M; Golz B; Rombeck N; H�hr D; Erbs G; Steinau HU; Olbrisch RR Address: Abteilung f�ur Umweltpathologie des Medizinischen Instituts f�ur Umwelthygiene, Heinrich-Heine-Universit�at

D�usseldorf. Source: Zentralbl Chir, 1997, 122:7, 551-64 Abstract: Local morphological reaction patterns on breast implants can be of high significance as possible starting point for controversely discussed systemic immune response triggered by silicon or silicone. Therefore, the collagenous capsules of 149 explanted mammoplasty prostheses were examined macroscopically, under a scanning electron microscope and light- microscopically using antibodies to the macrophage antigen CD68, vimentin, muscle actin, and the proliferation antigen MIB1, and were then correlated with anamnestic data (implanted type of prosthesis, indication for im- or explantation). According to our examinations,

the in-vivo durability of the prostheses' shells is considerably decreasing with the expansion of their surfaces. Regardless of the type of the prostheses' surface regularly a chronic- proliferating inflammation pattern could be identified in the periprosthetic capsulectomy specimens starting with a synovial metaplasia of proliferating CD-68-negative and vimentin-positive mesenchymal cells in the area surrounding the implants and ending by its transformation into a stage of dense hyaline collagenous fibrous tissue after an advanced implantation period (> 2 years). By this, the texturing of the prosthesis surface modifies only the course, but not the quality of the chronically fibrosing inflammation. Bleeding of prosthesis as well as the

incorporation of the polyurethane-foam coating of different prosthesis types into the periprosthetic breast capsule lead to a significant lymphoplasmacytic infiltration, partly with participation of local vessels as defined in a "silicone vasculitis". Morphological signs of an at least local immune response are detectable in 8.3% of the examined fibrotic capsules even without a morphologically identifiable foreign-body embedding. They can be possibly referred to- as well as the complete absence of hyaline collagenous fibrous tissue in 30% of the cases-a yet not causally clarified, inter-individually different susceptibility of the implant bearers. Only the systematic registration of the above-mentioned morphological reaction patterns in a "prosthesis-

passport" together with the additional clinical observation of the patients can ensure in future the realistic estimation of potential health risks caused by silicone breast implants. HISTOLOGIC FEATURES OF BREAST CAPSULES REFLECT SURFACE CONFIGURATION AND COMPOSITION OF SILICONE BAG IMPLANTS Author: Kasper CS Address: Baylor University Medical Center, Department of Pathology, Dallas, Texas. Source: Am J Clin Pathol, November, 1994, 102:5, 655-9 Abstract: The fibrous capsules that develop around silicone gel breast implants may become excessively thickened and result in

painful hardened breasts. This article examines the microscopic anatomy of 80 periprosthetic breast capsules removed during a 2-year period (1990-1992), and describes the histopathologic characteristics of capsules adjacent to the more recently modified implant types. Capsules were examined by routine light microscopy, with and without polarization. Several distinctive histologic patterns were recognized, and these unique patterns could be correlated with the implant type used. All capsules were lined by a cellular membrane resembling synovium. Capsules adjacent to smooth-surfaced implants were lined by an intact histiocytic membrane of uniform thickness. In contrast, the membrane adjacent to textured implants varied in thickness, and was disrupted along its length.

In addition, the inner surface of capsules adjacent to textured implants was conspicuously festooned with small (.25 to .5 mm) knob-like projections that were not seen in capsules adjacent to smooth-surfaced implants. A variety of foreign materials also were observed either within or adjacent to the capsules, and included droplets of liquid silicone, irregular solid fragments of the bag envelope, geometric crystalline fragments of polyurethane, and talc. Thus, the microanatomic features of periprosthetic breast capsules reflect the composition and surface configuration of the corresponding silicone bag type. CAPSULE QUALITY SALINE-FILLED SMOOTH SILICONE, TEXTURED SILICONE, AND POLYURETHANE IMPLANT SIN RABBITS: A LONG-TERM STUDY Author: Bucky LP; Ehrlich HP; Sohoni S; May JW Jr

Address: Massachusetts General Hospital, Boston. Source: Plast Reconstr Surg, May, 1994, 93:6, 1123-31; discussion 1132-3 Abstract: Recently, there have been many new designs in both the surface texture and chemical composition of breast implants that claim reduced constrictive capsular formation. The purpose of this study was to utilize a quantitative method to determine the firmness of capsules formed around saline-filled smooth silicone, textured silicone, and polyurethane implants in an experimental rabbit model 1 year after implantation. Our objective was to analyze the histologic, biologic, and biochemical content of the respective capsules to account for any differences in physical behavior. Forty- five smooth silicone, textured silicone, and polyurethane implants were

placed in one of three positions beneath the panniculus carnosus muscle of New Zealand White rabbits. After 1 year, all capsules were palpated and classified according to firmness. Intracapsular static and dynamic pressure measurements were obtained by placing a pressure monitor (Stryker) in an injector port attached to the individual implants. Capsular firmness was significantly greater in the textured silicone implants than in the smooth silicone or polyurethane implants after 1 year. The dynamic qualities of the periprosthetic soft tissues were measured while saline was injected into the implants. The capsules around the textured silicone implants generated significantly higher pressures than the smooth silicone or

polyurethane counterparts. The capsules around the polyurethane implants were the softest and most compliant in all categories. Histologically, there is a significant inflammatory response surrounding the textured silicone implants that does not exist in the capsules around the smooth silicone implants. The capsules around the polyurethane implants have the least fibrous tissue deposition. There is a decrease in the proportion of type III collagen in the capsules around the textured silicone implants versus smooth silicone or polyurethane implants. The in vitro contraction patterns of the fibroblast-populated collagen lattices do not reveal the contraction differences observed in vivo in rabbits. However, there are many components that determine contractility. This area deserves further investigation.

Opinions expressed are NOT meant to take the place of advice given by licensed health care professionals. Consult your physician or licensed health care professional before commencing any medical treatment. "Do not let either the medical authorities or the politicians mislead you. Find out what the facts are, and make your own decisions about how to live a happy life and how to work for a better world." - Linus ing, two-time Nobel Prize Winner (1954, Chemistry; 1963, Peace)