COURT documents on the ingredients of implants......more education

[Guest guest]

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 permanentorder to preserve evidence at that time. The breast implant examinedfor this case was used in a 1989 surgery.

INVENTORY OF PRODUCTION SAMPLESEXHIBIT B

RAW MATERIALS

ACETONE ACS REAGENT SOLVENTALUMINA, ACTIVATED FILLERCAB-O-SIL S-170 SILICA-BAG FILLERCHLORETHENE-BULK SOLVENTCHLORETHENE-DRUM SOLVENTCHLOROPLATINIC ACID 0.4% PLATINUMDIETHYLENE BLYCOL MBE ACETATE SOLVENTMEDICAL ADHESIVE A.MISC. ADHESIVEETCH ETHYNYL CYCLOHEXANOL PROCESS AIDZINC STEARATE SURFACTANT

Intermediate materials

Name DescriptionSGM-26 GUMSGM-33 GUMSGM-35 GUMMDF-0069 CATALYSTDC2FLUID O.65CST FLUIDLS 422 BASEDC 1107 FLUIDQ1-0043 FLUIDF1-0049 FLUIDQ1-2287 ME VI CYOLLOS3-8015 PLATINUM IIQ4-2782 FLUIDQ4-2826 PR FLLUIDQ4-2839 PL FLUID6-3570 CL FLUID7-2046A ELASTOMER7-2046B ELASTOMERQ7-2127 BASE STOCKQ7-2146 GEL FLUIDQ7-2150 GEL FLUIDQ7-2151 FIRM GELQ7-2159A STANDARD GELQ7-2167 GEL FLUIDQ7-2168 GEL FLUIDQ7-2317 1000CST FLUIDQ7-2420 BASEQ7-2424A BASEQ7-2424B BASEQ7-2553 BASE

Page2

Q7-2198 ADHESIVEQ7-2373 SHEETINGQ7-2423 DISPERSIONQ7-2551 DISPERSIONQ7-2868 SHEETINGQ7-2869 SHEETINGQ7-2503 INFILTRATION VALVEQ7-2517 FILL TUBE ASSEMBLYQ7-2316 MAMMARY ENVELOPE, LPRQ7-2595 MAMMARY ENVELOPE, TDPQ7-3062 MAMMARY ENVELOPE, HPRQ7-3063 MAMMARY ENVELOPE, TDP-UPEQ7-3024 MAMMARY ENVELOPE, LPE-UPEQ7-3028 MAMMARY ENVELOPE, TEX INNER8-0102 MAMMARY ENVELOPE, MSI-UPE8-0104 FILL TUBE ASSEMBLY

FILL TUBE NOZZLE COMPONENT

SLS CONNECTOR COMPONENTSLS NEEDLE COMPONENTTUBING, MDF-0108 COMPONENT

FINISHED PRODUCTS (in sterile packaging)

NAME QUALITY TO BE RETAINEDSILASTIC II-LOW PROFILE ROUND 50SILASTIC II-HIGH PROFILE ROUND 50SILASTIC II-TEARDROP 50SILASTIC II-GEL/SALINE 50SILASTIC MSI-LOW PROFILE ROUND 50SILASTIC MSI-HIGH PROFILE ROUND 50SILASTIC MSI-MODERATE PROFILE ROUND 50

Page 3SILASTIC 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-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.

Page 7

< /div>

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.

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

Page 11

Page12

Page 13

Page 14

Page 15

Page16

Page 17

Page 18

Page 19

Page 20

Page 21

Page 22

Page 23

Page 24

Page 25

Page 26

Page 27

Page 28

Page 29

Page 30

Start the year off right. Easy ways to stay in shape in the new year.

[Guest guest]

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 permanentorder to preserve evidence at that time. The breast implant examinedfor this case was used in a 1989 surgery.

INVENTORY OF PRODUCTION SAMPLESEXHIBIT B

RAW MATERIALS

ACETONE ACS REAGENT SOLVENTALUMINA, ACTIVATED FILLERCAB-O-SIL S-170 SILICA-BAG FILLERCHLORETHENE-BULK SOLVENTCHLORETHENE-DRUM SOLVENTCHLOROPLATINIC ACID 0.4% PLATINUMDIETHYLENE BLYCOL MBE ACETATE SOLVENTMEDICAL ADHESIVE A.MISC. ADHESIVEETCH ETHYNYL CYCLOHEXANOL PROCESS AIDZINC STEARATE SURFACTANT

Intermediate materials

Name DescriptionSGM-26 GUMSGM-33 GUMSGM-35 GUMMDF-0069 CATALYSTDC2FLUID O.65CST FLUIDLS 422 BASEDC 1107 FLUIDQ1-0043 FLUIDF1-0049 FLUIDQ1-2287 ME VI CYOLLOS3-8015 PLATINUM IIQ4-2782 FLUIDQ4-2826 PR FLLUIDQ4-2839 PL FLUID6-3570 CL FLUID7-2046A ELASTOMER7-2046B ELASTOMERQ7-2127 BASE STOCKQ7-2146 GEL FLUIDQ7-2150 GEL FLUIDQ7-2151 FIRM GELQ7-2159A STANDARD GELQ7-2167 GEL FLUIDQ7-2168 GEL FLUIDQ7-2317 1000CST FLUIDQ7-2420 BASEQ7-2424A BASEQ7-2424B BASEQ7-2553 BASE

Page2

Q7-2198 ADHESIVEQ7-2373 SHEETINGQ7-2423 DISPERSIONQ7-2551 DISPERSIONQ7-2868 SHEETINGQ7-2869 SHEETINGQ7-2503 INFILTRATION VALVEQ7-2517 FILL TUBE ASSEMBLYQ7-2316 MAMMARY ENVELOPE, LPRQ7-2595 MAMMARY ENVELOPE, TDPQ7-3062 MAMMARY ENVELOPE, HPRQ7-3063 MAMMARY ENVELOPE, TDP-UPEQ7-3024 MAMMARY ENVELOPE, LPE-UPEQ7-3028 MAMMARY ENVELOPE, TEX INNER8-0102 MAMMARY ENVELOPE, MSI-UPE8-0104 FILL TUBE ASSEMBLY

FILL TUBE NOZZLE COMPONENT

SLS CONNECTOR COMPONENTSLS NEEDLE COMPONENTTUBING, MDF-0108 COMPONENT

FINISHED PRODUCTS (in sterile packaging)

NAME QUALITY TO BE RETAINEDSILASTIC II-LOW PROFILE ROUND 50SILASTIC II-HIGH PROFILE ROUND 50SILASTIC II-TEARDROP 50SILASTIC II-GEL/SALINE 50SILASTIC MSI-LOW PROFILE ROUND 50SILASTIC MSI-HIGH PROFILE ROUND 50SILASTIC MSI-MODERATE PROFILE ROUND 50

Page 3SILASTIC 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-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.

Page 7

< /div>

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.

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

Page 11

Page12

Page 13

Page 14

Page 15

Page16

Page 17

Page 18

Page 19

Page 20

Page 21

Page 22

Page 23

Page 24

Page 25

Page 26

Page 27

Page 28

Page 29

Page 30

Start the year off right. Easy ways to stay in shape in the new year.