Part 2 of 4 - Court Documents: Manufacturers' Internal Memos

[Guest guest]

Subj: Part 2 of 4 - Court Documents: Manufacturers'

Internal Memos

Date: 10/16/04 9:41:29 PM US Mountain Standard Time

From: myrlj@... (Myrl Jeffcoat)

From anonyomous sister - scanned but not corrected -

possibly from the Catch files

(Continued:

Document #8 - Minnesota Mining and Manufacturing Co.)

I should point out that I tend to be conservative in

forecasting the whims of Federal regulatory

agencies.......I see little hope at the present time

for an altruistic position on the part of the FDA on

behalf of the medical device industry....hopefully,

the statutory authority of the FDA " will be tempered "

by administrative " forethought. "

If you have any questions, please call.

JBS:fmp

Document #9: Document submitted by Minnesota Mining

and Manufacturing:

MMM000000956

This document, from 1976, reveals Minnesota Mining

and Manufacturing's serious concerns about the safety

of its McGhan silicone gel breast implants. A

Minnesota Mining and Manufacturing employee admits

that " based on Mr. McGhan's comments, it appears that

virtually no documented safetyand efficacy data exist

on his implant products. " While reluctant to pass any

judgments on the McGhan implant, the employee feels

the need to point out that " serious deficiencies

appear to exist with (these) products from the

documentation standpoint. "

April 9, 1976

Interoffice Correspondence: Minnesota Mining and

Manufacturing:

(Confidential)

Subject: McGhan Company

cc: D. M. Pryor - 223-35, D. V. Murray - 223-35, and

J. E. on -

223-35

W.E. COYNE

From: G.M. HORGAN

(First paragraph is blacked out)

Unfortunately, when Mr. McGhan visited us last week

my laryngitis condition prevented the asking of

numerous questions on not only the (blocked out), but

on his other implants as well. Based on Mr. McGhan's

comments, it appears that virtually no documented

safety and efficacy data exists on his implant

products. In addition, it sounds like his company will

be producing their own silicone.

It will be necessary for them to establish

biocompatibility of thatsilicone as they will have had

insufficient biological experience with their

material. Since the (long statement blocked out), and

other implants may remain in pre-market clearance, we

must assess what impact such condition will have on

Mr. McGhan's business. Please note I'm not making any

judgments on Mr. McGhan's products as such. I'm only

pointing out that serious deficiencies appear to exist

with his products from the documentation standpoint.

Jerry

GMH:et

Document #10: Interoffice Memo

(Shortened due to length)

TO: (name inked out)

CC: J. - CO2426, G. Jabubctak - 090

FROM: W. BOLEY - CO3101 (F000838)

SUBJECT: BIOLIGICAL SAFETY TESTING OF GEL FOR

IMPLANTS

The purpose of this memo is to establish a position

statement for responding to questions regarding the

safety testing available for various " medical grade "

gels. The gels in question are: Q7-2218, Q7-2167/2168,

2159A, and Q7-150 and Q2146. One additional gel that

needs to be considered for historic purposes is

X-3-0885....this is the only gel to my knowledge that

has had long-term implant testing performed on it.

This testing is reported in I.B.T. Report #86199,

November 29, 1968. " Chronic Implantation Studies of

Polysiloxanes in Dogs. " The material was tested in 3

dogs, two of which were sacrificed (killed) at 2 years

and the third at 3years.

The gel Q7-2218 has a formulation that is

sufficiently different from the other gels such that

the testing cannot be extrapolated. Gel Q7-2218 only

has tissue cell culture data available for it.

Therefore, if we are to continue to sell this

material as " Medical Grade, " immediate action should

be taken to bring it into compliance with the business

definition of " Medical Grade. " However, I want to

emphasize that to my knowledge, we have no valid

long-term implant data to substantiate the safety of

gels for long-term implant use. Only inferential data

exists to substantiate the long-term safety of these

gels for human implant applications.

BRISTOL MYERS:

Document #11: Submitted by Bristol-Myers: August 15,

1985

Bristol Myers-Squibb

Interoffice SPEEDIMEMO: #264953 - TRIP

(Handwritten Memo)

This document, from 1985, reveals that Bristol-Myers

Squibb knew that the polyurethane cover on its gel

implants was harmful, and that the company " had known

products of polyurethane's are toxic and in some cases

carcinogenic. " But, instead of demanding studies, the

memo concluded that only " time will tell " if these

implants are a threat to women's bodies.

(See Wall Street Journal article below in the

Criminal Activity Section of the Syndicate Seven

Brothers Joint Ventures when OSHA, and other

governmental agencies sent telegrams to 26 companies

using Union Carbide's polyurethane, and that it was

" imperative to stop using polyurethane. "

That OSHA and other government departments would

institute " criminal proceedings " against those who

didn't comply with the mandate ruling. Was

Bristol-Myers one of the twenty-six companies

receiving the OSHA telegram?)

(Lynn - FYI: R.

TO: Rick Stolfa

AT: From Bristol Plant: Surg. 9:73-77, 85

DATE: 8/15/85

SUBJECT: Polyurethane Cover on Gel-filled Mammaries

Macrophages engulfing foreign body particles in a

portion of the body - this is correct. What we try to

do is keep implant " debris " to a minimum.

Of the two materials, there is more evidence to

support SR (scientific research) as being the least

harmful. Polyurethane's have no real history of

implantation without deterioration, and we know

deterioration products of polyurethane's " are toxic " ,

and in some cases " carcinogenic " - whether they are

released in such low levels as to be no threat to the

human body - time will tell.

Signed Will L.

MEP000041322

Document #12:

Produced by Brisol-Myers: ME1000098043

Surgitek Memorandum

Surgitek - Subsidiary of Bristol-Myers This memo from

1990 reveals that Bristol-Myers Squibb had " clear

notice " that there were problems with its

polyurethane-covered implants. Bristol-Myers received

comments that its implants were prone to infection and

that this causes the polyurethane to " dissolve and

migrate. " Further, the polyurethane " does scatter

around the body and it does do it fast. "

September 12, 1990

FROM: B. Helloing

DATE: September 12, 1990

TO: G.

SUBJECT: Polyurethane

As we discussed, I think we've got to take RAPID

(caps and also underscored) action to clear up any

misunderstanding about the strength of our scientific

evidence on polyurethane that exists in New York. I've

attached a list of the questions that I think have to

be answered, but I think we'd better be sure we all

have them and that we understand the specific

questions that have been raised. To do that, you

should call Margaret and Larry and get them to give

you their specific questions. Once we understand the

questions, we have to develop a clear answer to each

one that a non-scientist can understand. After we get

the answers, we've got to clear up New York's concerns

either by a letter or more likely, by a face-to-face

meeting. I'll call tomorrow and we can see where we

are on this.

RJH:kj

Attachment continued on next page:

ME1000098043 "

Document. #12 (Continued)

Page No. 2: Attachment

ME1000098044

Specific Questions to Answer: Explain:

Why the Szycher stuff says not to use polyester base

polyurethane's in implants, and why it doesn't apply

here.

Explain Szycher's comments to Larry on the fact that

much " better " polyurethane's exist.

Explain Szycher's comment to Larry that this

polyurethane iscontraindicated for this use. (Now

imposed). Our previous information indicated that the

polyurethane will remain in the capsule.

**Hand notation: (bio-resorbed) Explain several

recent comments Szycher made to Larry. It does

dissolve and migrate.

All the polyurethane will be gone in 15 years. He saw

a capsule that was infected and the infection caused

all the foam to disappear in a short time.

How is the lady doing? The obvious conclusion is that

this stuff " does " scatter around the body and it does

do it FAST.

That's what we've got to get cleared up.

Specifically:

(1) What happens to it over time.

(2) Is anything that happens a problem to the body.

(3) What does Szycher mean by his second statement in

the article about aromatic polyurethane's forming MDA

when improperly processed? Enough is enough!

Talk to the Convatec poly expert I have you, and find

out why he Says better polyurethane are available.

Either understand his point, or, HELP him understand

ours. If he's being relied on, we have to be saying

the same thing.

RJH/kj : 9/12/90

From anonyomous sister - scanned but not corrected -

possibly from the Catch files

(Continued:

Document #8 - Minnesota Mining and Manufacturing Co.)

I should point out that I tend to be conservative in

forecasting the whims of Federal regulatory

agencies.......I see little hope at the present time

for an altruistic position on the part of the FDA on

behalf of the medical device industry....hopefully,

the statutory authority of the FDA " will be tempered "

by administrative " forethought. "

If you have any questions, please call.

JBS:fmp

Document #9: Document submitted by Minnesota Mining

and Manufacturing:

MMM000000956

This document, from 1976, reveals Minnesota Mining and

Manufacturing’s serious concerns about the safety of

its McGhan silicone gel breast implants. A Minnesota

Mining and Manufacturing employee admits that " based

on Mr. McGhan's comments, it appears that virtually no

documented safety and efficacy data exist on his

implant products. " While reluctant to pass any

judgments on the McGhan implant, the employee feels

the need to point out that " serious deficiencies

appear to exist with (these) products from the

documentation standpoint. "

April 9, 1976

Interoffice Correspondence: Minnesota Mining and

Manufacturing: (Confidential)

Subject: McGhan Company

cc: D. M. Pryor - 223-35, D. V. Murray - 223-35, and

J. E. on - 223-35

W.E. COYNE

From: G.M. HORGAN

(First paragraph is blacked out)

Unfortunately, when Mr. McGhan visited us last week my

laryngitis condition prevented the asking of numerous

questions on not only the (blocked out), but on his

other implants as well. Based on Mr. McGhan’s

comments, it appears that virtually no documented

safety and efficacy data exists on his implant

products. In addition, it sounds like his company will

be producing their own silicone.

It will be necessary for them to establish

biocompatibility of that silicone as they will have

had insufficient biological experience with their

material. Since the (long statement blocked out), and

other implants may remain in pre-market clearance, we

must assess what impact such condition will have on

Mr. McGhan's business. Please note I'm not making any

judgments on Mr. McGhan's products as such. I'm only

pointing out that serious deficiencies appear to exist

with his products from the documentation standpoint.

Jerry

GMH:et

Document #10: Interoffice Memo

(Shortened due to length)

TO: (name inked out)

CC: J. - CO2426, G. Jabubctak - 090

FROM: W. BOLEY - CO3101 (F000838)

SUBJECT: BIOLIGICAL SAFETY TESTING OF GEL FOR IMPLANTS

The purpose of this memo is to establish a position

statement for responding to questions regarding the

safety testing available for various " medical grade "

gels. The gels in question are: Q7-2218, Q7-2167/2168,

2159A, and Q7-150 and Q2146. One additional gel that

needs to be considered for historic purposes is

X-3-0885....this is the only gel to my knowledge that

has had long-term implant testing performed on it.

This testing is reported in I.B.T. Report #86199,

November 29, 1968. " Chronic Implantation Studies of

Polysiloxanes in Dogs. " The material was tested in 3

dogs, two of which were sacrificed (killed) at 2 years

and the third at 3 years.

The gel Q7-2218 has a formulation that is sufficiently

different from the other gels such that the testing

cannot be extrapolated. Gel Q7-2218 only has tissue

cell culture data available for it. Therefore, if we

are to continue to sell this material as " Medical

Grade, " immediate action should be taken to bring it

into compliance with the business definition of

" Medical Grade. " However, I want to emphasize that to

my knowledge, we have no valid long-term implant data

to substantiate the safety of gels for long-term

implant use. Only inferential data exists to

substantiate the long-term safety of these gels for

human implant applications.

BRISTOL MYERS:

Document #11: Submitted by Bristol-Myers: August 15,

1985

Bristol Myers-Squibb

Interoffice SPEEDIMEMO: #264953 - TRIP

(Handwritten Memo)

This document, from 1985, reveals that Bristol-Myers

Squibb knew that the polyurethane cover on its gel

implants was harmful, and that the company " had known

products of polyurethane's are toxic and in some cases

carcinogenic. " But, instead of demanding studies, the

memo concluded that only " time will tell " if these

implants are a threat to women's bodies.

(See Wall Street Journal article below in the Criminal

Activity Section of the Syndicate Seven Brothers Joint

Ventures when OSHA, and other governmental agencies

sent telegrams to 26 companies using Union Carbide's

polyurethane, and that it was " imperative to stop

using polyurethane. " That OSHA and other government

departments would institute " criminal proceedings "

against those who didn't comply with the mandate

ruling. Was Bristol-Myers one of the twenty-six

companies receiving the OSHA telegram?)

(Lynn - FYI: R.

TO: Rick Stolfa

AT: From Bristol Plant: Surg. 9:73-77, 85

DATE: 8/15/85

SUBJECT: Polyurethane Cover on Gel-filled Mammaries

Macrophages engulfing foreign body particles in a

portion of the body - this is correct. What we try to

do is keep implant " debris " to a minimum. Of the two

materials, there is more evidence to support SR

(scientific research) as being the least harmful.

Polyurethane's have no real history of implantation

without deterioration, and we know deterioration

products of polyurethane's " are toxic " , and in some

cases " carcinogenic " - whether they are released in

such low levels as to be no threat to the human body -

time will tell.

Signed Will L.

MEP000041322

Document #12:

Produced by Brisol-Myers: ME1000098043

Surgitek Memorandum

Surgitek - Subsidiary of Bristol-Myers

This memo from 1990 reveals that Bristol-Myers Squibb

had " clear notice " that there were problems with its

polyurethane-covered implants. Bristol-Myers received

comments that its implants were prone to infection and

that this causes the polyurethane to " dissolve and

migrate. " Further, the polyurethane does scatter

around the body and it does do it fast. "

September 12, 1990

FROM: B. Helloing

DATE: September 12, 1990

TO: G.

SUBJECT: Polyurethane

As we discussed, I think we've got to take RAPID (caps

and also underscored) action to clear up any

misunderstanding about the strength of our scientific

evidence on polyurethane that exists in New York. I've

attached a list of the questions that I think have to

be answered, but I think we'd better be sure we all

have them and that we understand the specific

questions that have been raised. To do that, you

should call Margaret and Larry and get them to give

you their specific questions. Once we understand the

questions, we have to develop a clear answer to each

one that a non-scientist can understand. After we get

the answers, we've got to clear up New York's concerns

either by a letter or more likely, by a face-to-face

meeting. I'll call tomorrow and we can see where we

are on this.

RJH:kj

Attachment continued on next page:

ME1000098043”

Document. #12 (Continued)

Page No. 2: Attachment

ME1000098044

Specific Questions to Answer: Explain:

Why the Szycher stuff says not to use polyester base

polyurethane's in implants, and why it doesn't apply

here.

Explain Szycher's comments to Larry on the fact that

much " better " polyurethane's exist.

Explain Szycher’s comment to Larry that this

polyurethane is contraindicated for this use. (Now

imposed). Our previous information indicated that the

polyurethane will remain in the capsule.

**Hand notation: (bio-resorbed) Explain several recent

comments Szycher made to Larry. It does dissolve and

migrate.

All the polyurethane will be gone in 15 years. He saw

a capsule that was infected and the infection caused

all the foam to disappear in a short time. How is the

lady doing? The obvious conclusion is that this stuff

" does " scatter around the body and it does do it FAST.

That's what we've got to get cleared up. Specifically:

(1) What happens to it over time.

(2) Is anything that happens a problem to the body.

(3) What does Szycher mean by his second statement in

the article about aromatic polyurethane's forming MDA

when improperly processed? Enough is enough!

Talk to the Convatec poly expert I have you, and find

out why he says better polyurethane are available.

Either understand his point, or, HELP him understand

ours. If he's being relied on, we have to be saying

the same thing.

RJH/kj : 9/12/90