Court documents on implants, ingredients and toxicity

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list of ingredients"

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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

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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

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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!!!!!!

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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

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Beagle Implant Studies.... from Bristol 1978 ~ 7/23/99

View this article only Newsgroups: alt.support.breast-implantDate: 1999/07/23 The 11th Circuit Court of Appeals in Atlanta, GAhas affirmed (upheld) the decision rendered byFederal Judge C. Fawsett in the Barrow vs. BMS/MEC case in Orlando, FloridaOctober, 19, 1998 for $750,000+. Judge Fawsett found MEC guilty of fraudfor concealing gel bleed and for hiding thebeagle studies that indicated some of thedogs died and silicone was found in multipleorgans including lungs, kidneys, ovaries, etc. Bristol Myers Squibb was released by

Dunleavy of Weitz & Luxemborg one minutebefore closing arguments on the last day of trialWITHOUT the consent or agreement of Ms. Barrow. In 1992, Bristol Myers Squibb presented this same falsedata to the FDA on these now infamous "beagle studies." Bristol Myers Squibb was denied Summary Judgementreleasing them from breast implant liabilityon April 25, 1995, according to Judge Sam Pointer's orders According to the court documents, BMS purchasedMEC in 1982. Ms. Barrow received her implants in 1985.

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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 Studiesperformed by Industrial Bio-Test or Cape Laboratories. A summary ofthe studies performed and also those in-progress is shown in Table 1. The animals implanted, the implant sites, and the type of implant areshown in Figures 1 - 19. No sheets are available on animals 738H, 722Hand 736H. A list of the materials implanted, implant size(whereavailable), and material use is shown in Table 2. My impression in going through the studies is that the majority of theimplant studies concern materials that have, been discontinued, suchas MEC 114 and MEC 127. These materials wire used for mammaryprosthesis. The gel they contained, I understand, has also

beendiscontinued. Interestingly, tissue inflammation was observed with theMEC 114 prosthesis but not with the MEC 114 shell material. Somehemorrhage into the surrounding tissues also appeared to be present.No studies were performed to establish whether the reaction was due tothe gel material or the Dacron attachment on the back of theprosthesis intended for tissue

in-growth. Examination of other organs also revealed instances of possiblepneumonia of the lung and hyperplasia of lymphoid tissue, in the largeintestine. The cause and significance of these findings were notdiscussed by the veterinary pathologists. The findings are furthercomplicated by the presence of different materials in the same animal.One wouldn't be able to pin the effect to a specific material orwhether the effect might have resulted from a combination orsynergistic effect of both materials. * I submitted Dacron felt, presently in use as attachment to mammaryprosthesis to North American Science Associates. They found thematerial to be toxic to cells in tissue

culture. This may explain theinflammatory response seen in our studies. Smahel 1 examined thehistology of 9 capsules around silicone implants from 7 patients. The Page 8 implants were removed because of breast pain and constrictivefibrosis. He found chronic inflammatory

infiltration of qreat1yvarying 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 implantedmaterial. This will make interpretation of organ data difficult. Three of the animals (CC-74, 273 and 669M) also contain Plastigel.

Imet with L. Christensen and S. Aperavich and found that there is notraceability on this material. Both agree that it is probably GEmaterial. As you know we now purchase Plastigel precursor materialfrom Dow Corning. I discussed our dog studies with R. Wallin, Scientific Director ofNorth American Science Assoc. He was of the opinion that unless we hadgood material traceability, the study should be discontinued. He alsostated that as much information could be gained from 90 day rabbitstudies as from long-term dog studies. I feel that our present long-term beagle-study (5 animals) should bediscontinued without histopathology examinations. My

reasons are asfollows: 1) No traceability on Plastigel samples in 3 animals. Other materialused for implants in the animals has been discontinued. 2) The other 2 animals contain multiple materials & #8212;anydeleterious 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 indirect contact with living tissue. (Implant Studies) 5) According to R. Wallin, 90 day rabbit studies will give theinformation we need, in a shorter time and at a lower cost than thelong-term beagle studies. 6) The data we have and will obtain from Industrial Bio-Test isquestionable as you, the FDA and everyone else knows. As you know, I have outlined testing procedures that I think should beperformed on new materials and also addition

al lots of a previouslytested material. I am also looking at other implantable devices to seewhat testing has been performed on their component materials. Isuspect that many of these materials will also require implantstudies. I would recommend that long-term dog studies not be performedon these materials and instead use 90 day rabbit implants. I wouldalso recommend not using different material in the same animal unlesswe only are interested in the local effect of the materials. In orderto perform such a study, it would be necessary to separate imp1antsites so as to preclude the possibility of cross-reactions occurring. REFERENCES Smahel, J., HISTOLOGY OF THE CAPSULES CAUSING CONSTRICTIVEFIBROSISAROUND BREAST IMPLANTS. 8r~.t. Journal of Plastic Surgery,30:324-329, 1977.

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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.

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Yours Sincerely,

Henry , M.D.

HENRY JENNY, M.D., INC

HJ:LM

CC: Mr. Harry Butts

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