About D. Talcott

[Guest guest]

About D. Talcott

D. Talcott has been involved with the silicone

breast implant situation for many years. After

graduating from Purdue University with a BSChE in

Chemical Engineering he worked for Dow Corning until

February of 1976 then American Heyer-Schulte Corp.

until July of 1978. He was involved in the Research

and Development of silicone breast implants at both

companies. He resigned at both companies because of

poor research and management. He then went to

Borehinger Mannheim Corp. where a low bleed gel was

patented but not produced other than for a few

clinical trials. He has been working since 1982 in a

major attempt to make the world aware of

what silicones really are and their relationship to

disease.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Tom Talcott was a scientist who used to work for Dow

Corning. He resigned in the 70's or early 80's (not

sure which) because they would not heed his warnings

about the lack of the saftey of breast implants. He

then became one of our best friends and tried to warn

the government and other scientific communities that

these products were unsafe & should not be implanted

in a human body.

~~~~~~~~~~~~~~~~~~~~~~~~~~

I N T R O D U C T I O N

The following " Wanted " article by Tom Talcott, was

presented at the San Francisco Silicone Education

Conference on Saturday, July 19, 1997. This

conference was co-sponsored by ImPart, Inc. of the San

Francisco Bay Area and by C.O.S.S. of Denver

Colorado.

Mr. Talcott has generously given ImPart, Inc.

permission to transcribed and reproduce this article.

All rights are reserved. Please contact

Mr.Talcott at the following address for further

permission to reproduce his work:

D. Talcott

Talcott Consulting

26941 Cabot Road, Suite 133

Laguna Hills CA 92653

InPart would like to join the hundreds of thousands of

men women, and children harmed by silicone breast

implants in giving our heartfelt thanks and gratitude

to a man of extraordinary integrity and courage. In a

time Of incredible pressure to conform to the policies

and politics of the corporate gods, Mr. Talcott has

proven to be a man of conscience. He has been

motivated by an unlimited compassion for those

suffering from the

horribly disfiguring and chronic systemic illnesses

related to silicone poisoning. He has paid a high

price in both his personal health and career. We

understand, recognize and acknowledge what he has

given and what he has sacrificed on our behalf. We

give him the only thing we have left; our highest

honor, respect and gratitude.

May God richly reward and bless you Mr. Talcott for

telling the truth about silicone and the subsequent

human tragedy. With your indomitable faith and spirit

and others like you, we will be able to bring consumer

safety and corporate accountability into the new

millennium. We will be victorious!

Just as the tobacco companies are now being held

accountable, the manufacturers of silicone breast

implants will also be held accountable, assuring that

generations to come will not fall prey to the lies and

deception of inhumane corporate profiteers.

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- W A N T E D -

Several Journalists To Function As Investigative

Reporters To Study and Publicize The Real Science of

Silicones

D. Talcott BSChE Materials Consultant 1997 Tom

Talcott. All rights reserved.

Presented at the Silicone Education Conference San

Francisco, July 19, 1997

A Pulitzer Prize is awaiting a responsive journalist.

During the last few years the journalists and media

producers of the country have shifted from the

viewpoint that silicone breast implants are a

national health disaster to the view that silicones

have not been proven To be causative of any disease.

They imply that silicones are safe for any

implant use. This change encouraged by epidemiological

studies and other specific statement as in the PBS

Frontline program " Implants on Trial "

by many well respected health professionals in highly

respected positions GIVES THE PUBLIC AND MANY

IMPORTANT DECISION MAKERS (IN CONGRESS AND THE

COURTS) A

FALSE IMPRESSION ABOUT THE SAFETY OF SILICONES.

Marcia Angell M.D., Executive Editor of the New

England Journal of Medicine has summarized and

attempted to justify the conclusions of medical

science as reported by many journalists in her book

" Science on Trial " , published by

W.W. Norton & Company. The errors, misunderstandings,

poor interpretations of materials science and lack of

apparent awareness of important immunological studies

are many. The publisher might want to consider

recalling this book because of serious liability in

the " guarantee " made to current and potential

implantees that silicone is

safe.

The current public misconceptions about the science

and toxicology of silicone materials created by

journalists, the media and prominent health

professionals is causing dangerous, wrongful actions

by many parties.

Judges have in the past few months made decisions that

are preventing Women and children from obtaining

proper justice in breast implant and other

litigation concerning solid silicone implants such as

chin implants. This includes new confidentially

rulings on biocompatibility testing documents

which if available to health professionals would give

new understanding of how rapidly toxins or poisons in

silicone are administered as toxic drugs.

Congress has introduced a new Biomaterials Access

Assurance Act which will improperly allow

manufacturers to produce toxic silicones for use in

medical implants intended for human use.

Many journalists and health professionals in the media

appear to have been convinced by efforts of large

public relations organizations hired by Dow

Corning to publicize that silicones are safe for use

in medical implants. This reversal of opinion about

silicone safety is encouraging the continuation of the

very large HUMAN EXPERIMENT concerning silicone

implants. Many health professionals apparently have

committed their opinions without any attempt to

understand the world of materials science. In general,

good science in any field is based on a study of cause

and effect relationships, which has yet to be

completely agreed upon by the parties involved.

Some would have us believe that only greedy lawyers

and women are at fault for the current mass of

litigation. In reality, the women discovered at 1988

FDA Hearing that there were thousands of injured

women. The Connie Chung show also alerted the world

about the hazards of silicone. The attorneys were

simply very pleased, for a fee, to assist women in

recovering damages.

Additional Background

There should really be no controversy about silicones

or silicone breast implants causing disease today.

Safety and efficacy should have been proven three

decades ago by the manufacturers and the Plastic

Surgery Community. Safety and efficacy should have

been assured before mass marketing. Unfortunately one

of the manufacturers, Heyer-Schulte Corp., introduced

a

liquid type gel implant in 1972. The plastic surgeons

had been asking for such a device to obtain a more

natural appearing results after augmentation.

Acceptance of this new product by surgeons was

essentially instantaneous without waiting for long

term results. The early false success of this product

was due in part to a lower profile design which took

longer for the scar capsules around the implant to

give a typical spherical contracture (a contracture

of scar tissue around the implant to form a sphere and

accompanied by painful chronic inflammation). Dow

Corning in 1975 proceeded with the development of a

fluid gel implant based on Heyer-Schulte's success

without knowing of the high rupture rates occurring

with the product. A large number of anecdotal problems

persisted to the extent that the Congressional

Hearing, entitled " Is the FDA Protecting Patients from

the Dangers of Silicone Breast Implants " Ted Weiss

chairman, was held in December of 1990.

At that hearing I warned about the similarity of the

bleed from breast implants to the outlawed use of

liquid silicone injections. I also discussed the

fluid consistency of the silicone gel and the tendency

of the more fluid gel to cause rupture. The lack of

immediate removal of the spilled gel by surgeons was

because they had been misled into believing that the

fluid gel was not toxic. I demonstrated an

accelerated test for determination of the extent or

amount of silicone bleed that was allowed to mix with

tissue. This type of testing still is not being used

in lot testing of devices.

Also at that hearing B. Vasey, M.D., Professor

and acting Chief of Rheumatology, at the University

of South Florida testified about his experience and

his success of implant removal helping in the

resolution of serious disease symptoms. In a summary

paper published in August 1994 (1) he reports during

an average follow up of 22 months after implant

removal 24 women improved clinically, 8 did not

change and one worsened.

He and his 6 co-authors believed that the series

supports a relationship between silicone breast

implants and rheumatic disease signs and symptoms.

In Table 3 of this paper he points out that 11 other

papers report a total of over 51 women showing

improvement after implant removal. Dr. Angell feels

this is simply a placebo effect. It is my under-

standing that a placebo effect is usually only a

temporary resolution of symptoms.

These hearings were preceded by an FDA General and

Plastic Surgery Advisory Panel Hearing, on the safety

of silicone breast implants, in November of 1988. The

presentations given by knowledgeable attorneys,

engineers and women with very disfiguring multiple

surgeries and systemic illness symptoms gave vivid

warnings that serious problems existed in the use of

silicone gel filled breast implants. The relatively

large number of women injured by physical

disfigurement and sever systemic illness symptoms

encouraged the victims to organize and publicize their

plight. This activity has only been partially

successful.

It should not be surprising that attorneys were

anxious to help the victims for a contingency fee. It

should be noted that many plaintiffs attorneys are

having serious financial problems at this time

financing their activities while the defense

attorneys are paid very lucrative hourly fees.

One early lawsuit, the 1984 Stern vs Dow Corning case

ended with a 1.7 million jury award. It is my

understanding that in this trial a witness discovered

fraud concerning one of the animal (dog) studies. The

important happening was that a copy of a document the

witness had studied before trial did not have the

identifying dog numbers as did the copy presented At

trial.

It was suggested that the witness study the documents

overnight. The next morning the defense attorney said

they did not wish to continue questioning on this

document at which time the judge questioned the

witness, contributing to the juries decision to

convict Dow Corning of fraud. It is most unfortunate

that in accepting a reduced award the plaintiff and

the attorneys firm agreed to a confidentially order on

all of the scientific studies presented at trial.

These documents and others critical to understanding

the real science of silicone did not become available

to the FDA until a few days before Dr. Kessler

declared a moratorium on the use of silicone gel

filled breast implants It appears that the proponents

of silicone implants have never properly studies

those, and additional documents made available in the

discovery concerning breast implants and other

silicone litigation.

Recently I have come to understand that situations are

exactly as one should expect. To believe they should

be difference, better or less controversial in the

case of silicone is unrealistic considering the total

inputs or lack thereof by Victims, Medical Science,

Materials Science & Technology, Immunological Science,

Attorneys, FDA Personnel, Congress, Public Relations

Firms, Manufacturers and the Courts.

There has been very little cooperation or attempt to

understand the position of the proponents or opponents

of silicone safety by the opposing sides. We have a

highly polarized situation that we all helped to

create by gross statements and lack of real

interdisciplinary scientific investigation to obtain

the truth about silicone.

It should be pointed out here, that the much touted

Peer Review Process " to give credibility to scientific

endeavors has failed to date and will continue to fail

until a much broader interdisciplinary science

approach is started.

Could Medical Science Be Wrong About Silicone Breast

Implants Not Causing Serious Disease?

Dr. Angell states in her book (p. 196) " Although it is

certainly possible that new studies might find a

small association (to disease), enough is already

known to say that a strong association is extremely

unlikely.

At most breast implants could be a very weak risk

factor of disease. " Angell is obviously convinced

that the studies are not flawed in some basic

manner to make them completely invalid.

A study by this author indicates that at least ONE

FATAL FLAW that makes all epidemiological studies of

silicone breast implants invalid. This flaw is because

implants can not relate to disease, only toxic

materials or toxins that migrate from the implants can

cause disease.

The dosage of chemicals that migrate from silicone

implants and other solid devices have not been

properly considered. These chemicals vary widely in

composition type and amount. As a consequence the

studies do not have a single universe of exposure that

is required to consider using statistical methods to

interpret the results.

As one example, the early Cronin breast implant

contained polychlorinated bi-phenyls (PCBs). (2) These

chemicals as contaminates in the environment are known

to adversely affect the reproductive system of birds.

There should therefore be some consideration of breast

implants containing poly-chlorinated bi-phenyls to be

related to causing the second generation effect

claimed by some victims of breast implants.

I am aware that two women who have children with

serious health problems were implanted with implants

containing PCBs. It should not be surprising when the

group of women exposed to high amounts of PCBs between

1963 and 1969 were lumped in studies with all other

implantees through 1992 that no effects about damage

to reproductive systems or off-spring were noted due

to the dilution effect. I am not sure questions about

the second Generation effect or reproductive

difficulties or affected children were even asked.

A second example is one of dosage of small silicone

molecules. Jack Carmichael, (3) a Dow Corning

scientist, in 1966 demonstrated and published that

equilibrium polymerization of silicone polymers

produce silicones containing small cyclic and linear

molecules. A change to a stronger catalyst in the

manufacture of medical grade silicone fluids by Dow

Corning about 1965 appears to explain a high

concentration of such species that led to poor device

performance as follows.

The minutes of Dow Corning's task force, that was

charged with the rapid development of a new breast

implant in 1975, indicated that a high bleed rate

batch of devices were produced. Experimental efforts

at that time could not produce a duplicate batch. This

result remained a mystery until Dow Corning admitted

they changed the process for the manufacture of

medical grade silicone fluid for injection. The new

process was described in discovery documents in a

lawsuit concerning injuries from the FDA and the

Plastic Surgery Association (ASPRS) approved clinical

trials of injectable silicone fluid in 1978 for the

single use to correct facial atrophy.

Based on Carmichael's work it was obvious that proper

control of the fluid would be impossible using a very

fast equilibrium catalyst. The swelling of the breast

implant envelope is dependent upon the size of the

fluid molecules to which it is exposed. Fluids

containing a high concentration of small molecules

swell the envelope to a greater extend that standard

fluids causing a higher bleed rate and a higher dosage

of the toxins to the victim.

A quality of MDX-4-4011 injectable grade silicone

fluid was obtained from defendant Dow Corning,

analyzed and found to contain 28 percent small

molecules (4). In a paper (5) published in the

American Medical Journal written by Dr. for

the AMA Committee on Scientific Affairs, it was

disclosed that Dow Corning only analyzed in a gas

chromatography column capable of detecting only the

smaller molecules of up to DP 20. A DP of 20 has 20

repeating Dimethysiloxane units in a molecule. In both

Carmichael's 1966 work and the above analysis, polymer

sizes of up to DP-40 were obtained. The high bleed

rates were the result of the extra swelling to make

the envelope more porous.

To summarize, this information means that the amount

of silicone contamination to a womans tissue and

immune system is unknown in every woman presented in

all epidemiological studies. Therefore there can be no

single universe for a proper statistical evaluation of

any epidemiological study.

I can sympathize with the statisticians for continuing

to make this error as I had the same experience in the

early 1950s. In searching for the reason erroneous

results in my work using statistics on production

quality problems, I found the answer in " Statistical

Quality Control " by Grant (6).

Grant points out that " in the application of

statistics to other fields than industrial quality

control, standard errors of averages are often

calculated for measurements which if tested by

Shewhart techniques, would show lack of control. Even

writers of textbooks on statistics sometimes make this

mistake. " He continues in footnote 1 " There seem to be

two reasons why the standard error is so frequently

misused in applications outside the field of quality

control in manufacturing.

One reason is Shewhart's contributions to statistical

theory, originally applied in manufacturing, are not

so well known as they ought to be to statisticians in

other fields. The other reason is that statisticians

in other fields are not subject to the immediate check

on the accuracy of the predictions which are so common

in manufacturing. In many other fields, if a

statistician, by computing a standard error where none

is justified, gives a false assurance of the accuracy

of a given average, it is likely everyone will have

forgotten about it by the time subsequent facts show

that he (or she) was wrong. "

If epidemiologists would like to perform a more valid

study they could compare:

1. Patients with low bleed devices that have not

ruptured (the low level of dosage) with

2. All other devices that have not ruptured

(moderately high and high level of dosage) and

3. Devices that have ruptured (the highest level of

dosage).

Unfortunately there are other details such as toxic

metal catalyst and solvent contamination that will

invalidate studies that can never be defined because

of improper testing and record keeping by the

manufacturers.

Can Good Valid Science Prevail and Provide Justice for

the Victims of Silicone Poisoning?

Before this can happen the new valid materials related

science needs to be publicized so that people in many

fields can be aware of the information and understand

the big picture. In Marcia Angell's book " Science on

Trial " in addition to her blind faith in faulty

epidemiological studies she fails to even mention

other important scientific efforts. Some point to the

metabolites of silicone interacting with the immune

system. Garrido (7), (8), (9) and co-workers using

nuclear magnetic resonance have shown the formation of

silicates and silica from silicone in distant parts of

the human bodies.

Medical scientists must eventually realize that this

large group of metabolites combined with the silicone

and other toxic chemicals migrating from the implants

are the cause of a wide variety of symptoms and

multiple diseases in humans.

Dr. Angell has also failed to mention other important

scientific findings related to the interaction of

these hundreds of chemicals in the immune system. She

makes no mention of the work of Shanklin and Smalley

(10), (11) showing cell mediated immune response to

the migratables from breast implants. Her staff has

apparently not searched sufficiently to find some of

the most recent results in the form of poster

sessions. Smalley, et al (12) have shown that

combinations of silicone and silica cause extreme

lymphocyte proliferation when testing the lymphocytes

of women exposed to silicone implants.

Smalley and Shanklin have also shown that 45 of 45

patients (13) exposed to saline filled silicone breast

implants have stimulations indices similar to those

exposed to gel filled implants. Should saline filled

breast implants still be allowed unlimited use for

augmentation? The women with symptoms of silicone

disease caused by saline filled implants are having

extreme difficulty in finding attorneys to take and

prosecute their cases.

The work by Drs. Wolfe,, Ezrailson (14) et. al., and

Garry (15) who've defined and successfully tested for

antibodies has been improperly ridiculed by many,

including the courts.

It should be mentioned that the FDA has drafted a

document entitled " Immunotoxicity Testing Framework " .

This document makes recommendations For using

immunological testing on materials for medical

devices.

A letter written by Drs. Smalley and Shanklin

concerning P. P. Narinis article " Repeated Exposure to

Silicone Gel Can Induce Delayed Hypersensitivity " was

published in the October 1996 issue of Plastic and

Reconstructive Surgery (Vol. 98, No. 5, p 915). His

references are a good source of additional information

on the subject of immune response. HE CONCLUDES " NOW

IS THE TIME FOR FURTHER INVESTIGATION IN AN EFFORT TO

INHIBIT THE INAPPROPRIATE STIMULATION OF T CELLS AND

THE IMMUNE SYSTEM. "

New Information Concerning The Causation of Silicone

Disease

Tissue engineering is a new field that involves the

growth of human tissue for subsequent use as implants.

Examples are artificial skin and cartilage.

At a recent American Society of Testing and Materials

Workshop on Tissue Engineering, May 6-7 in St Louis,

Missouri, Eugene Bell. PhD., CEO and President of

Tissue Engineering, Inc of Boston, Massachusetts, who

apparently is the father of this exciting new field

revealed that growth factors were required to be

present for the cells to demonstrate the proper

growth.

He indicated that these growth factors were

interferon's and cytokines. His detailed explanation

indicated that the growth factors are the same and

some similar to the cytokines released by macrophages

after the ingestion of silicone. Other animal work was

reported where the addition of growth factors to

encourage bone growth caused remodeling of bone at

distant sites. It seems reasonable that this mechanism

is responsible for the excessive scar tissue which

forms around breast implants.

About a month before this meeting Dr. S.W. Balkin, DPM

lectured at an American Medical Writers Association

meeting in Huntington Beach, California about his

experience using injected silicone in the feet of

diabetics to assist in healing serious debilitating

ulcers. It seems that the cytokines being released by

macrophages that had ingested silicone were directing

the cells to deposit tissue to heal the ulcers. To me

this is an unexpected benefit of silicone injection

and for some reason he found no systemic complication

from this use.

The mechanism also explains lung function loss when

the cells are instructed to increase collagen

structures of the lung or other organs. The mechanism

explains the death of some women due to lung problems

including the lady in British Columbia whose husband

wrote me about her final days. Deaths are another

factor not mentioned in any epidemiological studies.

The deaths reported to the FDA should make a good

analytical study by themselves.

Conclusion and Suggestions

There appears too be sufficient evidence that the

immune system is involved with silicone related

diseases that would seem advisable to use the new

immunological testing on the experimental human users

of silicone implants since 1992. It may be that

manufacturers, unknown to the public, have decreased

the amount of migratable silicone and other toxins to

a level that immune reactions do not occur.

It would be very worthwhile for the women who are

considering implants and the world to know.

Since silicone appears to be unique with its

interaction to form metabolites that interact with the

immune system, the manufacturers of more easily

oxidized organic polymers for use in medical devices

may not need to worry about causing serious disease

problems.

They should not interact as badly with the body or its

immune system and could be easily checked by

extraction and immunological testing in animals.

If interactions with the immune system are shown in

the experimental women implanted since 1992, these

results could end the experiment on hundreds of

thousands of men women and children.

This immunological testing could also define new

silicone materials that will not allow leaching of

migratable silicones to interact as badly as the

migratables from current silicone formulations that

are causing disease. To make silicone elastomers and

gels with near zero, extremely low levels of

migratables does appear to be a difficult if not

impossible task. There are organic polymers that would

appear capable of making much safer implants.

R e f e r e n c e s

1. Vasey, B. et al, Clinical Findings in

Symptomatic Women With Silicone Breast Implants

Seminars in Arthritis and Rheumatism, Vol. 24, No 1,

Suppl. 1, pp 22-28, August 1994

2. PCBs are from the 2, 4 Dichlorobenzoyl Peroxide.

It has only recently been shown that extremely high

temperature oven cures are required to remove these

toxins Re: Norplant Litigation Discovery.

3. Carmichael, Jack B. et. al. Analysis of Large

Linear and Cyclic Methysiloxanes and Computer

Calculation of the Chromatographic Data Journal Gas

Chromatography 1996 Vol. 4, No. 9, pp 347-349

4. Talcott, D. Silicones Used in Long-Term

Implantable Devices and Resultant Disease

International Journal of Occupational Medicine and

Toxicology, Vol 4, No. 1, pp 113-126

5. D.R., Council on Scientific Affairs,

American Medical Association, Silicone Gel Breast

Implants JAMA 1993; 270: pp 2602-2606

6. Eugene L. Grant " Statistical Quality Control " First

edition, Seventh ImPression 1946 McGraw-Hill Publ.,

New York

7. Leoncio Garrido, Bettina Pfleiderer, Bruce C.

, Carol A Hulka, B. Kopans Migration and

Chemical Modification of Silicone in Women With Breast

Prostheses Magnetic Resonance in Medicine, Vol 31, No.

3, March 1994

8. Leoncio Garrido, Bettina Pfleiderer, Mikhail

Papisov, Jerome L. Ackerman In Vivo Degradation of

Free Silicone Magnetic Resonance in Medicine, Vol 29,

pp 839-843, March 22, 1993

9. Bettina Pfleiderer, Jerome L. Ackerman, Leoncio

Garrido Migration and Biodegradation of Free Silicone

from Silicone Gel-Filled Implants After Long-Term

Implantation Magnetic Resonance in Medicine, Vol 30,

pp 839-843, July 7, 1993

10. Smalley, D.L., Puckett, D.H., Osborne, S.H., Hall,

M.F., s, M.V., Shanklin, D.R. Immunologic

Stimulation of Lymphocytes in Silicone Gel Breast

Implant Patients Presented at the 7th AnnuaL Meeting

of the Assoc. of Medical Laboratory Immunologists,

Boston, MA July 14, 1994

11. Smalley, D.L., Osborne, D.H., Puckett, D.H., Hall,

M.F., s, M.V., Shanklin, D.R., Retention of Cell

Mediated Immune Response in Silicone Gel Breast

Implant Patients Following Explantation Presented at

the 7th Annual Meeting of the Assoc. of Medical

Laboratory Immunologists, Boston, MA July 14, 1994

12. Smalley, D.L., Talcott, T.D., and Shanklin, D.R.

Response Enhancement in T Lymphocyte Memory Testing by

Triphasic Combination of Silicaceous Mitogens ASBMB,

ASIP, and AAI (Experimental Biology 96, Part 2, June

6, 1996, New Orleans, Louisiana

13. Shanklin, D.R. and Smalley, D.L. Differential

Capsulopathy in Silicone Implant Type Laboratory

Investigation 74:24A, 1996 (Abstract No. 123)

14. Wolfe, L.E., Lapp, M., , R.D., and

Ezrailson, E.G. Human Immune Response to

Polydimethylsiloxane : Screening Studies in a Breast

Implant Population FASEB J Vol. 7pp 1265-1268

15. Garry, R.F., Tenenbaum, A., et al Use of

Anti-Polymer Antibody Assay in Recipients of Silicone

Breast Implants Lancet: Vol. 349, No. 9050, pp 449-54,

February 15, 1997