Fw: Bristol Myers Squibb Hot Document from 1991

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More old information on BMS...love....Lea

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>>>>thanks Mystery Man sender!

>>>>--------------------------------

>>>>

>>>>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.

>>>>

>>>>

>>>>

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