Part 1 of 4 - Court Documents: Manufacturers' Internal Memos

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Subj: Part 1 of 4 - Court Documents: Manufacturers'

Internal Memos

From an anonyomous sister-scanned but not corrected

Court Documents: Manufacturers' Internal Memos COURT

DOCUMENTS:

MANUFACTURERS' INTERNAL MEMOS DOCUMENTING:

" THE CORPORATE SYNDICATE BREAST IMPLANT POISONING

COVER-UP "

Court Documents of Dow Chemical, Dow Corning, Bristol

Myers, Minnesota Mining and Manufacturing, and

Heyer-Schulte Hot Memos:

This is a just a few of the thousands of court

documents of corporate interoffice memos written and

circulated by the breast implant manufactures and

suppliers. If you are in possession of any other

documents, please forward them, and they will be

added. We will let the public see for themselves that

this " poisoning " was foreseeable and deliberate and

that they fractured the lives of hundreds of thousands

of humans for Billions upon Billions of dollars. These

Memos are taken directly from the court documents.

Below are Breast Implant Manufacturer's internal memos

and letters which were " uncovered " and presented as

Court Exhibits. DOW CORNING: DCC (Dow Chemical

Company) and DCW (Dow Corning ).

Document. #1: Produced by DCC and DCW: (M-440097):

Exhibit #29

This document from 1961 shows that Dr. Cronin,

one of the doctors credited with inventing silicone

breast implants, was advised by The Dow Corning Center

for Aid to Medical Research that silicones would

" bleed through The envelope, " and that it would

migrate within the body. Gel bleed and migration

expose the body's tissues to silicone, causing

systemic injury. Thus, the inventor and Dow knew of

the bleed problem before implants Were ever marketed.

(See Patents.).

January 24, 1961

Dr. D. Cronin

University Professional Buildings

6615 Street

Houston, Texas

Dear Dr. Cronin:

Since I am now associated with the Dow Corning Center

for Aid to Medical Research, Mr. Braley has asked me

to answer your letter of January 9.

Although the silicones are inert in the body, an

attempt to place Silicone fluids permanently in the

body would lead to other problems. If injected

directly into the body, the fluids will not remain in

the desired location.

A discussion of this problem is found in the enclosed

paper " Toxicology Of the Silicones. " If enclosed

within a silicone bag, the fluids would tend to

diffuse out through the walls of the silicone rubber

and be absorbed into the tissues.

Yours very truly,

Mrs. Ethel Mullison, Staff Associate

DOW CORNING (Continued)

Document #2: Submitted by DCC & DCW: (M3354):

PROPRIETARY Exhibit #53 Document # 2 is a letter, from

1968, to the Dow Corning Toxicology Department which

shows the widespread distribution of 360 fluid, the

Fluid used in silicone breast implants. It reveals

that there was widespread distribution in test dogs,

and that the fate and chemical nature of Silicone

after it " vacates the injection site was unknown. "

October 9, 1968

Dr. Riffkin

Parenteral Formulations Section

The Squibb Institute for Medical Research

New Brunswick, New Jersey 08903

Dear Dr. Riffkin:

I have been asked to answer your letter of September

18, 1968, to our Mr. E. E. Frisch regarding the

distribution and fate of injected silicones.

Enclosed you will find a report entitled " Studies of

the Effects of Injected Dow Corning 360 Fluid, 350

cc., in Dogs " . This study was carried out using C14

labeled DC 360 Fluid in order to determine the

distribution of such a polymer upon parentaral

administration. The results of this study indicate

that distribution occurs throughout the entire body

with no pronounced concentration in any specific

organ. It is evident by preliminary nature of this

study that the fate and chemical nature of the subject

material after it vacates the injection site is

unknown. I have also enclosed a copy of " Toxicology of

Certain Silicones Fluids " by R. R. McGregor as per

your request.

Sincerely, E. J. Hobbs, Toxicologist, Toxicology

Department

bcc: D. R. , E. E. Frison, M. J. Hunter, J. A.

McHard

DOW CORNING Document #3 and Document #4: (M540060 and

M-540061 and M-540062)

Produced by DCC and DCW

Mammary Task Force Minutes: Exhibit 106 These two (2)

documents (Document #3 and Document #4), from May 12,

1975, reveal that Dow was receiving reports from the

field about significant silicone bleed from implants.

Bleed problems were pronounced when implants were

handled or flexed, as would be expected when implanted

in a woman's body. Document #3: Produced by DCC & DCW:

(M-540061 and M-540062)

Mammary Task Force:

A. Abbott, J. Boone, T. Brodhagen,F. Dennett, A.

Rathjen, R. Garrett,D. Houle, J. Hoyt, W. Larson, C.

Leach, A Berg, P Meads, M. , K. Polmanteer, S.

s, B. Ringey, G. on, T. Salisbury, F.

Stark,T.

Talcott, J. :

The question of bleed from our product was brought

up. In Vancouver, and elsewhere on the West Coast

introduction, it was noted that after the mammaries

had been handled for awhile, the surface became oily.

Also, some were bleeding on the velvet in the

showcase.

Get samples from production, and West Coast samples

already shipped, and see if something can be done

about this. Also, samples from Heyer Schulte and

McGhan should be checked if possible. : Draw

up the orientation bars for both LP and Std. contours.

Also, optimize needles for filling mammaries to

prevent large holes: trocars and other points. Dave

in TSD is also working on the filling problem.

Salisbury: New data sheet for all products to be

available in September......this can also be used to

look at color and bleed with age.....with the changes

in the plastic surgery business that are happening

RIGHT NOW (Heyer Schulte, McGhan Medial, etc.), it was

felt that aggressive development and marketing

activity in the next four months will make a

tremendous difference in Dow Corning's position in

this market. The timeto act is NOW. AB/aa DOW CORNING

(Continued)

Document #4: Produced by DCC & DCW: (M-570062)

May 13, 1975

TO: Wil Larson,

cc: Tom Salisbury, Ann Berg, Art Rathjen, Forrest

Stark, Jim , Tom Brodhagen

FROM: Tom Talcott

SUBJECT: (Bleed of Mammary Prosthesis - Task Group

Action)

We are hearing complaints from the field about the

demonstration samples they are receiving. The general

claim is that the units bleed profusely after they

have been flexed vigorously.

Tom

TDT/aca

DOW CORNING (Continued)

Document #5: Produced by DCC & DCW: (M-19043):

Exhibit #161 This document, from March, 1977 is the

infamous " crossed fingers " memo in which a Dow

employee states the he responded to plastic surgeons

at an International Society of Plastic Surgeons

meeting as follows: " I assured them, with crossed

fingers, that Dow Corning too had an active

" contracture/gel migration " study underway.

Levier, Becker, Lentz, Oppelt, Fisch, Kelley,

s, Carlyle, Hoyt

FROM: C. Leach - CO2322

Bob, a year ago before you joined the Implant

Products PMS, Pat Walters was assigned the task of

researching subject phenomenon and recommending a

course of action for Dow Corning. This he did. As best

I can tell we have not taken significant action on any

of his recommendations and except for a " half-hearted

low priority program " through Dr. Kaminski at

Northwestern University. We have done little in the

past year. At the recent Tahao Meeting of the

International Society of Clinical Plastic Surgeons,

both McGhan and Medical Engineering did an excellent

job of merchandising their respective programs

designed to shed light on this issue.

Dr. Bob of McGhan detailed how he has devoted full

time the past six months in establishing programs to

study capsular tissue with the Plastic Surgeons across

the country.

Several of our customers, looking to us as leaders in

the industry, asked me what we were doing. I assured

them, with " crossed fingers, " that Dow Corning too had

an active " contracture/gel migration " study underway.

This apparently satisfied them for the moment, but one

of these days they will be asking us for the results

of our studies.

Beyond the mammaries and contracture. Dr. Swanson

recently has been urging that appropriate studies be

undertaken to determine the potential for migration of

silicones elastomers particles throughout the body.

Dr. Hiebauer continues to publicly discuss the

migration of such particles in his monkeys and it is

very likely just a matter of time until the orthopedic

community will be aggressively asking similar

questions to those we are now hearing from the Plastic

Surgeons.

I am not sure where this unrest is leading, but

suspect that our PMG, as the steward of Dow Corning's

implantable products, should not be to comfortable

with our current lack of focus and co-ordinated

leadership relating to this entire issue. I suggest

that this question be addressed at our next PMG

Meeting and clear definition given as to what answers

we can reasonably be expected to have as a

manufacturer of implantable silicone materials, what

answers we do have, and what steps need to be taken to

fill whatever gaps that may exist in our needed

storeroom of knowledge. In my opinion, the black

clouds are ominous and should be given more attention.

Cl Enc.

DOW CORNING (Continued)

Document #6: Produced by DCC & DCW: CM-001134:

Exhibit 173 The letter is from Dr. ph Connelly to

Boley, Head of Biomaterial Safety for Dow

Corning, inquiring about any possible link between

lupus and silicone implants. Boley replies that Dow

had performed " extensive safety testing, " and that it

is highly improbable that the symptoms of Dr.

Connelly's patient could be linked to implants. Now,

compare this statement by Boley to his statement

concerning safety in Document #7,which follows

Document #6 below.

January 22, 1980

Dow Corning

P. O. Box 100

Arlington, Texas 38002

Dear Sir,

This letter is in reference to the silastic breast

implants.

The patient is under the care of her family doctor

and has been feeling poorly, and he has run a medical

workup on her and had come up with some tests which he

says are suggestive of chronic lupus erythemoses. The

patient has come to me asking if there is any

possibility of the prostheses producing such changes.

I told her that the material used in the prostheses

is very inert. However, I was requested by her and by

her family physician to contact you regarding this,

and I would appreciate any information you would be

able to give me?

With kindest regards, I remain,

Sincerely,

ph R. Connelly, M. D.

Document #7: Produced by DCC and Dow Corning :

CM-001135

Compare this letter, by Boley, in 1983, to

his reply to Dr. Connelly in Document #6.

This 1983 Boley letter, which went to top Dow

management, states that " we have no valid long-term

implant data to substantiate the safety of gels for

long-term use. " Obviously, Boley lied to Dr. Connelly

in 1980. The admission that there was no data to

substantiate silicone implant safety was made 21 years

after breast implants were put on the market.

April 23, 1980

ph R. Connelly, M.D.

2828 Main Street

Buffalo, N.Y.

Dear Dr. Connelly:

Please excuse the delay in responding to your letter

of January 22, 1980.

Dow Corning, which you addressed your letter

to, is only a marketing arm for Dow Corning's plastic

surgery products. It appears that the marketing people

were uncomfortable in responding to your question and

were uncertain as to who should respond.

Dow Corning has performed extensive safety testing,

in animals, on the silicone materials from which

SILASTIC breast implants are made.

Based on these tests the materials used in the

implants have been judged safe. I have also reviewed

our product complaint files.

Your inquiry appears to be the first Dow Corning has

received asking whether a silicone breast implant

could be a causative agent for chronic lupus

erythematoses.

The data Dow Corning has suggests that it would be

highly improbably that your patient's symptom of

chronic lupus erythematoses could be attributed to the

silicone breast implants.

Sincerely yours,

F. Boley

Senior Group Leader

Health Care Group Research

WFB:ld

MINNESOTA MINING AND MANUFACTURING:

Document #8: Produced by Minnesota Mining and

Manufacturing:

MMM000000954 and MM000000955: Exhibit 198:

Compare the statements below by Minnesota Mining and

Manufacturing to the " DCC's Broley statement above in

Document #6 and Document #7.

Then, compare the Minnesota Mining and Manufacturing

Patent # 4,455,691, by Van Aken Redinger and

A. Compton, both of Santa Barbara, California,

Assignee: Minnesota Mining and Manufacturing Company,

St. , Minnesota

-

which was filed October 3, 1979, citing the fallacies

of Dow Corning's, Polmanteer' Patent #4,138,382,

granted by the

Patent Office on February 2, 1979.

This interoffice memo, from 1976, addresses Minnesota

Mining and Manufacturing's situation in light of the

Food and Drug Administration's impending

classification of breast implants as Class III Device.

Minnesota Mining and Manufacturing, in assessing its

McGhan subsidiary silicone gel breast implant product

line, concludes that: McGhan's silicone technology is

a technical accomplishment, but a clinical and

regulatory nightmare.

PMA (Pre-Market Approval)

The regulatory picture - but not the technical

picture - is somewhat more clear in consideration of

mammary prostheses. Basically, there will be a thirty

(30) month grace period after final classification of

mammary prostheses into Class III, through publication

by the FDA in the Federal Register, in order to gather

clinical data in substantiation of a PMA application.

The clinical data will have to be gathered under an

IDE.

After an administrative period of 6 months for a

decision by FDA,

one of two things will happen:

(1) The PMA (Premarket Approval) Application will be

found approvable and unrestricted marketing will be

permissible.

(2) The PMA Application will be found not approvable,

and additional data will have to be gathered under the

IDE. This means restricted marketing; the product can

only be sold to Approved Clinical Investigators.

I hope that McGhan is now actively conducting or

arranging clinical investigations concerning this

product line. Procrastination to the date of final

classification is unforgivable. McGhan's silicone

technology is a technical accomplishment, but a

" clinical and regulatory nightmare. " I understand that

they are manufacturing their own silicone polymers

after a decision by General Electric to discontinue

sale of their product for medical use.

Firms using Dow-Corning silicone for implantable

devices have a decided advantage, since this

corporation has a " Master File " with the FDA, which

has been maintained for years....this means that a

precedent has been set by Dow Corning of years of

clinical use in addition to periodic reporting to FDA.

Unfortunately, this is the benchmark by which other

attempts will be judged.

McGhan is in the unenviable position of having to

accredit their polymers in addition to their finished

product. I conservatively estimate that $75,000 may be

required for animal toxicological studies of " each

polymer " if required by the FDA. This includes a

carcinogenic study which I'm virtually certain

Dow-Corning has performed. Three polymers alone would

cost $225,000. How much animal toxicology has McGhan

performed on their silicone polymers? In the

short-term, it is penny-wise and pound-foolish not to

use Dow Corning silicones?

Two other silicone devices I imagine McGhan could

manufacture on short notice are drains and

hydrocephalus shunts. Drains may not be in Class III

if the greater than thirty (30) day residence

definition of implants is adopted by FDA. Shunts most

probably will be in Class III and, therefore, my

comments concerning mammary prostheses are also

applicable to them.

to be continued

From an anonyomous sister—scanned but not corrected

Court Documents: Manufacturers' Internal Memos

COURT DOCUMENTS: MANUFACTURERS' INTERNAL MEMOS

DOCUMENTING: " THE CORPORATE SYNDICATE BREAST IMPLANT

POISONING COVER-UP "

Court Documents of Dow Chemical, Dow Corning, Bristol

Myers, Minnesota

Mining and Manufacturing, and Heyer-Schulte Hot Memos:

This is a just a few of the thousands of court

documents of corporate interoffice memos written and

circulated by the breast implant manufactures and

suppliers. If you are in possession of any other

documents, please forward them, and they will be

added. We will let the public see for themselves that

this " poisoning " was foreseeable and deliberate and

that they fractured the lives of hundreds of thousands

of humans for Billions upon Billions of dollars. These

Memos are taken directly from the court documents.

Below are Breast Implant Manufacturer's internal memos

and letters which were " uncovered " and presented as

Court Exhibits. DOW CORNING: DCC (Dow Chemical

Company) and DCW (Dow Corning ).

Document. #1: Produced by DCC and DCW: (M-440097):

Exhibit #29

This document from 1961 shows that Dr. Cronin,

one of the doctors credited with inventing silicone

breast implants, was advised by The Dow Corning Center

for Aid to Medical Research that silicones would

" bleed through the envelope, " and that it would

migrate within the body. Gel bleed and migration

expose the body’s tissues to silicone, causing

systemic injury. Thus, the inventor and Dow knew of

the bleed problem before implants were ever marketed.

(See Patents.).

January 24, 1961

Dr. D. Cronin

University Professional Buildings

6615 Street

Houston, Texas

Dear Dr. Cronin:

Since I am now associated with the Dow Corning Center

for Aid to Medical Research, Mr. Braley has asked me

to answer your letter of January 9. Although the

silicones are inert in the body, an attempt to place

silicone fluids permanently in the body would lead to

other problems. If injected directly into the body,

the fluids will not remain in the desired location. A

discussion of this problem is found in the enclosed

paper " Toxicology of the Silicones. " If enclosed

within a silicone bag, the fluids would tend to

diffuse out through the walls of the silicone rubber

and be absorbed into the tissues.

Yours very truly,

Mrs. Ethel Mullison, Staff Associate

DOW CORNING (Continued)

Document #2: Submitted by DCC & DCW: (M3354):

PROPRIETARY Exhibit #53

Document # 2 is a letter, from 1968, to the Dow

Corning Toxicology Department which shows the

widespread distribution of 360 fluid, the fluid used

in silicone breast implants. It reveals that there was

widespread distribution in test dogs, and that the

fate and chemical nature of silicone after it " vacates

the injection site was unknown. "

October 9, 1968

Dr. Riffkin

Parenteral Formulations Section

The Squibb Institute for Medical Research New

Brunswick, New Jersey 08903

Dear Dr. Riffkin:

I have been asked to answer your letter of September

18, 1968, to our Mr. E. E. Frisch regarding the

distribution and fate of injected silicones. Enclosed

you will find a report entitled " Studies of the

Effects of Injected Dow Corning 360 Fluid, 350 cc., in

Dogs " . This study was carried out using C14 labeled DC

360 Fluid in order to determine the distribution of

such a polymer upon parentaral administration. The

results of this study indicate that distribution

occurs throughout the entire body with no pronounced

concentration in any specific organ. It is evident by

preliminary nature of this study that the fate and

chemical nature of the subject material after it

vacates the injection site is unknown.

I have also enclosed a copy of “Toxicology of Certain

Silicones Fluids” by R. R. McGregor as per your

request.

Sincerely, E. J. Hobbs, Toxicologist, Toxicology

Department

bcc: D. R. , E. E. Frison, M. J. Hunter, J. A.

McHard

DOW CORNING Document #3 and Document #4: (M540060 and

M-540061 and M-540062)

Produced by DCC and DCW

Mammary Task Force Minutes: Exhibit 106

These two (2) documents (Document #3 and Document #4),

from May 12, 1975, reveal that Dow was receiving

reports from the field about significant silicone

bleed from implants. Bleed problems were pronounced

when implants were handled or flexed, as would be

expected when implanted in a woman's body.

Document #3: Produced by DCC & DCW: (M-540061 and

M-540062)

Mammary Task Force:

A. Abbott, J. Boone, T. Brodhagen,F. Dennett, A.

Rathjen, R. Garrett,D. Houle, J. Hoyt, W. Larson, C.

Leach, A Berg, P Meads, M. , K. Polmanteer, S.

s, B. Ringey, G. on, T. Salisbury, F.

Stark,T. Talcott, J. :

The question of bleed from our product was brought up.

In Vancouver, and elsewhere on the West Coast

introduction, it was noted that after the mammaries

had been handled for awhile, the surface became oily.

Also, some were bleeding on the velvet in the

showcase.

Get samples from production, and West Coast samples

already shipped, and see if something can be done

about this. Also, samples from Heyer Schulte and

McGhan should be checked if possible. : Draw

up the orientation bars for both LP and Std. contours.

Also, optimize needles for filling mammaries to

prevent large holes: trocars and other points. Dave

in TSD is also working on the filling problem.

Salisbury: New data sheet for all products to be

available in September......this can also be used to

look at color and bleed with age.....with the changes

in the plastic surgery business that are happening

RIGHT NOW (Heyer Schulte, McGhan Medial, etc.), it was

felt that aggressive development and marketing

activity in the next four months will make a

tremendous difference in Dow Corning's position in

this market. The time to act is NOW. AB/aa

DOW CORNING (Continued)

Document #4: Produced by DCC & DCW: (M-570062)

May 13, 1975

TO: Wil Larson,

cc: Tom Salisbury, Ann Berg, Art Rathjen, Forrest

Stark, Jim , Tom Brodhagen

FROM: Tom Talcott

SUBJECT: (Bleed of Mammary Prosthesis - Task Group

Action)

We are hearing complaints from the field about the

demonstration samples they are receiving. The general

claim is that the units bleed profusely after they

have been flexed vigorously.

Tom

TDT/aca

DOW CORNING (Continued)

Document #5: Produced by DCC & DCW: (M-19043): Exhibit

#161 This document, from March, 1977 is the infamous

" crossed fingers " memo in which a Dow employee states

the he responded to plastic surgeons at an

International Society of Plastic Surgeons meeting as

follows: “I assured them, with crossed fingers, that

Dow Corning too had an active " contracture/gel

migration " study underway.

Levier, Becker, Lentz, Oppelt, Fisch, Kelley,

s, Carlyle, Hoyt

FROM: C. Leach - CO2322

Bob, a year ago before you joined the Implant Products

PMS, Pat Walters was assigned the task of researching

subject phenomenon and recommending a course of action

for Dow Corning. This he did. As best I can tell we

have not taken significant action on any of his

recommendations and except for a " half-hearted low

priority program " through Dr. Kaminski at

Northwestern University. We have done little in the

past year. At the recent Tahao Meeting of the

International Society of Clinical Plastic Surgeons,

both McGhan and Medical Engineering did an excellent

job of merchandising their respective programs

designed to shed light on this issue.

Dr. Bob of McGhan detailed how he has devoted full

time the past six months in establishing programs to

study capsular tissue with the Plastic Surgeons across

the country.

Several of our customers, looking to us as leaders in

the industry, asked me what we were doing. I assured

them, with " crossed fingers, " that Dow Corning too had

an active " contracture/gel migration " study underway.

This apparently satisfied them for the moment, but one

of these days they will be asking us for the results

of our studies.

Beyond the mammaries and contracture. Dr. Swanson

recently has been urging that appropriate studies be

undertaken to determine the potential for migration of

silicones elastomers particles throughout the body.

Dr. Hiebauer continues to publicly discuss the

migration of such particles in his monkeys and it is

very likely just a matter of time until the orthopedic

community will be aggressively asking similar

questions to those we are now hearing from the Plastic

Surgeons.

I am not sure where this unrest is leading, but

suspect that our PMG, as the steward of Dow Corning’s

implantable products, should not be to comfortable

with our current lack of focus and co-ordinated

leadership relating to this entire issue. I suggest

that this question be addressed at our next PMG

Meeting and clear definition given as to what answers

we can reasonably be expected to have as a

manufacturer of implantable silicone materials, what

answers we do have, and what steps need to be taken to

fill whatever gaps that may exist in our needed

storeroom of knowledge. In my opinion, the black

clouds are ominous and should be given more attention.

Cl Enc.

DOW CORNING (Continued)

Document #6: Produced by DCC & DCW: CM-001134: Exhibit

173

The letter is from Dr. ph Connelly to

Boley, Head of Biomaterial Safety for Dow Corning,

inquiring about any possible link between lupus and

silicone implants. Boley replies that Dow had

performed “extensive safety testing,” and that it is

highly improbable that the symptoms of Dr. Connelly’s

patient could be linked to implants. Now, compare this

statement by Boley to his statement concerning safety

in Document #7,which follows

Document #6 below.

January 22, 1980

Dow Corning

P. O. Box 100

Arlington, Texas 38002

Dear Sir,

This letter is in reference to the silastic breast

implants.

The patient is under the care of her family doctor and

has been feeling poorly, and he has run a medical

workup on her and had come up with some tests which he

says are suggestive of chronic lupus erythemoses. The

patient has come to me asking if there is any

possibility of the prostheses producing such changes.

I told her that the material used in the prostheses is

very inert. However, I was requested by her and by her

family physician to contact you regarding this, and I

would appreciate any information you would be able to

give me? With kindest regards, I remain,

Sincerely,

ph R. Connelly, M. D.

Document #7: Produced by DCC and Dow Corning :

CM-001135

Compare this letter, by Boley, in 1983, to his

reply to Dr. Connelly in Document #6.

This 1983 Boley letter, which went to top Dow

management, states that " we have no valid long-term

implant data to substantiate the safety of gels for

long-term use. " Obviously, Boley lied to Dr. Connelly

in 1980. The admission that there was no data to

substantiate silicone implant safety was made 21 years

after breast implants were put on the market.

April 23, 1980

ph R. Connelly, M.D.

2828 Main Street

Buffalo, N.Y.

Dear Dr. Connelly:

Please excuse the delay in responding to your letter

of January 22, 1980. Dow Corning, which you

addressed your letter to, is only a marketing arm for

Dow Corning’s plastic surgery products. It appears

that the marketing people were uncomfortable in

responding to your question and were uncertain as to

who should respond.

Dow Corning has performed extensive safety testing, in

animals, on the silicone materials from which SILASTIC

breast implants are made. Based on these tests the

materials used in the implants have been judged safe.

I have also reviewed our product complaint files. Your

inquiry appears to be the first Dow Corning has

received asking whether a silicone breast implant

could be a causative agent for chronic lupus

erythematoses.

The data Dow Corning has suggests that it would be

highly improbably that your patient's symptom of

chronic lupus erythematoses could be attributed to the

silicone breast implants.

Sincerely yours,

F. Boley

Senior Group Leader

Health Care Group Research

WFB:ld

MINNESOTA MINING AND MANUFACTURING:

Document #8: Produced by Minnesota Mining and

Manufacturing:

MMM000000954 and MM000000955: Exhibit 198:

Compare the statements below by Minnesota Mining and

Manufacturing to the " DCC's Broley statement above in

Document #6 and Document #7. Then, compare the

Minnesota Mining and Manufacturing Patent # 4,455,691,

by Van Aken Redinger and A. Compton,

both of Santa Barbara, California, Assignee: Minnesota

Mining and Manufacturing Company, St. , Minnesota

- which was filed October 3, 1979, citing the

fallacies of Dow Corning's, Polmanteer' Patent

#4,138,382, granted by the Patent Office on February

2, 1979.

This interoffice memo, from 1976, addresses Minnesota

Mining and Manufacturing's situation in light of the

Food and Drug Administration’s impending

classification of breast implants as Class III Device.

Minnesota Mining and Manufacturing, in assessing its

McGhan subsidiary silicone gel breast implant product

line, concludes that: McGhan's silicone technology is

a technical accomplishment, but a clinical and

regulatory nightmare. PMA (Pre-Market Approval)

The regulatory picture - but not the technical picture

- is somewhat more clear in consideration of mammary

prostheses. Basically, there will be a thirty (30)

month grace period after final classification of

mammary prostheses into Class III, through publication

by the FDA in the Federal Register, in order to gather

clinical data in substantiation of a PMA application.

The clinical data will have to be gathered under an

IDE. After an administrative period of 6 months for a

decision by FDA, one of two things will happen:

(1) The PMA (Premarket Approval) Application will be

found approvable and unrestricted marketing will be

permissible.

(2) The PMA Application will be found not approvable,

and additional data will have to be gathered under the

IDE. This means restricted marketing; the product can

only be sold to Approved Clinical Investigators.

I hope that McGhan is now actively conducting or

arranging clinical investigations concerning this

product line. Procrastination to the date of final

classification is unforgivable. McGhan's silicone

technology is a technical accomplishment, but a

" clinical and regulatory nightmare. " I understand that

they are manufacturing their own silicone polymers

after a decision by General Electric to discontinue

sale of their product for medical use.

Firms using Dow-Corning silicone for implantable

devices have a decided advantage, since this

corporation has a " Master File " with the FDA, which

has been maintained for years....this means that a

precedent has been set by Dow Corning of years of

clinical use in addition to periodic reporting to FDA.

Unfortunately, this is the benchmark by which other

attempts will be judged.

McGhan is in the unenviable position of having to

accredit their polymers in addition to their finished

product. I conservatively estimate that $75,000 may be

required for animal toxicological studies of " each

polymer " if required by the FDA. This includes a

carcinogenic study which I'm virtually certain

Dow-Corning has performed. Three polymers alone would

cost $225,000. How much animal toxicology has McGhan

performed on their silicone polymers? In the

short-term, it is penny-wise and pound-foolish not to

use Dow Corning silicones?

Two other silicone devices I imagine McGhan could

manufacture on short notice are drains and

hydrocephalus shunts. Drains may not be in Class III

if the greater than thirty (30) day residence

definition of implants is adopted by FDA. Shunts most

probably will be in Class III and, therefore, my

comments concerning mammary prostheses are also

applicable to them.

to be continued