Implant materials and beagle study

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list of ingredients "

http://yukonmom47.tripod.com/id5.html

Bristol Meyer Squibb-Surgitek chemical list:

introduced into U.S.Dist.

Court of MN.

4th Division, Judge S. Doty, in May 1992. Dow

entered a permanent order to preserve evidence at that

time. The breast implant examined for this case was

used in a 1989 surgery.

INVENTORY OF PRODUCTION SAMPLES

EXHIBIT B

RAW MATERIALS

ACETONE ACS REAGENT SOLVENT

ALUMINA, ACTIVATED FILLER

CAB-O-SIL S-170 SILICA-BAG FILLER

CHLORETHENE-BULK SOLVENT

CHLORETHENE-DRUM SOLVENT

CHLOROPLATINIC ACID 0.4% PLATINUM

DIETHYLENE BLYCOL MBE ACETATE SOLVENT

MEDICAL ADHESIVE A.MISC. ADHESIVE

ETCH ETHYNYL CYCLOHEXANOL PROCESS AID

ZINC STEARATE SURFACTANT

Intermediate materials

Name Description

SGM-26 GUM

SGM-33 GUM

SGM-35 GUM

MDF-0069 CATALYST

DC2FLUID O.65CST FLUID

LS 422 BASE

DC 1107 FLUID

Q1-0043 FLUID

F1-0049 FLUID

Q1-2287 ME VI CYOLLOS

3-8015 PLATINUM II

Q4-2782 FLUID

Q4-2826 PR FLLUID

Q4-2839 PL FLUID

6-3570 CL FLUID

7-2046A ELASTOMER

7-2046B ELASTOMER

Q7-2127 BASE STOCK

Q7-2146 GEL FLUID

Q7-2150 GEL FLUID

Q7-2151 FIRM GEL

Q7-2159A STANDARD GEL

Q7-2167 GEL FLUID

Q7-2168 GEL FLUID

Q7-2317 1000CST FLUID

Q7-2420 BASE

Q7-2424A BASE

Q7-2424B BASE

Q7-2553 BASE

Page2

Q7-2198 ADHESIVE

Q7-2373 SHEETING

Q7-2423 DISPERSION

Q7-2551 DISPERSION

Q7-2868 SHEETING

Q7-2869 SHEETING

Q7-2503 INFILTRATION VALVE

Q7-2517 FILL TUBE ASSEMBLY

Q7-2316 MAMMARY ENVELOPE, LPR

Q7-2595 MAMMARY ENVELOPE, TDP

Q7-3062 MAMMARY ENVELOPE, HPR

Q7-3063 MAMMARY ENVELOPE, TDP-UPE

Q7-3024 MAMMARY ENVELOPE, LPE-UPE

Q7-3028 MAMMARY ENVELOPE, TEX INNER

8-0102 MAMMARY ENVELOPE, MSI-UPE

8-0104 FILL TUBE ASSEMBLY

FILL TUBE NOZZLE COMPONENT

SLS CONNECTOR COMPONENT

SLS NEEDLE COMPONENT

TUBING, MDF-0108 COMPONENT

FINISHED PRODUCTS (in sterile packaging)

NAME QUALITY TO BE RETAINED

SILASTIC II-LOW PROFILE ROUND 50

SILASTIC II-HIGH PROFILE ROUND 50

SILASTIC II-TEARDROP 50

SILASTIC II-GEL/SALINE 50

SILASTIC MSI-LOW PROFILE ROUND 50

SILASTIC MSI-HIGH PROFILE ROUND 50

SILASTIC MSI-MODERATE PROFILE ROUND 50

Page 3

SILASTIC MSI-GEL/SALINE 50

CHEMICAL PROFILE for BREAST IMPLANTS

1. Methyl Ethyl Ketone

2. Cyclohexanone

3. Isopropyl alcohol

4. Denatured Alcohol

5. Acetone

6. Urethane

7. Polyvinyl Chloride (Liquid vinyl) This ingredient

was used in all medical devices made at Lab,

from tubing to gel.

8. Lacquer Thinner

9. Ethyl Acetate

10. Epoxy Resin

11. Epoxy Hardener - both 10 & 11 are chemically known

as glycosides Ether

of Bisphenol A.

12. Amine

13. Printing Ink

14. Toluene

15. Dichloromethan (Methylene Chloride) This breaks

down in the body so blood cannot carry oxygen:

Metabolizes carbon monoxide poisoning. Causes CSN

depression.

16. Freon

17. Silicone

18. Flux

19. Solder

20. Metal cleaning Acid

21. Lofol (Formaldehyde)

22. Talcum Powder

23. Color Pigments as Release Agents

24. Oakite (Cleaning Solvent)

25. Eastman 910 glue (Cyanoacyrylates)

26. Ethylene Oxide (ETO)

27. Carbon Black

28. Xylene

29. Hexone

30. Hexanone2

31. Thixon-OSN-2

32. Antioxidant (Rubber)

33. Acid stearic

34. Zinc Oxide

35. Naptha (Rubber Solvent)

36. Phenol

37. Benzene - Known Carcinogen!!!!!

KNOWN TO CAUSE IMMUNE DISEASE!!!!!!

Page 4

Page 5

McGhan Implants Ingredients from FDA ~ Chief of PS

Devices

Date: Sunday, December 05, 1999 10:20 AM

Subject: McGhan Implants

Ms. Pyron:

Your e-mail dated November 25 regarding McGhan Medical

breast implants was forwarded to me. You had two

inquiries: when your implants were manufactured and

what are the material constituents. For the former,

FDA does not have information on the date of

manufacture of implants based on lot numbers. For

this you can contact McGhan Medical in Santa Barbara,

CA, 1-800-624-4261. Regarding the materials, this

style of implant has a silicone rubber shell and is

filled with silicone gel. The silicone rubber contains

the following substances:

1. small amounts (parts per million) of various

smaller silicones

2. small amounts (50 - 100 parts per million) of

metals like tin and platinum and very trace amounts of

other metals

3. trace amounts of volatile materials like xylene and

other organic compounds

4. considerable amounts (approximately 20 parts per

hundred) of finely powdered silica that is tightly

bound to silicone rubber pouch

The filler material contains silicone oil and silicone

gel in addition to the four materials (chemicals)

listed above.

I hope this answers your questions.

Sincerely,

Chief, Plastic and Reconstructive Surgery Devices

---------------------------------------

Page 6

Beagle Implant Studies.... from Bristol 1978 ~

7/23/99

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 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

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

Beagle Implant Studies ~ 3/28/1978 ~ Bristol

BMS000069953/1142

March 28, 1978

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. The

Page 8

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:

1) 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 & #8212;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.

---------------------------------

Page 9

1977/Dr warns FDA regarding liquid silicone

Thanks to Pam Dowd for sending us the following letter

from Dr. to the FDA regarding liquid silicone.

This letter was part of the

evidentiary files of breast implant litigation. . .

Myrl

HENRY JENNY, M.D.

HENRY JENNY M.D., INC.

PLASTIC AND COSMETIC SURGERY

TELEPHONE: 714.327.1117

12 December, 1977

Mr. Rudolf Apodaca HFD-316

Compliance Evaluation Branch

Bureau or Drugs

5600 Fishers Lane

Rockville, MD 20852

Dear Mr. Apodaca:

On October 31, 1974 I sent to you a scientific paper

with photographs

and slides on the harmful effects of liquid silicone

injected into the

human body.

I then asked you to please review the paper and the

slides and send

them to Mr. Harry E. Butts, HFX-100 Division of

Compliance, Bureau of

Medical Devices and Diagnostic Products, 5600 Fishers

Lane, Rockville,

MD 20852. As of this date, I have not heard from you

nor from Mr. Harry

Butts.

I think that I might expect the courtesy of a response

as well as

return of my work.

Since that date I have collected further information

on the

transgression of liquid silicone particles through the

gel-filled

prosthetic shell into surrounding tissues and some of

my observations

have been confirmed by a Doctor Shamel who is a

scientific worker at

the University of Zurixh, Switzerland.

I am amazed that no action has been taken, nationwide,

against the

injection of liquid silicone and I am also amazed that

you have not

taken a closer look at the possible dangerous effects

of the liquid

silicone portions of the gel transgressing through the

shell and then

being absorbed into the human body.

Page 10

Yours Sincerely,

Henry , M.D.

HENRY JENNY, M.D., INC

HJ:LM

CC: Mr. Harry Butts