Part 3 of 4 - Court Documents: Manufacturers' Internal Memos

[Guest guest]

Subj: Part 3 of 4 - Court Documents: Manufacturers'

Internal Memos

From anonymous sister - scanned but not corrected -

possibly from the Catch files

THE HEYER-SCHULTE HOT MEMOS: Baxter International

Note: American Hospital Supply Corporation had much

earlier purchased Dow Chemical's Bioscience

Enterprise, Inc. The Heyer Schulte Corp. was then a

subsidiary of the American Hospital Supply

Corporation. As Baxter Travenol Labs, Baxter Travenol

had previously tested breast implants for Heyer

Schulte Corporation. This testing was done BEFORE

Baxter Travenol Labs purchased American Hospital

Supply Corporation and Heyer Schulte. Later, when

Baxter Travenol Labs had purchased American Hospital

Supply Corporation AND Heyer Schulte, it then changed

its name to become Baxter International.

Heyer-Schulte was a medial devices subsidiary company

of The American Hospital Supply Corporation. In 1972,

it lured several scientists and salesmen from Dow

Corning to start their own breast implant business,

The McGhan Corp. McGhan of The Dow Corning

Corp., led the group. Two years later, in 1974, Don

McGhan started his own breast implant company, McGhan

Medical Corporation in Santa Barbara, California. The

Minnesota Mining and Manufacturing Co. purchased

McGhan Medical. Don McGhan then formed another

company, Mentor Corp. The FDA is still allowing Don

McGhan's second company, The Mentor Corp., to

manufacture breast implants.

The Women now must sign AN INFORMED CONSENT FORM, and

the company MUST maintain a patient database. The

Heyer-Schulte Hot Memos also reveal the deliberate and

massive " corporate cover-up " and also, the

" intermarriage corporate connections " of these

corporations. Many of the breast implant scientists,

engineers, etc., made the implant circuit and worked

at each of the manufacturer's plants. They all knew

each other.

HEYER SCHULTE HOT MEMOS:

Document #13:

Baxter International - Heyer Schulte

Baxter 78608,78609,78610, 78611,78612,

78613,7861478615,7861678617,78618

J. Rudy,

Heyer-Schulte Corp.

Date: July 14, 1976

From: G. Frugard

SUBJECT: TRIP TO DOW CORNING

There are both positive and negative aspects to my

trip to Dow Corning. On the positive side, I feel that

I was successful in bringing back a comprehensive

summary (much of it verbatim) of all their animal

data, or at least all that I was given access to. The

negative aspect is that the data doesn't answer the

key questions I presented to Dow concerning migration

and the consequences. Also, as you will see, many of

these experiments were not well controlled.

(He met with Joe Radzius, Dow Corning attorney, and

FDA and legal liaison who knows Jim Rudy well and

sends his regards.)

The format of our meeting will probably be used by

Dow Corning with other interested parties, due, for

the most part, to Dow's concern over making statements

concerning the safety and efficacy of their material,

which may be difficult to substantiate (my

interpretation) based on conversation.

Dow Corning is concerned about the Amendments to the

Food and Drug Commission (FDA) and what will be

required of them. Top management is apprehensive about

the withdrawal of General Electric and Rhone-Poulenc

and others from the medical segments of the elastomer

market. Whether or not we want to be more specific and

emphatic about the possible hazards of uncontained

silicone is a decision that will need to be made. A

general summary of such complications would include:

(1-4 and 5: migration of the silicone, with mild to

severe consequences, including reduction of (blanked

out)....breast size and absorption of the silicone by

the blood and lymph systems, resulting in damage to

the liver and kidneys. Epidermal response was focal

and consisted of sicharosis, a canthosis and

hyperkeratosis.

The dermal reaction was situationed beneath the

epidermal lesion and consisted of a small focus of

fibroblasts and capillary proliferation accompanied by

a mononuclear cell inflammatory infiltration. Main

reaction of test group: Mononuclear infiltration;

foreign body giant cells; almost all minimal or

minimal to moderate connective tissue proliferation.

Document #14

Baxter International #78611

Biometric Testing, Inc.

Biometric Laboratory, New Jersey

Rabbit Implant With Histopathology Of Gel Implants:

Twenty-one days past implants animals killed. An

autopsy was performed on each rabbit. All tissues and

organs fixed pending instructions from Dow.

(No instructions were sent.)

Findings: Histopath exam - of muscle sites revealed

mild to acute inflammatory reaction. The reaction (at

every site) was characterized by a typical

inflammatory cell infiltrate with or without

fibroblastic activity.

..... " 14 day - death - rabbit died 4 days past

implant: pulmonary congestion, G.I. hemorrhaging and

general " atrophy of all major organs. "

Reference # A-1544:

March 6, 1975

Chief Investigator: Carson, Ph.D.

He viewed the Dog Study and copied verbatim: Baxter

Id.

#78616,78617,78618.

See Below: Study: Chronic Implantation Studies of

Polysiloxanes in Dogs.

Document #15:

HRONIC IMPLANTATION STUDIES OF POLYSILOXANES IN DOGS:

Laboratory: Food and Drug Research Laboratories

Maurice Avenue at 58th Street

Maspath, New York

Chief Investigator: Carson, Ph.D., Director,

Biological

Division

REFERENCE: Report:

Chronic Implantation Studies of Polysiloxanes in

Dogs: Covers three-year studies of effects in dogs of

implanted plastic materials in both cured and uncured

states and in physical forms of solid film, perforated

film, sponge amorphousforms and miniature artificial

breasts over protracted periods.

STUDY DESCRIPTION:

Pure bred beagles 5-7 months age. Each sample

implanted in four replicates which were excised, one

or two at a time at three, nine and twenty-four or

thirty-six months.

RESULTS:

" The site of the intramuscular implant DCX-0885 was

surrounded by a lining of granulamatous inflammation

tissue in one dog and hyalinized connective tissue

reaction of 3+ in another and a fibrous reaction 1+ in

a third animal.

CONCLUSION:

Table #1: Study Results for DCX-3-0885:

(a) The conclusion reached in study #1: " perhaps all

gels were reactive. "

( Concerning migration: Study #IV indicates that

the gel migrates at least into the capsule,

" ....multiple small oval spaces containingfragments of

clear (nonfibrogenic) test material were often present

in the connective tissue capsule that surrounded the

main implant site. "

Unfortunately, the data collected in this study does

not answer questions concerning migration, even though

that was the main objective (of the study.)

Attachments: Page two of letter to Heyer-Schulte from

Dow concerning disclosure, signed by Mac

stating that: I complied with their request for copies

of my notes.

Frugard

GF/id

Attachments: Page two of letter to Heyer-Schulte from

Dow concerning disclosure, signed by Mac

stating that: I complied with their request for copies

of my notes.

Document #16:

Ineroffice Correspondence

Heyer Schulte Corporation

Date: October 17, 1975

From: Jim Rudy

Sub: Mammaries

Account Representatives and Regional Managers:

Regional Managers

Ray Hanacek

East*

Rudi Schulte

TRADE SECRET

MB 184487,184488

Since my arrival at Heyer-Schulte, I have been taught

that " soft is good " in discussing mammaries,

especially gel-filled mammaries....with these

considerations in mind, two weeks ago Dick Polito

obtained for us twelve mammaries of McGhan manufacture

and a similar quantify of Dow-Coring units.

These were delivered along with a similar quantify of

Heyer-Schulte mammaries to the people at the Corporate

Technology Center in Santa Ana for comparative

physical testing. Gel viscosity was compared by

placing samples from each manufacturer in a

cylindrical container as pictured and measuring the

time for a steel ball to fall through the mass. The

results indicate a startling difference. Time for the

steel ball to fall through gels of each manufacturer

were:

Heyer-Schulte - 4075 seconds

Dow Corning - 3330 seconds

McGhan 55 seconds. No wonder McGhan's (3-M) feels

softer. Their gel is virtually not crosslinked.

Document #17

Heyer-Schulte: Interoffice Memo

Date: October 30, 1975

From: Jim Rudy, President of Heyer Schulte

Beverly Siow

cc: Joe Utt, Tom Hyans, East

Attched is a copy of " Injectable Fluid Silicone

Therapy - Human Morbidity and Mortality " by

Ellenbogen, M. D.; Rita Ellenbogen, M. D., Leonard

Rubin, M. D.

This paper describes problems relating to physical

migration Including Liver dysfunction, and foreign

body granuloma inn four victims of silicone

injection. It is my understanding that similar

mononuclear and giant cell reaction results in some

patients wherein silicone gel has escaped from the

shell.

Jim Rudy JR:ja (Note: And the silicone envelope).

Document #18

Interoffice Memo

TRADE SECRET

MB184489

Heyer-Schulte

Date: November 20, 1975

From: Jim Rudy, President

Sub: More on Mammary Safety vs. Performance

We are working on preparation of the gel filled

mammary comparisons by an independent lab, which I

promised in my letter of October 17, 1975. I am

advised that some significant number of customers

(plastic surgeons,) don't particularly doubt the

conclusions, but are not impressed with the importance

of gel-viscosity or shell strength.

I suggest that this is a naive position and one which

will be changing in the relatively near future.

To illustrate, Heyer-Schulte now has 15 active law

suits involving leaking mammary implants. Of these

fifteen, nine occurred in 1975 alone.

At the ASPRS (American Society of Plastic and

Reconstructive Surgeons) in Toronto, I attended a

session and was amazed at the Naiveteacute; of several

plastic surgeons who rose to discuss ruptured

implants. They seemed to believe that all gel was

either " cohesive " or " non-cohesive " , and that it would

be sold in a mammary implant only if it were the

former.....I believe these factors are important. I

recognize that this type of information must be used

carefully, as it is not our policy to sell by knocking

competition.

.....the hazards which could be associated with use

of our products and with which they may not be as

familiar as they could be.

Jim Rudy - cc: Ray Hanacek, East, Rudi Schulte

Document #19

Heyer-Schulte Corporation

American Hospital Supply Corporation/(Baxter

International Corp.)

MB184491

400 Pine Avenue

Goleta, California

March 29, 1976

Cauley , M.D.

1010 East Third Street

Chatanooga, Tennessee 37403

Dear Dr. :

This letter is to follow-up and confirm elements of

our telephone conversation of March 23. We were

concerned with one of your patients who had been

augmented with.......until approximately 10 months

post-implant.

Despite apparently commonly held opinions to the

contrary, it is not surprising that migration of the

gel occurred........In such cases, it has been our

practice to attempt to maintain rapport with such

patients by reacting rapidly with a humanistic concern

and expressing a willingness to minimize any financial

impact that such disappointing results incur.

Accordingly, without implying liability on our part;

but in an effort to help this patient and maintain

good relations with our public, we would be happy to

supply replacement implants and if the situation

warrants, we could also consider defraying hospital

expenses. Please keep us posted on ANY situation which

develops with this patient.

Sincerely, A. Rudy, President; JR;je

Document #20

Baxter International: #79038

Memo: March 5, 1976

Bob:

Here are the mammary papers. I've separated them into

two piles.

The Folder with the pink star on the front contains

those papers (arranged alphabetically by author) which

seem to me most useful for extracting data.....the

other pile contains the papers which seemed to me less

useful.....papers dealing mainly with matters of

surgical technique (which I assume we want to say

little---if anything-about....

Betsy.

Document #21

WARNINGS

BAX 79042-79045

" .....the silicone rubber mammary envelope has a law

tear strength....note:

Gel prostheses may be easily ruptured when still hot

from the autoclave....the gel interior of these

products is vulcanized to minimize the migration of

gel should a rupture occur in the silicone envelope.

However, should the silicone envelope be ruptured,

Heyer-Schulte cannot guarantee reliable gel

containment, and the prosthesis should be replaced.

Whether or not we want to be more specific and

emphatic about the possible hazards of un-contained

silicone is a decision that will need to be made.

Most pertinent here are the papers on the

complications of silicone injections: " Ellenboggen,

Injectable Fluid Silicone Therapy, " " Symmara, Silicone

Mastitis in Topless Waitresses. " and most especially

the paper by Boo-Cahi on " The Complications of

Augmentation Mammaplasty by Silicone Injects, " which

discusses the problems resulting from injecting a

vulcanized (gel-type) silicone.

A general summary of such complications would

include:

(1). one recorded case of intravascular injection of

silicone resulting in death;

(2). hypo-pigmentation of the breast;

(3). hard, nodular lumps;

(4). silicone mastitis;

(5). migration of the silicone, with mild to severe

consequences, including reduction of (.......whited

out) and absorption of the silicone by the blood and

lymph systems, resulting in damage to the liver and

kidneys;

See also Goldwyn, " An Unusual Complication of the Use

of the Cronin Implant for Augumentation Mammaplasty, "

who reports a case of wound infection.

Cronin and Greenbert, " Our experiences with the

Silastick Gel Breast Prosthesis, " pg. 4. Guardian,

" Complications of Breast Implantations, Pg 32;

infection is manifested by swelling, tenderness, pain,

fever and a positive culture. It may appear in the

immediate postoperative period or weeks, months, or

even years after insertion of the implant. IN THE

ABSENCE OF CLASSIC SYMPTOMS, sub-acute or chronic

infections may be DIFFICULT to diagnose. " ,

" Silastic Breast Implants: Coping with Complications,

p. 590, neural complications, etc., have been

reported. See also articles by Freeman, Courtiss,

Gurdin, , Owsley, McKinney, McDougall, Corso, De

Cholnoky, Rubin, Berens, , Conway, ,

Synder, , Brauer, Goldwyn, Psillakis, Bing,

Brown, Dunsif, Stubenbord, Conway, Schwager, Gutherie,

Imber, Lipshutz, Little, Nedelman, Mazzoni, Peacock,

Van Winkle, Ross, Ballantyne, etc. "

(Published articles by Plastic Surgeons).

Notation: Houston physician, Dr. Cronin, was the

inventor of the first mammary implant. The next three

pages reference articles written by plastic surgeons

relating to complications from silicone envelope and

silicone gel implants. Papers written by world-wide

plastic surgeons as far back as late 1960s and

submitted to their journals but never disclosed to the

public.

The Plastic Surgeons & Reconstructive Society (ASPRS),

and the AMA, knew as early as the 1960's of the

complications and dangers, but did not advise the

public. They kept implanting. They got richer. They

and the AMA joined forces with the breast implant

manufacturers: i.e. the infamous Mayo Clinic, Harvard

Report, and the New England Journal Reports with their

financial contributions.

Document #22

Veterans Administration Hospital

Palo Alto, California 94304

When replying, refer to 640/112

Baxter International #37080

April 29, 1976

Mr. Ken Eckhardt

Product Director, Plastic Surgery

Heyer-Schulte Corporation

P. O. Box 946

Goleta, California 93017

Dear Mr. Eckhardt:

Enclosed is a copy of our paper on " Local Tissue

Reaction to Ruptured Thin Gel Prostheses. " This paper

has been submitted for publication in Plastic and

Reconstructive Surgery.

The enclosed manuscript and illustrations will also

serve as our final report to you on the research

project on this problem which was partially funded by

your company. Should you have any further questions,

we would be more than happy to endeavor to supply the

answers.

We are still more than anxious to complete our study

on the effects of steroids as the capsule formation

around these implants. A small pilot study has yielded

some very interesting results, but we are unable to go

ahead with the full study, because we are not yet in

receipt of the total number of 60 small implants that

you had earlier promised to supply us. We are now in

receipt of a total of 19 implants. We would appreciate

receiving the balance for a total of 60 as soon as it

is convenient for you.

Yours sincerely,

Lars M. Vistines, M. C.

Chief, Surgical Service

Enclosure:

Document #23

Report: From the Division of Plastic and

Reconstructive Surgery, Veterans Hospital and Stanford

University Medical Center, Palo Alto, California.

Supplied by the Heyer-Schulte Corporation, Santa

Barbara, California

Baxter 37081

" Experimental Study of Tissue Response to Ruptured

Gel Filled mammary Prostheses " : W. Bentley,

M.D., Lars M. Vistnes, M.D., A.Ksander, M.D.,

C. Fogarty, M. D.

Funded, researched in 1976). Due to the length of the

document, only portions are given.

Page 1: Baxter International #37082

" Over the past decade, gel filled prostheses have

been used for mammary augumentation. The resulting

encasing fibrous capsule has continued to be a

significant problem. Tissue response to the various

synthetic materials has been well documented, and

recently the relationship between alloplastic breast

prostheses and capsule formation has been explored

experimentally in this laboratory. We felt this was a

timely study because some plastic surgeons have

advocated the purposeful incision into the prosthesis

wall to release gel into the fibrous capsule as a

solution to the hard breast after augmentation....The

unruptured, but not the ruptured specimens, showed a

significantly thicker capsule superficially....in the

un-ruptured specimens a local acute inflammatory

response was noted at 10 days with polymer nuclear

leukocytes and round cells incorporated in the

collegeous capsule (Fig. 1) (Note: the ruptured

specimens had dispersed the silicone throughout the

body.)

....Figure 3 In the ruptured specimens, gel globules

(which on the histological section showed as vacuoles)

were seen in the capsule at 10 days, while at 42 days,

the gel, in smaller globules, had migrated into the

surrounding connective tissue (Figure 4). A local

inflammatory response with fibroblastic activity and

giant cell formation was elicited in these areas. Some

of the ruptured prostheses showed no evidence of gel

remaining in the silicone envelope at the time of

sacrifice. Seven out of 15 specimens in the 41 day

ruptured group were lost due to extensive interaction

with the surrounding tissue that interfered with

dissection.

DISCUSSION:

This study not only documents, under controlled

conditions, the mammary prosthetic implants elicit an

inflammatory response with resultant fibrous capsule

formation, but also suggests that ruptured implants

favor formation of a thicker capsule. Also worth

noting, is the apparent migration of the gel away from

the implantation site to unknown locations and with

unknown effects.

The present tendency by manufacturers of breast

implants towards ever thinner envelopes and a " filler "

that is getting further away from gel and closer to

silicone liquid, must be looked at in the light of

these experimental findings, and the question must be

asked whether the possible advantages of these changes

outweigh the disadvantages.

SUMMARY:

.....capsule thickness was significantly increased in

the ruptured prostheses in response to the exuded gel.

The gel migrated through the capsule and into the

surrounding connective tissue eliciting an

inflammatory response with capsule thickening. Lars H.

Vistines, Md. D., Department of Surgery, Palo Alto

Verternas Hospital, Palo Alto, California.

ACKNOWLEDGEMENTS: We wish to thank Mr. Jeff Shyshaka,

of the Medical Illustration Service, and Mr. Jon

Kosek, M.D., of the Laboratory Service For assistance

in evaluation them. Both are of the Veterans

Administration Hospital, Palo Alto, California. Page 3

(Baxter International #37084).

THE HEYER-SCHULTE HOT MEMOS: Baxter International

Note: American Hospital Supply Corporation had much

earlier purchased Dow Chemical's Bioscience

Enterprise, Inc. The Heyer Schulte Corp. was then a

subsidiary of the American Hospital Supply

Corporation. As Baxter Travenol Labs, Baxter Travenol

had previously tested breast implants for Heyer

Schulte Corporation. This testing was done BEFORE

Baxter Travenol Labs purchased American Hospital

Supply Corporation and Heyer Schulte. Later, when

Baxter Travenol Labs had purchased American Hospital

Supply Corporation AND Heyer Schulte, it then changed

its name to become Baxter International.

Heyer-Schulte was a medial devices subsidiary company

of The American Hospital Supply Corporation. In 1972,

it lured several scientists and salesmen from Dow

Corning to start their own breast implant business,

The McGhan Corp. McGhan of The Dow Corning

Corp., led the group. Two years later, in 1974, Don

McGhan started his own breast implant company, McGhan

Medical Corporation in Santa Barbara, California. The

Minnesota Mining and Manufacturing Co. purchased

McGhan Medical. Don McGhan then formed another

company, Mentor Corp. The FDA is still allowing Don

McGhan's second company, The Mentor Corp., to

manufacture breast implants. The women now must sign

AN INFORMED CONSENT FORM, and the company MUST

maintain a patient database. The Heyer-Schulte Hot

Memos also reveal the deliberate and massive

" corporate cover-up " and also, the " intermarriage

corporate connections " of these corporations. Many of

the breast implant scientists, engineers, etc., made

the implant circuit and worked at each of the

manufacturer's plants. They all knew each other.

HEYER SCHULTE HOT MEMOS:

Document #13:

Baxter International - Heyer Schulte

Baxter 78608,78609,78610, 78611,78612,

78613,7861478615,7861678617,78618

J. Rudy,

Heyer-Schulte Corp.

Date: July 14, 1976

From: G. Frugard

SUBJECT: TRIP TO DOW CORNING

There are both positive and negative aspects to my

trip to Dow Corning. On the positive side, I feel that

I was successful in bringing back a comprehensive

summary (much of it verbatim) of all their animal

data, or at least all that I was given access to. The

negative aspect is that the data doesn't answer the

key questions I presented to Dow concerning migration

and the consequences. Also, as you will see, many of

these experiments were not well controlled. (He met

with Joe Radzius, Dow Corning attorney, and FDA and

legal liaison who knows Jim Rudy well and sends his

regards.)

The format of our meeting will probably be used by Dow

Corning with other interested parties, due, for the

most part, to Dow's concern over making statements

concerning the safety and efficacy of their material,

which may be difficult to substantiate (my

interpretation) based on conversation.

Dow Corning is concerned about the Amendments to the

Food and Drug Commission (FDA) and what will be

required of them. Top management is apprehensive about

the withdrawal of General Electric and Rhone-Poulenc

and others from the medical segments of the elastomer

market. Whether or not we want to be more specific and

emphatic about the possible hazards of uncontained

silicone is a decision that will need to be made. A

general summary of such complications would include:

(1-4 and 5: migration of the silicone, with mild to

severe consequences, including reduction of (blanked

out)....breast size and absorption of the silicone by

the blood and lymph systems, resulting in damage to

the liver and kidneys. Epidermal response was focal

and consisted of sicharosis, a canthosis and

hyperkeratosis.

The dermal reaction was situationed beneath the

epidermal lesion and consisted of a small focus of

fibroblasts and capillary proliferation accompanied by

a mononuclear cell inflammatory infiltration. Main

reaction of test group: Mononuclear infiltration;

foreign body giant cells; almost all minimal or

minimal to moderate connective tissue proliferation.

Document #14

Baxter International #78611

Biometric Testing, Inc.

Biometric Laboratory, New Jersey

Rabbit Implant With Histopathology Of Gel Implants:

Twenty-one days past implants animals killed. An

autopsy was performed on each rabbit. All tissues and

organs fixed pending instructions from Dow. (No

instructions were sent.)

Findings: Histopath exam - of muscle sites revealed

mild to acute inflammatory reaction. The reaction (at

every site) was characterized by a typical

inflammatory cell infiltrate with or without

fibroblastic activity. ..... " 14 day - death - rabbit

died 4 days past implant: pulmonary congestion, G.I.

hemorrhaging and general “atrophy of all major

organs. "

Reference # A-1544:

March 6, 1975

Chief Investigator: Carson, Ph.D.

He viewed the Dog Study and copied verbatim: Baxter

Id. #78616,78617,78618.

See Below: Study: Chronic Implantation Studies of

Polysiloxanes in Dogs.

Document #15:

HRONIC IMPLANTATION STUDIES OF POLYSILOXANES IN DOGS:

Laboratory: Food and Drug Research Laboratories

Maurice Avenue at 58th Street

Maspath, New York

Chief Investigator: Carson, Ph.D., Director,

Biological Division

REFERENCE: Report:

Chronic Implantation Studies of Polysiloxanes in Dogs:

Covers three-year studies of effects in dogs of

implanted plastic materials in both cured and uncured

states and in physical forms of solid film, perforated

film, sponge amorphous forms and miniature artificial

breasts over protracted periods.

STUDY DESCRIPTION:

Pure bred beagles 5-7 months age. Each sample

implanted in four replicates which were excised, one

or two at a time at three, nine and twenty-four or

thirty-six months.

RESULTS:

“The site of the intramuscular implant DCX-0885 was

surrounded by a lining of granulamatous inflammation

tissue in one dog and hyalinized connective tissue

reaction of 3+ in another and a fibrous reaction 1+ in

a third animal.

CONCLUSION:

Table #1: Study Results for DCX-3-0885:

(a) The conclusion reached in study #1: “perhaps all

gels were reactive.”

( Concerning migration: Study #IV indicates that the

gel migrates at least into the capsule, " ....multiple

small oval spaces containing fragments of clear

(nonfibrogenic) test material were often present in

the connective tissue capsule that surrounded the main

implant site. "

Unfortunately, the data collected in this study does

not answer questions concerning migration, even though

that was the main objective (of the study.)

Attachments: Page two of letter to Heyer-Schulte from

Dow concerning disclosure, signed by Mac

stating that: I complied with their request for copies

of my notes.

Frugard

GF/id

Attachments: Page two of letter to Heyer-Schulte from

Dow concerning disclosure, signed by Mac

stating that: I complied with their request for copies

of my notes.

Document #16:

Interoffice Correspondence

Heyer Schulte Corporation

Date: October 17, 1975

From: Jim Rudy

Sub: Mammaries

Account Representatives and Regional Managers:

Regional Managers

Ray Hanacek

East*

Rudi Schulte

TRADE SECRET

MB 184487,184488

Since my arrival at Heyer-Schulte, I have been taught

that " soft is good " in discussing mammaries,

especially gel-filled mammaries....with these

considerations in mind, two weeks ago Dick Polito

obtained for us twelve mammaries of McGhan manufacture

and a similar quantify of Dow-Coring units. These were

delivered along with a similar quantify of

Heyer-Schulte mammaries to the people at the Corporate

Technology Center in Santa Ana for comparative

physical testing. Gel viscosity was compared by

placing samples from each manufacturer in a

cylindrical container as pictured and measuring the

time for a steel ball to fall through the mass. The

results indicate a startling difference. Time for the

steel ball to fall through gels of each manufacturer

were:

Heyer-Schulte - 4075 seconds

Dow Corning - 3330 seconds

McGhan 55 seconds. No wonder McGhan’s (3-M) feels

softer. Their gel is virtually not cross-linked.

Document #17

Heyer-Schulte: Interoffice Memo

Date: October 30, 1975

From: Jim Rudy, President of Heyer Schulte

Beverly Siow

cc: Joe Utt, Tom Hyans, East

Attched is a copy of " Injectable Fluid Silicone

Therapy - Human Morbidity and Mortality " by

Ellenbogen, M. D.; Rita Ellenbogen, M. D., Leonard

Rubin, M. D.

This paper describes problems relating to physical

migration including liver dysfunction, and foreign

body granuloma inn four victims of silicone injection.

It is my understanding that similar mononuclear and

giant cell reaction results in some patients wherein

silicone gel has escaped from the shell.

Jim Rudy JR:ja (Note: And the silicone envelope).

Document #18

Interoffice Memo

TRADE SECRET

MB184489

Heyer-Schulte

Date: November 20, 1975

From: Jim Rudy, President

Sub: More on Mammary Safety vs. Performance

We are working on preparation of the gel filled

mammary comparisons by an independent lab, which I

promised in my letter of October 17, 1975. I am

advised that some significant number of customers

(plastic surgeons,) don’t particularly doubt the

conclusions, but are not impressed with the importance

of gel-viscosity or shell strength. I suggest that

this is a naive position and one which will be

changing in the relatively near future. To illustrate,

Heyer-Schulte now has 15 active law suits involving

leaking mammary implants. Of these fifteen, nine

occurred in 1975 alone.

At the ASPRS (American Society of Plastic and

Reconstructive Surgeons) in Toronto, I attended a

session and was amazed at the Naivet & eacute; of

several plastic surgeons who rose to discuss ruptured

implants. They seemed to believe that all gel was

either " cohesive " or " non-cohesive " , and that it would

be sold in a mammary implant only if it were the

former.....I believe these factors are important. I

recognize that this type of information must be used

carefully, as it is not our policy to sell by knocking

competition. .....the hazards which could be

associated with use of our products and with which

they may not be as familiar as they could be.

Jim Rudy - cc: Ray Hanacek, East, Rudi Schulte

Document #19

Heyer-Schulte Corporation

American Hospital Supply Corporation/(Baxter

International Corp.)

MB184491

400 Pine Avenue

Goleta, California

March 29, 1976

Cauley , M.D.

1010 East Third Street

Chatanooga, Tennessee 37403

Dear Dr. :

This letter is to follow-up and confirm elements of

our telephone conversation of March 23. We were

concerned with one of your patients who had been

augmented with.......until approximately 10 months

post-implant. Despite apparently commonly held

opinions to the contrary, it is not surprising that

migration of the gel occurred........In such cases, it

has been our practice to attempt to maintain rapport

with such patients by reacting rapidly with a

humanistic concern and expressing a willingness to

minimize any financial impact that such disappointing

results incur. Accordingly, without implying liability

on our part; but in an effort to help this patient and

maintain good relations with our public, we would be

happy to supply replacement implants and if the

situation warrants, we could also consider defraying

hospital expenses. Please keep us posted on ANY

situation which develops with this patient.

Sincerely, A. Rudy, President; JR;je

Document #20

Baxter International: #79038

Memo: March 5, 1976

Bob:

Here are the mammary papers. I've separated them into

two piles. The folder with the pink star on the front

contains those papers (arranged alphabetically by

author) which seem to me most useful for extracting

data.....the other pile contains the papers which

seemed to me less useful.....papers dealing mainly

with matters of surgical technique (which I assume we

want to say little---if anything—about....

Betsy.

Document #21

WARNINGS

BAX 79042-79045

" .....the silicone rubber mammary envelope has a low

tear strength....note: gel prostheses may be easily

ruptured when still hot from the autoclave....the gel

interior of these products is vulcanized to minimize

the migration of gel should a rupture occur in the

silicone envelope. however, should the silicone

envelope be ruptured, Heyer-Schulte cannot guarantee

reliable gel containment, and the prosthesis should be

replaced. Whether or not we want to be more specific

and emphatic about the possible hazards of

un-contained silicone is a decision that will need to

be made. Most pertinent here are the papers on the

complications of silicone injections: " Ellenboggen,

Injectable Fluid Silicone Therapy, " " Symmara, Silicone

Mastitis in Topless Waitresses. " and most especially

the paper by Boo-Cahi on " The Complications of

Augmentation Mammaplasty by Silicone Injects, " which

discusses the problems resulting from injecting a

vulcanized (gel-type) silicone.

A general summary of such complications would include:

(1). one recorded case of intravascular injection of

silicone resulting in death;

(2). hypo-pigmentation of the breast;

(3). hard, nodular lumps;

(4). silicone mastitis;

(5). migration of the silicone, with mild to severe

consequences, including reduction of (.......whited

out) and absorption of the silicone by the blood and

lymph systems, resulting in damage to the liver and

kidneys;

See also Goldwyn, " An Unusual Complication of the Use

of the Cronin Implant for Augumentation Mammaplasty, "

who reports a case of wound infection. Cronin and

Greenbert, " Our experiences with the Silastick Gel

Breast Prosthesis, " pg. 4. Guardian, " Complications of

Breast Implantations, pg 32; infection is manifested

by swelling, tenderness, pain, fever and a positive

culture. It may appear in the immediate postoperative

period or weeks, months, or even years after insertion

of the implant. IN THE ABSENCE OF CLASSIC SYMPTOMS,

sub-acute or chronic infections may be DIFFICULT to

diagnose. " , " Silastic Breast Implants: Coping

with Complications, p. 590, neural complications,

etc., have been reported. See also articles by

Freeman, Courtiss, Gurdin, , Owsley,

McKinney,McDougall,Corso, De Cholnoky, Rubin, Berens,

,Conway, , Synder, , Brauer,

Goldwyn, Psillakis, Bing, Brown, Dunsif, Stubenbord,

Conway, Schwager, Gutherie, Imber, Lipshutz, Little,

Nedelman, Mazzoni, Peacock, Van Winkle, Ross,

Ballantyne, etc. "

(Published articles by Plastic Surgeons).

Notation: Houston physician, Dr. Cronin, was the

inventor of the first mammary implant. The next three

pages reference articles written by plastic surgeons

relating to complications from silicone envelope and

silicone gel implants. Papers written by world-wide

plastic surgeons as far back as late 1960s and

submitted to their journals but never disclosed to the

public. The Plastic Surgeons & Reconstructive Society

(ASPRS), and the AMA, knew as early as the 1960's of

the complications and dangers, but did not advise the

public. They kept implanting. They got richer. They

and the AMA joined forces with the breast implant

manufacturers: i.e. the infamous Mayo Clinic, Harvard

Report, and the New England Journal Reports with their

financial contributions.

Document #22

Veterans Administration Hospital

Palo Alto, California 94304

When replying, refer to 640/112

Baxter International #37080

April 29, 1976

Mr. Ken Eckhardt

Product Director, Plastic Surgery

Heyer-Schulte Corporation

P. O. Box 946

Goleta, California 93017

Dear Mr. Eckhardt:

Enclosed is a copy of our paper on " Local Tissue

Reaction to Ruptured Thin Gel Prostheses. " This paper

has been submitted for publication in Plastic and

Reconstructive Surgery.