Bristol Myers Squibb Hot Document from 1991

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Subject: Bristol Myers Squibb " Hot Document " from 1991

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Date: Sat, 31 Oct 1998 18:25:02 -0700

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From: ilena rose <ilena@...>

Subject: Bristol Myers Squibb " Hot Document " from 1991

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Memorandum:

Date: May 2, 1991

L. Schopp

From: A. Kydonieus

Subject: Breast Implants

CONFIDENTIAL AND PRIVILEGED COMMUNICATION

Larry,

I am in receipt of the memo from Russ Bantham that you

sent to me. The memo is dated April 26 and contains a

list of polymeric materials that are used in medical

devices and the possible monomers that could leach out

from these polymeric materials.

You asked me to determine if any of the above

mentioned materials could be used as examples to help

us with the FDA on the Surgitek issue. My comments are

as follows:

1) I do not believe that this would be a good approach

because it could open up a Pandora's Box. I don't

think there is any specific real danger other than

most of these issues are of emotional, psychological

and political nature and thus should not be stirred

up.

2) Some of the monomers indicated in Russ's memo are

very toxic materials and at the same level of toxicity

as 2,4, toluene diamine. For example, formaldehyde is

an experimental carcinogen, tumorigin and teratogen,

as well as a suspected human carcinogen. In addition,

it is a human skin and eye irritant. Styrene is an

experimental carcinogen and teratogen, as well as a

suspected human carcinogen. However, we cannot compare

the toxicity of the 2,4 TDA from the breast implants

to that of the devices where the acetal (formaldehyde)

and the polystyrene (styrene) are used.

To compare the toxicity of two devices, you would have

to know the amounts, in ppb of the toxicants released

from the respective devices and do a risk assessment.

The other issue to be taken into account is the risk

to benefit ratio, which would not favor the breast

implant devices.

In summary these comparisons can be made if the data

is available and a lot of effort in developing

accurate toxicant release profiles is expanded.

However, I see more risk than benefit in this kind of

exercise. Again, I will be happy to compare the

toxicological profiles of some of the other devices to

breast implants if it is desirable, but substantial

data would be required, which may or may not exist in

the company's files.