www.BreastImplantAwareness.org/myrl.html
Disinformation Myrl is now Industry Friendly ... she removed every
trace of the Dow Documents from her websites ... and aimed all her
hatred and jealousy and frustrations at me, instead!

http://web.archive.org/web/20001206141900/www.info-implants.com/Document.html
What an industry coup for Dow to have Myrl Jeffcoat to help their
'image.'

PLAINTIFFS' TRIAL EXHIBIT LIST ABSTRACTS FOR DOW CORNING Excerpts
From: "DOW DOCUMENTS" WHERE THERES SMOKE THERES FIRE

Document #1
CONCEALING FROM FDA FRAUD/MISREPRESENTATION MISCELLANEOUS -
RECKLESS/CONSCEOUS DESREGARD

"Internal Audit and Corrective Action Plan" prepared by Dow Corning of
its Toxicology Laboratory. The audit uncovered four studies in which a
former Dow Corning employee (Mark Bejarano) created false data and
violated Good Laboratory Practices (GLP). The studies which were
falsified are a lifetime breast implant gel study in rats, a
biodurability study of elastomer in orthopedic devices, a breast
implant elastomer study.

The falsification involved the technician, Bejarano. who created
multiple slides from a single animal and labeled them as though they
had come from different animals. The report states, "It has been
acknowledged by Mr. Bejarano that he: did create multiple slides, made
a mistake, acted on his own, acted contrary to his Dow Corning
training, and did not tell his supervisor or anyone else what he had
done." (p.4 or Temporary Dow Corning Bates Number 411) Dow Corning
claims that none of the four studies were published or relied on for
data on the safety of breast implants, that an outside audit will also
be done, and that Dow Corning will examine its operating procedures
for the toxicology laboratory to make sure it complies with applicable
regulatory requirements.



Appendix A is a list of studies in Dow Corning's PMAA master file and
a list of studies                        in Dow Corning Corporation's
blue book.

Appendix B is a list of studies containing duplicate slides created by
Mark Bejarano.

Appendix C is qualifications of the consultant.

CITE: DCC 411000406 - 411000525, Exhibit 25 to Zimmer Deposition;
Exhibit 4 to Bejarano Deposition; Exhibit 5 to Bey Deposition; Exhibit
35 to McKennon Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work
Product/Privileged & Confidential

Document #2

ACKNOWLEDGEMENT OF NEED FOR TESTING TESTING

Research Project Description titled "Organosilicone Anticholesterol
Agents" The intent of this experiment is to isolate organosilicon
compounds capable of lowering total serum cholesterol in several
species and of ameliorating atheromata in rabbits. Data collected
coincidental to other experiments have indicated a number of
organosilicon compounds that can lower serum cholesterol,
triglycerides, and/or phospholipids in normally fed mice and rats.
Dimethylpolysiloxanes can ameliorate atheromata in rabbits.

CITE: DCC 16001089 - 16001091, Exhibit to Bennett Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work
Product/Privileged & Confidential

Document #3

ACKNOWLEDGEMTN OF NEED FOR TESTING COHESIVENESS-LIQUID COMPONENT OF
GEL KNOWLEDGE OF SYSTEMIC DISEASE TESTING

Dow Corning Research Project Description entitled "Metabolism Of
Organosilicone Compounds." The intent is to study systematically the
absorption, distribution, storage, metabolism and elimination of those
organosilicon structures forming the basis of silicon chemistry as
exploited by Dow Corning. There have been no systematic explorations
of the metabolism of these classes of organosilicon compounds. Such
explorations are necessary for their predictive value in selecting and
developing efficacious biological applications, and in defining the
environmental impact of all present and future products.

CITE: DCC 16001081 - 16001083, Exhibit to Bennett Deposition, and
Exhibit to Isquith Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work
Product/Privileged & Confidential

Document #4

1970 ACKNOWLEDGEMENT OF NEED FOR TESTING KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS MISCELLANEOUS - ORGANIZATIONAL SURVEY
TESTING

Draft of the "Proposed Agreement For Cooperative Research Program
between Dow Corning and Lepetit Pharmaceutical Company to research the
use of silicone compounds in biological systems. "These silicon
chemicals will likely be used systemically rather than locally, and
their utility in biological systems. "These silicon chemicals will
likely be used systemically rather than locally, and their utility in
biological systems may dependent more upon their chemical, rather than
their physical properties. (p.1)

The proposal notes that Dow Corning has acquired information that
certain silicones are biologically active and has instituted a
Biomedical Research Laboratory in July 1965 "to probe the potential
utility of such silicon chemicals across the broad disciplines of
biology, i.e., plant sciences, microbiology and animal science." (p.
2) Dow Corning Does have the capability to conduct research on
silicons in the pharmaceutical areas while Lepetit "has been engaged
in s specific endocrine cooperative research program with DC for a
period of two years." (p. 3) The proposal states that the parties
would cooperate to develop new silicon chemicals as drugs including
silicones with activity as androgen depression, central nervous system
depression, antimicrobial activity, etc. (pp. 3-4). Additionally, Dow
Corning and Lepetit personnel will exchange research and information
and will travel to the other's facilities.

CITE: DCC 2801011379 - 281010391, Exhibit to Bennett Deposition (also
used as Exhibit 65 by Dow Corning), Exhibit to Blocksma Deposition
(used by Dow Corning), Exhibit to Isquith Deposition, Exhibit to
LeBeau Deposition, Exhibit to Petraitis Deposition, Exhibit to Rowe
Deposition, Exhibit 17 to Popoff Deposition, Exhibit to Julius Johnson
Deposition, and Exhibit to MDL LeVier Deposition. WITNESS: Bennett
(Authenticated in Bennett, Vol. II, p. 455-457). DISPOSITION: Not
admitted in Toole (II) v. Baxter Healthcare.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work
Product/Privileged & Confidential

Document #5

KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS MISCELLANEOUS -
COMPLICATIONS TESTING TISSUE REACTION

Script of an internal Dow Corning seminar presented by Dr. Isquith,
and Tony Bennett and Pat Walters on the subject of microbiology.
Isquith states that, "Our (Biomedical Research) primary function is to
investigate the microbiology of organosilicon compounds through basic
research. A secondary function is the development of utility from the
information gathered, either academically or in an applied form. A
third function is that of service. We are interested in the
preservation, biodegradability, and microbiology of existing Dow
Corning products." (p. 2)

Abbott notes that the Microbiology Section has "the capability of
conducting research in most areas of microbiology (i.e., Virology,
tissue culture, immunology, mycology, bacteriology, etc.)" (p. 3) He
notes that one function is to search for organisms capable of silicone
degradation. (p.3) There is also a section on Page 3 which is crossed
out on Silanols and then a handwritten outline on Silanols (Slide 2)
beginning on page 4. Abbott states that silanols have provided "much
basic research information on the relationship of organosilicon
compounds to microorganisms and has suggested new areas of research."
(p. 6)

CITE: Temporary Dow Corning Bats Number 671 - 685, Exhibit 4 to
Isquith Deposition.



Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work
Product/Privileged & Confidential

Document #6

ACKNOWLEDGEMENT OF NEED FOR TESTING TESTING

Research Project Description titled "Antiparkinsonism Activity of
2,6-cis- and 2,6-trans-(PHMESIO)2(ME2SIO)2)." The objective is to
evaluate (PhMeSiO)2(Me2SiO)2) as an antiparkinsonism agent. It has
been shown that these compounds increase whole brain dopamine within 5
days of daily oral administration.

CITE: DCC 16001084 - 16001085, Exhibit to Isquith Deposition, Exhibit
to LeVier Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work
Product/Privileged & Confidential

Document #7

COHESIVENESS - LIQUID COMPONENT OF GEL MISCELLANEOUS - COMPLICATIONS
TESTING

Report titled "Discussion of Toxicology of Various Dow Corning
Products." Topics include gel bleed, silicone transport across the
skin, the need for further testing. Dr. Carson recommended that all
possible evidence of adverse effects be collected with supporting data
of literature on our part to show that Dow Corning has no part in
these. The presence of Low Molecular Weight in 350 cs. is the same as
in lower cs.

CITE: DCC 281041877 - 281041882.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work
Product/Privileged & Confidential

Document #8

KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS TESTING

Handwritten synopsis by Lake titled "Status of Biological Testing of
Sila-admantoner Compounds, Dow Corning Report 4234" of research
projects and patent activity. It includes notes regarding fibroblasts
and immunopotentiation, antigen modification, and joint research on in
vitro carcinogen bioassay.

CITE: LAK 133, Exhibit to Radonovich Deposition, Exhibit to Boley
Deposition, and Exhibit to Lake Deposition.

Document #9

TESTING TISSUE REACTION

Dow Corning document: "I. Silicone Oils As Miticides (or
mite-repellents)"; "II. Aphid Control With Silicone Emulsions"; "III.
Effect Of Silicone Emulsions On Mealy Bugs"; and "IV. Effects Of
Silicone Oils On Cockroaches." The document was authored by "JWR"
(unknown who this is). "Mites do not willingly invade silicone treated
bean plants if untreated ones are available." (DCC 16001144). Mites
are not controlled by silicone-treated cucumber plants, possibly
because the silicone oil is absorbed into the plant. A silicone spray
was "completely effective in discouraging them. It is possible that a
minor component, relatively volatile, may be acting as a contact
insecticide." (Id.)

Wild mustard plants sprayed with DC 200 fluid 10 cs. eliminated
aphids. "The impression gained is that the insecticidal (or repellent)
activity is due to some component of the fluid which has gone
(presumably by evaporation or by becoming chemically bound within the
plant) or a hydroxy-ended material. It seems worthwhile attempting to
identify the active species and trying to modify it chemically to
obtain a long-term effect." (DCC 61001145).

Pachysandra plants, infested with mealy bugs, were sprayed with an
antitranspirant emulsion with 5% silicone. After 5 days, all mealy
bugs on the treated plants were eliminated. "The silicone appears to
be slower acting here than upon other insects; possibly a repellent,
rather than an insecticidal, effect is involved." (DCC 61001146).

In the 1950s, Texaco and Shell did studies on hydrocarbon oils as
insect attractants. In 1968, it was found by Gorzinski (of Dow
Corning) that DC 360 fluid appeared to have an insect attractant and
insecticidal activity. Cockroaches were attracted to the petri dish
with silicone fluid. After coming out of the fluid, they "never got
more than a few inches from the dish before dying." These results
indicate "some type of activity existed in the DC 360 fluid...." (DCC
61001147).

CITE: DCC 16001144 - 16001147, Exhibit to Bennett Deposition, Exhibit
11 to McKennon Deposition, Exhibit 8 to Harris County Gehring
Deposition, Exhibit to Harris County and MDL LeVier Depositions,
Exhibit to Ryan Deposition, and Exhibit to Isquith Deposition.
WITNESS: Bennett (Authenticated in Bennett, Vol. IV, p. 880;15 -
882:8). DISPOSITION: Admitted in Toole (II) v. Baxter Healthcare.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work
Product/Privileged & Confidential

Document #10

KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS

LeVier, Dow Corning, memo to C. Lentz and Nelson regarding "Activities
Related to 2,6-cis." There are twelve Dow Corning Products currently
being sold by the Medical Business that could contain levels of
2,6-cis originating from SBM-18 in excess of the estimated allowable
body burden. Medical Products has no active program to identify
replacement stock other than conversion of developmental products
based on SGM-18 wherever possible. The greatest concern rests with the
replacement identified for SGM-18 (elastomer) in that it may be
necessary to re-qualify the new stock for medical use including
long-term implantation studies.

CITE: DCC 281031092, Exhibit to MDL and Harris County Tyler
Deposition, Exhibit 8 to Harris County LeVier Deposition, Exhibit to
MDL LeVier Deposition, and Exhibit to Ryan Deposition, NOTE: See
document # 11 for attachment.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work
Product/Privileged & Confidential

Document #11

MISCELLANEOUS

Table of 2,6-cis levels in selected products which was attached to
LeVier's memo (see document # 10 above). MDX-4-4514 (elastomer),
shunts, penile implants, chin implants, and other products all
contained 2,6-cis.

CITE: DCC 281031093, Exhibit to Tyler Deposition. NOTE: See document #
10.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work
Product/Privileged & Confidential

Document #12

VIDEOTAPE PRODUCED AT ZIMMER DEPOSITION ON D4.

CITE: No Bates Number, Exhibit to Zimmer Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work
Product/Privileged & Confidential

Document #13

10/08/92 COHESIVENESS - LIQUID COMPONENT OF GEL MISCELLANEOUS TESTING

"Catalog and Review of D4 Studies." This is a list of all studies by
Dow Corning on D4. There is a handwritten note at the top that says:
"Meeting Oct. 16, 1992, Stark/BeyZimmer."

CITE: DCC 260000855 - 260000878. WITNESS: Exhibit to Zimmer
Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLTON/PSC Attorney Work
Product/Privileged & Confidential

Document #14

MISCELLANEOUS - ORGANIZATIONAL SURVEY MISCELLANEOUS - LOBBYING

List of "Desired Product Champion Features" includes that the
relationship with the product champion should fit the Dow Corning
Silicone Group Business Strategy. "PC (product champion) needs to
understand and buy-in to the Silicones Group Business Strategy."
Listed features include that the PC serve as a substantive resource to
Dow Corning, be loyal to the company, have positive peer influence, be
politically astute, and demonstrate teamwork with Dow Corning. The
document lists the names of product champions in the United States and
Europe and includes a manual prepared by Lois Duel dated September 1,
1989 which addresses issues such as the desired product champion
features, the role of the product champion, product champion
management and specific product champion issues.

CITE: KKA 210877 - 210886

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work
Product/Privileged & Confidential

Document #15

KNOWLEDGE OF LIQUID SILICONE DANGERS MISCELLANEOUS MISCELLANEOUS -
COMPLICATIONS TESTING

Confidential report entitled "Chronology of Silicone Injection." The
report provides a historical account from Dow Corning's perspective of
the use of liquid silicone injections and the establishment of the
Center for Aid to Medical Research. It notes that Dow Corning 200
fluid was used for industrial applications. When the Medical Products
Division was established in the early 1960's, the 200 fluid was
designated Dow Corning 360 Medical Fluid. The report notes that, "The
original label on the new product carried the inscription 'formerly
Dow Corning 200 Fluid.'" (DCC 267371450) The report also discussed the
indictments against Dow Corning officials for distributing the drug,
360 fluid, and the pleas of no contest which were eventually entered.

CITE DCC 267371444 - 267371466. NOTE: The document also has Bates
numbers QDC 124506 - 124528 on it as well as Bates numbers MM 369861 -
3698883.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work
Product/Privileged & Confidential

Document #16

ACKNOWLEDGEMENT OF NEED FOR TESTING SILICA TESTING TISSUE REACTION

W.D. Galloway reports on the "Analysis of Lifetime Carcinogenicity
Study of Silicone Gels" conducted by Dow Corning under GLP regulations
using Sprague-Dawley rats injected with Q7-2159A and MDF-0193 gels.
Galloway states:

"Both of the gel-implanted groups showed a large number of cancers
compared to the control group. Particularly striking was the number of
sarcomas (principally fibrosarcomas) which occurred in the treated
groups."

"The only obvious deficiency is that only one dose level was used.
Ordinarily, three doses are used, and five are preferred. Based on the
results obtained, I have little doubt that NTP would classify these
substances as likely animal carcinogens."

"According to Dow Corning, ... the tumors were peculiar to rats, the
so called foreign body tumors."

"Absent epidemiologic data, and without waiting for results of
additional lifetime studies, knowledge of the mechanism by which these
tumors was induced is critical to estimating human risks. It is
possible that the tumors were chemically induced, rather than being
induced by a by a physical mechanism, as Dow suggests. If this is the
case, then the argument that such tumors do not occur in man is
untenable. If the tumors were chemically induced, the active agent is
more likely to be one of the several chemicals which make up the gel,
rather than a metabolically produced reactive intermediate, since the
tumors which did occur did not occur selectively in metabolically
active organs such as the liver."

"Recent studies have shown that siloxanes may act as estrogen-like
substances and can enhance the growth of tumor cells."

CITE: M 780064 - 780065.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work
Product/Privileged & Confidential

Document #17

COHESIVENESS - LIQUID COMPONENT OF GEL KNOWLEDGE OF GEL BLEED
MISCELLANEOUS SILICA

Dow Corning materials identification list for final devices. It lists
all materials used in final devices with a Dow Corning code number.
The two manufacturing sites, Michigan and Tennessee, use different
identification codes. The list also gives material formulations,
indicates the need for a low-bleed outer shell liner, identifies
whether "responsive" gel or "firm" gel is used, and notes the
percentage of silica used in the formulations.

CITE: KMM 447209 - 4477224

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work
Product/Privileged & Confidential

Document #18

Post 10/92 COHESIVENESS - LIQUID COMPONENT OF GEL KNOWLEDGE OF GEL
BLEED MISCELLANEOUS - COMPLICATIONS RUPTURE SHELL STRENGTH - THICKNESS

Dr. O. Gordon Robinson Presents a paper entitled "Rate of Rupture of
Silicone Prostheses: Excerpt From A Study Of Over #3000 Personal Cases
and Twenty-Five Years Experience" at the Symposium on Reoperative
Aesthetic Surgery of the Face and Breast in Naples. Florida. Robinson
discusses results obtained after 115 patients were followed after the
fall of 1990 after receiving breast implants. Of the 115 patients, 57%
had rupture of one or both implants. An additional 20% had moderate to
severe bleed on one or both sides. The patients had the implants from
six months to 25 years. Dr. Robinson concludes that all gel and
bi-lumen implants:

"should be replaced at about the eighth post-operative year because it
can be fairly well predicted that at this stage the prostheses in most
cases would still be intact and much easier to replace. If a period of
time longer than twelve to fourteen years is allowed to elapse, then
the prostheses have a good chance of being ruptured and the exchange
would be much more difficult.

CITE: PSC Medical Articles CD, J 2698 - Exhibit 2 to Robinson
Deposition, Exhibit 25 to McKennon Deposition. WITNESS: Robinson.
DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare

Dow Corning Trial Exhibit List PENDLETON/PSC Attorney Work
Product/Privileged & Confidential

Document #19

Post/10/92 KNOWLLEDGE OF GEL BLEED MISCELLANEOUS - COMPLICATIONS
RUPTURE SHELL DEGRADATION SHELL STRENGTH - THICKNESS

Dr. O. Gordon Robinson's abstract of a paper entitled "Disruption Rate
Of Silicone Gel Prostheses - A Report Of 200 Cases." 200 patients from
02/91 - 10/92 had their silicone gel implants removed. The time from
implantation ranged from six months to 25 years. Robinson found that
104 or 52% had one or both implants ruptured, 43 or 21.5% had severe
bleed, and 147 or 73.5% had "distortion" - rupture plus severe bleed.
Based on this data, Robinson projected future rupture rates using the
Kaplan-Meier survival curve, and concluded that in 20 years, only 3.4%
of the patients will have both prostheses still intact. He states,
"Gel filled mammary prostheses wear out and in a certain predictable
time frame. Based on this study, patients can be advised with a
certain degree of accuracy as to the probable condition of their
prostheses."

CITE: No Bates Number, Exhibit 3 to Robinson Deposition. WITNESS:
Robinson DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare.

Document #20

10/92 COHESIVENESS - LIQUID COMPONENT OF GEL KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS - COMPLICATIONS RUPTURE
SHELL STRENGTH - THICKNESS

Dr. O. Golden Robinson presents a paper entitled "Breast Implant
Removal Or Exchange: which updated his prior study of 200 patients. He
has seen an additional 100 patients and presents nine charts of
statistics. Chart 2 lists "symptoms" of patients including burning and
pain, numbness and tingling in extremities, joint and muscle pain,
joint and muscle dysfunction, enlarged liver, flu symptoms, loss of
appetite, swelling, arthritis symptoms, fibrocystic disease,
deformity, kidney failure, vision problems, chronic fatigue, lupus,
rash, insomnia, and hair loss. Of the 300 patients, 154 had a ruptured
prosthesis, and 214 had a "disrupted" prostheses, i.e. loss of
integrity of the silicone shell or severe silicone bleed where
silicone "strings out at least 12 inches from intact capsule." (p.1).

CITE: No Bates Number, Exhibit 4 to Robinson Deposition. WITNESS:
Robinson DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work
Product/Privileged & Confidential

Document #21

Post 10/92 KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS - COMPLICATIONS
RUPTURE RUPTURE - CLOSED CAPSULOMTOMY SHELL DEGRADATION SHELL STRENGTH
- THICKNESS

Dr. O. Gordon Robinson's charts on the age of prostheses a significant
number of implants ruptured 6-16 years post-implantation, (
observations at surgery 36.9% of his 73 patients were symptomatic),
follow-up (most did not show any change in symptoms during follow-up),
symptomatic (patient relates to prostheses-arthritic profile, refer,
and "No Closed Capsulotomies"), asymptomatic (patient happy), and
questions ("Do mammary prostheses last forever? What contributes to
the silicone envelope wearing out? ... How do you tell if an implant
is ruptured? ..."

CITE: No Bates Number, Exhibit 9 to Robinson Deposition. WITNESS:
Robinson DISPOSITION: Not admitted in Toole (II) v. Baxter Healthcare.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work
Product/Privileged & Confidential

Document #22

Post 10/92 COHESIVENESS - LIQUID COMPONENT OF GEL KNOWLEDGE OF GEL
BLEED KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS - COMPLICATIONS
RUPTURE SHELL STRENGTH - THICKNESS

Draft of Dr. O. Gordon Robinson's paper entitled, "Breast Implant
Removal Or Exchange." This is a draft of document number 22.

CITE: No Bates Number, Exhibit 10 to Robinson Deposition. WITNESS:
Robinson. DEPOSITION: Not admitted in Toole (II) v. Baxter Healthcare.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work
Product/Privileged & Confidential

Document #23 through#31

#23

ANY FOLLOW-UP STUDIES BY DR. O. GORDON ROBINSON.

This includes an abstract by Dr. Robinson and Dr. Edwin Bradley
entitled "Disruption Rate of Silicone Gel Prostheses - A Report of 200
Cases" published in the January 1995 issue of the American Medical
Association Journal.

#24

PHOTOGRAPHS OF PLAINTIFF'S EXPLANT SURGERY

#25

EXPLANTED IMPLANTS OF PLAINTIFF AND PHOTOGRAPHS THEREOF.

#26

MEDICAL RECORDS OF PLAINTIFF.

#27

MEDICAL BILLS OF PLAINTIFF.

#28

PATHOLOGY SLIDES AND TISSUE SAMPLES OF PLAINTIFF.

#29

SPECIMEN BREAST IMPLANTS.

#30

SELECTED COMPLAINT REPORTS, FORMS AND/OR RESPONSES.

#31

ALL PRODUCT DATA SHEETS OF DOW CORNING FOR MAMMARY PROSTHESES.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work
Product/Privileged & Confidential

Document #32

09/14/54 SILICA KNOWLEDGE OF SYSTEMIC DESEASE

H.C. Spencer, Dow Chemical, note regarding "Dow Corning Hydrophobic
Silica." Testing shows a "high order of toxicity from dust
inhalation."

CITE: TDC 5488.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work
Product/Privileged & Confidential

Document #33

03/28/55 MISCELLANEOUS - COMPLICATIONS SILICA TISSUE REACTION

"Report Of Trip To Saranac Lake Laboratories" by V.K. Rowe of Dow
Chemical prepared for Dow Corning. Rowe and other Dow Chemical
scientists visited Saranac Laboratory to verify work they had done on
D.C. Degusa silica for Dow Corning. Rowe, et al. reviewed the work and
wrote this report on the conclusions of the tests.

Dow Corning silica consists of crystalline silica. Rowe states that,
D.C. Degusa (silica) dust is "capable of causing diffuse cellular
infiltration and fibrotic changes in the lungs and other organs of
certain types of animals. It also produces bronchitis and sometimes
emphysema." However, he concludes that it is not likely to cause
silicosis" in the ordinary sense of the word. If fibrotic changes of
the lungs develop in man, they will probably be diffuse in character.
If exposure is stopped, a measure of recovery is quite possible.
Exposure to crystalline free silica reactivates and aggravates
tuberculosis & causes progressive lesions." (DCC 299000444).

CITE: DCC 266000443 - 266000453, Exhibit to Lynch Deposition, and
Exhibit to California Braley Deposition.

Dow Corning Trial Exhibit List Abstracts PENDLETO/PSC Attorney Work
Product/Privileged & Confidential

Document #34

01/00/56 TESTING KNOWLEDGE OF LIQUID SILICONE DANGERS GEL MIGRATION

Dow Corning Report No. 1377 on "The Physiological Assimilation Of DC
200 Fluid" by M.B. Chenoweth (Dow Chemical), R. Holmes and F. Stark. A
copy was distributed to Collings, Bass, Kauppi, Hunter, Hutchison,
Hyde, Blackburn, Bennett, McHard, CRI, and others including Beamer of
Dow Chemical. "An increasing use of siloxanes for medicinal
applications has resulted in the need for information on their
biological activity. Previous experiments of The Dow Chemical Company
Biochemical Department has shown that many of these compounds were
toxicologically inert. It was the purpose of this experiment to
determine to what extent the polydimethylsiloxanes were assimilated,
and if so were they were metabolized." (I 169). C14 labeled PDMS in
antifoam emulsion was administered to 2 albino rats and 2 lactating
dogs. "The preoperative care, administering of the labeled fluid,
sacrificing and dissecting of the animals was carried on by Dr. M.B.
Chenoweth of The Dow Chemical Biochemistry Department. Samples of
tissue were analyzed with the cooperation of Dow's Radiochemistry
Laboratory." (I 171). With intramuscular injection, the C14 siloxane
was found in the intestines, right adrenal, skin and hair, heart,
skull bone, brain, kidney, urine, liver, muscle, lung, renal fat,
blood and spleen. (I 172). Rats fed with the material had siloxane in
the ileum, stomach and content, bladder and urine and kidney. (I 174).
"The actual amount present may be greater by a factor of 3
corresponding to total polydimethylsiloxane from Dow Corning 200 Fluid
and from gum. It is unlikely that the polydimethylsiloxane in the gum
would be more readily assimilated than the lower molecular weight 200
Fluid." (I 174). A lactating dog fed with the material has siloxane in
the skin and hair, brain, bile,, liver, kidney, heart, milk, urine,
skeletal muscle, lung, adrenal, and blood. (I 175). A second lactating
dog also had siloxane in the bile, skin and hair, adrenal, urine,
spleen, lung, heart, liver, thyroid, pancreas, blood from lung,
skeletal muscle, and milk. (I 175).

"The studies conducted along these lines (C14 labeled fluid) to date
have shown that these compounds are absorbed from the
gastro-intestinal tracts to a slight extent, the amount absorbed being
of the order of .0001%. Toxicological studies have shown these
compounds to be inert." (I 175). There is a cite to the lab notebooks
for the studies. on 259803.

CITE: KMM 259794 - 259803, Exhibit to Harris County LeVier Deposition,
Exhibit to Tyler Deposition, Exhibit 20 to Harris County Zahalsky
Deposition. DUPLICATE: I 167 - 176.

Dow Corning Trial Exhibit List Abstracts PENDLETON/PSC Attorney Work
Product/Privileged & Confidential

Document #35

02/09/56 KNOWLEDGE OF LIQUID SILICONE DANGERS MISCELLANEOUS
MISCELLANEOUS - COMPLICATIONS TESTING

McGregor, Dow Corning, memo to Rowe, Dow Chemical Biochemical
Research, enclosing 9 samples of silicone fluids for determination of
the effect of intravenous injection. McGregor wants to know if any of
the silicone fluids can be tolerated when injected intravenously. The
silicone samples include 200 fluid, 555 fluid, 710 fluid, antifoam AF
emulsion (which contains 30% 200 fluid), and XEC-5027 (which contains
10% 200 fluid).

CITE: OOT 43674 - 43700, Exhibit to K. Olson Deposition, Exhibit to
Rowe Deposition, Exhibit 24 to Harris County Rowe Deposition. and
Exhibit to McHard Deposition.

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Product/Privileged & Confidential

Document #36

08/00/57 KNOWLEDGE OF LIQUID SILICONE DANGERS MISCELLANEOUS
MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

Study by Stark titled " The Physiological Activity Of Dow Corning 200
Fluid." By a mechanism unknown at this time, a small amount of Dow
Corning 200 Fluid is absorbed through the skin by the adrenal and
kidneys of a rabbit.

CITE: KMM 259804 - 295808.

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Product/Privileged & Confidential

Document #37

10/05/57 COHESIVENESS - LIQUID COMPONENT OF GEL MISCELLANEOUS -
COMPLICATIONS TESTING TISSUE REACTION

Dow Corning's version of a "Report Prepared for Dow Corning
Corporation, Midland, Michigan on Five Silicone Materials." The
original report (see document #38 below) was prepared by Dr. W.
Deichmann of the University of Miami on October 5, 1957 but was a
report on six silicone materials. This version of Dr. Deichmann's
report was altered to delete one compound and to delete all adverse
effects identified in Dr. Deichmann's original report.

In this version, five Dow Corning silicones were fed to albino male
and female rats for a period of 90 days. The silicones were Dow
Corning 200 Fluid (50, 350, 1000, 10000 and 60000 cs.). Based on the
observations of body weight, food intake, hematology, organ weight at
necropsy, and their gross and microscopic appearance, it was concluded
that none of the Dow Corning 200 Fluids of the viscosity range fed
caused any harmful or deleterious effects.

CITE: KKM 7896 - 7930. NOTE: Includes a summary of animal safety
studies relating to dimethylpolysiloxane fluid. See document #38 for
the original, unaltered version of Dr. Deichmann's report produced by
Dow Chemical. This altered version of the report was produced by Dow
Corning.

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Document #38

10/05/57 COHESIVENESS - LIQUID COMPONENT OF GEL MISCELLANEOUS -
COMPLICATIONS TESTING TISSUE REACTION

Dr. W. Deichmann's original "Report Prepared for the Dow Corning
Corporation, Midland Michigan on Six Silicone Materials" Six Dow
Corning silicones were fed to albino male and female rats for a period
of 90 days. The silicones were Dow Corning 200 Fluid (50, 250, 1,000,
10,000, and 60,000 cs.) and Dow Corning Z-4141 Solvent Free (the
latter compound is the compound deleted by Dow Corning is document #37
above).

ORIGINAL REPORT

2 rats died during experiment there was a marked decreased in the
number of leukocytes. This difference is considered statissignitically
significant. It is feeding of apparent there is a depression
signifi-in the output of granulocytes leukocyte by the bone
marrow.animals. The livers of the rat fed Z-4141 were significantly
greater than the controls. This is consistent with of the rats fed
Z-4141 were the observation of liver damage in these animals. The
feeding of the six compounds depressed the granulocytic or elements of
the peripheral tail blood of female rats. The livers significantly
heavier than the livers of the controls and also demonstrated fatty
infiltration or degeneration.

DOW CORNING ALTERED REPORT

only 1 rat died there was an apparent decrease in the number of
leukocytes. This is not statistically ficant. The dietary DC 200
fluids had no cant effect upon the counts of the treated The feeding
of the five compounds had no harmful deleterious effects. None of the
organ weights differed from the controls.

CITE: TDC 6079 - 6100.

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Document #39

10/09/57 COHESIVENESS - LIQUID COMPONENT OF GEL MISCELLANEOUS -
COMPLICATIONS TESTING TISSUE REACTION

Dr. Deichmann, University of Miami, writes to McGregor, Dow Corning,
enclosing the results of the review of the six Dow Corning silicone
compounds. He informs McGregor that all six compounds depressed the
granulocytic elements of the peripheral (tail) blood of the female
rats, and that the livers of rats fed Z-4141 were significantly
heavier than the controls and demonstrated fatty infiltration or
degeneration.

CITE: M 420103.

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Document #40

12/09/57 KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS - COMPLICATIONS
TESTING TISSUE REACTION

Letter from K.J. Olson and checked by V.K. Rowe, Dow Chemical
Biochemical Research, to R.R. McGregor of Dow Corning with copies to
H.H. Gay (Dow Chemical) and E.M. Adams (Dow Chemical ??) on "Results
Of Range Finding Microbiological And Toxicological Tests on B-756-92
(a linear dimethylpolysiloxane of 6 units end-blocked with
2,4,5-trichlorophenxy radicals - being evaluated as potential
fungicide for athlete's foot)." The tests showed appreciable
antifungal activity. "If large amounts of the material are allowed to
remain in contact with large areas of skin, absorption may result in
systemic injury and may even produce death." Slight hyperemia followed
the 3rd and 4th application and the rabbit died "possibly due from
systemic injury due to absorption through the skin." The other 2
rabbits also died.

Attached is a data sheet prepared by Olson and McCollister, a
toxicology work sheet, "Request For Applications Testing," and eye
contact, skin contact - irritation, and skin contact absorption test
records. NOTE: The document is stamped, "This Report Is The Property
Of The Dow Chemical Company."

CITE: TDC 6158 - 6175, Exhibit to K. Olson Deposition, and Exhibit to
McHard Deposition.

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Document #41

04/09/58 ACKNOWLEDGEMENT OF NEED FOR TESTING KNOWLEDGE OF SYSTEMIC
DISEASE MISCELLANEOUS
MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

"Pharmacological Test Data For Various Organofunctional Silicon
Compounds, Report No. 1641," by Speier of Dow Corning. Pharmacological
screening test data for 61 organofunctional silicon compounds are
examined for use in drugs. In early 1952, a program was agreed upon
with Eli Lilly for the pharmacological examination of assorted
organofunctional silicon compounds. "The screening of these compounds
has shown that a great many organofunctional silicon compounds and
polymers have totally unexpected activities. Certain ones proved to be
acutely toxic, even though closely similar structures were not
especially toxic." (DCC 281002214).

All the results are contained in Mellon Institute notebook 318 - all
61 tests in this study contain a reference to notebook 318. There is
also a reference to Earl Warrick's work at the Mellon Institute at
281002226.

CITE DCC 281002213 - 281002230, Exhibit to Tyler, MDK and Harris
County Depositions, Exhibit to Bennett Deposition, Exhibit to McHard
Deposition, and Exhibit to Ryan Deposition. WITNESS: Bennett (ancient
document exception to hearsay). DISPOSITION: Not introduced in Toole
(II) v. Baxter Healthcare.

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Document #42

07/31/58 KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS - COMPLICATIONS
TESTING TISSUE REACTION

Olson, Dow Chemical Biochemical Research, letter to McGregor, Dow
Corning, with copies to Gay, Dow Chemical, and McHard regarding the
results of skin irritation, skin absorption and acute oral feeding
tests on Dow Corning 555 Fluid and Ethylan (a modified lanolin), file
no. T2.42-54-1.

In McGregor's 06/05/58 letter to Rowe he indicated that Helen Curtis
Industries had observed untoward systemic effects in rabbits and rats
due to absorption of the material through the skin. Autopsy revealed
small yellowish bubbles and petochone (illegible) on the liver and
lungs. Olson applied the material to the skin of rabbits and fed it to
another group for 5 days/ The results for the skin sensitization tests
are illegible. There was a questionable to mild kidney disturbance in
animals fed 555 fluid.

The conclusions on 6532 state that DC 555 fluid has a low acute oral
toxicity, is essentially non-irritating to the skin upon prolonged
repeated contact, and that there is no indication that the material is
absorbed through the skin in sufficient amounts to produce systemic
damage. Attached is a toxicology work sheet, "Requests For Screening
Or Application Testing," and skin contact absorption and acute oral
toxicity test results.

CITE: TDC 6526 - 6555, Exhibit to McHard Deposition, and Exhibit to K.
Olson Deposition.

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Document #43

07/05/62 KNOWLEDGE OF LIQUID SILICONE DANGERS MISCELLANEOUS -
COMPLICATIONS TESTING TISSUE REACTION

Olson and Sadek, Dow Chemical Biochemical Research, letter to McHard,
Dow Corning, on toxicity by subcutaneous injection of Dow Corning 200
Fluids and Dow Corning 555 And 550 Fluids. Dow Corning 200 fluid 10
cs. resulted in a moderate inflammatory response in the subcutis as
indicated by the presence of polymorphonuclear cells and a very large
mononuclear cells. "This type of inflammatory reactions is interpreted
as due to infection." With DC 555 and 550 Fluid, all injection sites
showed evidence of inflammatory reaction indicated by the presence by
mononuclear cells and polymorphonnuclear cells.

CITE: TDC 7493 - 7515, Exhibit 9 to Hancock Deposition, Exhibit to
McHard Deposition, and Exhibit to K. Olson Deposition.

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Document #44

07/12/62 SHELL STRENGTH - THICKNESS

S. Braley, Dow Corning, reports on a telephone call with Dr. Gerow
regarding his findings from the use of the saline silastic prosthesis.
A leak was discovered during implantation and Dr. Gerow "sealed it
with cement on the operating table...." Also, he wanted Dow Corning to
"make the Gel gooier." Dr. Gerow reports that the saline he has been
using in some of the silastic sacs has been in animals for nine months
and that the body sets up a chemical balance. He has analyzed the
fluid inside the sacs after this nine months and found protein, SO4
ions and also indications that the body had set up a balance of
magnesium and other ions. Finally, Dr. Gerow stated that the "direct
injection technique has worked out beautifully."

CITE: M 320001 - 320002.

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Document #45

09/14/62 TESTING

Dow Chemical Texas Division, Agricultural Research, study by F.C.
Turner, K.G. Seymour, and J.B. Jackson on "Tropical Application Of
Various Solvents And Solutions To Evaluate Dermal Irritation." Report
No. 210. The report was circulated many persons including K.W. McCory
of Dow International; persons at Bioproducts: Adm., J.E. Johnson;
An.Sci. R and D, T.A. Hymas; Plt.Sci. R and D, K.C. Barrons; Midland
BRC Files, L.J. Lippie: Registration Section. G.E. Lynn; Synthesis
Group, W. Reifschneider; and Formulation Res., J.W. VanValkenburg; to
V.K. Rowe of Biochemical Research; and to the following persons at
Pitman-Moore: C.W. Hinman, G.R. Burch, and D.C. Brinkman.

Dow Corning 200 fluid - silicone oil with 49% espesol 5 content was
administered in 10 cc dosages to shaved strips on the hide to test for
suitable solvents for Ruelene. Dow Chemical hoped to find a solvent
that didn't damage the hides of cattle when Ruelene was administered.
The DC 200 fluid was rated ad bad, which indicated that the hide had
extreme cracking or sloughing at 10 and 16 days after application.
(TDC 7542).

CITE: TDC 7537 - 7543.

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Document #46

10/04/62 ACKNOWLEDGEMENT OF NEED FOR TESTING COHESIVENESS - LIQUID
COMPONENT OF GEL KNOWLEDGE OF GEL BLEED KNOWLEDGE OF LIQUID SILICONE
DANGERS SHELL STRENGTH - THICKNESS TISSUE REACTION

S.Braley, Dow Corning, memo regarding telephone call to Dr. Thomas D.
Cronin. Braley told Cronin that the uncatalyzed breast material could
not be sent out because there were too many problems with it. The
problems with measuring and the variability of both the base material
and the mixing techniques necessitates different amounts of cross-link
resulting, along with the variability in mixing techniques, can cause
difficulties.

Dr. Frank Gerow was also on the telephone and talked about the results
he was getting regarding tissue reaction to the direct injection of
the material.

Cronin said that he is not concerned about leakage if he were to use
the thin material because a film forms around the implant retaining
the material in place. Cronin said that he is getting chlorine,
potassium and proteins both in and out through the wall of the bag.
This is on apparently good bags.

It was decided that it would be wise to continue the work for long
range testing for the acceptability of the material.

CITE: OOM 320665 - 320666.

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Document #47

10/31/63 KNOWLEDGE OF LIQUID SILICON DANGERS GEL MIGRATION

Dr. Walter Berman writes to Silas Braley, Dow corning, reporting on
his injection of silicone fluid in mice. Two days after injection,
silicone was found in most organs including the brain, liver, spleen,
intestinal wall, adrenal and kidney. He also found "evidence of at
least radio activity and most probably silicone in the brain and all
of the various other organs...."

CITE: M 420051 - 420052.

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Document #48

11/27/63 TESTING TISSUE REACTION

Dow Chemical's Bioproducts Department report by Whitney, Pollock and
Pauley on "Fluorosilanes As Fumigants." Six flourosilanes:K-56,425 =
n-propyltrifluorosilane; K-56,426 = ethylmethyldifluorosilane;
K-57,317= trimethylfluorosilane; K-59,489 = mehtyltrifluorosilane;
K-59,697 =chlorometthyldifluoromethylsilane; K-58,739 = silicon
tetrafluoride; andK-681 = methyl bromide were evaluated as fumigants
for control of insects and microorganisms. All were very active
against post-embryonic stages of tests insects. Tri and difluoro
silanes were active against bacteria and molds. Most of the compounds
killed all flour beetle eggs at one lb/1000 cu. ft. with a 16-hour
exposure.... A patent disclosure has been submitted and further
research is recommended for these and related compounds.

Results of toxicological work with mammals is reported in reports
55.11-56425-1, 55.11-56426-1, 55.11-56427-1, 55.11-57317-1, and
55.11-2-1. the usefulness of these compounds has been reported in
Patent Disclosure no. 16193. NOTE: None of these reports or patent
disclosures were produced to the PSC.

"Further exploration of the biological and physical properties of
these and related compounds is recommended."

CITE: TDC 8901- 8904.

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Document #49

00/00/64 MISCELLANEOUS - COMPLICATIONS SILICA
STERILIZATION/CONTAMINATION TISSUE REACTION

Braley, Dow Corning, states in the Trans American Society of
Artificial Internal Organs, "The Medical Silicones," that electrical
charges exist on the surface of the silicone elastomer. Silicone
elastomers are described as non-adherence products, nothing will stick
to them "However, because of the dialectic (sic) properties of
silicone rubber, it will develop a surface charge and can hold dust,
lint, (etc.).... This is not true adhesion." Additionally, the reason
that the attempt to create a silicone vascular prostheses, to be
inserted in a blood vessel, failed is because of the electrical
charges on the surface which caused the blood to clot at the ingress
end of the silicone prostheses tube.

Braley also describes the chemical composition, the characteristics
and the various applications of silicone.

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Document #50

01/13/64 GEL MIGRATION KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS -
COMPLICATIONS TESTING TISSUE REACTION

McHard memo to Hunter with copies to Braley, Dingman, Hobbs, and
Stebleton regarding "Notes on visit to Battelle Memorial Institute on
December 19, 1963." McHard and Hobbs met with representatives of
Battelle and discussed the "Toxicology of silicones - past and future.
... 1. Variation in toxicity with animal species. 2. Effect of polymer
size on toxicity. 3. Extent of body metabolism. 4. Fate in kidney and
liver. 5. Fate of catalysts. 6. Extent of carcinogenicity." Also
discussed was silastics for breast implants. Battelle's study showed
that the physical properties of silicone rubber when implanted were
significantly affected/decreased. Also, "There was considerable
discussion on how the various polymer sizes may be transported across
the G.I. tract and how they may find their way into the kidney, liver,
and subsequently, the urine."

CITE: KMM 299059 - 299063.

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Document #51

05/16-17/64 COHESIVENESS-LIQUID COMPONENT OF GEL KNOWLEDGE OF LIQUID
SILICONE DANGERS KNOWLEDGE OF SYSTEMIC DISEASE TISSUE REACTION

Silicone Injection committee Meeting on 05/16-17/64 attended by D.J.
Badamo, S. Braley, C.E. Haberstoch, R.R. McGregor, E.G. Mullison, S.L.
Bass, H.D. Dingman, E. Hodnett, M.J. Hunter, J.A. McHard, A.W. Rhodes
and L.F. Stebleton of Dow Corning; by Drs. Ashley, Blocksma, Dingman,
Edgerton, Goulian, Lederer, Murray and Rees, who are medical
consultants; and by Steve Carson and Bernard Oster of Food & Drug
Research Laboratories. Materials considered for the injectable trials:
dimethyl siloxane 360 Medical Fluid "(formerly 299 fluid)";
phenylmethyl siloxanes including 555- "cyclic, very low molecular
weight, 704 - linear, very low molecular weight, 550 - dimethyl and
phenylmethyl copolymer; large amount of phenyl...." and others.

CITE: DCC 267371390 - 267371417, Exhibit to McHard Deposition, and
Exhibit to K. Olson Deposition. DUPLICATE: m 30531 - 30558; KMM 183981
- 184009.

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Document #52

05/28/64 FRAUD/MISREPRESENTATION GEL MIGRATION MISCELLANEOUS -
COMPLICATIONS TISSUE REACTION

Braley memo to Ashley, Blocksma, R. Dingman, Edgerton, Goulian,
Lederer, Murray, Rees, Badamo, Bass, H. Dingman, Haberstroh, Hodnett,
Honter, McHard, Mullison, Rhodes, and Stebleton regarding the attached
article in the May 25, 1964 issue of "The Insider"s Newsletter."
Unknown factors with silicone injections include absorption, migration
and hardening.. Braley writes, "We have no knowledge where the
reporter obtained this information. If anyone knows anything about
this, we'd appreciate hearing from him. We are trying to keep such
articles as this out of the public eye as much as possible."

CITE: M 350063 - 350064.

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Product/Privileged & confidential

Document #53

09/22/64 KNOWLEDGE OF LIQUID SILICONE DANGERS GEL MIGRATION

Thomas Rees letter to Braley, Dow Corning, regarding the finding of
altered fat cells in animals subcutaneously injected with silicone.
Rees states that the spleens of the mice that have been injected with
massive amounts of the material show definite collection of silicone
within macrophages.

CITE: KMM 167416.

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Document #54

09/24/64 TISSUE REACTION SHELL DEGRADATION SHELL STRENGTH - THICKNESS

Letter from Dr. Thomas Cronin to William Rhodes, General Manager of
Dow Corning. Dr. Cronin reports that Dr. Brauer had to remove seven
implants when, at intervals of 2-4 months, a blister would start in
the scar and gradually break down. "(S)ome clear, straw colored fluid
would be released"

CITE: KMM 150269 - 150270. NOTE: Ivory flakes were being used to
prepare the implants prior to surgery.

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Document #55

11/12/64 EMBOLISM KNOWLEDGE OF LIQUID SILICONE DANGERS

Harry Dingman, Dow Corning's Legal Counsel, writes to Ban Smart of the
FDA and informs him of a reported fatality following injection of a
silicone. Dr. Crenshaw, California, injected a woman with silicone
(source and type unknown) mixed with a vegetable oil. she "then went
into a coma in a matter of a few hours, and died within a few days.
Dr. Aronow had not received a formal coroner's report, but the
informal comment was to the effect that death was due to fat emboli in
the lung and possibly in the liver. A suspicion of possible
encephalitis was being checked by having a culture run on the brain."
(emphasis added).

CITE: KKM 1275 - 1276. DUPLICATE: KMM 48637 - 48638.

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Document #56

12/00/64 KNOWLEDGE OF LIQUID SILICONE DANGERS MISCELLANEOUS -
COMPLICATIONS TISSUE REACTION

"Tissue Reactions to Injected Silicone Liquids, A Report of Three
Cases," Archives of Dermatology, Vol. 90, 538-593 by Winer, Sternberg,
Lehman and Ashley. Drs. Oppenheimer and Russell observed fibrosarcomas
developing in 1.7% to 40% of the test animals. Drs. Hur and Neuman
observed malignant epithelial tumors that were believed to be of sweat
gland origin. The conclusion drawn from the test data is that "there
seems to be sufficient evidence at this time that complications of
this nature are to be expected."

CITE: I 253 - 259, Exhibit 7 to McGhan Deposition, and Exhibit 16 to
California Braley Deposition. DUPLICATE: PSC Medical Articles CD, J
3598 - 3603.

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Document #57

12/08/64 KNOWLEDGE OF LIQUID SILICONE DANGERS TISSUE REACTION

Dr. Franklin Ashley writes to Silas Braley, Dow Corning, regarding a
"girl in Las Vegas who received the injections and had the eye
trouble." The 28 year old woman received 30 injections into the
breast.

Ten to fifteen minutes following her final injection she noted onset
of nausea followed by dizziness and almost complete loss of vision. At
the same time she developed severe left anterior chest pains without
dyspnea or tachypnea.

She was seen by an Internist who treated her with ACTH thinking that
this possibly represented an anaphylactoid reaction. Visual
disturbance cleared somewhat with ACTH. During this immediate post
treatment period she experienced some loss of memory, as well as poor
coordination which cleared gradually over a period of time. Also noted
during this time was hematuria which lasted for one day only; no
recurrence has been noted.

One week following the onset of symptoms she was evaluated by Dr.
Albouth, at which time he noted a questionable positive Rhomberg and
ophthalmologic findings consisting of some loss of visual acuity and
hemorrhages within and anterior to the retina.

Follow-up to date has been over a six month period with the latest
notation that her gait has returned to normal. Her dizziness has
disappeared, but she still experiences some visual difficulties,
specifically loss of visual acuity. (emphasis added).

CITE KKH 63126 - 63127.

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Document #58

01/29/65 KNOWLEDGE OF LIQUID SILICONE DANGERS

Franklin Ashley, UCLA Center for the Health Sciences, to Braley, Dow
Corning, reporting the death of a patient after various injections of
silicone around the face. (emphasis added).

CITE: M 340057.

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Document #59

04/01/65 CONCEALING FROM FDA KNOWLEDGE OF LIQUID SILICONE DANGERS

Dr. Franklin Ashley responds to Silas Braley's, Dow Corning, letter
concerning a girl in Argentina who was injected with large amounts of
silicone fluid. "I believe this would fit in also with the
observations of Goulian and others where a large quantity was injected
any one time, and was taken up by the lymphatics. We have not observed
this in any of our cases, however, probably due to the fact that we
inject only a small quantity each time.... I do not think this should
be reported to the FDA as it is an isolated case and from another
country, and we do not know exactly what they injected really."
(emphasis added).

CITE: M 340044.

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Document #60

05/27/65 EMBOLISM KNOWLEDGE OF LIQUID SILICONE DANGERS

Frank Ashley, M.D., reports to Silas Braley of Dow Corning regarding a
consultation with a patient in Las Vegas. Ashley states, "My
diagnosis, of course, was multiple silicone emboli from the liquid
silicone and possible additives, in the lungs, brain, liver, kidney
and retina." (emphasis added).

CITE: M 340037.

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Document #61

06/24/65 KNOWLEDGE OF LIQUID SILICONE DANGERS GEL MIGRATION

Dr. T. Rees writes a letter to Dr. Silas Braley and Fred Dennett, Dow
Corning Center for Aid to Medical Research. Dr. Rees states "The
inevitable has happened. We found a case of carcinoma of the breast in
a 37 year old woman who has had both breast heavily injected with pure
silicone material." He states'

"The carcinoma itself was a very small, isolated, intraductal type of
carcinoma in the upper portion of the tail of the breast and there
were some involved lymph nodes in the axilla. There are multiple
'silicone cysts' throughout the tissue and some of the silicone was
injected in the immediate vicinity of the carcinoma. Also of
considerable interest is that there is evidence of silicone deposits
in the lymph nodes of the axilla and thus it appears that the silicone
is drained to a certain extent by the lymphatic system..... We are
thinking of writing this up as a case report, but would like the view
of the entire committee before we commence doing so. We are hesitant
to report it because undoubtedly it will create quite a stir but feel
that the case must be reported for the sake of thoroughness and
completeness. We are open to counsel as to just what manner this
should be done. (emphasis added).

CITE: KMM 105815 - 105816, Exhibit to D. McGhan Deposition. DUPLICATE:
KMM 3802 - 3803.

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Document #62

10/05/65 ACKNOWLEDGEMENT OF NEED FOR TESTING MISCELLANEOUS -
COMPLICATIONS SILICA TESTING

Hobbs memo to Snedeker with copies to McHard regarding
"Recommendations for the toxicological evaluation of J. Treated Dow
Corning Silica Type A." "At the present time very little is known on
the toxicity of the various treated silicas at Dow Corning.... The
exact toxic manifestations are unknown. They will cause death in
laboratory animals by various routes of administration, including
inhalation, for a period of four hours or less. Although these are
high concentrations for a short period of time. we must assume until
proven otherwise that low concentrations over long periods of time are
detrimental to health. It is therefore our recommendation that acute
range-finding studies be performed on J Treated Silica." Testing
programs (such as annual chest x-rays of workers) have been run with
the cooperation of the Dow Medical and Biochemistry Departments on
problems which have arisen with various chemicals. The programs at Dow
and Dow Corning were dropped but, "Recently problems have arisen with
chemicals and compounds which indicate that such a preventative
medical testing program is not only desirable but also advisable....
While toxicity studies are being carried out on some of these
materials at the Dow Biochemistry Department, they are made with
animals, usually on short term acute exposures. This type of
information does not indicate what might happen over long periods of
time subjected to less than acute exposures." The document also talks
about a Medical-Biological-Safety Committee."



CITE: KKA 230245 - 230249, Exhibit to McHard Deposition and Exhibit to
K. Olson Deposition.

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Product/Privileged & Confidential

Document #63

10/27/65 ACKNOWLEDGEMENT OF NEED FOR TESTING COHESIVENESS - LIQUID
COMPONENT OF GEL GEL MIGRATION SHELL DEGRADATION SHELL STRENGTH -
THICKNESS TESTING TISSUE REACTION

Burdick, Dow Corning, memo to Don McGhan, Weiler, VerVoort, and
Pellikka regarding "Mammary Implants." He states:

"There are still a number of questions concerning our breast units
that have not been answered. We know that a quantity of low molecular
weigh material is exuding from the bag, but that is all.

He suggests a test to extract the material and analyze it. Burdick
states:

"This test should tell us how the gel is affecting the rubber bag.
Adhesion and tear strength should also be related to swell. The
extractables may be of low enough molecular weigh to migrate
throughout the body. If so, what quantity are we talking about?

CITE: OOM 321439 - 321449, Exhibit to Bennett Deposition and Exhibit
to D. McGhan Deposition.

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Document #64

11/15/65 EMBOLISM KNOWLEDGE OF LIQUID SILICONE DANGERS

Dr. Ashley authors a paper, "Silicone Fluid And Soft Tissue
Augmentation, as a result of the Boca Raton symposium. "Of
significance is the fact that the clinical use of silicon liquids in
man preceded any responsible and controlled experiments in animals."
As a result of the concern, ASPRS set up a committee consisting of Dr.
Franklin Ashley, Dr. Ralph Blocksma, Dr. Reed Dingman, Dr. Milton
Edgerton, Dr. Dicran Goulian, Jr., Dr. Francis Lederer, Dr. Joseph
Murray, Dr. Norman Orentreich, and Dr. Thomas Rees.

Dr. Ashley provides a historical overview of the chemical properties
and development of silicone. He notes that with intravenous injection
of silicone fluid in animals, large doses are usually fatal in rabbits
and can produce emboli and death in dogs. He found no tissue reaction
in animals when liquid silicone was injected subcutaneously.

Dr. Ashley also notes that silicone oil "will have a tendency to
disappear" within the body and that:

"(S)ignificant questions ... remain unsolved. First, what is the body
distribution within its tissues of any absorbed material? Second, what
is the ultimate fate of the absorbed material? ... Third, if
significant amounts are absorbed, does the body excrete the material,
and if so, how, and how much? Fourth, if some is retained, in which
organ or organs is a harmful effect produced - if any? Indeed, there
is some evidence that silicone oils may be transported to far removed
tissues and organs. In another study, one week after the intramuscular
injection of a rat with dimethyl polysiloxane, 90 per cent of the
C(14) labeled liquid oil was detected within the tissues of the
intestinal tract. The fate and presence of silicone oil in human
biology is unknown." (emphasis added). He further notes that, "In
large subcutaneous injections of silicone fluid, examination of the
contents of the abdominal cavity showed that the mesenteric and
omental fat was abnormally firm, with loss of normal color and
adherence to adjacent viscera. This suggests that there may have been
transport of silicone oil through the abdominal cavity." (emphasis
added).

Animal studies of injection of RTVS 5392 silicone fluid showed tumor
development in rats at eight, fifteen, and nineteen months after
injection. MDX 44010 silicone fluid was also injected in mice, rats
and monkeys. Nearly all animals developed hair loss over the implanted
site, and several rats developed superficial cutaneous ulcers directly
over the silicone mass. Both of these symptoms resolved themselves
within six weeks. He also noted a significant "exothermic reaction,"
"pronounced local reactions," and tumor development in 3 of 6 rats at
14 and 16 months post-injection. He concludes:

"Although it is only speculation, the initial exothermic injection
reaction and tissue injury may have provided a carcinogenic
influence.... (T)he incidence of 3:6 (3:22) should not be attributed
to random chance occurrence.... Tumor formation about buried
synthetics has had important consideration by some, but discounted by
others.... (A) tumor incidence of 3:6 or 3:22 indicates a need for
further animal experimentation." (emphasis added). He notes that human
clinical experience in 35 patients noted breast abscess and apparent
tumor formation. He reports on three cases of carcinoma of the breast
in women following injection of silicone fluid. One woman developed a
palpable axillary lymph node eight months following injection and
required a radical mastectomy. Surrounding the cancerous lesion were
"multiple small silicone cysts. The silicone was also found in the
axillary lymph modes removed with the radical specimen."

"At least two deaths are known to have followed the subcutaneous
injection of 100.0ml. or more of Dow Corning 360 Medical liquid given
in one single administration.... At least one patient is known to have
developed blindness during the subcutaneous injection of Dow Corning
360 Medical liquid.... There is no reason to believe that the human
will tolerate intra-arterial and/or intravenous injections any better
than the experimental animals. (emphasis added).

CITE: M 360096 - 360141.

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Document #65

01/14/66 ACKNOWLEDGEMENT OF NEED FOR TESTING KNOWLEDGE OF SYSTEMIC
DISEASE MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

McHard memo to Bass with copies to Bennett, Dingman, Hunter, W.T.
Rossiter and Rowe regarding "Toxicological testing of Dow Corning Pan
Shield." McHard is reporting on the results of a meeting today with
Rowe and Bennett regarding DC Pan Shield. An initial formulation of
this product indicated no apparent toxicological problems. However,
the catalyst wasn't potent enough to cure on the pan; therefore a new
catalyst was used and the product reformulated. Based on the results
of the testing with the first catalyst, no toxicological problems were
anticipated and so marketing decisions were made about the product. As
they got into the 90-day testing program, the toxicological
information was insufficient to assure the degree of product safety
necessary. Therefore, Rowe, Bennett and McHard met today (1/14/66) to
review this product. "(I)t is our recommendation that marketing
studies, even short-termed pilot tests, be postponed until product
safety data can be accumulated."

There are indications that adequate non-toxic oral levels may not be
achieved. "It should also be borne in mind that if Dow Corning were
obliged to defend the safety of this product today in a court of law,
we would be at a serious disadvantage since we could be forced to
disclose all data which has any bearing on the components of the
product. You can well appreciate what our position would be in this
event?"

CITE: DCC 281041086 - 281041087.

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Document #66

06/06/66 ACKNOWLEDGEMENT OF NEED FOR TESTING MISCELLANEOUS -
COMPLICATIONS TESTING TISSUE REACTION

Minutes of meeting with the FDA in Washington DC regarding Dow Corning
555 Fluid. Present were Steve Carson and Bernard Oser (FDRL), Otis
Fancher (IBT), Bass, Bennett, Dingman and McHard (all of DC) and Drs.
Lehman, Marzulli and Nelson with the FDA. McHard reported on the
chemical composition of DC 555 and a summary of Dow Corning's 555
fluid Safety Evaluation Program. DC 555 has been used in cosmetic
preparation for 12 years. It was decided to have more detailed
subacute tests performed on rabbits at IBT. The testicular size of the
test rabbits was reduced and spermatogenesis was depressed on
microscopic examination. The effect was traced to the DC 555 fluid in
the hand cream. FDRL then evaluated the fluid and found no such
activity in rats or guinea pigs, noted a marginal effect in dogs, and
observed activity in the rabbit but not as severe as that noted at
IBT.

"A consultation was held with Drs. Oster*, Carson*, Calandra
(Industrial Bio-Test Labs.), and Rowe, toxicologist of the Dow
Chemical Company. These consultants felt that the data were indicative
of a species specific response and therefore it was suggested that a
male monkey series be started in which the material would be applied
dermally repeatedly." The studies were done at IBT. A dose applied
dermally repeatedly." The studies were done at IBT. A dose of 5 mg.kg.
produced a statistically significant effect. McHard mentioned that
"the effect requires 20 days of daily application in the rabbit, but
the effect is not grossly present until the 16th-17th day.:

Oral studies in monkeys was begun in 1965. It was noted that in the
orally dosed males, it was difficult to obtain ejaculate and a
subsequent biopsy at 5 months of oral dosing in the males showed a
marked depression of spermatogenesis at the 2000 mg.kg. level, and 2
of 3 monkeys showed spermatogenic depression at the 50 mg.kg. level.

McHard commented on the isolation of chemical species to determine the
active agent. Dow Corning has not yet identified the specific
structure which causes the observed systemic effect. McHard also
commented on the quality-control of the product. McHard also noted
that no ill effect had been observed or reported from people at Dow
Corning exposed in the production area. Dingman hoped that the
findings on DC 555 fluid would not cast any reflections on DC medical
grade 360 fluid or industrial grade 200 fluids.

CITE: KMM 418744 - 418775, Exhibit to Bennett Deposition, Exhibit to
Rowe Deposition, and Exhibit to McHard Deposition.

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Document #67

07/00/66 KNOWLEDGE OF LIQUID SILICONE DANGERS GEL MIGRATION

T. Rees, et al., submits to Dow Corning a report titled "Visceral
Response to Subcutaneous and Intraperitoneal Injections of
Polymethylsiloxane in Mice" which evaluates histologically the
systemic distribution of silicone fluid. Results indicate silicone
deposition in the spleen, liver, adrenals, pancreas, ovaries,
abdominal lymph nodes and kidneys of the test animals, suggesting
distribution by the reticuloendothelial mechanism.

CITE: KKM 31076 - 31087.

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Document #68

08/02/66 KNOWLEDGE OF LIQUID SILICONE DANGERS KNOWLEDGE OF SYSTEMIC
DISEASE MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

Braley memo to Ashley, Blocksma, Dingman, Edgerton, Goulian, Lederer,
Murray, Orentreich, Steve Carson, Bennett, Bennett, Hunter and McHard
regarding the attached letter and paper from Thomas Rees. Rees' letter
is dated 7/26/66 and notes that this is a privileged communication. "I
hope this work doesn't open a can of worms but I can't see any
alternative to publishing it." The draft paper notes that subcutaneous
administration of massive amounts of silicone produces considerable
alteration of the tissue structure of the subcutis. The fat cells in
the immediate vicinity of the encapsulated silicone show varying
degrees of atrophy and the intracellular fat contains small regular
vacuoles. Intraperitoneal injections or subcutaneous doses in excess
of a total dose of 7 ml in mice resulted in widespread microscopic
lesions by 3 months. The silicone also produced a generalized
alteration of the abdominal and epicardial adipose tissue. The fat
cells showed a finely granular, eosinophilic cytoplasm. "In many
abdominal organs which included adrenals, lymph nodes, liver, kidney,
spleen, pancreas, and ovary, focal infiltrates of macrophages with
abundant clear cytoplasm were encountered. The nature of the
cytoplasive material within the macrophages has not been ascertained,
but it is presumed to be silicone as those lesions did not occur in
control animals. The early adrenal lesions were found at the
corticomedullary junction; as the lesions become more extensive they
extended through the entire cortex. In the liver. lesions were
observed in all parts of the hepatic lobule. The results of this study
indicate that dimethylpolysiloxane fluid is deposited in the spleen,
liver, adrenals, pancreas, ovaries, abdominal lymph nodes, and kidneys
of mice when given by intraperitoneal injection of small amounts or by
subcutaneous injection of large amounts, 7-8 ml. Smaller subcutaneous
doses, 1 ml. of liquid silicone in the same animal species
occasionally causes similar lesions which occur only in the sona
reticularis of the adrenal glands." "The mechanism of absorption and
systemic distribution of silicone fluid in mice is still unknown.
Venous embolism or phagocytosis with distribution in the
reticuloendothelial system seems to be likely possibilities. Most
visceral lesions did not occur prior to three months following
injection except in isolated instances. This delay seems to implicate
the reticuloendothelial system as being the most likely method of
transfer."

CITE: KMM 31074 - 31087.

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Document #69

09/06/66 MISCELLANEOUS - ORGANIZATIONAL SURVEY

Minutes of the Board of Directors' Meeting for Dow Chemical Company
with a reference to a secrecy agreement with Dow Corning Corporation
regarding the biological properties of silicones.

CITE: TDC 11625 - 11627, Exhibit to Bennett Deposition and to Julius
Johnson Deposition.

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Document #70

10/10/66 KNOWLEDGE OF LIQUID SILICONE DANGERS MISCELLANEOUS - PRODUCT
LABELING TESTING

Memo from Don McGhan (at Dow Corning) to McIntyre with copies to
Pellikka, Hutchison, Bennett, Burdick, Weiler and Diamond regarding
"Biological Testing of 360 Fluid, Our Project No. 5152." Steve Carson
of FDRL, Harry Dingman of Dow Corning's legal staff, and McGhan
"strongly suggest" that Dow Corning not proceed with biological
testing of Dow Corning 360 fluid in containers smaller than 440
pounds. McGhan asks McIntyre to "review your marketing objective for
360 Medical Fluid and determine if biological labeling and
certification is required in container sizes smaller than 440 lbs. in
order to increase sales of the product."

CITE: KKA 7168, Exhibit to D. McGhan Deposition.

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Document #71

10/12/66 MISCELLANEOUS - COMPLICATIONS MISCELLANEOUS - SALES
STERILIZATION/CONTAMINATION TESTING

"Chemical Research Progress Report (Restricted), Report No. 2964," by
R. McCarty and J. Speier - all of Dow Corning. Dr. Hunter established
a committee of Bennett, Hobbs, McCarty, Stark, Weyenberg and Speier to
isolate and identify a pharmacologically active substance believed to
be present in DC 555 fluid..

Silanols are referenced on DCC 281002126 - 281002126 - they are
"profoundly toxic" and have effect as a CNS depressant. Silanols have
been under study since 10/65. There is a reference to the Mellon
Institute on DCC 281002127. Also note that Dow Corning was using Dow
Chemical's animals and testing facilities.

CITE: DCC 281002121 - 281002162, Exhibit to Bennett Deposition,
Exhibit to McHard Deposition, Exhibit to Ryan Deposition, Exhibit to
Isquith Deposition and Exhibit to LeVier Deposition. WITNESS: Bennett
(ancient document exception to hearsay). DISPOSITION: Admitted in
Toole (II) v. Baxter Healthcare.

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Document #72

01/10/67 ACKNOWLEDGEMENT OF NEED FOR TESTING TESTING

Rowe memo to McHard with copies to Bennett, Dingman, Heuerman, and
Hunter. This memo is in reply to the 12/16 memo from McHard on Product
Safety. Rowe has looked over the IBT testing outline and feels that
"in general, (it) contains the type of information I believe is
necessary. However, I do believe that some of the work which has been
listed should be done at an earlier stage and a minimum of liability."
Rowe gives advice on the types of tests and the timing of the
necessary tests in his critique of the IBR testing plan. Further, "I
also have my doubts about the wisdom of selling the material, even
though it is intra-state, before you at least have long-term studies
going, and the data indicates no likely hazard. I realize that
intra-state sales can be made without FDA approval, but nevertheless,
if you were challenged, I fear that you would have difficulty in
convincing any court that you had acted in a responsible way even
though you might be within the limitations of the Federal Food, Drug,
and Cosmetic Act." He states that he will be happy to discuss any of
these matters further with McHard.

CITE: DCC 281041120.

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Document #73

02/01/67 ACKNOWLEDGEMENT OF NEED FOR TESTING KNOWLEDGE OF LIQUID
SILICONE DANGERS KNOWLEDGE OF SYSTEMIC DISEASE MISCELLANEOUS -
ORGANIZATIONAL SURVEY TESTING

Minutes of the meeting of the Executive Committee. Includes notes
regarding a joint agreement with The Dow Chemical company pertaining
to certain silicone products designated as DC-555, DC-555A, and
compounds derived from and related thereto, and a joint development
agreement relating to the physiological effects resulting from
ingestion or injection into the systems of animals and men of
particular physiologically active silicones.

CITE: DCC 1010001438 - 101001440, Exhibit to Bennett Deposition,
Exhibit to LeBeau Deposition, Exhibit to Rowe Deposition, Exhibit to
Caldwell Deposition, Exhibit to McHard Deposition, Exhibit to Julius
Johnson Deposition, and Exhibit to LeVier Deposition.

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Document #74

02/08/67 KNOWLEDGE OF LIQUID SILICONE DANGERS KNOWLEDGE OF SYSTEMIC
DISEASE

"Report to Dow Corning Corporation Rabbit Teratogenic Study, TX-114,"
by Industrial Bio-Test Laboratories. Nine test groups consisting of
fifteen pregnant does were used in this study. It appears that TX-114
produces no adverse effect upon maternal growth or upon the ability to
carry the reproduction process successfully form six to eighteen days
inclusive. The number of resorption sites noted appears to be
proportional to the total amount of material administered. It is felt
that this reflects system damage to the maternal organism which
obscures the secondary effect upon the developing fetal system. At a
level of 200 mg/kg subcutaneously, slight alterations (clubbing of
extremities and umbilical hernias) were observed in proportions which
approach the upper limits of an expected non-treatment group. "(I)t is
felt that the material is non-teratogenic. However, the incidence of
abnormalities seen at lower levels, especially 200 mg/kg, would lead
to a conclusion that the teratogenic potential of the material should
be investigated in at least one other species and possibly in another
rabbit strain." Eldon Frisch, Dow Corning, in a 12/331/87 document,
claims that this study was inconclusive. "(C)lubbing of extremities
and umbilical hernias were near the upper limit...." (emphasis added).

CITE: I 661 - 702. DUPLICATE: KMM 115833 - 115873; (Referenced in KMM
407480 - 407482). NOTE: See 12/31/87 entry in Master Timeline.

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Document #75

02/16/67 KNOWLEDGE OF GEL BLEED KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

"Discussion Of Toxicology Of Various Dow Corning Products." A meeting
was held on 02/16/67, present were Steve Carson (FDRL), Fancher (IBT),
V.K. Rowe (Dow Chemical), Bennett, Boone, Braley, Bennett, Dingman,
Hobbs, Hunter, Don McGhan, McHard and Radzius. They discussed the
IND's on file with the FDA including the IND for burned hand, the
silicone injection IND, the bladder treatment IND, applications for
Silastic rubber dental liner and dental impression material such as
permanent tooth implants using Silastic rubber to anchor tissue
contact material, implant testing on new or modified formulations,
corneal implants, in-dwelling catheters, needle and syringe treatment,
DC 360 medical fluid, elastomer for coating pacemakers, comparison of
the reproductive studies carried out at FDRL including the findings of
club footing and resorption as a result of the treatment, DC FS-1265
fluid and foot and hand protector products ("A recent report as a
result of a one-year feeding in rats did seem to show a dose-related
effect on testis and accessory sex organ weight but V.K. Rowe thought
that because of the species difference and the time involved in the
test and the fact that the test was oral and not dermal and since all
of the dermal data looked good, there should not be any reason to
suspect this product" (DCC 281041880), and tests on Dow Corning 555
fluid and 360 medical fluid.

A discussion was also held on the different viscosity grades of "Dow
Corning 200 fluid or Dow Corning 360 fluid" compare with regard to
polymer size distribution. Although higher viscosities show broader
distributions, "there appears to be almost as much of the lower
polymer ends in the 350-centistoke" as in the lower viscosities.
(DCC281041877). The agenda is located at 281041882.

CITE: DCC 281041877 - 281041882, Exhibit to Bennett Deposition,
Exhibit to McHard Deposition, Exhibit to Rowe Deposition, and Exhibit
to LeVier Deposition.

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Document #76

03/10/67 MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

"Summary of Toxicological Testing of Dow Corning FS-1265 Fluid and
Ointment, Foot Protective" by "jar" (Joseph Radzius). It was reported
to the FDA in June 1966 that Phenylmethyl polysiloxane - DC 555 fluid
- exhibited biological activity, i.e., a depressant effect on
spermatogenesis and a reduction in testicular size. Dow Corning
elected to withdraw the product form the market. Very recently Dow
Corning received a report from FDRL on a 12-month oral administration
of FS-1265 fluid in rats which also showed a dose-related
spermatogenic arrest, depressed testicular and seminal vesicle size
similar to that observed for 555 fluid. Thus, this fluid also exhibits
biological activity.

CITE: DCC 281041861 - 281041863.

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Document #77

03/14/67 TESTING

Dow Corning study titled "Biologically Active Organosilicon compounds,
Report No. 3035," by McCarty, Lee and Burk. Test data on 83
organosilicon compounds which have proved active in biological
screens. The activity listed includes anti-cancer, anti-malarial,
anti-echistosomasis, anthelmintics, soil bonding agents, premergent
herbicides, post-emergent herbicides, anti-coccidiosis, fungicides and
bactericides, contact insecticides, fumigants, anti-crusting agents,
and general pharmacological screen in which the compounds were
examined for use in drugs. Dow Chemical does the screen on
agricultural, animal science, solvent stabilizers, etc. on these
compounds.

CITE: DCC 281002231 - 281002247, Exhibit to Tyler MDL and Harris
County Depositions, Exhibit to Bennett Deposition, Exhibit to Ryan
Deposition, Exhibit to Julius Johnson Deposition, Exhibit to Himnam
Deposition, and Exhibit to LeVier Deposition.

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Product/Privileged & Confidential

Document #78

03/21/67 KNOWLEDGE OF LIQUID SILICONE DANGERS KNOWLEDGE OF SYSTEMIC
DISEASE TESTING TISSUE REACTION

S. Carson, Food and Drug Research Laboratories, issues report entitled
"Summary of Histopathological findings in Primates." Findings include
cystic spaces with vacuolated cell and a few foreign body type cells
in soft tissues and around minor salivary gland tissue and skeletal
muscles, cystic spaces with vacuolated cells and foreign body type
giant cells in both breasts, acute necrotizing pneumonitis in the
lungs, similar changes in the submaxillary gland, degenerative changes
in the kidneys, pleural fibrosis and edema in the lungs, small and
large cystic spaces in the dermis and subcutaneous tissues, focal
calcification in the adrenal glands, chronic stomach inflammation, and
chronic phclonephritis in the kidneys. Include letter sent from F.
Ashley to S. Carson dated 12/02/66 enclosing pathological slides
showing area and amount injected and the autopsy date of the animal.
Includes letter from S. Carson to S. Sternberg dated 01/04/67
enclosing slides prepared from tissues of sumi apes sent by Dr.
Ashley; a member of the Silicone Injection Committee of the Dow
Corning Corporation (Carson and Food and Drug Research Laboratories
are consultants for Dow Corning Corporation). Carson writes:

"The tissues which Dr. Ashley submitted together with information
regarding total volumes injected and the date of the last injection
(copy enclosed) represent some of the most critical tissues available
in the United States since they involve between two and three years of
chronic study....This material represents the closest parallelism to
human experience that we have been able to obtain in any animal
studies to date.

... We have mentioned that this material is precluded from use in
mammary tissue augmentation. However there is a considerable black
market in a Japanese product which contains a similar silicone fluid
with some type of oil."

CITE: T 822 - 832, Exhibit 107 to Harris county Rathjen Deposition.
DUPLICATE: F 316 - 326.

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Document (On PLAINTIFF'S LITERATURE LIST)

(this is between #78 & #79)

04/00/67 (ON PLAINTIFF'S LITERATURE LIST)

F. Ashley, S. Braley, T. Rees, D. Goulian and D. Ballantyne author
"The Present Status of Silicone Fluid in soft Tissue Augmentation"
published in Plastic and Reconstructive Surgery, Vol. 39, No. 4,
411-420. The clinical use of silicone liquids in man preceded any
responsible and controlled experiment in animals. The unresolved
problem related to silicone is migration to distant organs, cautioning
against its use for mammary augmentation. The authors report one case
of unnecessary force during the injection of silicone that may have
caused blindness in one patient by possibly disrupting the arterial or
venous system. They also caution against using silicone fluid with any
additives such as olive oil.

CITE: PSC Medical Articles CD, J 157 - 166.

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Document #79

04/28/67 GEL MIGRATION KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

"Reproduction Study, Albino Rats, TX-114, Dow Corning Tox. File No.
1059-5" conducted by Industrial BIO-TEST Laboratories, Inc. and
sponsored by Dow Corning Corporation. PDMS, 350 cs., was tested for
its effects on fertility, reproductive performance, embryongenesis and
perinatal and postnatal performance in rats and rabbits. Albino rats
given up to 1000 mg of TX-114 per kilogram of body weight daily by
subcutaneous injection show normal growth patterns, have the desire to
mate and the ability to conceive, carry the reproduction process to
parturition and are able to successfully nourish the resulting
progeny. The offspring are free of external and internal malformations
and are judged to be normal as indicated by both normal survival
indices and progeny body weights. Treatment with TX-114 from
implantation through the completion of organogenesis did not produce
teratogenic effects in the rat. Lactation, measured in rats by dosing
parental animals from the end of fetal organogenesis through the
lactation period, was unaffected by daily subcutaneous administration
of TX-114.

CITE: P 13605 - 13611.

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Document #80

04/28/67 KNOWLEDGE OF LIQUID SILICONE DANGERS TESTING TISSUE REACTION

"Studies of the Effects of Dow Corning 360 Medical Grade fluid
(MDX-4-4011) on Reproduction in Rats and Rabbits" conducted at Food
and Drug Research Laboratories and sponsored by Dow Corning. This
polysiloxane compound was subcutaneously administered to rats and
rabbits. One significant effect is a dose-related incidence of
in-utero mortality at 200mg. and 1000 mg. during the third trimester
of rat pregnancy. (FDA 26359 - 26377: T001064 - 001103). Eldon Frisch,
Dow Corning, in a 12/31/87 document claims that this study was
inconclusive. The fetuses of some rats had "slight increase in
frequencies of incomplete developed sternebra and incomplete closure
of cranial bone. Some rabbits in the FDRL study had slightly higher in
utero mortality."

CITE: T 1064 - 1103 (Referenced in KMM 407480 - 407482). NOTE: See
12/31/87 entry. DUPLICATE T 996 - 1029.

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Document #81

07/19/67 MISCELLANEOUS SILICA STERILIZATION/CONTAMINATION

"Dip Coated Mammary", project no. MD-50 by P. Lange, L. Crusen. This
report constitutes the final phase in the transfer of Medical
Development Project No. 50, dip Coated Mammary, to the Medical
Products Plant. This report contains the raw material specifications,
formulations, manufacturing procedures, formulation specifications and
the dip coating procedure and specifications..

CITE KMM 320434 - 320454.

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Document #82

08/17/67 CONCEALING FROM FDA FRAUD/MISREPRESENTATION KNOWLEDGE OF
LIQUID SILICONE DANGERS MISCELLANEOUS - PRODUCT LABELING MISCELLANEOUS
- RECKLESS/CONSCIOUS DISREGARD

Women's Wear Daily article titled "Dow Corning Indicted on Breast
Expanding Fluid." charges include illegal distribution and improper
labeling of Medical Fluid 360. It is charged that the labeling failed
to include adequate directions for use and adequate safety warnings.
The indictment also charges that the drug had not been approved by the
FDA and had not been exempted from the normal requirements of the
Food, Drug and Cosmetics Act.

CITE: GEG 8984 - 8986.

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Product/Privileged & Confidential

Document #83

10/18/67 TESTING

J. McHard, Dow Corning, memo to I. Hutchinson, Bennett, Dingman,
Hunter and Don McGhan describing the policy in the toxicological
evaluation of Silastic silicone rubber for implant use. It involved a
two year implantation in dogs with one interim sacrifice in six
months. Providing there was no toxicity and tissues looked normal,
marketing could begin after six months. Based on recent information
from the Medical Products Division, he believes that Dow corning is
not strictly adhering to its toxicological evaluation policy.

CITE: KMM 337147.

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Product/privileged & Confidential

Document (NOT ON PLAINTIFF'S EXHIBIT LIST)

(this is listed between #83 & #84)

10/30/67 (NOT ON PLAINTIFF'S EXHIBIT LIST)

Hobbs, Dow Corning, memo to H. Dingman, Hutchison, Don McGhan, McHard,
and Pellikka regarding "Minutes of Meeting Held October 27, 1967." The
meeting was held at the request of Hutchison: "to discuss toxicity
testing of SILASTIC implants and more specifically the penile implant.
Ira expressed his feelings relative to the necessity of 2-year
toxicity studies on new materials in dogs. In general he feels the
2-year study is not necessarily due to the absence of carcinomas being
produced when foreign bodies have, through the years, been implanted
into the human body. Ira did feel the 2-year data would be
advantageous to have on record in case of product liability and also
if and when the FDA assumes the regulation of devices.

J.A. McHard expressed the recommendations of the Product Safety
Committee based on advice from various Dow Corning consultants, i.e.,
Steve Carson, V.K. Rowe, Joe Calandra and (illegible). This
recommendation is that new SILASTIC (illegible). This recommendation
is that new SILASTIC (illegible) to be used for long-term implants
shall have a 2-year carcinogenicity study in dogs. Preliminary
marketing could begin after the testing had progressed six months if
tissues are normal."

CITE DCC 204001107 - 204001108.

PENDLETON/PSC Attorney Work Product/Privileged & Confidential

Document #84

11/10/67 MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION SILICA

Hobbs and Himmelsback memo to Barry, Bennett, Clark, Fenn, Greenhalgh,
Hansen, Hargreaves, Hedlund, Hunter, Hyde, Donkle, C. Lentz, Maneri,
McHard, Nelson, Quinn, Ragborg, Ringey, Stinton, Tyler, Weyenberg and
Zeman regarding "Status of the Toxicity and Industrial Safe Handling
of J-DCA." J-DCA is Dow Corning Silica A; results from a recent study
indicate that under certain conditions, exposure to this "will cause
significant change in the links."

CITE: DCC 281041072 - 281041074.

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Document #85

12/15/67 KNOWLEDGE OF LIQUID SILICONE DANGERS TESTING TISSUE REACTION

Food and Drug Research Laboratories issues its report to Dow Corning
Corporation, "Studies of the Effects of Injected Dow Corning 360 Fluid
In Dogs." Fifteen beagles were subcutaneously injected with Dow
Corning 360 fluid in the scapular region for ten successive days.
There was a shifting of the injected mass, signs of mange,
fluctuations in weight, elevations of the hemoglobin concentrations,
differentials in the leukocytic counts, congestion and changes in all
organs. One of the beagles died with congestion of the liver, kidneys
and heart accompanied with hemorrphagic changes in the lungs and the
adrenals.

CITE: T 1202 - 1209, Exhibit to Petratis Deposition. DUPLICATE: T 1251
- 1302; KKH 8185 - 8290; FDA 33172 - 33227; F28 -79.

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Document #86

01/04/68 MISCELLANEOUS - ORGANIZATIONAL SURVEY

Minutes of the Board of Director's Meeting of Dow Chemical Company
with a reference to loans and advances made to Dow Corning
Corporation.

CITE: TDC 11702 - 11703, Exhibit to Bennett Deposition, and Exhibit to
Julius Johnson Deposition.

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Document #87

02/20/68 KNOWLEDGE OF LIQUID SILICONE DANGERS

Bureau of Regulatory compliance reports on the prosecution of Dow
Corning, Bass, Rhodes, and McIntyre for selling a new drug - Dow
Corning 360 Fluid - without an approved New Drug Application.

CITE I 470.

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Document #88

02/28/68 KNOWLEDGE OF LIQUID SILICONE DANGERS GEL MIGRATION

Steve Carson, Food and drug Research Laboratories, issues a Supplement
to the Report on "Studies of the Effects Of Injected Dow Corning 360
Fluid 350 cs In Dogs. " Following a single subcutaneous injection,
silicone was transported to all organs via the lymphatic or vascular
network.

"(D)espite parenteral route of administration, C(14) (DC 360 Fluid)
was present in the gastrointestinal tract, in the aorta and apparently
in the lymphatic pathways as evidenced by the lymph nodes, and
salivary glands, thus suggesting that transport and distribution in
these animals was via the vascular system, the lymphatic, and
recirculation via the bilary tract."

Distribution occurs throughout the entire body with no apparent
concentration in any specific organ. In Dow Corning's Toxicology
Report Reference 99, Dow Corning's abstract states, "The distribution
of radioactivity was ubiquitous with evidence of greater activity in
liver, spleen, kidneys, heart, lungs and brain.

CITE: T 38842 - 38866, Exhibit 3 to Harris County Rathjen Deposition.
DUPLICATE: KKP 16422; FDA 26696 - 26701; I 1333 - 1341; KKP 16422 -
16431; M 100145 - 100154.

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Document #89

03/07/68 ACKNOWLEDGEMENT OF NEED FOR TESTING MISCELLANEOUS -
ORGANIZATIONAL SURVEY TESTING

Minutes of the Board of Directors' Meeting of the Dow Corning
Corporation with reference to the officers of Dow Corning being
approved to sell to Dow Corning employees common stock in the Dow
Chemical Company. The minutes also refer to an agreement between Dow
Corning and Dow Chemical for joint research, development, evaluation
and commercialization programs on the physiological effects of
organosilicon compounds.

CITE: DCC 101001529 - 101001543, Exhibit to Bennett Deposition,
Exhibit to Julius Johnson Deposition.

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Document #90

04/22/68 TESTING TISSUE REACTION

"Histopathological Findings In Animals of Various Species from
Experiments conducted by Thomas D. Rees" is prepared S. Carson and
Food and Drug Research Laboratories for Dow Corning Corporation.
Findings using mice include various tissue reactions in the liver,
spleen, kidney, fat, adrenal glands, pancreas, ovaries, uterus,
endometrium, lymph nodes, small intestine, and stomach. Findings using
rats include various tissue reactions in the fat, spleen, kidney,
pancreas and adrenal glands. Findings in guinea pigs include various
reaction in the fat, kidney, pancreas, adrenal glands, spleen and
liver. Findings using hamsters include various tissue reactions in the
fat, spleen and kidneys.

CITE: T 1467 - 1528.

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Document #91

04/26/68 ACKNOWLEDGEMENT OF NEED FOR TESTING CONCEALING FROM FDA
MISCELLANEOUS - LOBBYING MISCELLANEOUS - ORGANIZATIONAL SURVEY TESTING

Rowe, Dow Chemical, letter to Goggin, the new President of Dow Corning
(who was recently transferred from Dow Chemical), regarding Dow
Corning's need to establish its own toxicology laboratory. Rowe states
that Dow corning has a "poor image" with the FDA which is "partly
deserved, partly undeserved." He suggests that Dow corning needs a
"change in philosophy" to turn its image around. He writes:

"Respect in Washington or elsewhere cannot be acquired except by
earning it through demonstrated competency, integrity, and an open
willingness to cooperate. I have had the feeling at times in the past
that these desirable characteristics have not always been apparent, in
fact, it has seemed to me that there has been a reluctance to deal
openly with FDA. An antagonistic approach toward FDA usually, in my
experience, results in a reaction on their part which, sooner or
later, becomes apparent in one form or another and will be regretted."

(p. 1) Rowe recommends that Dow Corning create a position entitled
"Director of Government Regulatory Relations" to interact with the FDA
and help Dow Corning's image. He also recommends that Dow Corning
Establish a toxicological laboratory in-house so that they are able to
"know and understand the physiological properties of all such
materials." (p. 6) The Dow Corning laboratory should be patterned
after the Dow Chemical laboratory. Rowe recommends Dow Corning hire
Ken Olson of Dow Chemical for this position. He also explains that:

"It appears to me that one of the most important areas for
toxicological study of DC materials, particularly those designed for
use in or on human beings, is that which may be called biochemical. By
this I mean studies which will completely describe the fate of
materials applied to, or administered to, the intact living organism
including animals and plants." (p. 9)

CITE: DCC 410000031 - 4100000040, Exhibit 2 to Bennett Deposition,
Exhibit 1 to LeBeau Deposition, Exhibit 6 to K. Olson Deposition, and
Exhibit to Rowe Deposition.

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Document #92 & #93
05/23-24/68 (this is listed as #92 & #93)

ACKNOWLEDGEMTN OF NEED FOR TESTING MISCELLANEOUS - COMPLICATIONS
TESTING TISSUE REACTION

Minutes of Meeting at Midland on May 23-24, 1968 with representatives
form Dow Corning, Industrial Bio-Test, Food and Drug Research
Laboratories, and the Dow Chemical Company." Attending were Bennett,
Calandra (IBT), Carson (FDRL), Bennett, Frisch, Hobbs, Hunter,
Hutchison, McHard, Radzius and Rowe, Dow Chemical. The subject of the
meeting was a "Toxicology Review of Dow Corning Products."

CITE: DCC 281041054 - 281041059.

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Document #94

05/31/68 TESTING TISSUE REACTION

FDA: "Informational Materials Supplied To clinical Investigators"
provided to the FDA sponsored by Dow Corning corporation for Dow
Corning 360 Medical Fluid 100 Centistokes (as used for the immersion
of burn victims). The purpose of this study is to evaluate continual
immersion therapy as a treatment modality in the management of the
burned patient. The fluid in which the patient is to be studied is Dow
Corning 360 Medical fluid of a viscosity of 100 centistokes. Dow
Corning 360 Medical Fluid (MDX-4-4066 Fluid) is a dimethylpolysiloxane
fluid and is identical to the product known to FDA scientists as Dow
Corning 200 Fluid except that more rigid quality control procedures
have been established for the medical grade product.

This fluid had been tested on pigs, monkeys, rabbits and dogs at Food
and Drug Research Laboratories. Observations were made of the effects
of administration to rabbits and rats of diets containing 1% Dow
Corning 360 Medical fluid, 50 or 350 centistokes, for eight to twelve
months, respectively. These were compared to effects resulting from
administration of the basal ration alone. No significant differences
were found between the groups receiving the polysiloxanes and the
basal control in growth or any of the parameters of physiological
function, organ weight, or tissue morphology.

Clinical experience with silicone immersion has included the immersion
treatment of thirteen healthy unburned control vs. eighteen burned
victims and the immersion treatment of one patient suffering from
toxic epidermal necrolysis. Results indicates that silicone immersion
is contraindicated in burn cases with open-chest injuries and/or
venous cutdown on the leg. Continued immersion is contraindicated if
sever skin rash develops which does not resolve with adequate skin
hygiene and/or rigorous quality maintenance of the silicone fluid.

Immersion may precipitate or increase hallucination. Immersion results
in external fluid pressure on the chest which may produce sufficient
splinting effect to reduce chest motion and prevent adequate aeration
of the lungs in those patients who are debilitated or who have chest
injuries. Intermittent positive pressure breathing may be required in
these cases to enhance aeration of the lungs.

Skin rash has been observed in immersed patients. Severe and
persistent skin rash which does not resolve with adequate skin hygiene
and quality maintenance of the fluid is adequate reason to terminate
immersion.

CITE: KMM 104968 - 105041.

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Document #95

06/03/68 COHESIVENESS - LIQUID COMPONENT OF GEL GEL MIGRATION TESTING

Dow Corning completes a study of the biological distribution of
dimethylpolysiloxane in adult male mice. Significant amounts of
radioactivity were found in the tissues and body fluids analyzed. The
level of absorption and the biological distribution of the
radioactivity were not dependent upon the molecular weight
distribution of the fluid or the method by which the fluids were
administered.

CITE: DCC 281001381 - 281001399, Exhibit to Harris Country LeVier
deposition, Exhibit 3 to Harris Country Rathjen Deposition, Exhibit 19
to Harris County Zahalsky Deposition, Exhibit to Harris County Tyler
Deposition, and Exhibit to Weyenberg Deposition.

DUPLICATE: M 100155 - 100174; DCC 242031103 - 242031121; FDA 43184 -
43202.

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Document #96

07/16/68 KNOWLEDGE OF LIQUID SILICONE DANGERS KNOWLEDGE OF SYSTEMIC
DISEASE

FDA: Dr. Wilson writes a letter to Dr. Inscoe of the FDA regarding his
analysis of the reproduction studies done on Dow Corning Medical Fluid
360 by Food and Drug Research Laboratories. He states that the reports
"were not presented in such a way as to inspire complete
confidence...." He also concludes the compound causes an "appreciable
increase in fetal death and resorption in rabbits" which is dose
related and also causes an increase in malformations in rabbits at
certain doses. Thus, "the compound under consideration cannot be
declared to have no teratogenic potential."

CITE: KMM 128723 - 128724.

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Document #97

08/08/68 GEL MIGRATION TESTING TISSUE REACTION

FDA: The FDA recommends that Dow Corning's IND 2702 remain ineligible
for reinstatement because of the lack of toxicity information,
deficient protocols and the lack of declaration that the IND has no
teratogenic potential. The FDA directs Dow Corning to provide data on
the metabolic fate and migratory sites of silicone, including studies
on the kidney and liver.

CITE: FDA 28545 - 28547. NOTE: See 09/24/68 entry.

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Document #98

10/09/68 KNOWLEDGE OF LIQUID SILICONE DANGERS GEL MIGRATION

Hobbs, Toxicologist at Dow Corning, letter to Dr. Charles Riffkin, The
Squibb Institute for Medical Research, responding to his inquiry about
the distribution and fate of injected silicones. He encloses the
study, "Studies of the Effects of Injected DOW CORNING 360 Fluid, 350
cs., in Dogs," stating:

"The results of this study indicate that distribution occurs
throughout the entire body with no pronounced concentration in any
specific organ. It is evident by the preliminary nature of this study
that the fate and chemical nature of the material after it vacates the
injection site is unknown.

CITE: FDA 27154 - 27155, Exhibit to K. Olson Deposition.

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Document #99

10/17/68 FRAUD/MISREPRESENTATION MISCELLANEOUS - COMPLICATIONS
MISCELLANEOUS - PRODUCT LABELING TESTING

Olson memo to Pail with copies to Bennett, Currie, Gergle, Hobbs,
Hunter, McHard, Radzius and Vaughn regarding "Suitability for
Industrial Use of Protective Hand Cream Formulated with Dow Corning
FS-1265 Fluid Unstripped of Cyclic Trimer." The Dow Corning Toxicology
Department recommends the use of Protective Hand Cream, industrially,
does not pose a significant hazard, and "represents an appropriate
risk for Dow Corning." Olson reviews the studies to date on FS-1265
Fluid including studies by IBT - 20 day subacute dermal study in
rabbits (spermatogenic depression was found to be mild to moderate in
the controls and not significantly different in the test groups);
one-year dietary feeding study in rats ("There was evidence of
decreased spermatogenesis in the male test animals"); IBT - 14 week
dermal toxicity in rhesus monkeys (biopsies at 30-days showed
testicular hypoplasia); Dow Chemical (cyclic trimer possesses a
relatively high acute oral toxicity); and IBT - acute percutaneous
absorption study. He recommends industrial use of Protective Hand
Cream containing less than 15 p.p.m. of cyclic trimer and that this is
an appropriate risk. "We wish to emphasize that the front label
flagrantly (sic) misrepresents the product from an efficacy viewpoint.
All data generated to date shows, unequivocally, that the cream does
not protect against the irritating properties of the chemicals
studied. Ethically, such advertising leaves much to be desired and is
frowned upon by government agencies and all who are charged with
matters pertaining to consumer protection and proper representation"

CITE: DCC 218041771 - 281041776, Exhibit to K. Olson Deposition, and
Exhibit to LeVier, Deposition.

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Document #100

11/29/68 KNOWLEDGE OF SYSTEMIC DISEASE TESTING TISSUE REACTION

Steven Carson, Food and Drug Research Laboratories, issues a report on
"Chronic Implantation Studies of Polysiloxanes In Dogs" contracted by
Dow Corning. The report states:

"Chronic implantation studies were conducted in dogs over a three year
period utilizing a variety of polysiloxane materials. When possible
comparisons were made between solid and perforated wafers of
individual materials implanted into intramuscular, subcutaneous and
intraperitoneal sites. The number of implants utilized, provided for
microscopic examination of replicate tissues at each time period, i.e.
3, 9, 24, and 36 months.

Inasmuch as each type of polysiloxane was evaluated independently no
direct comparison between materials is provided, however the physical
forms of each were compared. It may be concluded that in every
instance the degree of reaction about the perforated implants was less
intense than that associated with the solid implant, particularly with
respect to the degree of fibrous reaction or extent of hyalinization
or inflammatory cell reaction.

Samples of polysiloxane materials 370, 372 (including Cronin breast),
fine and coarse sponge, silphenylene and LS each involved samples in
which the physical form of the implant was the major variable. In the
instance of the sponge implants (coarse and fine), a somewhat more
intense connective and fibrous tissue reaction was observed with fine
sponge in the initial 9 month period but lessened markedly at 24 and
36 months. The prosthetic breast samples with 372 revealed no untoward
tissue reactions. Comparison of cured and uncured samples 386, 382,
5392, X-3-0855 and Medical Adhesive Type A generally revealed a more
severe inflammatory cell reaction at 3 months in the uncured samples
of 386, 5392 as compared to the cured samples. This reaction was
absent at 24 and 36 months. The Medical Adhesive Type A differed, in
that the initial tissue reactions were minimal in each.

Generally, no untoward chronic tissue reactions were noted with any of
the implant materials. Systemic tissue responses were not observed at
24 or 36 months. There was no evidence of tumorigenesis, with any of
the samples or at any of the sites of implantation over a 3 year
period of testing in dogs."

The first page of this report states that "this report is not to
distributed outside Dow Corning Corporation."

CITE: T 2033 - 2096, Exhibit 35 to Bennett Deposition (used by Dow
Corning), Exhibit 29 to MDL Rathjen Deposition (used by Dow Corning),
and Exhibits 19 and 20 to Zahalsky Deposition. DUPLICATE: FDA 27384 -
27409.

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Document #101

01/29/69 SHELL STRENGTH - THICKNESS RUPTURE

G. Robertson, Dow Corning, memo to Koning regarding a mammary implant
ruptured 1 1/2 years after implantation which was returned by Dr.
Crosby. Robertson states, "(T)he envelope edges adjacent to the
rupture, appeared to be of a very low tear strength. The physical
properties of this envelope may never have been adequate." (emphasis
added).

CITE: KKH 1654.

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Document #102

03/24/69 KNOWLEDGE OF LIQUID SILICONE DANGERS KNOWLEDGE OF SYSTEMIC
DISEASE

Dr. Franklin Ashley, a clinical investigator for IND 2702, writes to
Dr. Frank McDowell regarding an article by Bishoff and Bryson on the
carcinogenicity of silicone in fluid in rats and mice. Braley, Dow
Corning, has reviewed the article and has stated to Dr. Ashley that:
"According to what he says, and he would not want to say this to you,
he feels that this article is well written and should not be
published. I agree."

CITE: OOM 320814.

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Document #103

06/10/69 MISCELLANEOUS - COMPLICATIONS TESTING TISSUE REACTION

Memo from Olson to Frisch with copies to Bennett, Hobbs, Hunter and
Radzius regarding "Telephone Communication with Dr. John Wilson of
Johnson & Johnson." Dr. Wilson, toxicologist at Johnson & Johnson, was
contacted by telephone regarding their subacute dermal rabbit study on
Dow Corning 556 and 360 fluids and Dow Corning MDDX-4-4122 wash
resistant base. Dr. Wilson stated that the materials had been applied
to rabbit skin daily. All animals showed a trend toward testicular
atrophy. "There was a suggestion of dose-response relationship with
Dow Corning materials although the effects were not statistically
significant. A subacute oral rat study is in progress." Olson
indicated to Wilson that Dow Corning would be concerned about positive
findings with the second study and would be agreeable to meeting with
them to compare their respective data.

CITE: DCC 281041112, Exhibit to McHard Deposition, Exhibit to K. Olson
Deposition, and Exhibit to LeVier Deposition.

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Document #104

07/15/69 KNOWLEDGE OF LIQUID SILICONE DANGERS GEL MIGRATION

Food and Drug Research laboratories report on the findings in the
chronic parenteral (intraperitoneal) study initiated by Dr.
Ballantyne, Rees and Hawthorne at the NYU School of Medicine. After
silicone fluid in the peripheral erythrocytes in early hematologic
examinations was observed, Dow Corning transferred the study and its
financial sponsorship from NYU to Food and Drug Research Laboratories.
"When the animals received 51 cc and 62 cc of fluid, inflammatory
cells were observed in the spinal meninges (which was not stated in
earlier reports). Injections of large volumes of silicone produces
wide spread deposition throughout the reticuloendothelial system,
silicone vacuole accumulation in cells and a systemic