Fwd: Part 4 of 4 - Court Documents: Manufacturers' Internal Memos

[Guest guest]

" (Note: This is why citizens must be aware of what is

going on behind the scenes. Citizens can, at any time,

become a corporate victim and member of a Class Action

which has been a latent " Corporate Cover-up. " This is

Why Tort Reform is being aggressively pushed. See Tort

Reform.) "

“An annoying experience induced this study. A silicone

gel-filled breast prosthesis, occasionally shown to

patients desiring augmentation, was laid aside in a

cabinet on top of a pile of newly printed writing

paper. Some time elapsed before this stationary was to

be used and, on removing the prosthesis, I found a

greasy patch exactly underneath. Respectfully, I

counted the waste of 203 sheets”

" In 80% of all cases, this phenomenon is preceded by

either a dental abscess, an acute inflammation of the

gallbladder, etc. This brings to mind streptococcus

hemolyticus infection, followed by arthritis,

nephritis and endocardial rheumatism.

Baxter International #77974. "

" We all have fear and trepidation over what silicones

may or may not do, but at some point in time, since

this information is known, we must, I believe,

ethically release it to the utilizers of silicone. "

" The problem: Dr. Vinnick is concerned that that the

GENERAL ELECTRIC GEL used in mammaries is: (1) NOT

cohesive and (2) is TOXIC. "

Document #24:

Heyer-Schulte Corporation

Interoffice Correspondence

Date: June 16, 1976

From: Jim Rudy

Sub: Dr. Vinnicks' Visit to Heyer-Schulte

Friday, June 18, 1976

Ken Eckardt

cc: Sam Koorajian, Tom Talcott, Joe Utt, Bob

The problem: Dr. Vinnick is concerned that that the

GENERAL ELECTRIC GEL used in mammaries is: (1) NOT

cohesive and (2) is TOXIC.

Heyer-Schulte is the most professionally responsive

manufacturer of mammy implants: (1) Willingness to

standup and " tell it like it is " concerning gel bleed

and migration-wise. (2) Conservative " recall " of clear

shell inflatables. (3) Heyer-Schulte intends to make

this professional posture increasingly evident. In all

product areas we have made a commitment to ourselves

to publish a fair summary of complaints received to

doctor's of record by the end of this year.

Special letters will, of course, be prepared at such

times as knowledge of a problem becomes know.

We believe that all gel used in current " responsive "

mammary implants will migrate; all silicone gives some

mild foreign body response. The Literature includes

examples of inflammation, polynuclear giant cell and

white cell response, classified as mild foreign body

reaction to: Dow Corning's 360 Medical Grade Fluid

(Vinnick's paper), Silastic 372, smooth shell material

(Vistnes studies in collaboration with Heyer-Schulte.)

These reactions appear quite consistent with that

known to us resulting from direct exposure of the gel

used in Heyer-Schulte mammary implants. We presume

that the Dow Corning " responsive gel " will give a mild

transitory foreign body response similar to that

reported in the above materials. Migrating gel will

Amplify this effect since literature and studies

indicate that these minimal foreign body responses are

more prevalent in the first month after implant and

subside thereafter. Thus, migrating gel would tend to

CONTINUOUSLY expose new tissue to a " fresh implant. "

we want Dr. Vinnick to understand the extent of our

activities and the degree of Our concern in these

areas.

Jim, JR:ja.

Baxter # International 48798.

Document #25

Heyer Schulte

MD129596

Date: August 2, 1977

H. Penoff, M.D.

Straub Clinic and Hospital

888 South King Street

Honolulu, HI 96813

Dear Dr. Penoff,

In your letter of July 6th, you asked if I could send

you information or reprints regarding silicone

chemistry, particularly in reference to bleed rates,

analysis of these and biological implications of this.

to my knowledge, there is nothing published or in the

form that I can send regarding these matters.

The work we have done to date is rather sketchy and

it will be the cooperative work with you that will

help us to look at the composition of bleed and bleed

rates and arrive at the biological implications.

We can say generically, that the bleed that comes

through the mammary prosthesis is very similar to the

silicone fluids that have been ....injections.....I

will be happy to discuss this in greater length with

you if we meet in San Franciso at the October Plastic

Surgery Meeting.

Sincerely, Heyer-Schulte Corporation,

T. D. Talcott,

Director, Materials Research and Development.

TDT:dk

cc: Ken Eckardt, Jim Rudy, Bob Pudenz, M.D., R.

Alastair Winn, Rudi Schulte.

Document #26

Henry , M. D.

Plastic and Cosmetic Surgery

November 17, 1977

Mr. Rudi Schulte

Heyer-Schulte Corporation

A subsidiary of American Hospital

600 Pine Avenue

Goleta, CA 93017

Dear Rudi:

" ..... I had a chance to visit Dr. Wilfingslader in

Innsbruck and also visit Dr. Smahel in Zurich. Dr.

Wilfingslander had done some more electronic

microscopic studies showing that definitely the

silicone of gel prostheses, and also, although in much

smaller amounts, the saline filled prosthesis...is

transported through the shell into the pseudo capsule

but furthermore, transgresses through the capsule into

the adjacent breast tissue. In microscopic studies,

it has been shown, included in the macrophages. In

addition to that, the most recent studies have shown

that silicone follows the inter-cellular space, a new

discovery that is somewhat frightening. We believe

that between the cells there are sub-microscopic,

infinitely small channels which eventually - probably

lead to the lymphatic system.

We are all very aware of the fact that the clear

shelled, thick walled prosthesis had a terrific

leakage rate. I believe, in my own hands, at the

present, 80%. ....prostheses has microscopic to large

pores through which gel can freely extrude. It doesn't

take a genius brain to conclude that the thinner the

gel, the more likely transgression through the shell

as well as into the body will occur.....that once

silicone is present in the body, in the form of

microscopic droplets, especially inter-cellularly, or

in the in-between cell phase, it becomes an

irreversible process and silicone filling the

definition of being a pollutant. "

MD 129022.

Document #27

MD 199730

Dr. G. Hamm,

Dr. E. Schatten

Dr. H. Hartley, Jr.

Dr. M. ,

Plastic & Reconstructive Surgery, Suite 111 3350

Howell Hill Road, N.W.

Atlanta, Georgia

May 13, 1978

Mr. Tom Talcott

Heyer-Schulte Corporation

Box 946

Goleta, California

Dear Tom:

Thank you very much for taking the time and effort to

bring me up to Date on what's happening in the

silicone industry. I am sorry that we can't make the

results of your findings immediately known, for I

believe, and have believed for about two years, that

this study was necessary.

I can understand Tom Hynes' anxiety over the

situation. We all have fear and trepidation over what

silicones may or may not do, but at some point in

time, since this information is known, we must, I

believe, ethically release it to the utilizers of

silicone. Again, the best way to do this may be to go

through a group of clinical investigators, as we

discussed, using the double lumen prosthesis, some

with and some without steroid. I think we can probably

get ten clinical investigators to get together over

the next two or three years, release this information

to them initially, work out a program and go from

there. This would seem ethically right to me all the

way around.

Sincerely, H. Hartley, Jr., M.D.

Document #28

ASTM F-4 COMMITTEE MEETING

Houston, Texas

November 15-18, 1978

(ASTM stands for American Standards Testing Materials

Association).

Below find my report and comments on the ASTM F-4

Committee Meeting held in Houston, Texas, November

15-18, 1978.

F 04.20.06.72 - short Term Implant Testing - Chaired

by Dr. Stanley

Brown, Dartmouth University.

This Standard now will confine it's scope to

establishing a method for " short term screening " test

of materials for biomedical implant applications.

.....which shows 95% confidence level. Argument by K.

Buchin of Extrocorporeal, that this will cause

unnecessary delays And expense.

Dr. Horowitz also warned the " industry

representatives " that the new Federal G.L. P.'s give

specific directions on the handling of lab animals

that may escalate the costs of animal testing. Further

muddying the well was the data in the Food and Drug

Administration Funded Study on this subject done by

TRAVENOL LABS, INC., which did not come to any new

conclusions on test methods.

F4.20.01.12: Polysulfane Resin for Medical

Applications - Chaired by Dr. N. Ballintyn UNION

CARBIDE COMPANY.

Dr. Gerhar Brauer of the N.B.S., pointed out that the

present specification called out " such low extractable

levels that ordinary lab equipment will be unable to

accurately make measurements. " F4.50: Neurosurgical

Subcommittee - Chaired by Dr. J. McFadden.

This session was " poorly attended " by the various

task force chairmen. The only real discussion was

regarding the proposed shunt standard. With

representatives from Dow Corning, Extracorporeal,

Heyer-Schulte,and the Bureau of Medical Devices in

attendance, a most interesting discussion took place.

It was noted that the latest draft of the Standard

contained reference to ASTM Standard F469 (originally

intended for evaluation of local tissue reaction). The

representatives from Holtar and Dow " objected to this

callout " and asked how it got into the Standard. The

Dow and Holtar folks also said that they had flow

tested their product to the proposed standard and

could not find any correlation with the present means

that they report performance tests! Many other barbs

were passed until Dr. McFadden became visibly

disturbed. F4.50.11: Protective Guards for

Neurosurgical Drills - Chaired by Dr. J. McFadden.

This initial task force session provided an

interesting insight on the way ASTM Standards begin.

In his practice, Dr. McFadden has seen " many cases " of

drills and perforators plunging through the skull and

causing brain damage. To this end, he prepared a

Standard for a yet to be invented guard to be placed

on hand and power driven neurosurgical drills. It also

appeared that he intends this " Standard " to have a

very high priority on his FDA Advisory Panel

Classification List. To this end he requested Input

from various manufactures regarding the suitability of

the Standard and how long it would be before their

equipment had such features. Only " one " hand drill

company responded, and it's response was not positive.

For the second time that day Dr. McFadden became

visibly disturbed and closed the session.

(Note: This is why citizens must be aware of what is

going on behind the scenes. Citizens can, at any time,

become a corporate victim and member of a Class Action

which has been a latent " Corporate Cover-up. " This is

Why Tort Reform is being aggressively pushed. See Tort

Reform.)

F4.l1: Opthamology - Chaired by Dr. Halberg.

This session was well attended by curious

representatives from Dow Corning, Minnesota Mining and

Manufacturing, A.O., and GAF.

The Opthamology Manufacturers Association, Stortz,

M.M.A. FDA and two consumer advocate groups. Dr.

Halbert is apparently a very political force in the

ASTM and the Contact Lens Society. To this end, he

proposed that this ASTM task force limit it's scope to

the definition of material specifications for (No. 2)

Contact Lens Materials. It was shown that the Foley

Catheter (silicone) and Neuro Shunt Standards are

being presented to the Food and Drug Administration as

samples of the type of work that " voluntary standards "

are capable of producing.

Note: Both become clogged. See Chemical Deception by

Dr. Marc Lappe.

See Forty Years of Firsts below concerning Dow

Corning's purchase of a large contact lens business at

this time).

F4.92.01: Voluntary/Regulatory Guidelines. Chaired by

Mann, ABBOTT LABORATORIES. Lamb, of the

BMD, reported that the Food and Drug Administration

would like to see most device standards enforcement to

remain " voluntary " rather than have the government

adopt mandatory guidelines.

Note: (See neuro drills in the paragraph above. FDA

is our governmental public protector or corporate

friend)?

F4.20.06: Bio-compatability Section - Chaired by Dr.

Stanley Brown, Dartmouth University.

This session was a summary of the activities of the

various bio-compatibility task force groups. The FDA

is more bogged down and is less responsive than the

ASTM at this stage of Standards enforcement.

Points of interest included: (1-4): No. 2. The effects

of particulate matter will be addressed in a new

Standard on particulate matter contamination, i.e.,

glove, talcum and sponge particles. No. 4. The

National Bureau of Standards is looking at SILICONE to

" replace polyethylene " as the USP implant material.

General Comments:

Bristol Myers, Dow Corning, 3-M, NBS, and

, B-M, were Heavily involved in committee

activities. Personalities and Rank play a heavy role

in the direction several committees are taking. Some

proposed Standards are being weakened with the

realization that they may become FDA Guidelines.

Overall, I feel that I learned much about

bio-compatibility testing and the " political workings "

of the ASTM.: Hancock. JH:ss

MD#114723

The Crux of the Cover-up: Dow Chemical had produced

polyethylene and would lose contracts. Dow Chemical's

subsidiary manufactured silicone. Monopoly on medical

materials.

Dow Chemical's subsidiary Dow Corning worked closely

with the doctor who is now President of the Plastic

Surgeons Society. A top ex-Dow Chemical executive is

now President of the American Standards for Testing

Material Association and he is pushing to put implants

back on the market to win back silicone contracts. He

is willing to sacrifice women of the future for

corporate greed. That is one of the reasons this disk

is being prepared.

What if the breast implant manufacturers had let the

public know of All the:

(1) deaths, (2) implant complications, (3) suicides,

etc., of their " implant women guinea pigs " since 1964?

General Electric, 3-M, Dow Corning, Bristol Myers,

Union Carbide, etc., had the corporate " monopoly " on

producing silicone. It would have been a " corporate

coup de grais. "

Document #29

Heyer-Schulte Interoffice Correspondence: MD#121382

From: tom Hyans

Date: December 21, 1978

Cave

cc: Hancock, Kris Foss,

Encs:

:

Note the attached correspondence from Dr. Henry

and my memo to you of November 15, regarding prior

discussions with Dr. . Concerning the prior memo:

There was a comment on the second page above a device

implanted by , which was explanted by a surgeon

in Augusta, Florida. The device explanted contained a

growth which was identified as a " fungus. "

Also, on the same page of that memo, I recalled for

you the association between Dr. Smahel of Zurich and

Dr. and the fact that both of these gentlemen

are busily documenting the occurrence of

silicone-containing capsular vacuoles and

para-capsular fibrosis surrounding silicone-like

materials in para-capusular tissue. Dr.

suggested that it might be worth our while to invite

Dr. Smahel to Goleta for a visit and discuss his

research. I might add that the literature for the last

few years has contained papers in a similar vein. It's

not apparent to me that there is anything newsy in Dr.

Smahel's data, except for the fact that Dr. is

busily transmitting this data that he receives from

Dr. Smahel to the Food and Drug Administration. As you

will note in his November 30th letter, he indicates

that he has sent more information to Dr. Parrish, who

is the Executive Secretary representing the Food and

Drug Administration on the Plastic Surgery Devices

Classification Panel, but has received NO RESPONSE

from him.

The bottom paragraph of Page one begins Dr. 's

commentary on some explained mammary prostheses which

he returned to me through Vicki Jung.

By a copy of my memo to Bob Jerks, I have informed you

of " what I intend to do with those. " Note that his

reference to " liquid silicone " is not to injectable

silicone, but rather to the silicone which is

described in his pathology reports as being

" extravated silicone in the walls of the fibrous

pseudocapsules. " The slides which he describes are

" moderately " interesting. They have been turned over

to Bob Jenks.

TEH:ss

MD#121383

Document #30

#J0000218

British Journal of Plastic Surgery (1976) Exudation

of Silicones Through the Envelope of Gel-Filled Breast

Prostheses:

An in Vitro Study

By B. Bergman, Plastic Surgeon and A. E. Van

Der Endy, Analytical chemist, Department of Plastic

and Reconstructive Surgery and Clinical Chemistry,

Amsterdam, Holland

An annoying experience induced this study. A silicone

gel-filled breast prosthesis, occasionally shown to

patients desiring augmentation, was laid aside in a

cabinet on top of a pile of newly printed writing

paper. Some time elapsed before this stationary was to

be used and, on removing the prosthesis, I found a

greasy patch exactly underneath. Respectfully, I

counted the waste of 203 sheets and shortly afterwards

I recalled that the total amount of the substance in

the paper could hardly be derived from the sweaty

hands which ever held the prosthesis. More likely, it

had something to do with the filling but, when asked,

none of the agencies (companies) distributing mammary

implants could supply information.

Because of the increasing problems of capsule

formation around implanted breast prostheses, it was

thought to be of interest to measure the degree of

diffusion of silicone gel through the envelope of

various readily available prostheses in vitro,

especially since, while manufacturers do give detailed

information of the technical properties of their

product, there is " no mention of any leakage

phenomenon. "

In all the histological studies of capsular tissue

around breast implants, silicone particles coming from

all prostheses were present.

It may be assumed that they play an important role in

the constrictive fibrosis (Wilfingseder et al., 1974),

Smahel (1977) leaves the mechanism of the interaction

between prosthesis and capsule. Our preliminary

findings on silicone gel " leakage " in vitro support

the findings of these studies. If colloidal silicone

enters the tissues, it may cause a local granulomas,

be transported in " granules " to the lymph glands and

it can produce serious lesions. Should it enter the

blood stream, it might be filtered by vital Organs and

give rise to systematic diseases. #J0000220.

Summary: This is a summary of 2,000 mammoplasties

scanning a period of ten years. The formation of a

scar around a mammary prosthesis is physiological. It

is called " pseudo encapsulation. " It lacks epithelium

and elastic tissues. Mycotic and bacterial infection,

discreet as well as chronic lead to an immediate,

slowly progressive fibrous capsule.

Contamination with the liquid silicone from the gel

leads to a parcapusular as well as perivascular

fibrosis (siliconomas). It is a slow, and progressive

process, that ends with the intravasion of the liquid

silicone.

Secondary infection transmitted via the circulatory

system leads to a " delayed " but sudden fibrous

capsule. Immunosensitization leads to a delayed, yet

acute edema, as well as a progressive fibrous capsule.

GOTCHA!: Note: Sure is more definitive than the Mayo

or Harvard. Look at their own number of 2,000

mammoplasties vs. the 749 in the other manufactured

paid-for " hype " studies. Look at the length of time-

ten years. Look at the results.

Document #30: Page 3 Continued: Heyer-Schulte: Baxter

International

#77972 (Continued).

Contents of the Saline Prosthesis:

The prosthesis is comprised of saline, dextran,

hydrocortisone, " gel and silicone. " The silicone wall

of the prosthesis is comprised of a semi-permeable

membrane. (Allows fluids to disperse, yet also allows

body fluids to enter the chamber.) Dr. Smahel was

equally successful at discovering the presence of

intracapillary microdroplets. This serves to prove the

migration of liquid silicone from the gel through the

prosthetic wall, pseudocapsule and glandular mammary

tissue as well as the circulatory system. The invasion

of the blood vessels and lymphatic ganglions by the

liquid silicone " was ascertained years ago. " The

hystological image of the para-capusular fibrosis

after injection of the liquid silicone " is identical "

to that of the silicone liquid originating from the

gel. It should be a matter of concern that the liquid

silicone will causethrombosis of the capillaries of

the brain, as well as the liver and kidneys. The human

body is not capable of catabolizing the silicons. The

resulting condition is one of " pollution. " Baxter

International #77972.

In 80% of all cases, this phenomenon is preceded by

either a dental abscess, an acute inflamation of the

gallbladder, etc. This brings to mind streptococcus

hemolyticus infection, followed by arthritis,

nephritis and endocardial rheumatism.

Baxter International #77974.

Document #24:

Heyer-Schulte Corporation

Interoffice Correspondence

Date: June 16, 1976

From: Jim Rudy

Sub: Dr. Vinnicks' Visit to Heyer-Schulte

Friday, June 18, 1976

Ken Eckardt

cc: Sam Koorajian, Tom Talcott, Joe Utt, Bob

The problem: Dr. Vinnick is concerned that that the

GENERAL ELECTRIC GEL used in mammaries is: (1) NOT

cohesive and (2) is TOXIC.

Heyer-Schulte is the most professionally responsive

manufacturer of mammy implants: (1) Willingness to

standup and " tell it like it is " concerning gel bleed

and migration-wise. (2) Conservative " recall " of clear

shell inflatables. (3) Heyer-Schulte intends to make

this professional posture increasingly evident. In all

product areas we have made a commitment to ourselves

to publish a fair summary of complaints received to

doctor's of record by the end of this year. Special

letters will, of course, be prepared at such times as

knowledge of a problem becomes know.

We believe that all gel used in current " responsive "

mammary implants will migrate; all silicone gives some

mild foreign body response. The literature includes

examples of inflammation, polynuclear giant cell and

white cell response, classified as mild foreign body

reaction to: Dow Corning's 360 Medical Grade Fluid

(Vinnick's paper), Silastic 372, smooth shell material

(Vistnes studies in collaboration with Heyer-Schulte.)

These reactions appear quite consistent with that

known to us resulting from direct exposure of the gel

used in Heyer-Schulte mammary implants. We presume

that the Dow Corning " responsive gel " will give a mild

transitory foreign body response similar to that

reported in the above materials. Migrating gel will

amplify this effect since literature and studies

indicate that these minimal foreign body responses are

more prevalent in the first month after implant and

subside thereafter. Thus, migrating gel would tend to

CONTINUOUSLY expose new tissue to a " fresh implant. "

we want dr. Vinnick to understand the extent of our

activities and the degree of our concern in these

areas.

Jim, JR:ja.

Baxter # International 48798.

Document #25

Heyer Schulte

MD129596

Date: August 2, 1977

H. Penoff, M.D.

Straub Clinic and Hospital

888 South King Street

Honolulu, HI 96813

Dear Dr. Penoff,

In your letter of July 6th, you asked if I could send

you information or reprints regarding silicone

chemistry, particularly in reference to bleed rates,

analysis of these and biological implications of this.

to my knowledge, there is nothing published or in the

form that I can send regarding these matters.

The work we have done to date is rather sketchy and it

will be the cooperative work with you that will help

us to look at the composition of bleed and bleed rates

and arrive at the biological implications.

We can say generically, that the bleed that comes

through the mammary prosthesis is very similar to the

silicone fluids that have been ....injections.....I

will be happy to discuss this in greater length with

you if we meet in San Franciso at the October Plastic

Surgery Meeting. Sincerely, Heyer-Schulte Corporation,

T. D. Talcott, Director, Materials Research and

Development.

TDT:dk

cc: Ken Eckardt, Jim Rudy, Bob Pudenz, M.D., R.

Alastair Winn, Rudi Schulte.

Document #26

Henry , M. D.

Plastic and Cosmetic Surgery

November 17, 1977

Mr. Rudi Schulte

Heyer-Schulte Corporation

A subsidiary of American Hospital

600 Pine Avenue

Goleta, CA 93017

Dear Rudi:

" ..... I had a chance to visit Dr. Wilfingslader in

Innsbruck and also visit Dr. Smahel in Zurich. Dr.

Wilfingslander had done some more electronic

microscopic studies showing that definitely the

silicone of gel prostheses, and also, although in much

smaller amounts, the saline filled prosthesis...is

transported through the shell into the pseudo capsule

but furthermore, transgresses through the capsule into

the adjacent breast tissue. In microscopic studies, it

has been shown, included in the macrophages. In

addition to that, the most recent studies have shown

that silicone follows the inter-cellular space, a new

discovery that is somewhat frightening. We believe

that between the cells there are sub-microscopic,

infinitely small channels which eventually - probably

lead to the lymphatic system.

We are all very aware of the fact that the clear

shelled, thick walled prosthesis had a terrific

leakage rate. I believe, in my own hands, at the

present, 80%. ....prostheses has microscopic to large

pores through which gel can freely extrude. It doesn't

take a genius brain to conclude that the thinner the

gel, the more likely transgression through the shell

as well as into the body will occur.....that once

silicone is present in the body, in the form of

microscopic droplets, especially inter-cellularly, or

in the in-between cell phase, it becomes an

irreversible process and silicone filling the

definition of being a pollutant. "

MD 129022.

Document #27

MD 199730

Dr. G. Hamm,

Dr. E. Schatten

Dr. H. Hartley, Jr.

Dr. M. ,

Plastic & Reconstructive Surgery, Suite 111

3350 Howell Hill Road, N.W.

Atlanta, Georgia

May 13, 1978

Mr. Tom Talcott

Heyer-Schulte Corporation

Box 946

Goleta, California

Dear Tom:

Thank you very much for taking the time and effort to

bring me up to date on what’s happening in the

silicone industry. I am sorry that we can’t make the

results of your findings immediately known, for I

believe, and have believed for about two years, that

this study was necessary. I can understand Tom Hynes’

anxiety over the situation. We all have fear and

trepidation over what silicones may or may not do, but

at some point in time, since this information is

known, we must, I believe, ethically release it to the

utilizers of silicone. Again, the best way to do this

may be to go through a group of clinical

investigators, as we discussed, using the double lumen

prosthesis, some with and some without steroid. I

think we can probably get ten clinical investigators

to get together over the next two or three years,

release this information to them initially, work out a

program and go from there. This would seem ethically

right to me all the way around.

Sincerely, H. Hartley, Jr., M.D.

Document #28

ASTM F-4 COMMITTEE MEETING

Houston, Texas

November 15-18, 1978

(ASTM stands for American Standards Testing Materials

Association).

Below find my report and comments on the ASTM F-4

Committee Meeting held in Houston, Texas, November

15-18, 1978.

F 04.20.06.72 - short Term Implant Testing - Chaired

by Dr. Stanley Brown, Dartmouth University.

This Standard now will confine it's scope to

establishing a method for " short term screening " test

of materials for biomedical implant applications.

.....which shows 95% confidence level. Argument by K.

Buchin of Extrocorporeal, that this will cause

unnecessary delays and expense.

Dr. Horowitz also warned the " industry

representatives " that the new Federal G.L. P.'s give

specific directions on the handling of lab animals

that may escalate the costs of animal testing. Further

muddying the well was the data in the Food and Drug

Administration Funded Study on this subject done by

TRAVENOL LABS, INC., which did not come to any new

conclusions on test methods.

F4.20.01.12: Polysulfane Resin for Medical

Applications - Chaired by Dr. N. Ballintyn UNION

CARBIDE COMPANY. Dr. Gerhar Brauer of the N.B.S.,

pointed out that the present specification called out

" such low extractable levels that ordinary lab

equipment will be unable to accurately make

measurements. "

F4.50: Neurosurgical Subcommittee - Chaired by Dr. J.

McFadden. This session was " poorly attended " by the

various task force chairmen. The only real discussion

was regarding the proposed shunt standard. With

representatives from Dow Corning, Extracorporeal,

Heyer-Schulte, and the Bureau of Medical Devices in

attendance, a most interesting discussion took place.

It was noted that the latest draft of the Standard

contained reference to ASTM Standard F469 (originally

intended for evaluation of local tissue reaction). The

representatives from Holtar and Dow " objected to this

callout " and asked how it got into the Standard. The

Dow and Holtar folks also said that they had flow

tested their product to the proposed standard and

could not find any correlation with the present means

that they report performance tests! Many other barbs

were passed until Dr. McFadden became visibly

disturbed.

F4.50.11: Protective Guards for Neurosurgical Drills -

Chaired by Dr. J. McFadden. This initial task force

session provided an interesting insight on the way

ASTM Standards begin. In his practice, Dr. McFadden

has seen " many cases " of drills and perforators

plunging through the skull and causing brain damage.

To this end, he prepared a Standard for a yet to be

invented guard to be placed on hand and power driven

neurosurgical drills. It also appeared that he intends

this " Standard " to have a very high priority on his

FDA Advisory Panel Classification List. To this end he

requested input from various manufactures regarding

the suitability of the Standard and how long it would

be before their equipment had such features. Only

" one " hand drill company responded, and it's response

was not positive. For the second time that day Dr.

McFadden became visibly disturbed and closed the

session.

(Note: This is why citizens must be aware of what is

going on behind the scenes. Citizens can at any time

become a corporate victim and member of a Class Action

which has been a latent " Corporate Cover-up. " This is

why Tort Reform is being aggressively pushed. See Tort

Reform.) F4.l1: Ophthalmology - Chaired by Dr.

Halberg.

This session was well attended by curious

representatives from Dow Corning, Minnesota Mining and

Manufacturing, A.O., and GAF. The Opthamology

Manufacturers Association, Stortz, M.M.A. FDA and two

consumer advocate groups. Dr. Halbert is apparently a

very political force in the ASTM and the Contact Lens

Society. To this end, he proposed that this ASTM task

force limit it's scope to the definition of material

specifications for (No. 2) Contact Lens Materials. It

was shown that the Foley Catheter (silicone) and Neuro

Shunt Standards are being presented to the Food and

Drug Administration as samples of the type of work

that " voluntary standards " are capable of producing.

Note: Both become clogged. See Chemical Deception by

Dr. Marc Lappe. See Forty Years of Firsts below

concerning Dow Corning’s purchase of a large contact

lens business at this time).

F4.92.01: Voluntary/Regulatory Guidelines. Chaired by

Mann, ABBOTT LABORATORIES. Lamb, of the

BMD, reported that the Food and Drug Administration

would like to see most device standards enforcement to

remain " voluntary " rather than have the government

adopt mandatory guidelines.

Note: (See neuro drills in the paragraph above. FDA is

our governmental public protector or corporate

friend)?

F4.20.06: Bio-compatibility Section - Chaired by Dr.

Stanley Brown, Dartmouth University.

This session was a summary of the activities of the

various bio-compatability task force groups. The FDA

is more bogged down and is less responsive than the

ASTM at this stage of Standards enforcement. Points of

interest included: (1-4): No. 2. The effects of

particulate matter will be addressed in a new Standard

on particulate matter contamination, i.e., glove,

talcum and sponge particles. No. 4. The National

Bureau of Standards is looking at SILICONE to " replace

polyethylene " as the USP implant material.

General Comments:

Bristol Myers, Dow Corning, 3-M, NBS, and

, B-M, were heavily involved in committee

activities. Personalities and Rank play a heavy role

in the direction several committees are taking. Some

proposed Standards are being weakened with the

realization that they may become FDA Guidelines.

Overall, I feel that I learned much about

bio-compatibility testing and the " political workings "

of the ASTM.: Hancock. JH:ss

MD#114723

The Crux of the Cover-up: Dow Chemical had produced

polyethylene and would lose contracts. Dow Chemical's

subsidiary manufactured silicone. Monopoly on medical

materials.

Dow Chemical's subsidiary Dow Corning worked closely

with the doctor who is now President of the Plastic

Surgeons Society. A top ex-Dow Chemical executive is

now President of the American Standards for Testing

Material Association and he is pushing to put implants

back on the market to win back silicone contracts. He

is willing to sacrifice women of the future for

corporate greed. That is one of the reasons this disk

is being prepared. What if the breast implant

manufacturers had let the public know of all the: (1)

deaths, (2) implant complications, (3) suicides, etc.,

of their " implant women guinea pigs " since 1964?

General Electric, 3-M, Dow Corning, Bristol Myers,

Union Carbide, etc., had the corporate " monopoly " on

producing silicone. It would have been a " corporate

coup de grais. "

Document #29

Heyer-Schulte Interoffice Correspondence: MD#121382

From: tom Hyans

Date: December 21, 1978

Cave

cc: Hancock, Kris Foss,

Encs:

:

Note the attached correspondence from Dr. Henry

and my memo to you of November 15, regarding prior

discussions with Dr. . Concerning the prior memo:

There was a comment on the second page above a device

implanted by , which was explanted by a surgeon

in Augusta, Florida. the device explanted contained a

growth which was identified as a " fungus. "

Also, on the same page of that memo, I recalled for

you the association between Dr. Smahel of Zurich and

Dr. and the fact that both of these gentlemen

are busily documenting the occurrence of

silicone-containing capsular vacuoles and

para-capsular fibrosis surrounding silicone-like

materials in para-capusular tissue. Dr.

suggested that it might be worth our while to invite

Dr. Smahel to Goleta for a visit and discuss his

research. I might add that the literature for the last

few years has contained papers in a similar vein. It's

not apparent to me that there is anything newsy in Dr.

Smahel's data, except for the fact that Dr. is

busily transmitting this data that he receives from

Dr. Smahel to the Food and Drug Administration. As you

will note in his November 30th letter, he indicates

that he has sent more information to Dr. Parrish, who

is the Executive Secretary representing the Food and

Drug Administration on the Plastic Surgery Devices

Classification Panel, but has received NO RESPONSE

from him.

The bottom paragraph of Page one begins Dr. 's

commentary on some explained mammary prostheses which

he returned to me through Vicki Jung. By a copy of my

memo to Bob Jerks, I have informed you of " what I

intend to do with those. " Note that his reference to

" liquid silicone " is not to injectable silicone, but

rather to the silicone which is described in his

pathology reports as being " extravated silicone in the

walls of the fibrous pseudocapsules. " The slides which

he describes are " moderately " interesting. They have

been turned over to Bob Jenks.

TEH:ss

MD#121383

Document #30

#J0000218

British Journal of Plastic Surgery (1976)

Exudation of Silicones Through the Envelope of

Gel-Filled Breast Prostheses:

An in Vitro Study

By B. Bergman, Plastic Surgeon and A. E. Van

Der Endy, Analytical chemist, Department of Plastic

and Reconstructive Surgery and Clinical Chemistry,

Amsterdam, Holland

An annoying experience induced this study. A silicone

gel-filled breast prosthesis, occasionally shown to

patients desiring augmentation, was laid aside in a

cabinet on top of a pile of newly printed writing

paper. Some time elapsed before this stationary was to

be used and, on removing the prosthesis, I found a

greasy patch exactly underneath. Respectfully, I

counted the waste of 203 sheets and shortly afterwards

I recalled that the total amount of the substance in

the paper could hardly be derived from the sweaty

hands which ever held the prosthesis. More likely, it

had something to do with the filling but, when asked,

none of the agencies (companies) distributing mammary

implants could supply information.

Because of the increasing problems of capsule

formation around implanted breast prostheses, it was

thought to be of interest to measure the degree of

diffusion of silicone gel through the envelope of

various readily available prostheses in vitro,

especially since, while manufacturers do give detailed

information of the technical properties of their

product, there is " no mention of any leakage

phenomenon. "

In all the histological studies of capsular tissue

around breast implants, silicone particles coming from

all prostheses were present. It may be assumed that

they play an important role in the constrictive

fibrosis (Wilfingseder et al., 1974), Smahel (1977)

leaves the mechanism of the interaction between

prosthesis and capsule. Our preliminary findings on

silicone gel " leakage " in vitro support the findings

of these studies. If colloidal silicone enters the

tissues, it may cause a local granulomas, be

transported in " granules " to the lymph glands and it

can produce serious lesions. Should it enter the blood

stream, it might be filtered by vital organs and give

rise to systematic diseases. #J0000220.

Summary: This is a summary of 2,000 mammoplasties

scanning a period of ten years. The formation of a

scar around a mammary prosthesis is physiological. It

is called " pseudoencapsulation. " It lacks epithelium

and elastic tissues. Mycotic and bacterial infection,

discreet as well as chronic lead to an immediate,

slowly progressive fibrous capsule. Contamination with

the liquid silicone from the gel leads to a

parcapusular as well as perivascular fibrosis

(siliconomas). It is a slow, and progressive process,

that ends with the intravasion of the liquid silicone.

Secondary infection transmitted via the circulatory

system leads to a " delayed " but sudden fibrous

capsule. Immunosensitization leads to a delayed, yet

acute edema, as well as a progressive fibrous capsule.

GOTCHA!: Note: Sure is more definitive than the Mayo

or Harvard. Look at their own number of 2,000

mammoplasties vs. the 749 in the other manufactured

paid-for " hype " studies. Look at the length of time-

ten years. Look at the results.

Document #30: Page 3 Continued: Heyer-Schulte: Baxter

International #77972 (Continued). Contents of the

Saline Prosthesis:

The prosthesis is comprised of saline, dextran,

hydrocortisone, " gel and silicone. " The silicone wall

of the prosthesis is comprised of a semi-permeable

membrane. (Allows fluids to disperse, yet also allows

body fluids to enter the chamber.) Dr. Smahel was

equally successful at discovering the presence of

intracapillary microdroplets. This serves to prove the

migration of liquid silicone from the gel through the

prosthetic wall, pseudocapsule and glandular mammary

tissue as well as the circulatory system. The invasion

of the blood vessels and lymphatic ganglions by the

liquid silicone " was ascertained years ago. " The

hystological image of the para-capusular fibrosis

after injection of the liquid silicone " is identical "

to that of the silicone liquid originating from the

gel. It should be a matter of concern that the liquid

silicone will cause thrombosis of the capillaries of

the brain, as well as the liver and kidneys. The human

body is not capable of catabolizing the silicons. The

resulting condition is one of " pollution. " Baxter

International #77972.

In 80% of all cases, this phenomenon is preceded by

either a dental abscess, an acute inflammation of the

gallbladder, etc. This brings to mind streptococcus

hemolyticus infection, followed by arthritis,

nephritis and endocardial rheumatism.

Baxter International #77974.