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37*? MS Id sto. H333 NEUROPSYCHOLOGICAL DEFICITS ASSOCIATED WITH SILICONE GEL BREAST IMPLANTS DISSERTATION Presented to the Graduate Council of the University of North Texas in Partial Fulfillment of the Requirements For the Degree of DOCTOR OF PHILOSOPHY By Mary E. Kasper, B.A., M.A. Denton, Texas August, 1996

Transcript of MS Id sto. H333/67531/metadc...American women underwent augmentation or reconstructive mammoplasty...

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37*?

MS Id sto. H333

NEUROPSYCHOLOGICAL DEFICITS ASSOCIATED WITH

SILICONE GEL BREAST IMPLANTS

DISSERTATION

Presented to the Graduate Council of the

University of North Texas in Partial

Fulfillment of the Requirements

For the Degree of

DOCTOR OF PHILOSOPHY

By

Mary E. Kasper, B.A., M.A.

Denton, Texas

August, 1996

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37*?

MS Id sto. H333

NEUROPSYCHOLOGICAL DEFICITS ASSOCIATED WITH

SILICONE GEL BREAST IMPLANTS

DISSERTATION

Presented to the Graduate Council of the

University of North Texas in Partial

Fulfillment of the Requirements

For the Degree of

DOCTOR OF PHILOSOPHY

By

Mary E. Kasper, B.A., M.A.

Denton, Texas

August, 1996

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t-iV-

Kasper, Mary E. Neuropsychological Deficits Associated

with Silicone Gel Breast Implants. Doctor of Philosophy

(Clinical Psychology), August, 1996, 70 pp., 6 tables,

references, 64 titles.

Thirty-two silicone breast implant patients scored in

the mild to moderate range of impairment on the Halstead-

Reitan Neuropsychological Battery. An unusual number of

patients had positive tests for antinuclear antibody on

immunological testing and a high incidence of EEG

abnormalities were found. Personality testing revealed an

MMPI profile which is typical for neuropsychological^

impaired subjects but components were consistent with

extreme emotional distress. None of the subjects were near

the cutoff score for malingering or faking bad on the F-K

index of the MMPI. There was no apparent relationship

between length of exposure and the severity of neurological

impairment. Also, explanted subjects performance was not

improved when compared to subjects whose implants were still

in place.

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TABLE OF CONTENTS

Page

LIST OF TABLES iv

Chapter

I. INTRODUCTION 1

Silicone and its Medical Uses Silicone and Autoimmune Disorders Why Silicone Breast Implants are Thought to

be Harmful Complications Associated with Silicone Breast

Implants Importance of Study

II. METHOD 21

Subjects Materials Procedure

III. RESULTS 28

Description of Sample Neuropsychological Test Scores of Silicone

Implant Patients Versus Published Cutoff Scores

Comparison of Silicone Breast Implant Group to Published Scores from SLE Patients

Length of Exposure to Silicone Implants and Neuropsychological Deficits

Patients with Silicone Implants Versus Patients who have had Their Implants Removed

Patients with Documented Rupture Versus Patients with Documented Intact Implants

IV. DISCUSSION 39

Limitations of Study Research Directions

APPENDICES 50

REFERENCES 62

111

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LIST OF TABLES

Table Page

1. Mean WAIS-R IQ Values for Silicone Breast Implant Patients 56

2. Means of Silicone Implant Patients on the Most Sensitive Components of the HRNB 57

3. Mean Personality Test Scores of Silicone Breast Implant Patients 58

4. Silicone Implant Patients' HRNB Performance Versus Cutoff Scores Used to Determine Brain Damage 59

5. Silicone Implant Patients Performance Versus Three Groups of Systemic Lupus Eretymatosus Patients' Performance on Trails A and B and Finger Tapping Tests 60

6. Silicone Implant Patients Performance Versus Three Groups of Systemic Lupus Eretymatosus Patients' Performance on the WAIS-R 69

IV

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CHAPTER I

INTRODUCTION

From 1962 to the early 1990's, 300,000 to two million

American women underwent augmentation or reconstructive

mammoplasty and were implanted with silicone breast

prostheses (Smith, 1993). Despite the large number of

silicone implants, the long term effects of silicone

implants were unknown. Due to the laws applicable to

medical devices, implant manufacturers were not required to

show that the devices were safe and effective.

Silicone breast implants were unregulated until 1976,

when the Medical Device Amendments to the Food, Drug and

Cosmetic Act (21 U.S.C.A. S 360 et seq; West 1976) gave the

FDA the authority to regulate all medical devices. However,

the 1976 act only required devices classified as high risk

(Class III) to be proved safe and effective. The FDA did

not classify silicone breast implants as Class III devices

until 1988, and it was not until 1991 that the FDA required

manufacturers to submit premarket approval (PMA) or proof of

the product's safety and effectiveness (Rohrich & Clark,

1993). The FDA advisory panel met to evaluate data

presented by seven breast implant manufacturers, and the

following year concluded that there was insufficient

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evidence to prove implants were safe and effective.

Consequently, in 1991 the FDA imposed restrictions on the

use of silicone implants (Human Resources and

Intergovernmental Subcommittee of the Committee on

Government Operations, 1993). As a result of the FDA's long

inaction, a large number of women received silicone breast

implants, a product with long term sequelae that are not yet

fully understood.

Silicone and its Medical Uses

Silicone is a general term that refers to a generic

class of materials that are composed of polymer chains of

alternating silicon and oxygen atoms. The viscosity of

silicone is determined by the average length of the chains

(Kossovsky & Heggers, 1987). Many types of medical implants

are pure silicone, silicone encased, or silicone treated.

Examples of other silicone based medical products include

silicone encased pacemakers, silicone clips used in tubal

ligations, silicone hydrocephalus shunts, and silicone joint

prostheses (Englert, Howe, Penny & Brooks, 1994). Some

physicians believe that silicone is a biologically inert

material, as evidenced by its many successful uses (Giltay,

Moens, Riley, & Tan, 1994). Others believe that silicone

has a high degree of biocompatibility, but is not a

biologically inert substance (Spiera, Gibofsky & Spiera,

1994). The many failures of implants associated with

periprosthetic fibrosis, lymphadenopathy, silicone

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migration, and silicone fragmentation are believed to be

related to silicone bioreactivity (Heggers, Kossovsky,

Parsons, Robson, Pelley, & Raine, 1983; Kossovsky & Heggers,

1987). These authors believe that some individuals may be

predisposed to silicone hypersensitivity, which involves an

immunological reaction to silicone. The hypothesis that

some individuals are silicone hypersensitive would be

consistent with the fact that not all breast implant

patients appear to develop complications.

Silicone and Autoimmune Disorders

Many of the common complications currently thought to

be associated with silicone breast implants are autoimmune

disorders. To clarify how silicone relates to autoimmune

disorders, a brief explanation of the immune system follows.

The immune system is composed of white blood cells that

function to protect the body against toxins (bacteria,

viruses, foreign substances, etc.). Macrophages are

important immune cells which ingest, kill, and digest

foreign substances, and send messages that mobilize other

immune cells. Antibodies are substances that bind to the

foreign substance and help identify it for attack by other

immune cells, and differentiate the foreign substance from

body tissue. The immune system is able to effectively

differentiate the foreign substance from body tissues until

the amount of the foreign substance surpasses a critical

level. At this point, the immune system becomes

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overwhelmed, and works as hard as it can in an attempt to

rid the body of the toxins. In these circumstances, the

immune system may become confused and attack various body

tissues. This immune system overload may only affect one

part of the body, or may affect the entire body. Autoimmune

disorders can affect the central nervous system (CNS),

although the exact mechanism of pathogenesis is not known.

Some researchers have proposed that the autoimmune disorder

can affect the brain through vasculitis and/or antibodies

against nervous system tissue (Bluestein, 1984; Denburg &

Temesvari, 1983). This type of immune system dysfunction is

hypothesized to happen in silicone breast implant patients

as a result of chronic silicone exposure (Vasey & Feldstein,

1993; Lewy, 1994).

Why Silicone Breast Implants are Thought to be Harmful

There are two main reasons why silicone gel breast

implants are thought to be more likely to cause immunologic

problems than other types of silicone implants. The first

is that all silicone breast prostheses release some of their

gel content into the patient's system, where it can then

migrate. Most other types of implants are made of hard

silicone, which is less likely to migrate, and is much

easier to remove in the case of complications (Vasey &

Feldstein, 199 3). The most common type of breast implant is

similar to the prototype model developed in the 1960's,

which consists of a silicone rubber envelope or shell that

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is filled with silicone gel (Sanger, Kolachalam, Komorowski,

Yousif, & Matloub, 1992). In some cases the silicone shell

ruptures, releasing silicone gel into the patient's system.

Estimates of implant rupture range from 4% (Atwood et. al,

1994) to 16% (Nelson^ 1981). Many times implant ruptures

are "silent" and go undetected until the patient has surgery

for implant exchange or a mammogram (Rohrich & Clark, 1993).

Fifty seven patients out of a sample of 96 who underwent

implant removal due to complications were found to have

ruptured implants (Shoaib, Patten, & Calkins, 1994).

Ruptured implants are commonly seen by plastic surgeons

during implant revision surgery, and some believe that

"ruptured implants are often not detectable, asymptomatic,

and not likely to cause problems" (Berger & Bostwick, 1995).

Silicone gel is also able to migrate into the patients'

system through an intact envelope. In a study of tissue

samples from 41 women undergoing implant revision surgery,

free silicone resulting from gel bleed was found in 70% of

the patients. While the authors did not observe free

silicone in the remaining 30% of the cases, they believe

that silicone escaped from the envelope in each instance, as

they found evidence of empty holes and cysts in surrounding

breast tissue representing silicone damage in every patient

(Kasper & Chandler, 1994). Other sources agree that all

breast implants leak silicone gel through the hard silicone

envelope (Atwood et al., 1994).

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The second hypothesis, related to why silicone gel

implants are associated with problems to a greater degree

than other types of silicone implants, is related to their

placement in the body. The location of the implant makes it

likely that the silicone that escapes from the implant will

drain into the lymphatic system, which makes an immunologic

response more likely (Kossovsky & Heggers, 1987).

The silicone gel that escapes from the implant shell is

a major area of concern. However, some researchers believe

that the nature of the silicone envelope may be contributing

to the autoimmune problems experienced by many silicone

implant patients. The silicone shell of the implant is

recognized as a foreign substance by the immune system. The

immune system sends macrophages to attack the implant shell

and causes microscopic pieces of silicone to be shed into

surrounding tissues. This process is known as shell

erosion. Shell erosion is thought to be due to the

composition of the shell, as it has been observed in saline

filled implants as well as in silicone gel filled implants

(Vasey & Feldstein, 1993).

In review, it appears that the majority of breast

implant recipients will have gel outside the prosthesis

envelope either through rupture or gel bleed, as well as

exposure to microscopic pieces of silicone due to shell

erosion. The location of the implant may also facilitate

drainage into the lymphatic channels of the upper body.

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Some implant patients may be predisposed to silicone

hypersensitivity, and gradually develop an immunologic

reaction, and subsequent rheumatic and CNS complications.

Complications Associated With Silicone Breast Implants

Although all physicians do not agree on what types of

complications are associated with silicone breast implants,

the most commonly listed major health concerns include:

capsular contracture, a possibility of increased cancer

risk, delayed mammographic detection of breast tumors, and

implant rupture or gel migration, contributing to the

development of autoimmune disorders and subsequent CNS

deficits (Rohrich & Clark, 1993). Capsular contracture is a

condition that can occur after implantation, when the

fibrous capsule surrounding the implant becomes hard,

uncomfortable, and sometimes deforms the breast (Brautbuar,

Vojdani, & Campbell, 1994).

Researchers are not in agreement as to the risk of

cancer associated with gel implants, and the implications

silicone implants have for mammography (Rohrick & Clark,

1993). In a study involving 68 breast augmentation

patients, a 3 0% decrease was noted in the area of breast

tissue visualized by standard compression mammography

(Handel, Silverstein, Gamagami, Jensen, & Collins, 1992).

Eklund, Busby, Miller and Job (1988) developed a modified

mammography procedure for breast implant patients designed

to increase the amount of breast tissue visualized. The

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Eklund mammography technique has been shown to be

ineffective in increasing the amount of tissue visualized in

patients with moderate or severe capsular contracture

(Handel et al., 1992). Some mammography units do not

utilize the Eklund technique with implant patients, because

of the possibility of implant rupture during the procedure

(Bantick & Taggart, 1995). The health concerns that are

most salient to this investigation of central nervous system

deficits are the risks of implant rupture, gel migration and

the resulting risk of autoimmune disorders.

At the present time, there is no definitive

epidemiologic data that establishes a link between silicone

gel breast implants and autoimmune diseases (Bridges &

Vasey, 1993). Some believe that the connection between

silicone breast implants and autoimmune disorders may be

coincidental, as this type of disorder is most common in

young thin women, and young thin women are the typical

implant recipients (Atwood et. al, 1994). A commonly cited

retrospective study involving a record review of 749 women

failed to find an association between rheumatoid arthritis,

SLE, Sjoren's Syndrome, dermatomyositis, polymyositis,

systemic sclerosis, ankylosing spondylitis, psoriatic

arthritis, polymyalgia rheumatica, vasculitis, arthritis

associated with inflammatory bowel disease, polychondritis,

Hashimoto's thyroiditis, primary biliary cirrhosis,

sarcoidosis, and cancer other than breast cancer (Gabriel,

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O'Fallon, Kurland, Beard, Woods, & Melton, 1994). While

this study was well designed, the sample had been exposed to

implants for a relatively short time (M = 7.8 years

exposure), and diagnoses of atypical Lupus or atypical

Multiple Sclerosis were not included, both of which are

common diagnoses for silicone breast implant patients.

There are many studies that suggest a relationship

nonetheless. Typical signs of autoimmune disorders include:

pain and swelling of joints, tightness, redness or swelling

of the skin, swollen glands or lymph nodes, unusual and

unexplained fatigue, swelling of the hands and feet, and

hair loss (U.S. Food and Drug Administration, 1994). The

group of specific neurologic and autoimmune diseases are

referred to as human adjuvant diseases. This group of

disorders associated with silicone gel implants includes:

systemic lupus erythematosus (SLE), scleroderma,

polymyositis, rheumatoid arthritis, mixed connective tissue

disease, Sjogren's syndrome, fibrositis, carcoidosis,

atypical neurologic diseases such as atypical Lupus and

atypical Multiple Sclerosis, and myositis (Spiera, Gibofsky,

& Spiera, 1994), as well as silicone adjuvant disease (Lewy,

1994) .

Silicone implants and Systemic Lupus Erythematosus.

SLE is defined as "a chronic inflammatory disease of

connective tissue that causes injury to the skin, joints,

kidneys, nervous system, and mucous membranes" (Taber, 1993,

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p. 1139). SLE is one of the more serious of the autoimmune

diseases listed above, and is the autoimmune disorder most

commonly associated with central nervous system involvement.

The central nervous system is estimated to be compromised in

30 to 75% of patients with SLE (Carbotte, Denburg, Denberg,

Nahmias, & Garnett, 1992; Kushner et al., 1987).

SLE with nervous system involvement is often referred

to as Neuropsychiatric SLE (NP-SLE). There is currently no

consistent diagnostic clinical criteria for NP-SLE (Kassan,

& Lockshin, 1979). Neuropsychological testing of SLE

patients, and NP-SLE patients showed cognitive impairment to

be present in 66% of a sample of NP-SLE patients, and in

almost half of SLE patients in which there previously was no

suspected CNS involvement (Denberg, Carbotte, & Denberg,

1987). It appears that although the term NP-SLE is in use,

it is currently of questionable usefulness in discriminating

SLE with CNS impairment from SLE without CNS impairment.

Neuropsychological testing is thought to be the most

sensitive method to evaluate CNS involvement in SLE, and has

been shown to be more useful than Magnetic Resonance Imaging

(MRI), Computerized Tomography (CT) etc. (Carbotte, Denburg,

Nahmias, & Garnett, 1992; Mondrego, Venegas, Cuenca, Moreno,

& Delgado, 1994)

Denburg, Carbotte & Denburg (1987) administered a

complex battery of standard neuropsychological tests to 86

women diagnosed with SLE. SLE patients with suspected CNS

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involvement (NP-SLE) showed a pattern of neuropsychological

test results that the authors believe is reflective of

diffuse or multifocal CNS dysfunction. Results showed this

group to differ significantly from a control group on verbal

and nonverbal measures of memory, Reasoning and fluency

(speed).

Silicone svmptomotolav may comprise a distinct

disorder. Current research suggests that the autoimmune

symptoms associated with silicone breast implants (SBI) that

are sometimes diagnosed as SLE or other connective tissue

disorders may in fact be a unique syndrome composed of

diverse symptomatology (Solomon, 1994). The silicone

syndrome was first identified in 1964 and labeled Adjuvant

Breast Disease (Miyoshi et al.). An adjuvant is a substance

that changes or enhances immune system functioning. An

entire sample of 100 consecutive cases of silicone exposed

patients presented with a variety of neurological,

rheumatological and nonspecific symptoms that differed

markedly from idiopathic rheumatological or neurological

disorders (Shoaib, Patten, & Calkins, 1994).

Common symptoms include: weakness, fatigue, myalgia,

morning stiffness, arthralgia, short term memory loss,

sensory loss, headache, dry eyes and mouth (Solomon, 1994).

Patients with adjuvant breast disease typically have at

least 20 complaints and commonly endorse over 50% of the

common disease symptoms (Patten, & Shoaib, in press). A

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list of common symptoms is contained in the Information

Sheet: Breast Implant Cases (Krusz, 1994) in Appendix A.

Lappe (1993) also believes that silicone related

symptoms represent a distinct syndrome. He refers to this

syndrome as "silicone reactive disorder" (p. 348), based on

findings that the most seriously ill patients in his study

showed antibody patterns that were uncharacteristic of other

disorders, and the fact that the disorder associated with

silicone appears to be partially reversible. Approximately

7 0% of patients experience a lessening of their rheumatic

symptoms within two years after removal of their implants

(Patten & Shoaib, 1995; Vasey & Feldstein, 1993). Most

classic autoimmune disorders do not show this pattern of

revers ib i1ity.

Lewy (1994) also believes that there is a unique

syndrome associated with silicone breast implants. He

refers to the syndrome as Silicone Human Adjuvant Disease

(SHAD), "a multisystem disorder with a unique combination of

impaired higher neurological functions, neuropathic

symptoms, arthralgias, and constitutional symptoms

associated with multiple autoantibodies and easily found

abnormalities on imaging" (p. 1). Forty-seven percent of

230 implant patients showed areas of demyelination,

infarction or vasculitis on brain MRI (Lewy, 1993). Lewy

describes a typical SHAD patient's symptoms as: burning

chest and shoulder, breast tenderness and pain, insomnia,

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difficulty breathing, palpitations, rapidly worsening short

term memory loss, confusion, presence of at least one

autoantibody on lupus panel testing, and prolific basic

protein antibody production.

Rheumatologists at the University of South Florida

Medical School have also observed a common group of symptoms

in silicone implant patients who develop problems. This

syndrome, referred to as silicone disease, consists of the

following six symptoms: chronic fatigue, inflammation and

muscle pain, joint pain and swelling, swollen lymph nodes in

chest, neck underarms and groin, low grade fever (100 to 101

degrees), and gastrointestinal symptoms including cramping

and abdominal pain. Other common symptoms include:

burning/crawling sensations indicative of peripheral nerve

problems, night sweats, memory loss, dry eyes and mouth,

headache, rashes, difficulty swallowing, bladder problems,

sinus irritation, numbness or altered sensation in the body,

skin tightening, lung problems, decreased sex drive, and

depression. Silicone breast implant patients presenting at

the University of South Florida Medical School often show

constellations of these symptoms, plus a borderline positive

antinuclear antibody test, and the absence of a "butterfly"

facial rash, or kidney disease. The absence of a butterfly

rash and kidney disease is significant as these symptoms

would suggest that the patient is suffering from true SLE

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rather than atypical lupus due to silicone toxicity (Vasey &

Feldman, 1993).

The theory that silicone toxicity may result in an

atypical disease has been met with criticism by some who

believe that this syndrome is a fabrication of unscrupulous

plaintiff attorneys (Bernstein, 1995). Bernstein states

that this theory was invented because, as there is no clear

definition of an "atypical" disease, it is impossible to

engineer an epidemiological study to determine the existence

or causes of this type of disorder. On the surface this

argument may appear plausible to some, however there is

enough medical evidence to explore the theory that some

silicone implant patients may be suffering from a spectrum

of immune disorders.

Based on clinical observation of approximately 30

individual silicone breast implant patients, a Dallas

neurologist observed commonalities within the group. The

constellation of symptoms noted include; subtle EEG

abnormalities indicative of cortical irritability especially

in the posterior frontal and temporal lobes; confusion,

short term memory loss, and peripheral neuropathy (J. C.

Krusz, personal communication, October, 1994).

The above mentioned observations are consistent with a

recent study which found significant QEEG abnormalities on

100% of the first 23 silicone breast implant patients being

evaluated for neurocognitive symptoms (Hoffman, Stockdale,

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Hicks, & Schwaninger, in press). These authors found memory

related symptoms to be the most prevalent patient complaint

in this group, and the most common QEEG abnormalities to be

in the temporal region.

After examination of approximately 20 silicone breast

implant patients, a Dallas neuropsychologist believes that

there may be a distinct pattern of neuropsychological

deficits associated with silicone breast implants. After

observing these cases, clinical impressions are that these

patients tend to show impairment on the following portions

of the Halstead-Reitan Neuropsychological Battery: Category

test, Tactile Form Recognition, Tactual Performance Test

Total Time and Localization score, as well as mildly

depressed scores on the Finger Oscillation Test, and mild

deficits on the Digit Symbol subtest of the Wechsler Adult

Intelligence Scale-Revised (W. B. Jones, personal

communication, November 15, 1994).

Examination of central nervous system deficits in

silicone breast implant patients. Upon analysis, it appears

that many medical professionals believe that some type of

chronic, progressive autoimmune disorder is associated with

SBI's. Many believe that silicone toxicity leads to an

atypical neurologic disorder that shares common symptoms

with SLE as well as other autoimmune disorders like Multiple

Sclerosis.

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There is a general consensus that CNS involvement is

present in a large proportion of patients with SLE, and that

neurological and neuropsychological testing is an

appropriate way to investigate and document these deficits.

As silicone associated syndrome is' an atypical neurological

disease similar to SLE, neurological and neuropsychological

testing is an appropriate way to investigate CNS deficits in

this population as well.

While no studies of this type have yet been published,

a similar study of 15 women revealed interesting findings.

This small scale investigation found common abnormalities on

SPECT scans, especially statistically significant bilateral

temporal decreases. These authors also found that the

implant patients had significantly below average

performances on the verbal learning, short and long delayed

free recall, and delayed recognition portions of the

California Verbal Learning Test. However, their sample

showed average performance on measures of attention,

language and intelligence (Brown, Patten, Cooke, Shoaib, &

Jhingran, in press).

The purpose of the present study was to investigate a

possible association between neuropsychological deficits on

standard neuropsychological tests, neurological testing

(Quantitative Electroencephalogram), and autoimmune

symptomology in SBI patients. While this study will

primarily investigate central nervous system deficits

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associated with silicone breast implants, autoimmune data

will be included in an effort to make findings useful to a

wider range of health care professionals.

Five main research questions were investigated in this

study. The first level of analysis attempted to

differentiate silicone breast implant patients from normal

controls (using published norms) on neuropsychological,

neurological (QEEG, SPECT scan), and immunological measures.

A priori, the silicone implant group was expected to

significantly differ from normal controls on the following

scores; the Halstead-Reitan Impairment Index, and the Global

Neuropsychological Deficit Score (GNDS). The Impairment

Index and the GNDS are general indicators of

neuropsychological impairment. Exploratory analysis was run

on the remainder of the test scores, with special focus on;

Category Test, Tactual Performance Test Localization Score,

Tactile Performance Test Total Time, Finger Oscillation

Test, and the Digit Symbol subtest of the WAIS-R.

The second level of analysis attempted to determine if

SBI patients are significantly different from SLE patients

on neuropsychological measures using the norms for women

with SLE with suspected CNS involvement published in

Denberg, Carbotte and Denberg's 1987 study. A priori the

silicone implant group was expected to be different from the

SLE group norms on measures of cognitive speed. Exploratory

analyses was run on the remainder of the test scores.

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The third level of analysis attempted to determine

whether there is a typical neuropsychological profile

associated with patients who have or have had silicone

breast implants. The fourth research question examined

length of exposure to silicone implants and

neuropsychological deficits to determine if there is a

relationship. Finally we attempted to determine if patients

who have had their implants removed are significantly

different on test data than patients who still have their

implants.

Importance of Study

Currently the Brown et al. (in press) study stands

alone in addressing the neuropsychological deficits

associated with silicone gel breast implants. Since the

1992 FDA ruling that limited silicone breast implants to

controlled trials, there have been a large number of

articles speculating on possible side effects. The majority

of these articles address the rheumatic symptoms thought to

be associated with the implants, have small sample sizes,

and are composed of patients who have been exposed to

implants for less than 10 years. Some physicians have noted

irregularities in brain scans, confusion, and short term

memory loss in a significant number of their silicone breast

implant patients. However, it is not yet clear if there is

a common constellation of neuropsychological deficits

associated with the implants.

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1 9

This project began to research the relationship between

neuroimmunologic symptoms and neuropsychological deficits.

Results from this initial study add to the existing data on

the long term effects of silicone breast implants, and give

direction to future researchers in the area.

It is important that the relationship between central

nervous system deficits and silicone implants be

investigated for several reasons. Probably the most

significant reason is to be able to have more data on

silicone implants available to women with silicone breast

implants and professionals treating them. With more data,

better informed decisions could be made about treatment.

Women with silicone implants who suffer from some of the

associated symptoms may receive conflicting information

about the cause of those symptoms. One example involves a

43 year old woman experiencing significant confusion and

memory loss, who was told by her gynecologist that she

likely was having some type of premenopausal syndrome, and

that her problems were not implant related, while another

physician believed her implants may be the culprit (W. B.

Jones, personal communication, October 7, 1994). For women

experiencing significant difficulties, such conflicting

information can be quite distressing.

Another reason why it is imperative that more data is

compiled as to the side effects of silicone breast implants

is so that informed decisions about the surgical removal of

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implants (explantation) can be made. This procedure

generally costs between $1,500 and $30,000, and typically is

not covered by insurance companies (Vasey & Feldman, 1994).

It is essential that all types of symptoms associated with

silicone implants be - documented, so that women with

difficulties not likely to be implant related do not undergo

explantation unnecessarily.

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CHAPTER II

METHOD

Subjects

Files on silicone breast implant patients from the

offices of two neuropsychologists in private practice were

selected for use in the study. Supporting neurological data

was available for 16 subjects, and immunological data were

available on 19 subjects. Each of the files involve women

who were 18 years old or older at the time of the

evaluations. All of these women either had silicone breast

implants at the time of the evaluations, or at some time

previous to the evaluations. Data to be used in this study

were archival, and all identifying information was removed

during the coding process to ensure patient confidentiality.

This data set of 38 files represents the entire population

of silicone breast implant patients evaluated by these

service providers who have undergone neuropsychological

testing.

Materials

Data selected from the files for entry originally

included the following measures: the Halstead- Reitan

Neuropsychological Battery, Wechsler Adult Intelligence

Scale-Revised, the Controlled Oral Word Association Test,

21

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Paced Auditory Serial Addition Test, Recognition Memory

Test, the visual reproduction and logical memory subtests

from the Wechsler Memory Test, Rey Complex Figure Test,

Minnesota Multiphasic Personality Inventory, Beck Depression

Inventory, 22 channel Electroencephalogram (EEG),

Quantitative Electroencephalogram (QEEG), SPECT scan, and/or

other event related potentials, peripheral neuropathy data

(nerve conduction velocity study), antibody assay, and the

Information Sheet: Breast Implant Cases (Krusz, 1994). The

Information Sheet: Breast Implant Cases is contained in

Appendix A. After data entry began, it became evident that

very few subjects had been administered the Controlled Oral

Word Association Test, the Paced Auditory Serial Addition

Test, the Wechsler Memory Scale, the Rey Complex Figure

Test, EEG, and nerve conduction studies. Because of this,

these measures were deleted from further analysis.

Reliability and Validity of Measures. The Halstead-

Reitan Neuropsychological Battery is a standard battery of

tests designed to test the biological integrity of the

brain. This test battery yields the Impairment Index and

the General Neuropsychological Deficit Score as composite

scores, and is comprised of the following eleven subtests;

Lateral Dominance Examination, Reitan-Indiana Aphasia

Screening Test, Finger Tapping Test, Grip Strength, Sensory

Perceptual Examination, Rhythm Test, Speech-Sounds

Perception Test, Trail Making Test, Tactual Performance

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Test, and Category Test. The battery has been shown to have

sufficient validity. A study involving 50 brain damaged

subjects matched on gender, age and education with 50

control subjects showed differences between the two groups

on all subtests significant at the .001 level (Reitan,

1955).

The Wechsler Adult Intelligence Scale-Revised (WAIS-R)

is a commonly used measure of intellectual functioning.

Test-retest reliability of the WAIS-R has been found to be

.96. Construct validity has also been shown to be

sufficient, with comparisons with the Wechsler Bellevue

Intelligence test and the Wechsler Adult Intelligence Scale

yielding a correlation coefficient of .69 (Kaufman, 1990).

The MMPI is the personality test often administered to

complement the Halstead-Reitan Neuropsychological Battery

(Anastasi, 1988). The MMPI is made up of three validity

scales, and 10 clinical scales, and has been shown to have

sufficient reliability and validity. Typical test retest

reliability coefficients for the MMPI taken by psychiatric

patients at one to two week intervals were .80 to .85

(Schwartz, 1977). In the standardization sample, eight of

the clinical scales differentiated between a specified

clinical group and a normal control group of approximately

1500 people (Hathaway & McKinley, 1940, 1943). When used

with persons with cerebral damage, the MMPI customarily

yields a profile that reveals some degree of deviation from

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normal. Persons with cerebral damage often show elevations

on the first three clinical scales, although other

populations without cerebral damage also show elevations on

these scales (Reitan & Wolfson, 1993).

The validity scales of the MMPI have often been used in

an attempt to determine whether subjects are overreporting

symptoms, or faking bad on the MMPI (Rogers, Sewell, &

Salekin, 1994). A commonly cited method for determining

faking bad on the MMPI involve the validity scales F and K.

The F scale was developed to detect deviant or atypical

responses to MMPI items, and is comprised of items that are

endorsed by fewer than 10 percent of adult normals. The K

scale is designed to be a subtle index of attempts to deny

psychopathology (low scores) or to exaggerate

psychopathology (high scores) (Meehl & Hathaway, 1946).

These two validity scales are combined in the formula (F raw

score - K raw score), known as "F - K" index. When the F -

K index yields a high positive number, there is a

possibility that the profile is a fake bad profile (Gough,

1950). There is disagreement as to what cut score is

optimal, with estimates ranging from F - K > 0 t o F - K >

34, with optimum classification achieved with cut scoress of

> 12 and > 16 . For the purposes of our study, we will

employ the formula F - K > 16 as an index of faking bad on

the MMPI, as it has been shown to correctly identify 94% of

MMPI profiles (Berry, Baer, & Harris, 1991).

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The F - K formula is also used with the MMPI-2, however

changes in the F and K scales on the MMPI-2 necessitated

additional research as to the most useful cut score for the

F - K formula. Recent research indicates the formula F - K

> 7 yields a 87% hit rate for faking bad (Bagby, Rogers,

Buis, & Kalemba, 1994). For an index of faking bad on the

MMPI-2 the formula F - K > 7 will be used for the purposes

of this study.

While the F - K index is commonly used as indices of

exaggerating psychopathology, it primarily relates to faking

bad on the MMPI. It is unclear whether a subject's MMPI

presentation is correlated to their presentation on

neuropsychological measures. It is possible that a subject

may attempt to fake bad on the MMPI but not on

neuropsychological tests, or vice versa. In spite of these

difficulties in inferring faking bad from MMPI indices, we

used the F - K formula in this study because it was a

readily available commonly used index for assessing

malingering/faking bad.

The other measure of personality used in this study is

the Beck Depression Inventory (BDI). This is a 21 item self

report inventory designed to assess depressive

symptomatology. The BDI has been shown to be sufficiently

valid and reliable for inclusion in this study. Internal

consistency reliability was found to be .80 for single

episode depression, .86 for recurrent episodes, and .79 for

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dysthymia (Beck & Steer, 1993). Test retest reliability was

found to be .90 in a sample of college students when tested

at a two week interval (Lightfoot & Oliver, 1985). The BDI

has been shown to differentiate between Dysthymic and Major

Depression (Steer, Beck, Brown, & Berchick, 1987), and

between Generalized Anxiety Disorder and Major Depression

(Steer, Beck, Riskind & Brown, 1986).

The Information Sheet: Breast Implant Cases (Krusz,

1994) is a symptom checklist designed to elicit specific

information regarding autoimmune symptomology. It is a

checklist consisting of 37 symptoms that are checked yes or

no, and questions about type of silicone implant, and dates

of surgery. This self-report measure was recently designed,

and no validity or reliability information is available.

The quantitative EEG is a statistical analysis of the

quietest background activity available on an EEG recording.

The data are subjected to a neurometric analysis and

compared against controls from a normative database. Other

neurological data includes Brain Spec Scans. This test

involves a complex computer analysis of the brain's blood

flow and function.

Procedure

The procedure of this project entailed organizing and

entering data from the above described measures.

Neurological data was collected by a neurologist, and

qualified technicians. Brain Spec scan data was collected

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by Advanced Metabolic Imaging of North Dallas, a laboratory

certified by the American College of Nuclear Physicians.

The neuropsychological data was collected by

neuropsychologists and neuropsychological testing

technicians, who are advanced graduate students in

psychology with additional specialized training in

neuropsychological testing and scoring techniques. Twenty

of the subjects were administered the neuropsychological

battery by the principal author of the study, seven were

tested by a neuropsychologist, and 11 subjects had been

tested by other neuropsychological testing technicians.

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CHAPTER III

RESULTS

Description of Sample

The study group consisted of 38 files containing

neuropsychological evaluations from silicone breast implant

patients. Six files were dropped from further analysis due

to history of additional CNS insult. The remaining 32 cases

consisted of White, right handed females, who ranged in age

from 3 0 to 64 years (M = 45.81. SD = 8.69). Two patients

had undergone augmentation following mastectomy. One

mastectomy patient had been diagnosed with breast cancer,

and one had severe fibroid tumors of the breast. All other

patients had recieved implants for cosmetic reasons. The

minimum number of years of education completed was 7, and

the maximum was 18 (M = 13.41, SD = 2.20). Eleven patient

files contained immunologic and neurological data in

addition to a complete neuropsychological battery. Five

files contained only neurological data in addition to a

neuropsycholgical evaluation, and 8 files contained only

immunolgical data in addition to a neuropsycholgical

evaluation. Only 7 cases contained neuropsychological data

with no supporting neurological or immunologic data.

28

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The minimum number of years exposed to silicone

implants was 4, and the maximum was 27 (M = 14.10, SD =

5.95), representing a total of 451 years of implant

exposure. Sixteen of the files (50%) contained medical

documentation of implant rupture, which involved silicone

gel spilling outside of the envelope. Twenty six of the

files contained information on capsular contracture. Of

those 26, 12 patients (46.2%) had experienced capsular

contracture.

While ten patients still had silicone implants in place

at the time of the evaluation, twenty two women (68.8%) had

undergone surgical removal of the implants. Of this group,

only two (9.1%) had their silicone implants replaced with

saline breast implants. The minimum number of months

elapsed since explantation was 0, and the maximum was 39 (M

= 11.36, SD = 9.12).

Description of WAIS-R Performance. The mean Full Scale

IQ (FSIQ), Performance IQ (PIQ), and Verbal IQ (VIQ) values

for the sample fall within the Average range of performance.

The average VIQ/PIQ disparity was 7.8 points (SD = 4.8).

The four Wechsler subtests most useful in determining

premorbid intellectual abilities ("Hold" subtests) include

Information, Comprehension, Similarities and Vocabulary

(Reitan & Wolfson, 1993). Means for these subtests were 9.3

(SD = 2.1), 9.0 (SD= 1.8), 9.8 (SD = 2.1) and 10.3 (SD =

2.3) respectively. Analysis of WAIS-R subscales indicates

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that the highest mean scaled score was on the Vocabulary

subtest. This finding is consistent with the observation

that the Vocabulary subtest is relatively insensitive to

cerebral damage (Reitan, Horn & Wolson, 1988). These pattern

of test scores indicate that on the whole, the sample

experienced relatively normal neuropsychological maturation

during the developmental period.

The lowest scaled scores were on the Digit Symbol

subtest (M = 8.2, S D = 2.7). This finding is also

consistent with the observation that the Digit Symbol

subtest is the most sensitive of the Wechsler subtests to

cerebral impairment (Doehring, Reitan, & Klove, 1961; Klove

& Reitan, 1958; Reitan, 1955). While each of the means of

the "Hold" tests were higher than the mean of the Digit

Symbol subtest, paired t tests revealed the means of

Vocabulary and Similarities to be significantly higher

(t(31) = -.3.47, e <.005), and (t(31) = -3.24, p c.005)

respectively. Mean values for the subtests of the WAIS-R

are located in Table 1, located in Appendix B.

Description of Halstead-Reitan Neuropsychological

Battery fHRNB) performance. The most sensitive indicators

of neuropsychological impairment in the HRNB are the

Impairment Index and the GNDS. These two scores are

composite scores made up of other scores in the battery, and

general indicators of neuropsychological impairment.

Specific tests in the Battery known for their sensitivity to

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the biological condition of the brain are the Category Test,

Tactual Performance Test (TPT) Total Time, TPT Memory, TPT

Localization, Rhythm Test, Speech Sounds Perception Test,

Dominant Hand Tapping, and Part B of the Trail Making Test.

Means and standard deviations for these measures are

reported in Table 2 located in Appendix B.

Description of Personality Test Results. Twenty-seven

subjects had completed the MMPI, and two subjects had

completed the MMPI-2. Results of the MMPI were included for

analysis. To maintain continuity with related research,

subjects qualified as experiencing significant emotional

disturbance if they met the qualifications determined by

Denberg, Carbotte and Denberg (1987). These criteria define

emotional distress as T scores above 7 0 on two or more of

scales 2, 4, 6, 7, 8, and 9 on the MMPI. These authors do

not include scales 5 and 0 since those scales are relatively

insensitive to the presence of acute distress, and 1 and 3

because physical illness might elevate these two scales.

According to these criteria, 34% of the SLE patients in the

Denberg, Carbotte & Denberg (1987) study experienced

significant emotional distress at the time of evaluation.

This is in contrast to our finding that 70% (19) of our

sample experienced significant emotional distress at the

time of the evaluation. The most commonly elevated scale in

our sample was scale 2 (Depression), with 22 patients (81%)

scoring at or above a T score of 70. Pearson product moment

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correlation revealed no significant relationship between

depression and GNDS (r = .24, p = .24) or depression and

years exposed to implants (r =-.25, p = .21). A biserial

correlation revealed no significant relationship between

patients who had been -explanted versus patients who still

had their implants (r = .29, p = .15).

F - K scores were computed for all 27 MMPI profiles,

and for the two MMPI-2 profiles. Analysis revealed that no

subject had an F - K MMPI score above the cutoff of 16.

Neither of the MMPI-2 profiles yielded a F - K score in the

"fake bad" range (F - K > 7). These data indicate that it

is unlikely that these patients were attempting to malinger

on the MMPI or MMPI-2.

Findings from the Beck Depression Inventory were

consistent with the MMPI test results. A Pearson product

moment correlation revealed that the MMPI Depression Scale

(Scale 2) was highly correlated with the Beck Depression

Inventory (r = .76). Mean BDI scores for breast implant

patients of 22.6 (SD = 11.2) were well above the cutoff of

16 used to indicate the presence of significant depression

(t(26) = 3.08, p <.05). Means and standard deviations for

the personality tests are reported in Table 3 located in

Appendix B.

Immunological findings. Nineteen files contained

laboratory results including Antinuclear Antibody (ANA)

titer. Twelve of these subjects (63.2%) had abnormally high

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ANA levels. ANOVA revealed no significant difference on

GNDS between subjects with abnormal ANA titer and subjects

with normal ANA titer (F(l,17) = .008, E = .93). Fourteen

files contained laboratory results which included Rheumatoid

Factor titer. Nine of these subjects (64.3%) had abnormally

high Rheumatoid Factor levels.

Electrophysiological findings. Quantitative EEG

results were available for 13 patients. Four patients who

had not had a QEEG had undergone SPEC Scanning. Therefore,

electrophysiological data on brain functioning was available

on 16 (50%) of our sample. All 16 (100%) of the available

QEEG and records contained noted abnormalities. The most

common abnormality noted was some type of abnormality in the

temporal lobe(s), present in 14 (88%) of the cases. Frontal

abnormalities were noted in 10 (63%) of the cases. The

least common abnormalities noted were located in the

parietal lobe, with 6 cases (38%) exhibiting these type of

abnormalities.

The temporal lobes are known to be involved in the

storing and retrieval of memories, and temporal lobe

difficulties have been linked to memory difficulties. An

one way analysis of variance was computed to determine

whether subjects with temporal lobe problems were

significantly more impaired on a memory task than subjects

without temporal lobe problems. The memory task used was

the Memory component of the Tactual Performance Test. While

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this task does involve memory, it does not specifically tap

into temporal lobe abilities. However, it was the only

component of the battery that is specifically designated as

a memory task. ANOVA revealed no significant difference

between the two groups (F(l,15) = .18, p = .68).

Another HRNB test that known to be localized is the

Finger Tapping Test. This measure is sensitive to deficits

in the posterior frontal lobe area. To determine whether

subjects with frontal lobe abnormalities were significantly

more impaired on the finger tapping test than subjects

without frontal abnormalities, an ANOVA was used. The ANOVA

revealed no significant differences between the two groups

(F(l,15) = .32, E = -58).

Neuropsychological Test Scores of Silicone Implant Patients

Versus Published Cutoff Scores

Paired t tests revealed the sample to differ

significantly on several measures from Reitan's 1971 cutoff

scores used for inferring brain damage. A Bonferoni

correction was used to adjust for familywise error, yielding

an adjusted p of .006. The mean Impairment Index and GNDS

of the silicone implant patients were significantly more

impaired than the cutoff scores (t(29)= 4.63, pi <.001) and

(t(27) = 3.85, p = .001) respectively. Analysis of the

component tests of the HRNB revealed that the sample showed

significant deficits on three of the eight most sensitive

parts of the HRNB. These measures include the Category

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Test (t (31) = 4.17, e <.001), TPT Memory (t(31) = 5.82, e

<.001), , and dominant hand Finger Tapping (t(29) = -7.28, p

c.001). The silicone implant group was not significantly

more impaired than the cutoff scores for inferring brain

damage on TPT Total Time (t(31) = 1.82, 2 = -08), Trails B

(t(31) = -.07, p = .94), Rhythm Test (t(30) = .77, p = .45)

or on the Speech Sounds Perception Test (t(30) = -1.66, p =

.11). While the scores on the Localization component of the

TPT approached significance, (t(31) = -2.04, p = .05), they

did not meet the significance level of jo < .006 required by

the Bonferoni correction. Table 4 includes a comparison of

HRNB performance of silicone implant patients to published

cutoff scores used for inferring cerebral deficits. Table 4

is located in Appendix B.

Comparison of Silicone Breast Implant Group to Published

Scores From SLE Patients

Denburg, Carbotte and Denberg (1987) published

normative data from a sample of SLE patients. SLE patients

were classified into one of three groups; as Lupus with

active neuropsychiatric symptomology, inactive symptomology,

or Lupus without neuropsychiatric symptomology. The SLE

group tended to be younger than the silicone implant group,

with mean ages of 36.8 years, and 45.8 years respectively.

The SLE group tended to have completed fewer years of

education than the silicone implant group, with mean years

of eduction completed 11.8 years, and 13.4 years

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respectively. The silicone breast implant group was

compared to mean values for the three groups of SLE patients

using one sample t tests on Trails A, Trails B, Finger

Tapping Dominant, Finger Tapping NonDominant, WAIS-R FSIQ,

WAIS-R VIQ, and WAIS-R PIQ. A Bonferroni correction was

used to adjust for familywize error, yielding an adjusted JD

of .02. The silicone implant group did not significantly

differ from the SLE patients on any measures with the

exception of the WAIS-R values. A comparison of the

silicone implant group to the three groups of SLE patients

on Trails A and B and Finger Tapping is presented in Table

5. The silicone implant group had significantly lower WAIS-

R FSIQ, VIQ and PIQ values than all three SLE patient

groups. A comparison of the silicone implant group to the

mean of the three groups of SLE patients on the WAIS-R is in

Table 5, located in Appendix B.

Length of Exposure to Silicone Implants and

Neuropsychological Deficits

A hierarchical regression was used to determine whether

length of exposure to silicone breast implants was related

to severity of neuropsychological deficits on the HRNB. The

HRNB composite scores (Impairment Index and GNDS) were used

as indicators of neuropsychological deficit. Analysis

revealed that number of years of exposure to silicone breast

implants does not predict greater impairment on these two

variables (F(l,30) - .70, p = .50). Beta weights for the

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variables Impairment Index and GNDS were .21 and .24

respectively.

The relationship between length of exposure and

severity of deficits was also explored using Pearson product

moment correlations. These analyses revealed that there was

no significant relationship between length of time exposed

to implants, and the Impairment Index (r = .21, p = .26), or

between length of time exposed to implants and GNDS (r =

.11, p = .54).

Patients With Silicone Implants Versus Patients Who Have Had

Their Implants Removed

A one way MANOVA revealed no significant differences on

three variables between patients who had undergone

explantation and patients who still had silicone implants in

place at the time of evaluation. The three variables used

were the two HRNB composite scores (Impairment Index and

GNDS) and Trails B. Although the multivariate F was

significant (F(3,27) = 4.12, p = .016), breakdown into

univariate analyses revealed no significance for any of the

three variables [Impairment Index (F(l,29) = .70, p = .41),

GNDS (£(1,29) = 1.63, p = .21), Trails B (£(1,29) = 2.37, p

= .13)]. Stepdown F test revealed GNDS to be the only

significant variable when Impairment Index was covaried out

(F(l,28) = 7.53, p = .01). These results are in question

however due to the fact that the data violated the

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assumption of homogeneity of regression (F(l,27) = 6.97, p =

.014).

Patients With Documented Rupture Vs. Patients with

Documented Intact Implants

ANOVA was used to determine whether patients with

ruptured implants were significantly more impaired on the

GNDS than patients with implants not shown to be ruptured.

Analysis revealed that patients with ruptured implants were

not significantly more impaired on the GNDS than patients

whose implants had been shown to be intact (F(l,20) = .001,

E = -98)

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CHAPTER IV

DISCUSSION

While the sample group was composed entirely of white

females, this is not inconsistent with the general

population of silicone implant patients. Other studies from

the United States are also comprised largely of white

females. The sample differed from most current studies in

that our patients tended to be older (mean age = 45.81

years) and to have been exposed to implants longer (mean

years of implant exposure = 14.10).

Fifty percent of patient files contained medical

documentation of an implant rupture. In most cases, the

rupture was diagnosed during explantation, therefore some of

the remaining 50% of our sample may have had silent or

undetected ruptures. This high incidence of implant rupture

is inconsistent with 4% to 16% estimates of implant ruptures

in the general population of breast implant patients. The

incidence of implant rupture in our study is similar to that

of Patten & Shoaib (1995) who noted 60% of their explanted

Human Adjuvant Disease patients had experienced at least one

ruptured implant.

Of the 26 files with information on capsular

contracture, 46.2% had experienced this side effect. This

39

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is above the 10% to 40% estimates of capsular contracture in

the general breast implant population (Bridges & Vasey,

1993). The high incidence of implant failure and capsular

contracture indicates that the sample group was likely to be

comprised of individuals who were more sensitive to silicone

than the majority of silicone breast implant patients.

Overall, the sample group tended to present with a

valid testing profile consistent with mild generalized

cerebral deficits. Group performance on IQ measures fell

within the Average range, indicating adequate premorbid

neuropsychological development. Analysis of WAIS-R

intratest performance revealed group performance on the

Digit Symbol subtest to be lower than group performance on

any of the other subtests. Patients in the sample group

tended to score in the mild to moderate range of impairment

on the Impairment and in the mild range of impairment on the

GNDS, the two most sensitive HRNB measures. This pattern of

test results is consistent with mild to moderate

neuropsychological impairment of a diffuse nature acquired

during adulthood.

Personality measures revealed that the sample was

experiencing significant emotional distress and depression

at the time of evaluation. This is a typical type of

reaction to a mild brain injury (Gualtieri, 1995). It is

commonly known that brain damaged patients endorse more MMPI

symptoms than normals. Studies indicate that brain damaged

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MMPI profiles are characterized by primary elevations on the

neurotic triad (Scales 1, 2, 3) and secondary elevations on

the psychotic scales (Scales 6, 7, 8) (Dikmen, & Reitan,

1977) .

Persons unfamiliar with the intricacies of brain injury

may misunderstand this depressive reaction, and instead

believe this type of patient is hysterical or malingering.

This is a serious problem faced by many silicone breast

implant patients with organic brain syndrome. Because they

look much like anyone else, are typically verbal, and retain

their premorbid intelligence level, their deficits are

missed or dismissed by many laypersons and professionals.

This can be a constant source of frustration for persons

with toxic brain syndrome due to implants. These

frustrations are likely a contributing factor to the high

degree of emotional distress experienced by the sample

group.

Neurological and immunologic data was only available

for part of the sample, but was included in the study to

provide a better picture of the subject group. The QEEG and

Spec scan data that was available strongly supported our

neuropsychological test findings. All of the patients with

electrophysiological test data had exhibited abnormalities,

the most common being temporal lobe abnormalities.

Immunologic findings also tended to be positive. Sixty-

three percent of the subjects who had undergone ANA testing

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42

had abnormally high ANA titer, and 64% of those who had

undergone Rheumatoid Factor testing had abnormally high

Rheumatoid Factor titer.

Halstead-Reitan Neuropsychological Battery results for

the sample revealed some striking deficits. The patient

group scored more impaired than the cut scores used for

inferring brain damage on several of the most sensitive

measures in the battery. In addition to impaired composite

scores (Impairment Index and GNDS), the sample showed

significant deficits on the Category Test, TPT Memory,

dominant hand Finger Tapping, and deficits approaching

significance on TPT Localization. Scores for the sample

group were within the normal range on Trails B, Rhythm Test,

and Speech Sounds Perception Test.

These findings may be indicative of a

neuropsychological profile of an atypical neurologic

disorder due to silicone toxicity. In general such a

profile would consist of the following components. The

patient is likely to exhibit average WAIS-R intelligence,

with the Digit Symbol subtest being the lowest of the

subtest scores. Personality testing is likely to reveal

scores in the depressed range on the Beck Depression

Inventory. The MMPI typically shows a valid profile with

multiple elevations, indicating emotional distress.

Neuropsychological testing with the HRNB is likely to show

marked deficits in abstract reasoning and executive

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43

abilities (Category Test), in incidental memory (TPT Memory,

TPT Localization), and in upper extremity motor speed

(Finger Tapping). Performance on measures of attention and

concentration (Speech Sounds Perception Test, Rhythm Test)

is likely to be in the normal range', as is psychomotor speed

(Trails B).

Comparison of the silicone implant group to published

norms for patients diagnosed with Systemic Lupus

Erethrymatosus (Denberg, Carbotte & Denberg, 1987) revealed

the two groups to differ significantly only on WAIS-R

scores. Trails A, Trails B, Finger Tapping Dominant Hand

and Finger Tapping NonDominant Hand did not show significant

differences between the two groups. These findings are not

surprising, due to the similarities between the systemic

disorder caused by silicone toxicity and SLE. The two

disorders share so much in common that many silicone breast

implant patients are diagnosed with atypical Lupus (Lewy,

1994).

Although the mechanism of pathogenesis is not known,

the silicone syndrome bears striking similarities to SLE, a

known autoimmune disorder. The results of this study are

consistent with research indicating commonalities between

silicone implants and immune symptoms.

Length of exposure to silicone gel breast implants was

not a good predictor for severity of neuropsychological

deficits on the HRNB. There are several reasons why our

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44

data revealed no correlation between these two variables.

Firstly, the sample consisted of women who had been exposed

to implants on the average of 14 plus years. While all

implants are noted to bleed silicone through the intact

shell, the viscosity of the gel is likely to influence rates

of gel bleed, and consequently the amount of silicone gel

released into the patient's system. Half of our sample had

experienced a rupture of one or both implants, drastically

influencing the amount of silicone gel released into the

woman's system. The amount of gel released into a patient's

system appears to be a complicated equation, and cannot be

reliably estimated simply by length of exposure. In a much

larger sample, however it may be possible to assume that on

the average, the more years of implant exposure, the more

silicone the patient has been exposed to. Finally, the

intraindividual differences in reactivity to a toxin is

likely to account for some of the variability found.

Patients who had undergone explantation were not found

to be significantly different on neuropsychological testing

from patients who still had their implants. This analysis

was done in an attempt to investigate the observation that

many silicone adjuvant disease patients experience a

lessening of symptoms after explantation. This may have

been an inappropriate analysis for the sample group for

several reasons. Patients who had undergone explantation

surgery may have been experiencing greater difficulties

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45

previously, and their performance on our testing could have

represented a lessening of their condition. Also important

is that the explanted group had only been implant free for

less than a year on the average, and it takes about two

years for most patients symptoms to begin to abate. It

would be logical to assume that women who undergo

explantation surgery experience more implant related

symptoms than those who do not, however financial reasons

may also influence which patients undergo the procedure.

Finally, while most silicone adjuvant disorder symptoms are

said to decrease after explantation, it is unclear whether

the CNS deficits can be expected to improve. Due to the

complexity of the intervening variables, it is not

surprising that the explanted group did not appear

significantly different than the non-explanted group on the

HRNB.

A comparison of explanted patients with documented

rupture versus explanted patients with intact implants

revealed no significant differences between these two groups

on GNDS scores. This type of analysis was innapropriate to

perform on the entire population, due to the fact that it is

impossible to determine which non-explanted patients had

silent ruptures at the time of the evaluation.

The issue of malingering is a valid concern for

researchers in this area, due to ongoing legal battles

surrounding breast implants. No specific measure of

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46

malingering was included in the files used for the study

however. To address this issue, we utilized the F - K index

of faking from the MMPI. Analysis of the 29 available MMPI

and MMPI-2 F - K indices of faking bad revealed that only no

subjects had profiles in the faking bad range. These

results offer no evidence that the sample group exaggerated

their symptoms on the MMPI.

It is unclear whether we can assume that the sample

group did not attempt to malinger on the remainder of the

test battery. However, in addition to our MMPI findings,

several other points can be made in relation to malingering.

First, we observed the correct profile on tests of premorbid

ability, such as the WAIS-R. The patient group also showed

consistent abnormalities on neurological and immunological

measures. QEEG abnormalities were most commonly located in

the temporal lobe. Similar QEEG data was found by Hoffman,

Stockdale, Hicks, and Schwaninger (in press). Finally, our

results appear to be valid because they show similarities to

the findings of the only other existing study (Brown et al.,

in press) involving the neuropsychological performance of

silicone breast implant patients.

In summary, it appears that a significant number of

silicone implant patients with a history of implant related

problems and/ or atypical neurologic disorders can be

expected to exhibit significant neuropsychological deficits

on the HRNB. These data suggest that this patient group

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47

tends to suffer from a mild to moderate, diffuse organic

brain syndrome that can be observed on physiological and

neuropsychological measures. Typical HRNB battery

performance includes average WAIS-R, Speech Sounds

Perception Test, and Rhythm Test performance, with deficits

evident on Impairment Index, GNDS, Category Test, Finger

Tapping, TPT Memory and Localization. The patient group

tended to be experiencing significant emotional distress and

depression. Spec scan and QEEG data for a subset of the

sample confirmed physiological and structural CNS deficits,

most often in the temporal lobe.

Limitations of Study

The main limitation of this study was the small sample

size of patients with silicone gel breast implants. This

was a difficult limitation to overcome, because of the

involved nature of the test battery. Each patient file

represented a minimum of eleven hours of patient time and a

considerable expense. The lack of a control group also was

a significant limitation, but again the time and expense

that would have been involved would have been great.

Another limitation of the study also stemmed from the

small sample size. Some researchers report symptom

differences in the implant group by type of implant.

Presumably these symptom differences are due to the varying

degrees that the implants leak their contents, and to the

differing chemical composition of the silicone gel. If a

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48

great number of files were available, we would have been

able to subdivide our implant group by type of implant.

Research Directions

Future researchers may find it productive to continue

to explore neuropsychological deficits and silicone gel

breast implants. The HRNB seemed especially well suited to

this type of research, as it is a standard battery that is

commonly used by neuropsychologists. Additional measures of

malingering and motivation may be useful, due to the

litigation surrounding breast implants. It may be

interesting to compare the performance of patients involved

in litigation and patients not involved in litigation.

Future research to replicate our results would be

beneficial, as this is the first study of this kind using a

sufficient sample size.

One area of future research that may help to document

the CNS deficits associated with silicone adjuvant disease

involves the children of implant patients. Some physicians

are currently recommending explantation for implant patients

contemplating pregnancy, because silicone has been observed

in breast milk, and to cross the placental barrier (Lewy,

1994). No studies exist that explore pediatric CNS

difficulties related to prenatal silicone exposure, and/or

silicone transmitted through nursing. As medical

recommendations are being made for pediatric silicone

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49

exposed patients, studies examining this group would be

useful.

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APPENDIX A

INFORMATION SHEET: BREAST IMPLANT CASES

50

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51

Information Sheet

(Breast Implant Cases)

Full name of patient:

Full name of patient's present spouse:.

Address:

Telephone No. at work:.

Telephone No. at home:.

Facts about your implant surgery:

Date surgery performed:

Hospital or clinic of surgery:.

Surgeon performing implantation:.

Why were implants placed? Purely cosmetic,

reconstruction, following mastectomy, or other?.

Facts about removal of your implants (if applicable):

Not removed:

Date implants removed:.

Location of surgery:

Surgeon performing implant removal:.

Manufacturer of implants:

Name of manufacturer (if known):

Name of implant (if known):

Symptoms associated with implants:.

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52

Do you presently or have you previously had any of the

following?

Symptom Beginning Ending

Nipple Discharges Yes No_

Memory difficulties Yes No_

Shooting pains on

limbs and trunk Yes No

Pins and needles or

numbness on limbs/

trunk Yes No

Fatigue Yes No

Joint pain Yes No

Rash in breast

area Yes No

Burning in breast Yes No

area Yes No

Headaches Yes No

Swelling in face

or eyelids Yes No

Inflammation in

mouth or nasal

area Yes No_

Bitter taste in

mouth Yes No

Date Date

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53

Unusual lumps in

breasts Yes No_

Nausea/vomiting Yes No_

Hair loss/ thinning

of hair Yes No_

Abnormal periods Yes No_

Change of shape of

breasts Yes No_

Chronic flu-like

symptoms Yes No_

Irritation of skin

in bra area Yes No_

Severe/chronic

cough Yes No_

Swollen glands Yes No_

Mouth sores Yes No_

Prolonged difficulty

sleeping Yes No_

Night sweats Yes No_

Swollen joints Yes No_

Prolonged/persistent

diarrhea Yes No_

Prolonged fluid

retention Yes No_

Prolonged temperature

elevation Yes No

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54

Change in skin

texture Yes No_

Prolonged nasal

congestion Yes No_

Prolonged muscle

spasms Yes No_

Prolonged chest

pains Yes No_

Prolonged

dizziness Yes No_

Dry eyes Yes No_

Face pain or

tenderness Yes No_

Recurrent yeast

infections Yes No_

Kidney problems

too much urine/

too little urine Yes No

Other symptoms (Please specify in detail- use additional

paper, necessary).

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APPENDIX B

TABLES

55

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56

Table 1

Mean WAIS-R 10 Values for Silicone Breast Implant Patients

M SD n

Verbal Subtests

Information3 9.34 2 . 10 32

Digit Span 9 . 06 2.21 32

Vocabulary3 10. 28 2 . 30 32

Arithmetic 9.38 2 .31 32

Comprehension3 9.00 1.76 32

Similarities3 9.81 2 . 05 32

Performance Subtests

Picture Completion 8 . 50 2 .31 32

Picture Arrangement 8.44 2 .14 32

Block Design 8 . 66 2.22 32

Object Assembly 8.31 2.38 32

Digit Symbolb 8. 19 2.73 32

VIQ 98 . 19 8.24 32

PIQ 97 . 16 10.14 32

FSIQ 96.91 8. 12 32

aThese are the subtests most useful for determining premorbid IQ.

bThis is the subtest most sensitive to cerebral impairment.

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57

Table 2

Means of Silicone Implant Patients on the Most Sensitive

Components of the HRNB

M SD n

Composite Scores

Impairment Index . 59 . 22 30

GNDSa 35. 50 13 . 04 28

Subtest Scores

Category 65 .41 26 . 35 32

TPTb Total Time 18. 89 9. 91 32

TPTb Memory 7 . 03 1. 98 32

TPTb Localization 3 . 22 2. 17 32

Rhythm 25 .74 5 . 39 31

Speech 6 .81 4 . 00 31

Tapping (Dominant Hand) 35 .21 11 .12 30

Trails B 85 . 37 47 .39 32

aGlobal Neuropsychological Deficit Scale

bTactual Performance Test

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58

Table 3

Mean Personality Test Scores of Silicone Breast Implant

Patients

M • SD n

Minnesota Multiphasic Personality Inventory Scales

Validity Scales

L 54.33 12.55 27

F 63.96 12.14 27

K 54.67 8.15 27

Clinical Scales

1 (Hypochondriasis) 84.00 13.08 27

2 (Depression) 81.67 14.79 27

3 (Hysteria) 84.30 11.50 27

4 (Psychopathic Deviate) 69.33 10.88 27

5 (Masculinity-Femininity) 43.22 7.75 27

6 (Paranoia) 69.96 12.96 27

7 (Psychasthenia) 70.44 13.18 27

8 (Schizophrenia) 78.78 14.35 27

9 (Hypomania) 55.93 10.76 27

0 (Social Introversion) 59.70 11.24 27

Beck Depression Inventory (BDI) Total Score

BDI 22.63 11.17 27

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59

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Anastasi, A. (1988). Psychological Testing (6th ed.).

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Atwood, H. D., Bates, R. , Beckman, J. S., Bise, R. N.,

Franz, P. F., Goodman, R. C. , Lehmberg, R. W. , McCutcheon,

F. B., Moffett, T. R., Pope, N. A., Pullman, N. K.,

Shewmake, K. B., Still, E. F., Stuckey, J. G., Talbert, G.

E., Walley, L. R., & Yuen, J. C. (1994). The silicone gel

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