Court Documents: Manufacturers' Internal Memos pt 2

[Guest guest]

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.

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)

(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:

ME1000098043â€

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

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