List of ingredients"

CHEMICAL PROFILE for BREAST IMPLANTS

1. Methyl Ethyl Ketone

2. Cyclohexanone

3. Isopropyl alcohol

4. Denatured Alcohol

5. Acetone

6. Urethane

8. Lacquer Thinner

9. Ethyl Acetate

10. Epoxy Resin

12. Amine

13. Printing Ink

14. Toluene

16. Freon

17. Silicone

18. Flux

19. Solder

20. Metal cleaning Acid

21. Lofol (Formaldehyde)

22. Talcum Powder

23. Color Pigments as Release Agents

27. Carbon Black

28. Xylene

29. Hexone

30. Hexanone2

31. Thixon-OSN-2

33. Acid stearic

34. Zinc Oxide

36. Phenol

Page 5

View this article only 
Newsgroups: alt.support.breast-implant
Date: 1999/07/23 

The 11th Circuit Court of Appeals in Atlanta, GA has affirmed upheld) the 
decision rendered by Federal Judge Patricia C. Fawsett in the Barrow vs.
BMS/MEC case in Orlando, Florida October, 19, 1998 for $750,000+.

Judge Fawsett found MEC guilty of fraud for concealing gel bleed and for 
hiding the beagle studies that  indicated some of the dogs died and silicone
was found in multiple organs including lungs, kidneys, ovaries, etc.
 
Bristol Myers Squibb was released by Denise Dunleavy of Weitz & 
Luxemborg one minute before closing arguments on the last day of trial 
WITHOUT the consent or agreement of Ms. Barrow.
 
In 1992, Bristol Myers Squibb presented this same false data to the FDA 
on these now  infamous "beagle studies."
 
Bristol Myers Squibb was denied Summary Judgement releasing them
from breast implant  liability on April 25, 1995, according to Judge Sam 
Pointer's orders
 
According to the court documents, BMS purchased MEC in 1982.  
Ms. Barrow received  her implants in 1985.

Page 7


BMS000069953/1142

March 28, 1978
 
To:  JERRY HELMER
 
CC: D. SANDERS
M. HANSEN 
 
FROM: W. STITH
 
SUBJECT: BEAGLE IMPLANT STUDIES
 
I have reviewed the material in the file on the Beagle Implant Studies 
performed by Industrial Bio-Test or Cape Laboratories. A summary 
of the studies performed and also those in-progress is shown in Table 1.
The animals implanted, the implant sites, and the type of implant are shown in 
Figures 1 - 19. No sheets are available on animals 738H, 722H and 736H. 
A list of the materials implanted, implant size(where available), and material 
use is shown in Table 2.
 
My impression in going through the studies is that the majority of the implant 
studies concern materials that have, been discontinued, such as MEC 114 
and MEC 127. These materials wire used for mammary prosthesis. 
The gel they contained, I understand, has also been discontinued. 
Interestingly, tissue inflammation was observed with the MEC 114 
prosthesis but not with the MEC 114 shell material. Some hemorrhage
into the surrounding tissues also appeared to be present.

No studies were performed to establish whether the reaction was due 
to the gel material or the Dacron attachment on the back of the prosthesis
intended for tissue in-growth.
 
Examination of other organs also revealed instances of possible
pneumonia of the lung and hyperplasia of lymphoid tissue, in the large
intestine. The cause and significance of these findings were not discussed
by the veterinary pathologists. The findings are further complicated by the
presence of different materials in the same animal.

One wouldn't be able to pin the effect to a specific material or
whether the effect might have resulted from a combination or
synergistic effect of both materials.
 
I submitted Dacron felt, presently in use as attachment to mammary
prosthesis to North American Science Associates. They found the
material to be toxic to cells in tissue culture. This may explain the
inflammatory response seen in our studies.
 
Smahel 1 examined the histology of 9 capsules around silicone 
implants from 7 patients.  

Page 8
The implants were removed because of breast pain and constrictive
fibrosis.  He found chronic inflammatory infiltration of qreat1y varying
intensity in areas surrounding he Dacron attachment.
 
Currently there are five animals St. Wedge Creek with MEC implants. 
These animals (Fig. 15-19) all contain more than one type of implanted
material. This will make interpretation of organ data difficult. Three of the
animals (CC-74, 273 and 669M) also contain Plastigel. I met with
L. Christensen and S. Aperavich and found that there is no traceability 
on this material. Both agree that it is probably GE material. As you 
know we now purchase Plastigel precursor material from Dow Corning.
 
I discussed our dog studies with R. Wallin, Scientific Director of North
American Science Assoc. He was of the opinion that unless we had
good material traceability, the study should be discontinued. He also
stated that as much information could be gained from 90 day rabbit 
studies as from long-term dog studies.
 
I feel that our present long-term beagle-study (5 animals) should be 
discontinued without histopathology examinations. My reasons are as
follows:

No traceability on Plastigel samples in 3 animals. Other   material
 used for implants in the animals has been discontinued.

2) The other 2 animals contain multiple materials—any  
deleterious effects couldn't be linked to a specific material.

3) The animals presently cost $425 month to maintain.
 
4) USP XIX calls out rabbits for evaluation of a plastic material in direct 
contact with living tissue. (Implant Studies)
 
5) According to R. Wallin, 90 day rabbit studies will give the
information we need, in a shorter time and at a lower cost than the  long-term
beagle studies.
 
6) The data we have and will obtain from Industrial Bio-Test is
questionable as you, the FDA and everyone else knows.
 
As you know, I have outlined testing procedures that I think should
be performed on new materials and also additional lots of a previously
tested material. I am also looking at other implantable devices to see
what testing has been performed on their component materials. 
I suspect that many of these materials will also require implant studies.
I would recommend that long-term dog studies not be performed on
these materials and instead use 90 day rabbit implants. I would also 
recommend not using different material in the same animal unless we 
only are interested in the local effect of the materials. In order
to perform such a study, it would be necessary to separate  imp1ant 
sites so as to preclude the possibility of cross-reactions occurring.
 
REFERENCES
 
Smahel, J., HISTOLOGY OF THE CAPSULES CAUSING CONSTRICTIVE
FIBROSIS
AROUND BREAST IMPLANTS. 8r~.t. Journal of Plastic  Surgery,
30:324-329, 1977.