Eldon Frisch

In February 1984, Eldon Frisch, a Dow Corning scientist, wrote a memorandum to his colleagues at Dow Corning about a visit with Dr. Vinnik.

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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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.
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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.
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Frisch states, I want to emphasize that we do not recommend implantation of the gel except when fabricated in devices with intact silicone elastomer capsule..

CITE : DCC 240000861 - 240000862

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

Document # 172

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Eldon Frisch, Dow Corning, receives the report.
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Eldon Frisch, Dow Corning, responds to Milt Hinsch's memo on Greg Bicket's questions on gel bleed.The material which bleed from a mammary implant is a polydimethylsiloxane, or more appropriately a silicone fluid.It comes from within the gel.... Since the gel starts as a fluid, these materials are also fluids, and they tend to migrate about in the gel, eventually dissolving in the envelope and passing through it.... We have no scientific data to indicate whether or not the presence of the fluid polydimethylsiloxane which bleeds through the envelope increases or decreases the problems of capsular contracture. He questions whether Dow Corning's field inventories are getting too old, allowing the bleed (to become) more evident. Frisch also talks about injected silicone fluid studies which showed absorption of the silicone fluid into the body.We have no scientific evidence to indicate whether or not the presence of the fluid polydimethylsiloxane which bleeds through the envelope increases or decreases the problems of capsular contracture..

CITE : M 190259 - 190261, Exhibit 13 to California Braley Deposition (used by Dow Corning), Exhibit to Petraitis Deposition, Exhibit to MDL Rathjen Deposition.DUPLICATE : KKH 1561 - 1565 ; GEG 4023 -4025 ; M5700445 - 570047, KMM 3828 - 3830 ; GEG 4246 - 4250.

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Frisch suggests that Dow Corning attend these meetings and publish their own position that biodegradation does not occur. He also suggests an animal study at the University of Michigan because they are open to suggestions. (emphasis added).

CITE : M 190441 - 190443, Exhibit to Harris County Tyler Deposition

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

Document # 273

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Eldon Frisch, Dow Corning, memo to Virg Metevia regarding Dr. Julius Henry-Cohen's article on capsular contracture.Frisch states, during discussions with John Madden, M.D., we had reached a conclusion that probably most cases which develop thick fibrous capsules do so because of trauma to the fibrous capsule which creates local tissue damage and minute ruptures in the capsule without producing a major rupture which leads to complete loss of capsule integrity.... Damage to fibrous tissue is generally painful, and associated with rupturing of small blood vessels leading to small hematomas and an increase in the inflammatory process. Frisch also states that ruptures most likely occur because during certain activities such as love making, vigorous hugging, strenuous physical exercise, and that physicians can completely rupture a fibrous tissue capsule by externally squeezing the implant. (emphasis added).

CITE : OOM 320474 - 320476.NOTE : Dow Corning was not warning in its product inserts of rupture or recommending that doctors not perform closed capsulotomies.

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Dr. Abraham goes on to request an opportunity to review animal specimens from earlier studies and informs Frisch of improved detection techniques.
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Boley, Dow Corning, memo to Frisch, LeVier, Spielvogel, Cooper, Rylee, and Wessel regarding Baboon Study To Evaluate the Fate of Silicone Wear Particles. Boley notes that :.
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Eldon Frisch, Dow Corning, responds to Richard Swett, M.D., concerning an allergy-type reaction to Silastic brand implants made from medical grade silicone.
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Frisch states :.

Clinically, the implants have been used in several million patients with very few reports of suspected inflammatory or allergic reactions.In the past, with one recent exception, when the reactions were evaluated by patch testing, by subdermal implantation of a small specimen, or by cell culture studies of the implant the reactions have universally been negative..

Frisch notes another report of a potential allergic reaction to silicone reported by George Francis, M.D. (emphasis added).
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E. Frisch, Dow Corning, memo to R. Dumas, G. Jakubczak, and S. McGuire referring to a visit with Dr. Vinnik.
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Frisch suggests that Dow Corning attend these meetings and publish their own position that biodegradation does not occur. He also suggests an animal study at the University of Michigan because they are open to suggestions. (emphasis added).

CITE : M 190441 - 190443, Exhibit to Harris County Tyler Deposition

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

Document # 273

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Eldon Frisch, Dow Corning, memo to Virg Metevia regarding Dr. Julius Henry-Cohen's article on capsular contracture.Frisch states, during discussions with John Madden, M.D., we had reached a conclusion that probably most cases which develop thick fibrous capsules do so because of trauma to the fibrous capsule which creates local tissue damage and minute ruptures in the capsule without producing a major rupture which leads to complete loss of capsule integrity.... Damage to fibrous tissue is generally painful, and associated with rupturing of small blood vessels leading to small hematomas and an increase in the inflammatory process. Frisch also states that ruptures most likely occur because during certain activities such as love making, vigorous hugging, strenuous physical exercise, and that physicians can completely rupture a fibrous tissue capsule by externally squeezing the implant. (emphasis added).

CITE : OOM 320474 - 320476.NOTE : Dow Corning was not warning in its product inserts of rupture or recommending that doctors not perform closed capsulotomies.

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Dr. Abraham goes on to request an opportunity to review animal specimens from earlier studies and informs Frisch of improved detection techniques.
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Boley, Dow Corning, memo to Frisch, LeVier, Spielvogel, Cooper, Rylee, and Wessel regarding Baboon Study To Evaluate the Fate of Silicone Wear Particles. Boley notes that :.
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Eldon Frisch, Dow Corning, responds to Richard Swett, M.D., concerning an allergy-type reaction to Silastic brand implants made from medical grade silicone.
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Frisch states :.

Clinically, the implants have been used in several million patients with very few reports of suspected inflammatory or allergic reactions.In the past, with one recent exception, when the reactions were evaluated by patch testing, by subdermal implantation of a small specimen, or by cell culture studies of the implant the reactions have universally been negative..

Frisch notes another report of a potential allergic reaction to silicone reported by George Francis, M.D. (emphasis added).
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E. Frisch, Dow Corning, memo to R. Dumas, G. Jakubczak, and S. McGuire referring to a visit with Dr. Vinnik.
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Eldon Frisch, Dow Corning, memo to Bill Boley, Marcia Marsh, and Jim Wessel concerning Baxter Travenol's presentation at the biomaterials Meeting.
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Frisch states that Baxter tested a number of materials, including silicones, and have found that many, if not most, plastics and elastomers elicit an immunotoxicity reaction. ... This may be of interest in the alleged case of human adjuvant disease. (emphasis added).

CITE : KMM 37828

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

Document # 397

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Frisch, Dow Corning, letter to Dr. John Madden (cc to Boley) regarding a female hydrocephalic patient described in an attached abstract entitled Evidence For Immune Response to Silastic Implants by Michael R. Wasserman.
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CITE : DCC 800311717 - 800311729, Exhibit 9 to Bejarano Deposition, Exhibit to Frisch /Deposition, and Exhibit 32 to Zimmer Deposition.DUPLICATE : F 160 - 175 ; KMM 297691 - 297705.

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

Document # 417

03/26/85 SHELL STRENGTH - THICKNESS RUPTURE MISCELLANEOUS - PRODUCT