What Dow Corning Corporate documents have to say about silicone gel bleed in breast implants.
Document #7
00/00/00
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
Document #17
00/00/00
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
Document #18
00/00/00
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
Document #19
00/00/00
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
00/00/00
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
Document #22
00/00/00
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
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.
Dow Corning Trial Exhibit List Abstracts
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.
Dow Corning Trial Exhibit List Abstracts
Document #115
04/13/70
KNOWLEDGE
OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS - COMPLICATIONS
RUPTURE
TISSUE REACTION
Olson memo to Boone with copies to Hunter, Hobbs, Koning, Radzius and Stark regarding "Inflatable Mammary Toxicology."
He responds to Boone's memo stating, "The stability of dextran solutions in an implant situation over the long haul, particularly
if there is diffusion of body fluids across the membrane would be difficult to accurately assess without biological data generated
under use conditions. It is important to know these things prior to marketing. With my cursory knowledge of the problem I
would tend to feel that such a device might cause some patients and Dow Corning some degree of grief. I would think that a
rather extensive clinical investigation is indicated in order to assess benefit versus risk for Dow Corning."
CITE: KMM 146382-146384.
Dow Corning Trial Exhibit List Abstracts
Document #119
06/01/70
ACKNOWLEDGEMENT OF NEED FOR TESTING
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE
OF GEL BLEED
MISCELLANEOUS - COMPLICATIONS
SILICA
TISSUE REACTION
Minutes of the Inflatable Mammary Meeting sent to Bennett, Boone, Bennett, Hobbs, McIntyre, Olson, Rathjen and Stark.
CITE: KMM 77733 - 77750, Exhibit to Bennett Deposition and Exhibit to Isquith Deposition.
Dow Corning Trial Exhibit
List Abstracts
Document #136
05/04/72
TISSUE REACTION
SHELL STRENGTH - THICKNESS
KNOWLEDGE OF GEL BLEED
GEL
MIGRATION
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF LIQUID SILICONE DANGERS
Silas Braley, Dow Corning, letter to Dr. Douglas Lake expressing his reservations about the use of silicone to fill inflatable
implants. He states:
(T)here is a very good reasons for this: the silicone fluid being of the same basic nature as
the silicone polymer used to make the rubber will dissolve into the rubber and very seriously weaken and soften it... Another
factor which must be taken into consideration if a silicone fluid is used to fill a silicone rubber bag, is that the outer
surface of such a bag will become oily with the silicone fluid. This means that the fluid is now capable of being absorbed
by the body and very extensive toxicological work would have to be done to prove that this is not deleterious to the tissues....
We rejected the silicone fluids for the above reasons and went immediately to silicone gel. (emphasis added).
CITE: KMM 141906 - 141907, Exhibit 32 to California Braley Deposition.
Document #158
08/01/73
GEL MIGRATION
KNOWLEDGE OF GEL BLEED
SHELL STRENGTH - THICKNESS
Study by Alcott titled "Physical Comparison Between Camp External Mammary Prosthesis and Dow Corning Silastic External
Mammary Prosthesis." The Camp "Symmetry", external mammary prosthesis was found to be a tough, somewhat unyielding prosthesis.
A good fabrication system is used with good results. No migration of silicone oils through the envelope is likely since the
envelope is not a silicone rubber. The envelope may resist body fluid and odors better than silicone rubber. Camp's advertisement
is quite misleading since it implies that the same materials are used in implants.
CITE: KMM 354646 - 354651, Exhibit to Tyler Deposition.
Dow Corning Trial Exhibit List Abstracts
Document #183
01/28/75
KNOWLEDGE OF GEL BLEED
Art Rathjen memo to numerous Dow Corning employees regarding "Gel Bleed - New Gel In Mammary Prostheses Scheduled For June
1 Introduction." Rathjen writes that, "there is only a two week period before the new 'flo-gel' is scheduled to be formulated
and filling begins. A question has not yet been answered is whether or not there is an excessive bleed of the gel through
the envelope.... We must address ourselves to this question immediately.... The stakes are too high if a wrong decision is
made." (emphasis added).
CITE: F 541, Exhibit 38 to Harris County Rathjen Deposition, Exhibit to MDL Rathjen Deposition. DUPLICATE: KMM 260794;
KMM 19824; FDA 19671 - 19672; M 150001.
Dow Corning Trial Exhibit List Abstracts
Document #189
02/25/75
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
TISSUE REACTION
Nawash memo to Salisbury, both of Dow Corning, regarding low molecular weight gel diffusion. He writes:
"The reactivity between free low molecular weight silicones and the subcutaneous tissue seems
to be of increasing concern among plastic surgeons. It is thought that the soft gel used by Heyer-Schulte in the mammary implant
is obtained by mixing low viscosity silicone fluid in the regular gel. It is also thought that the low molecular weight components
of the fluid eventually diffuse through the rubber envelope of the breast implant and elicit the untoward reaction which is
occasionally observed and results in an undesirable, relatively thick fibrous capsule. I do not know the actual method used
by Heyer-Schulte to obtain their soft gel: nor do I know the process we developed for making our own soft gel.
However, If I may, I strongly recommend that we take measures to insure against the presence of
unwarranted free low molecular weight fluids in our now soft breast implant.
CITE: M 190133, Exhibit to Nawash Deposition, and Exhibit to MDL Rathjen Deposition.
Dow Corning Trial Exhibit List
Abstracts
Document #192
05/01/75
FRAUD/MISREPRESENTATION
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS - SALES
Boone memo to Hoyt, Leach & Salisbury with copies to Larson, Talcott, Peters, Brodhagen, Rathjen and Ringey regarding
"Oily Effect on New Mammaries." They have observed that the new mammaries tend "to bleed noticeably after the product is massaged
and handled. We are relatively confident that the doctor will not see any appreciable bleed on the product as it is removed
from the package. The salesman, however, will experience bleed on his detail samples, particularly the day after they have
been squeezed. It would be advisable for the salesman to understand this and clean his detail samples prior to demonstrating
to the customer."
CITE: KMM 220570, Exhibit to MDL Rathjen Deposition.
Dow Corning Trial Exhibit List Abstracts
Document #193
05/13/75
KNOWLEDGE OF GEL BLEED
Tom Talcott, Dow Corning, memo to Larson, Dow Corning Mammary Task Force and other Dow Corning colleagues, regarding silicone
gel bleed from implants. He states, "We are hearing complaints from the field about the demonstration samples they are receiving.
The general claim is that the units bleed profusely after they have been flexed vigorously. This may tie into the soaking
to wash off excess gel which was occurring in the early stages of production or the time interval between fill and cure....
Please run appropriate testing when you receive these samples to determine if a bleed rate problem exists."
CITE: F 743, Exhibit 43 to Harris County Rathjen Deposition, and Exhibit 12 to MDL Rathjen Deposition (used by Dow Corning).
DULICATE: M 16003; M 570062; FDA 19586; Staff Report prepared by the Human Resources and Intergovernmental Subcommittee of
the Committee on Government Operations, December, 1992, p. 17.
Dow Corning Trial Exhibit List Abstracts
Document #194
05/16/75
KNOWLEDGE OF GEL BLEED
Minutes of the meeting of the Dow Corning Mammary Task Force. Countdown to product introduction is "2 weeks, 16 days, 384
hours, 23,040 minutes." Rathjen began by reading a memo which officially turned the round and low profile rounds "back to
its jurisdiction." The minutes do not say what this jurisdiction is. On the issue of gel bleed, "A range of solutions is possible
- from reformulating the gel to eliminating salesmen's abuse of the product during demonstrations. It seems to be a function
of the porosity of the envelope; the lower molecular weight gel passes through the pores more easily, especially after stretching
and pulling."
CITE: F 590 - 596, Exhibit to MDL Rathjen Deposition, and Exhibit 44 to Harris County Rathjen Deposition. DUPLICATE: KMM
446988 - 446991: M540064 - 540070.
Dow Corning Trial Exhibit List Abstracts
Document #195
05/16/75
KNOWLEDGE OF GEL BLEED
Tom Salisbury memo to Dow Corning sales force regarding
the "Oily Phenomenon With New Mammary Prostheses." Salisbury writes that, "It has been observed that the new mammaries (sic)
with responsive gel have a tendency to appear oily after being manipulated. ... You should make plans to change demonstration
samples often. Also, be sure samples are clean and dry before customer detailing. Two easy ways to clean demonstration samples
while traveling, 1) wash with soap & water in nearest washroom, dry with hand towels, 2) carry a small bottle of IPA and
rag."
CITE: F 635, Exhibit 2 to Hinsch Deposition, Exhibit 63 to Harris County Rathjen Deposition, Exhibit to Nawash Deposition,
and Exhibit to MDL Rathjen Deposition. DUPLICATE: M 540071; KKA 152381; KKH 868: KMM446993: KMM 148337: KMM 518441: DCC 80061333
- 80061334.
Dow Corning Trial Exhibit List Abstracts
Document #201
08/12/75
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS
- COMPLICATIONS
TISSUE REACTION
Dr. Upton (Cronin"s associate) letter to Rathjen regarding capsular contracture. Dr. Wilflingseder and Dr. Laub have been
able to demonstrate small particles of free silicone inciting inflammatory reactions in adjacent soft tissue. They have noted
the same phenomenon. "Although the etiology of the problem is multifaceted, I am sure, we still wonder if the surface of the
silicone polymer plays a significant role."
Dow Corning Trial Exhibit List Abstracts
CITE: DCD 173003034, Exhibit 27 to MDL Rathjen Deposition (used byplaintiffs
and Dow Corning), Exhibit 120 to Harris County Rathjen Deposition. DUPLICATE: M 190146.
Document #210
12/12/75
KNOWLEDGE OF GEL BLEED
T. Talcott, Dow Corning, memo about a telephone call from Dr. Frank Gerow. Gerow attended a meeting in Phoenix recently
and reported that "the general tone to him was something is coming through the envelope to the tissue." Gerow concluded that
Dow Corning needed a "100% tied up gel now." Talcott writes that he's inclined to agree that something's coming through the
envelope. "Could it be miscellaneous contamination during our manufacturing process? Do we need an audit of the process?'
CITE: F 636, Exhibit to Frisch Deposition, Exhibit to MDL Rathjen Deposition, and Exhibit 64 to Harris County Rathjen Deposition.
DUPLICATE: M 170143; M190203; FDA 32914; DCC 242031351 - 242031352.
Dow Corning Trial Exhibit List Abstracts
Document 220
03/17/76
TISSUE REACTION
KNOWLEDGE OF GEL BLEED
Art Rathjen, Dow Corning, memo to numerous Dow Corning employees regarding a paper presented by Dr. Edward Terino at the
California Society of Plastic Surgeons on 03/03/76. The paper discussed a Dow Corning Silastic implant removed 10 years post-op.
Silicone was found on the outside of the implant and "pathology showed extensive foreign body giant cell granulomas.... This
event, as described by Dr. Terino, cannot be ignored. An attempt must be made to get an answer or explain this phenomenon
before the manuscript is submitted to the Journal for publication. If we don't, everyone of the 350 member audience, the Journal
readers, and the lawyers may interpret this as proof that our gel causes problems."
CITE; F 833 - 834, Exhibit 36 to California Braley Deposition, Exhibit 66 to Harris County Rathjen Deposition, and Exhibit
to MDL Rathjen Deposition. DUPLICATE: M 190247 - 190248; M 250038 - 250041; KMM242493 - 242494; DCC 240000437 - 240000438.
See 03/03/76, 03/19/76 and 03/26/76 entries. The implants were from lot number H0209.
Dow Corning Trial Exhibit List Abstracts
Document #222
03/19/76
ACKNOWLEDGEMENT OF NEED FOR TESTING
GEL MIGRATION
KNOWLEDGE OF GEL BLEED
Art Rathjen, Dow Corning, reports on the "backlash" from Dr. Terino's paper to the California Society of Plastic Surgeons.
Dr. Barker approached Rathjen after Dr. Terino's presentation and stated he was also studying capsular contracture. "He (Dr.
Baker) also subscribes to the possibility that the migration of fluid or low moleculars through the envelope which causes
the greasy feel to the envelope may be contributing to the contracture.... Nevertheless, the question remains in his mind,
as it does in a number of other plastic surgeons around the country "Dr. Baker wants to take Dow Corning's Silastic implants
in a centrifuge to collect what is forced through the envelope. The quantity of what comes through should then be implanted
in animals in a very small quantity to see what kind of tissue reaction develops. Rathjen thinks that it would be in the best
interest of Dow Corning if they were to "take the initiative" and attempt to do something of a similar basis first. He states
in this internal memo:
I think it would be embarrassing for Dow Corning and for any of our research expertise if we find
that this type of testing has to be left to a doctor in this field. If he were to come up with something detrimental, I think
we ought to be prepared for it. (emphasis added).
CITE: M 160001 - 160002, Exhibit to MDL Rathjen Deposition, Exhibit 67 to Harris County Rathjen Deposition. DUPLICATE:
M 190249 - 190250; DCC 17031054.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Work Product/Privileged &
Confidential
Document #224
03/22/76
KNOWLEDGE OF GEL BLEED
GEL MIGRATION
Handwritten note to Milt Hinsch from Greg Bicket, both of Dow Corning, discussing the bleed question and Dr. Terino's presentation.
Bicket notes that many persons are asking questions about, "What is that stuff on the outside of DC's implant.... Do you want
that bleeding into your patient's body ... will it cause capsule contracture. We say they all do it; McGhan must be cleaning
their implant very carefully." He lists 8 questions including whether the gel migrates and, if so, to what parts of the body
and with what effects. Bicket feels "uncomfortable" since he can't answer all of the questions. He notes that McGhan is raising
these questions with doctors.
CITE: M 160026 - 160027, Exhibit to Petraitis Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: GEG 4026 -
4027; M 190255 - 190256, KMM 3831 - 3832. NOTE: This date is approximate and is based on the date on the top of the page from
the ASPRS meeting on 03/22/76.
Dow Corning Trial Exhibit List Abstracts
Document #225
03/26/76
KNOWLEDGE OF GEL BLEED
FRAUD/MISREPRESENTATION
Art Rathjen, Dow Corning, letter to Dr. Terino with blind carbon copies to numerous Dow Corning employees. Despite Rathjen's
knowledge that gel bleeds through the envelope, Rathjen tells Dr. Terino that this is "physically impossible" from a polymer
chemistry standpoint. He attempts to cast doubt on Dr. Terino's claims that the substance on the outside of the Dow Corning
implant Dr. Terino examined was silicone gel, particularly since the implant was not torn or ruptured. Rathjen suggests that
Terino shouldn't publish his paper stating, "I truly think it would be to the best interest of all concerned if we try to
get some answers before there is any further dissemination of information which might be erroneous....(Rathjen) would like
to ... help solve the mystery, if that is possible, before your presentation is submitted for publication."
He requests that Dr. Terino send him any explanted Dow Corning prostheses with "a strange color or a questionable envelope
surface or seem to have a change in the normal physical qualities."
CITE; M 250018 - 250019, Exhibit to MDL Rathjen Deposition, and Exhibit 68 to Harris Country Rathjen Deposition. DUPLICATE;
DCC 240000435 -240000436; M 570126 - 570127.
Dow Corning Trial Exhibit List Abstracts
Document #229
04/13/76
KNOWLEDGE OF GEL BLEED
Milt Hinsch, Dow Corning, discussed how the market place is telling Dow Corning that improvements can be made to the current
production line including to the envelope, gel, and design of the prosthesis. One suggested improvement would be that the
gel should be a no bleed gel with very low viscosity, "Doctors are now being sensitized to the oiliness of our current prosthesis...."
Hinsch wants Dow Corning to place its name and product size on the mammary in case it needs to be removed and replaced for
any reason. "This is a consideration which will become more important as time goes on."
CITE: M 160007 - 160008. DUPLICATE: GEG 4343; M 160079 - 160080; KKH 2632.
Dow Corning Trial Exhibit List Abstracts
Document #230
04/14/76
KNOWLEDGE OF GEL BLEED
ACKNOWLEDGEMENT OF NEED FOR TESTING
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.
Dow Corning Trial Exhibit List Abstracts
Document #234
05/04/76
KNOWLEDGE OF GEL BLEED
GEL MIGRATION
TISSUE REACTION
Greg Bicket, Dow Corning, reports that he met with Dr. Richard Phares regarding the Silastic Mammary Prosthesis. He is
"interested in reports of freshly healed augmentations failing to adhere with subsequent loss of implant. (Phares) experienced
this, and was upset to hear others reports of this at the Southeastern meeting. Apparently, the theory is that the opposing
faces of the wound are closed, and in ten to fifteen days no appreciable healing has taken place. The suture lines then break
down, and the implants are not retained. 'Greasy implants" sliding into the pocket, providing a release agent against healing,
were postulated to be the cause."
Further, "The second area of concern was the reported actions of migrating gel/fluid of other manufacturers' gel. Giant
cells, granulomae, and siliconomae were reported in and around the locations where the migrating gel/fluid was said to have
come to rest." Phares proposes a dog study.
CITE" M 600009 - 600010, Exhibit to MDL Rathjen Deposition, and Exhibit 79 to Harris County Rathjen Deposition. DUPLICATE:
F 713 - 714; KMM 380053; DCC 80010141 - 80010142. NOTE: Dow Corning never followed through with a dog study. See 06/08/76
entry.
Dow Corning Trial Exhibit List Abstracts
Document #241
06/10/76
COHESIVENESS - LIQUID COMPONENT OF GEL
GEL MIGRATION
KNOWLEDGE OF GEL BLEED
Study by Brill titled "Development Of A Low Oiling Gel For The External Breast Prosthesis." The resulting gel caused substantially
less swell of the silicone rubber envelope and gave a low rate of migration of silicone material through the envelope compared
to existing silicon gels formed from low viscosity fluids and plasticizers. It was also shown that gels and fluids based on
methyltrifluoropropyl polymer as well as silicone organic copolymers could produce a very low order of elastomeric swell and
bleed with polydimethylsiloxane envelope rubber.
CITE: KKH 63280 - 63299, Exhibit to Petraitis Deposition, and Exhibit toMDL Rathjen Deposition.
Dow Corning Trial Exhibit
List Abstracts
Document #257
10/01/76
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF LIQUID SILICONE DANGERS
KNOWLEDGE OF SYSTEMIC
DISEASE
RUPTURE
STERILIZATION/CONTAMINATION
TISSUE REACTION
Donald Barker, M.D., presents a paper, "Reactions to Silicone Implants in the Guinea Pig," to the Scientific Session of
the American Society of Plastic and Reconstructive Nurses.
CITE: GEG 4000 - 40006. NOTE: Paper was published in the Aesthetic Plastic Surgery in 1978, authored by Barker and Sherrill
Lee Schultz, R.N.
Dow Corning Trial Exhibit List Abstracts
Document #266
01/10/77
ACKNOWLEDGEMENT OF NEED FOR TESTING
KNOWLEDGE OF GEL BLEED
Becker, Dow Corning, memo to C. Lentz regarding silicone found in tissue. He writes, "The question of bleed and contracture
is indeed of concern by our competitors and the physician. There is no question in my mind that Dow Corning's leadership position
is expected to provide answers to the questions. I am very surprised to find that we do not have any data on Si levels in
tissue or the distribution and fate of trace levels of polymer in the body." (emphasis added).
CITE: F 810, Exhibit to California C. Lentz Deposition, Exhibit to Harris County LeVier Deposition, Exhibit 70 to Harris
County Rathjen Deposition, and Exhibit to MDL Rathjen Deposition. DUPLICATE: KMM 260614; M 170124; KMM 380071.
Dow Corning
Trial Exhibit List Abstracts
Document #267
10/18/77
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS - COMPLICATIONS
MISCELLANEOUS - SALES
Rathjen, Dow Corning, memo to Bey, Hoyt, Hutchison, Lentz, and Nelson regarding "observations Relative To Dow Corning's
Future In The Mammary Implant And External Breast Markets." Rathjen states; "In my opinion, we, Dow Corning, are no longer
the recognized leaders or innovators in either segment; and our present position will continue to decline unless specific
measure are taken now to turn things around.... I am powerless to change anything, and my sphere of influence in this business
continues to diminish: hopefully, I still have the privilege to express opinions even if they are not shared by all."
CITE: KMM 12998 - 13000 and 13004, Exhibit to MDL Rathjen Deposition, and Exhibit 83 to Harris County Rathjen Deposition.
DUPLICATE: m 190101.
Dow Corning Trial Exhibit List Abstracts
Document #269
02/17/77
KNOWLEDGE OF GEL BLEED
ACKNOWLEDGEMENT OF NEED FOR TESTING
Larson, Dow Corning, memo to Bennett, Hoyt and Rathjen regarding mammary bleed. "The permeability of silicone elastomers
is a well known phenomena.... Permeation in this case is ... toxicologically unknown.... It is of great concern because of
what can be made of the unknown...." Also, "We would also anticipate bleed may be a function of heretofore unmeasured factors,
e.g. manipulation and stress.... Dow Corning's product development direction has been an attempt to strike a balance between:
1)What we factually know about bleed. 2)What gel and envelope polymer intermediates can be produced. 3)What toxicological
data we have on materials. (and) 4What is a marketable product.... In conclusion, any physiological effect or consequence
of this permeation remains speculative. What can be done and what should be done is an open topic of discussion." (emphasis
added).
CITE: OOM 320448 - 320449, Exhibit to MDL Rathjen Deposition, and Exhibit 71 to Harris County Rathjen Deposition. DUPLICATE:
KMM 176928; KKH 2263: M 150002 - 150003: M 190423 - 190424.
Dow Corning Trial Exhibit List Abstracts
Document #274
03/28/77
FRAUD/MISREPRESENTATION
KNOWLEDGE OF GEL BLEED
Dow Corning employee, D. Petraitis, memo regarding bleed studies for Dr. Barker. There is serious concern whether any gel
bleed data should be released to the public because "any general release of this data could be misinterpreted or misconstrued,
and could result in severe repercussions in the public sector." (emphasis added). Also, "The bleed measurement may not be
representative of actual in vivo results.... I still believe that Dow Corning should convey the impression that we are indeed
working in this area." (emphasis added).
CITE: F 633. DUPLICATE: KMM 264592. NOTE: Del Petraitis later worked for McGhan Nusel.
Dow Corning Trial Exhibit List
Abstracts
Document 275
03/31/77
TISSUE REACTION
FRAUD/MISREPRESENTATION
KNOWLEDGE OF GEL BLEED
Leach, Dow Corning, memo to Bob Levier regarding "Contracture Phenomenon." Leach refers to recommendations made by Pat
Walters on contracture and states that Dow Corning has taken no significant action on any of Walter's recommendations, except
for a "half-hearted" low priority program at Northwestern University. He reports that he is losing customers because doctors
believe Dow Corning implants bleed more than others. Leach writes:
Several of our customers looking to us as leaders in the industry, asked me what we were doing.
I assured them, with crossed fingers, that Dow Corning too had an active 'contracture/gel migration' study underway. This
apparently satisfied them for the moment, but one of these days they will be asking us for the results of our studies....l
I am not sure where this unrest is leading but suspect that our PMG, as the steward of Dow Corning's implantable products,
should not be to (sic) comfortable with our current lack of focus and coordinated leadership relating to this entire issue.
I suggest that this question be addressed at our next PMG Meeting and clear definition given as to what answers we can reasonably
be expected to have, and what steps need to be taken to fill whatever gaps that may exist in our needed storeroom of knowledge.
In my opinion, the black clouds are ominous and should be given more attention. (emphasis added).
CITE: F 717 - 718 (Handwritten note, "R-grand push. Where does Ron Kelley stand w/summarizing available data? John.")'
M 190439 - 190440 (Handwritten note, "Chuck, excellent memo. We must not be complacent as in past. Unlikely other co.’s
research will favor us. Are we going to do something? Dick.") Exhibit to MDL Rathjen Deposition. DUPLICATE: F 683 - 684; GEG
4028 - 4029; KMM 140266 - 140267.
Dow Corning Trial Exhibit List Abstracts
Document #282
08/24/77
KNOWLEDGE OF GEL BLEED
COHESIVENESS - LIQUID COMPONENT OF GEL
John R. Hilliard, Dow Corning, writes to Bob Gruber of Surgical Appliances Industries Inc., regarding a new gel to consider
as an alternative to the current gel. The new gel, X7-2339, bleeds only 60% more than the current gel, Z7-2339, while the
pre-1976 gel bleeds almost 600% more than the current gel.
CITE: M 250044.
Dow Corning Trial Exhibit List Abstracts
Document #304
06/00/78
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS - COMPLICATIONS
TISSUE REACTION
Donald E. Barker, M.D., Marvin I Retsky, M.D., and Sherill Schultz, R.N., report in the Plastic and Reconstructive Surgery
Journal that, "Modern silicone bag-gel breast implants leak silicone gel through the bag, the amount leaked varies from one
implant to another and is not constant for any type or brand, and the silicone will be found in fibrous thickening and various
degrees of inflammation will be found in capsules surrounding the implants...."
CITE: M 260116 - 2601121, Exhibit 44 to Harris County Duel Deposition (used by Dow Corning), Exhibit 37 to Frisch Deposition
(used by Dow Corning), Exhibit to D. McGhan Deposition, Exhibit to Oppelt Deposition, Exhibit 2B to Harris County Talcott
Deposition (used by Dow Corning), Exhibit 2 (and 125) to Harris county Rathjen Deposition, and Exhibit to Steward Deposition.
DUPLICATE: D 3583 - 3585, M 260269 - 260275.
Dow Corning Trial Exhibit List Abstracts
Document #310
02/27/79
GEL MIGRATION
KNOWLEDGE OF GEL BLEED
RUPTURE
SHELL STRENGTH - THICKNESS
Del
Petraitis memo to Bill Oppelt, both of whom are former Dow Corning employees who are now at McGhan Medical. Petraitis is critical
of Dow Corning's inflatable shells because of their method of dipping which results in significant differences in thickness,
making the shells "very susceptible to aneurysm formation."
With gel-filled implants, the shell thicknesses are less.
Also, he states that Dow Corning's gel "achieves its responsiveness by utilizing a large quantity of non-functional polymer
in the gel formation.... This free polymer is not chemically cross-linked and is only mechanically trapped in the gel matrix.
As a result, it is free to migrate through the shell and makes the entire implant much more prone to the 'bleed' phenomenon."
CITE: MCG 8487 -8489, Exhibit to Coyne Deposition, Exhibit to Grosh Deposition, Exhibit to Oppelt Deposition, Exhibit to
Schreiber Deposition, and Exhibit to Petraitis Deposition.
Dow Corning Trial Exhibit List Abstracts
Document #311
04/04/79
KNOWLEDGE OF GEL BLEED
GEL MIGRATION
Gene Jakubczak, Dow Corning, memo responding
to Bill Overton's, sales representative in Texas, memo to Milt Hinsch discussing gel bleed and the effect of therapeutic radiation.
Jakubczak begins by stating, "I remain intrigued that what appears to be obvious TS&D activities continue to be sent to
the marketing function. Is this by design? Is it due to lack of response from TS&D? Do sales personnel understand TS&D
functions? Do sales personnel understand who to contact? Enough!!"
In response to question of mammary bleed, Jacubczak states that Dow Corning's "fluid injection program ... does give some
guidance on what happens when polydimethylsiloxane is injected in-vivo. Dow Corning does have data from its industrial sales
effort on polydimethylsiloxane fluids. The buildup in organs is reviewed however, I do not know what it says.... If you detect
reluctance on DC's part to provide data bear in mind that most surgeons (obviously not all) do not deal well with scientific
accuracy as it impacts on data interpretation." (emphasis added).
With regard to Overton's question on what material is bleeding, Jacubczak states that, "The material referred to as bleed
represents the soluble fraction of the prosthesis gel component. Bleed is silicone (polydimethylsiloxane polymer)...." In
addition, "Silicone bleed has been shown to move out and away from the gel prosthesis. Insufficient information exists to
say how much and where it travels and accumulates, if it does, much less what are its affects. Dow Corning again from the
industrial sales side, does have data on polydimethylsiloxane fluid and its bio path and the effects in the body." (emphasis
added).
Finally, in response to whether there is any difficulty with x-ray and mammography exams of women with breast implants,
"experience will usually overcome difficulties.' Also, Jakubvczak will review the effect of therapeutic radiation on implants.
CITE: M 250045 - 250047.
Dow Corning Trial Exhibit List Abstracts
Document #320
03/14/80
KNOWLEDGE OF GEL BLEED
Milt Hinsch, Dow Corning, memo to Bartolo, Gant, Peters, Jakubczak, Haas, and Smith stating that, "We are now saying (seeing)
extremely greasy lots of Gel Saline Mammary implants. The H.P. envelope accentuates gel bleed." (emphasis in original).
CITE: KMM 518831.
Dow Corning Trial Exhibit List Abstracts
Document #323
04/29/80
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS - RECKLESS/CONSCIOUS DISREGARD
B. Schnabel, a Dow Corning salesman, writes Milt Hensch regarding a complaint from a customer, F. Grazier, M.D. The doctor
is complaining about excessive gel bleed and a "greasy" feel to the envelopes. "The lot number involved is H129700. It has
been brought to my attention that this particular lot was put on the market with prior knowledge of the bleed problem." Schnabel
continues, "As you know he (Dr. Grazer) had a bad experience with our varifils and with our gel salines he has yet another
bad experience and we wind up with egg on our face. To put a questionable lot of mammaries on the market is inexcusable. I
don't know who is responsible for this decision, but it has to rank right up there with the Pinto gas tank." (emphasis added).
CITE: F 629 - 630. DUPLICATE: M 250021; M 570058; F 628; KMM 232092 -232093; M 250022 - 250023; M 570059.
Dow Corning
Trial Exhibit List Abstracts
Document # 324
5/07/80
KNOWLEDGE OF GEL BLEED
Yolanda Sue Peters and
R. Gant, Dow Corning, author an internal Lab Report For Silastic II Mammary Implant Bleed Study. Gel bleed is "a property
common to all gel-filled prostheses" which is attributable to the semi-permeable nature of silicones and the similarity in
the composition of the gel and the envelope. Test results show that the fluorosilicone coating of the mammary envelope reduces
the bleed by approximately 90%."
CITE: KMM 136950 - 136958. DUPLICATE: D 2926 - 2935; KMM 151111 -151120; T 8417 - 8425.
Dow Corning Trial Exhibit List
Abstracts
Document #330
11/19/80
KNOWLEDGE OF GEL BLEED
Handwritten note from J. Reitsma to M. Hinsch, both of Dow Corning Wright, regarding problems with the gel-saline implants.
He states, "Milt, I feel we have a potential problem with the quality of our gel-saline mammary prosthesis, that is gel bleed
in excessive amounts going through the outer membrane in such volume as to cause a greasy look and feel to the using surgeon."
Several physicians have refused to use the product stating that they have no confidence in it - "it's to (sic) damn greasy."
Reitsma informs Hinsch that the gel-saline product "has me feeling uneasy about its quality and even safety. I can not in
good faith introduce this product to a competitive or new account."
CITE: KMM 232094 - 232095.
Dow Corning Trial Exhibit List Abstracts
Document #335
04/29/81
ACKNOWLEDGEMENT OF NEED FOR TESTING
GEL MIGRATION
KNOWLEDGE OF GEL BLEED
Peters, Dow Corning, memo to Jacubczak, Marlar, Rylee and Wessel reporting that Dr. Gerow has requested an injectable gel
for soft tissue augmentation (face and breast). There is very little published data on the fate of implanted gel. Some authors
feel that the gel which bleeds from the envelope contributes to capsular contracture. Dow Corning data indicates that the
gel is subdivided by vascularized connective tissue, which could result in the site of the implantation becoming very firm
(breast) and/or transport of gel away from the site. No data was received from Dr. Gerow. Seventeen of twenty doctors who
were asked for their opinions said they were not in favor of the concept. The commercialization of such a gel would require
long term animal studies, careful definition of the material, an IND and a campaign to overcome the bad press and emotions
associated with the disastrous results reported from silicone fluid injection. (emphasis added).
CITE: KMM 140223 - 140228, Exhibit to Blocksma Deposition, Exhibit to Peters Deposition, and Exhibit to MDL Rathjen Deposition.
Dow
Corning Trial Exhibit List Abstracts
Document #360
07/13/82
KNOWLEDGE OF GEL BLEED
Duel, Dow Corning, memo to Jakubczak regarding comments, questions and recommendations on the letter from Dr. Schmidt.
Among Duel's comments are shells are very oily, we lubricate the valves with silicone, H.P. shells have visually more bleed,
all gel-saline units bleed, and our distributors are well educated but poorly informed.
CITE: M 250033 - 250034.
Dow Corning Trial Exhibit List Abstracts
Document #370
02/03/83
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS - PRODUCT LABELING
G. Jakubczak, Dow Corning, memo to Milt Hinsch regarding revisions to the package insert for the Silastic implant. Jakubczak
suggests routing all comments on inserts to Jim Matherly, Chick Burda, Harvey Steinberg and Marcia Marsh since this is a "very
high potential liability product." Jakubczak suggest adding language on silicone bleed - "Silicone bleed from a gel filled
mammary has been identified in surrounding tissue."
CITE: KMM 301297 - 301301. NOTE: Need to cross check the final packageinsert to see if Jakubczak's suggestions were incorporated.
Dow
Corning Trial Exhibit List Abstracts
Document #382
09/30/83
COHESIVENESS - LIQUID COMPONENT OF GEL
TESTING
KNOWLEDGE OF GEL BLEED
Dow Corning "Investigation of Q7-2167/2168 Formulation Parameters Which Might Influence Gel Cohesivity And Bleed" by Joan
McMahon, Randall Sweet, and Virgil Metevia. They discuss that in mid-1982, Dow Corning Wright's TS&D requested the Medical
materials Department of Dow Corning to address issues of gel cohesivity and bleed with Q7-2159A (the gel used in Silastic
and Silastic II), which is the catalyzed version of Q7-2167/2168 gel.
Thirty (30) mammaries were taken from inventory and tested. 23.3% (7 of 30) failed the cohesivity test. Mammaries within
the same lot passed while others in the same lot failed this test. Some has excessive bleed and some did not. There was little
area where the gel would be cohesive and still fall in the specification range of 75-300. Data showed the specification could
be brought to 50-150 and still likely pass the ASTM F703-81 gel cohesivity test. The responsiveness of 50 penetrations was
not considered to be objectionable. Gel bleed is already known to be a problem.
CITE: KKA 121630 - 121669. DUPLICATE: KKA 88488 - 88495; KMM 270149 -270162; KMM 173990.
Document #385
12/13/83
CONCEALING FROM FDA
TISSUE REACTION
KNOWLEDGE OF GEL BLEED
FDA: "The FDA inspects Dow Corning's Hemlock plan and lists numerous violations in the complaint reporting system. The
investigator notes that Complaint MD 1081 dated 04/21/81 showed a "giant cell reaction with imbedded silicone particles."
Dow Corning failed to follow-up this complaint and get more information. Also, there were numerous complaints about implants
being "greasy" and Dow Corning had failed to respond to them. Other violations included production records, oven records,
"dirt & debris on top of packaged sterile mammaries," and other problems with sterility in the dipping room and manufacturing
process.
CITE: FDA 17098 - 17137.
Dow Corning Trial Exhibit List Abstracts
PENDLETON/PSC Attorney Work Product /Privileged
& Confidential
Document #406
08/14/84
KNOWLEDGE OF GEL BLEED
SHELL STRENGTH - THICKNESS
RUPTURE
R. Dumas, Dow Corning, memo to G. Jakubczak and others regarding "Project Report - Complaint Analysis, Plastic Surgery."
Dumas details the number and types of complaints received on mammary implants and notes that the most common complaints for
the gel-saline units were of a greasy surface and post-op deflation from pin hole leaks. Upon inspection, it was determined
that the pin holes were caused by "burs on the wire screen in the wash area.... Many of the pin hole leaks examined suggested
origination from this source." Dumas states that, "The appearance of some of these units made me sympathize with one surgeon
stating that he believed we were soaking the units on (in) Mazola oil before shipping. Since this bleed appears to be inherent
in the current design of the product a standard response has been developed to answer (sic) this type of complaint." (emphasis
added). NOTE: design defect.
The most typical complaint for the Silastic II is post-op suture or rupture during insertion. "The tear propagation (sic)
noted with the ruptures was found to be of a much less degree compared with the standard gel product.... There is an indication
that there may be more susceptibility to rupturing during insertion than that found with the standard gel unit."
Dumas noted that most of the complaints concerning the standard gel mammaries (sic) were of the "ease of tear propagation
(sic). In addition non-uniformity of the envelope was noted along most tears examined, suggesting thickness variation to be
a contributing factor to the rupture." NOTE: manufacturing defect.
Dumas' overall recommendations are that Dow Corning needs to develop a more uniform envelope thickness on all products,
reduce bleed characteristics, and increase stress resistance in the Silastic II.
Dumas also documents the practice of sending returned implants to TS&D from the Medical Plant in mail envelopes via
the plant mail. "Many of the units arrived in a smashed condition making analysis extremely difficult. Imagine trying to analyze
a mammary flattened like a pancake inside a gel soaked mail envelope."
CITE: KKA 119771 - 119774.
Dow Corning Trial Exhibit List Abstracts
Document #426
09/05/85
FRAUD/MISREPRESENTATION
GEL MIGRATION
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS - COMPLICATIONS
MISCELLANEOUS
- PREP PROGRAM
RUPTURE
RUPTURE - CLOSED CAPSULOTOMY
SHELL DEGRADATION
TISSUE REACTION
Dr. Garry Brody writes to Rylee, Dow Corning Wright, complimenting him on his "unique plans for replacing broken implants.
Not only should this be effective in controlling litigation but it also ought to be an excellent marketing tool." "Brody is
referring to the PREP warranty program Dow Corning recently announced. Attached are Brody's comments on the patient brochure.
He states, "I really do feel it hits the mark with just the right balance between what the manufacturer needs to tell the
physician and to transmit to the patient without discussing the medical side of things."
Brody enclosed sample questions and answers about silicone breast implants. The proposed answers including statements such
as:
"Reports of serious or life threatening problems directly related to the implant itself are rare.
There is no evidence that there is any relationship between breast implants and cancer.
All silicone materials will shed tiny microscopic amounts of material which are picked up by the
body's scavenger white blood cells and filtered by the lymph glands in the arm pits.
The gel filled implants tend to bleed tiny amounts of gel which travels the same routes. This
very minute quantity of silicone that escapes the implant and travels in the body appears to be harmless.
Occasionally, closed capsulotomy can cause bruising, bleeding or even rupture of the implant."
CITE: KMM 41248 – 41261
Dow Corning Trial Exhibit List Abstracts
Document #429
10/01/85
EMBOLISM
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF LIQUID SILICONE DANGERS
MISCELLANEOUS
- COMPLICATIONS
SHELL DEGRADATION
TISSUE REACTION
In an Infor-Med, Natural Y discusses the recurring problems of painful fibrosis and implant distortion associated with
the standard smooth silicone implant. "The dangerous implications of ongoing fibrosis, accompanied by cell anoxia, vascular
impairment and pain, have been consistently documented by microbiologists and histologists as being precursive to cancer.
Additionally, the hazards of free silicone, well documented in silicone injections, are leading to more granulomas and silicone
gorged lymph nodes." The memo also describes more specific and basic areas of concern: "Smooth surfaced polymers, because
of their disruptive effect on cell products, are generally regarding as unsuitable for long term implantation.... Early design
smooth silicone breast prostheses -- commercially available until the mid 1970's – were vulnerable to extreme gel bleed
and volume loss.... Possibility of embolism."
CITE: MEI 4230 – 4233
Dow Corning Trial Exhibit List Abstracts
Document #430
10/10/85
GEL MIGRATION
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE
TESTING
TISSUE
REACTION
Study titled "Characterization of C-U Silicone Elastomer Shells." The use of plastic embedding significantly enhances our
ability to resolve the presence of silicone gel as well as those cells involved in the response. Plastic embedding provides
retention of the interface between the fibrous capsule and the foreign body. The silicone gel is removed from the immediate
locality and taken to the periphery of the capsule where one can only assume it is then transferred to the reticuloendothelial
system as observed with similar materials used in other clinical situations A significant difference in degree of cellularity,
number of lymphocytes and cells at the interface is noted when gel implants are compared to the extracted implants. It is
my impression that the use of silicone gel prostheses represents a significant risk to the patient. The literature suggests
that individuals can develop an allergic and immunologic reaction to silicone gel and oil. It would behoove us to develop
in an expeditious fashion a non-permeable silicone shell with subsequent replacement of the gel with another polymer system.
CITE: CUI 300317 - 300414, Exhibit 11 to D. McGhan Deposition, Exhibit to Oppelt MDL and Harris County Depositions, Exhibit
7 to Harris County Pool Deposition, and Exhibit to MDL Pool Deposition.
Dow Corning Trial Exhibit List Abstracts
Document #433
12/04/85
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
Matherly sends a confidential memo to Jakubczak, Dow Corning, regarding "Dow Complaint MD2579." In it, he states that,
"The claim is really extraordinary in that it alleges that gel volume has been lost while envelope integrity is maintained."
Matherly then suggests "We probably should include a carefully constructed professional statement (from you or Lois) that
would discount weight loss from an intact envelope." He also discusses the investigator's inability to find any other problem
with the prosthesis, "He, I don't believe, meant to convey the message that I think is obvious here, and which seems to be
very dangerous in that it implies something he didn't observe." Matherly says he is seeing enough problems in the Complaint
Analyses that he is scheduling a meeting in January to review concerns and provide training.
CITE: KKH 38544
Dow Corning Trial Exhibit List Abstracts
Document #439
04/29/86
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE
TISSUE REACTION
In an Infor-Med, Jackie Markham, Natural Y Surgical Specialties, claims that there is overwhelming agreement among ASAPSs
members that the less exposure of silicone to the lymphatic system the better because it means less of a load on the immune
system. Surgitek and Dow Corning are accused of dumping and "fire-saleing" high-bleed mammary implants which they had advocated
for years on the market.
CITE: MEI 4237 – 4239
Dow Corning Trial Exhibit List Abstracts
Document 448
01/00/87
GEL MIGRATION
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE
SHELL DEGRADATION
SILICA
TISSUE
REACTION
Z. Glaser writes a brief article or report entitled "Chemistry of Silicones used for breast implants and other soft tissue
applications." Glaser discusses the composition of silicone breast implants, gel migration and bleed, and degradation of silicone
by the body. He cites two cases where gel migration into the lymph nodes was noted and an "acute serum-sickness-like reaction"
occurred 24 hours past implantation, both instances were from intact implants.
CITE: M 780070 - 780073. NOTE: See 01/00/85 entry. See 07/25/88 entry; possible attachment to M 780066 - 780069.
Document 457
04/01/87
ACKNOWLEDGEMENT OF NEED FOR TESTING
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE
OF GEL BLEED
Dow Corning Quality Assurance Department Report 0058 by Sharon McCoy entitled "Factors Affecting The Integrity And Stability
Of Q72159A Mammary Gel And Intermediates." The objectives of the study were to identify causes of gel penetration drift, identify
causes of gel depolymerization and determine feasibility of using SiH to vinyl ratios to predict final gel penetration values.
(OOT 41655) On the issue of depolymerization of the gel, she states that "Potassium in Ql-0043 appears to cause depolymerization
in the finished product Q7-2159A when levels exceed 1.75 ppm, taking test repeatability into account" (Id.)
CITE: Hancock Deposition, Exhibit to Olson Deposition, and Exhibit to Isquith Deposition. OOT 41654 - 41676, Exhibit to
Harris County Burda Deposition, Exhibit to Petraitis Deposition, Exhibits 11 and 27A
Dow
Corning Trial Exhibit List Abstracts
Document #518
01/29/91
COHESIVENESS - LIQUID COMPONENT OF GEL
FRAUD/MISREPRESENTATION
KNOWLEDGE OF GEL BLEED
FDA: Department of Health and Human Services pharmacologist, Hoan My Do Luu, letter to Dow Corning and Dan McGunagle of
the Breast Implant Task Force regarding Appendix A and B, supplements to PMA P910039A (Silastic II H.P.) and P910040A (Silastic
MSI single lumen silicone gel-filled mammary implants). The letter deals with the summary of extraction data for Dow Corning
Silastic shells, gels and patches. Luu states that "the reporting of low amount of cyclics (less than 2% wt) in the summary
report is misleading because the company selectively reported only two of the 17 cyclics found in the components' extracts.
The firm selectively reported the amount recovered for cyclic tetrameter (D4) and pentameter (D5) as total volatile cycles.
Other shortcomings were found in the methodology protocols used such as incomplete extraction in ethanol, ethanol: CH2CL2
and saline, lack of controls and validation of the methodology.... The reporting of no detectable siloxane residues in saline
extracts was questionable." See original document for additional questions regarding Dow Corning's reporting.
CITE: FDA 12281 - 12290. NOTE: See entries of 12/20/91, 02/05/92, 02/06/92 and 03/13/92
Dow Corning Trial Exhibit
List Abstracts
Document #524
06/19/91
KNOWLEDGE OF GEL BLEED
TESTING
Varaprath, Dow Corning, report on internal Dow Corning Wright study entitled "Composition(al) Analysis of Mammary (Implant)
Gel Bleed." Analysis states:
"Silicone gel bleed was collected from mammary implants fabricated with and without a fluorosilicone
barrier interlayer using accelerating conditions to collect significant quantities via a short period of time (not in in-vivo
simulation). The -prostheses used in the test were 1) Low Profile Round (LPR) Design High Performance (H.P.) Mammary Prosthesis
with no fluorosilicone barrier, and 20 SILASTIC II LPR H.P. Mammary prosthesis which contain fluorosilicone barrier interlayers.
The test method for gel bleed collection is documented by the author. The fluorosilicone barrier was shown to reduce the amount
of gel bleed by approximately a factor of 20 (i.e., 837.3 + or - 64.9 mg. without barrier vs. 44.3 + or - 5.6 mg. barrier).
After collection, the gel bleed was analyzed using different spectrochemical techniques to determine its composition (i.e.,
sivinyl and Si-H were detected by infrared spectroscopy, platinum by atomic absorption spectroscopy, and molecular distribution
by gel permeation chromatography). The molecular weight distribution of the LPR samples was relatively close to the reference
material, Q7-2317, while the SILASTIC II samples exhibited significantly lower molecular weight distribution that the reference.
The Sivinyl content of the LPR samples averaged 156. + or - 13.5 ppm; SILASTIC II samples averaged 100.0 + or - 7.0 ppm; and
Q7-2317 was 9.8 + or - 7.4 ppm. Infrared and atomic absorption spectroscopy did not detect Si-H or platinum."
Adverse effects are listed as N/A. CITE: FDA 33559 - 33569.
Dow Corning Trial Exhibit List Abstracts
Document #526
09/13/91
KNOWLEDGE OF GEL BLEED
RUPTURE
SHELL DEGRADATION
SHELL STRENGTH - THICKNESS
TESTING
TISSUE
REACTION
FDA: Letter from the FDA to B. Lipscomb, Director of Clinical and Regulatory Affairs for Dow Corning Wright. Dow Corning
Wright submitted 229 studies to the FDA in its PMA for the Silastic II Mammary Implant H.P. and the MSI Mammary Implant H.P.
but the FDA states, "we believe that the PMA lacks information needed to show that there is reasonable assurance that the
device is safe and effective for its intended use." The FDA then lists "major deficiencies" in the PMA including lack of specific
data on rupture testing, tear resistance testing, abrasion resistance, gel bleed performance testing, pharmacokinetic/biodegradation
studies, mutagenicity testing, manufacturing information, and clinical and non-clinical investigations.
CITE: m 780258 - 780265. DUPLICATE: M 780092 - 780100: M 780101 -780103; KKA 178597 - 178604.
Dow Corning Trial Exhibit
List Abstracts
Document #527
10/09/91
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
TESTING
FDA: FDA Materials Research Engineer, Lawrence D. Coyne, Ph.D., issues a memorandum titled "Dow Corning single and Double
Lumen Silastic II and Silastic MSI Breast Prothesis: In-Depth Review of Gel Bleed Testing." He reviews eight Dow Corning reports
of gel bleed permeation testing, two of which provide useful information:
"The bleed consists of approximately 80% compounds of low molecular weight (=5300) in the range
of, although lower than, the linear (i.e., uncross-linked) polydimethylsiloxane compound found in the original gel fill. Approximately
4% is composed of components of very low molecular weight (=525) which may correspond to unreacted or deliberately added dimethylcyclosiloxanes.
The remainder, approximately 16%, is of much higher molecular weight (=245,000) and probably arises from unreacted or degraded
parts of the cross-linked material found in either the gel or the shell material. It is vital that a thorough and adequate
extraction of the original gel fill and shell be performed so as to resolve the origin of these detected bleed products!"
Also noted is that for simulating in vivo gel bleed, use of mineral oil rather than saline as solvent in testing is better
and proper, since it: "represents more realistically the in vivo state in which large concentration gradients outside the
shell are maintained by the turnover and replenishment of body fluids possibly with the assistance of some active transport
process. These conditions do not exist in a static in vitro experiment employing a very poor solvent such as saline."
The writer particularly criticizes a Dow Corning bleed study due to:
"the complete lack of chemical or molecular weight distribution analysis of the bleed product.
The importance of determining the identity of the bleed product, in addition to its total accumulated weight, cannot be overstated.
The barrier layers of these "low-bleed" devices may in reality be much more efficient at retarding the passage of components
of higher molecular weight, but be relatively permeable toward potentially more hazardous low molecular weight linear and
cyclical molecules. The chemical analysis of this study is not nearly thorough enough. Concentrations of unreacted functionalities
as a useful quantity, but even more important is the complete identification of the lower molecular components, which would
be expected to pose the most significant health risk."
CITE: DCC 241000088 - 241000101.
Dow Corning Trial Exhibit List Abstracts
Document #529
12/20/91
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
RUPTURE
SHELL STRENGTH
- THICKNESS
TESTING
FDA: Lawrence Coyne, Material Research Engineer for the FDA, provides an in-depth review of Gel Bleed and Mechanical Testing
submitted in Dow Corning's 12/13/91 Amendment (Volume 1) concerning Single and Double Lumen Silastic II and Silastic MSI Breast
Prostheses, PMAs P910039A and P910040A. One notable deficiency in the testing is "the absence of any reported values for the
total energy to rupture." Also:
a. Tensile Strength Testing
Coyne's "examination of the raw data for ultimate elongation reveals
that a number of inordinately low elongation values were simply disregarded in calculating average values of this property."
As such, Dow Corning's calculations were artificially high, within ASTM F703 guideline; however, inclusion of all data would
have brought the mean average down to "a clearly unacceptably small and highly fluctuating value." Coyne attributes the low
values to poor manufacturing quality control leading to "chemical differences within the shells."
b. Patch/Valve Tensile Testing
Significantly lower values of ultimate elongation and tensile
strength in the patch material and the shell material in the vicinity of the patch would appear to indicate the higher probability
of device rupture in these areas.
Finally, Coyne finds Dow Corning's gel bleed study unacceptable, as it "does not include any chemical or molecular weight
characterization of the gel bleed products.... Also, contrary to what might be expected, the bleed rates were higher in terms
of a weight basis for the firm gel as opposed to the soft or responsive gel."
CITE: FDA 12423 - 12431.
Dow Corning Trial Exhibit List Abstracts
Document #537
03/02/92
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
KNOWLEDGE OF GEL BLEED
MISCELLANEOUS
- COMPLICATIONS
RUPTURE
SHELL DEGRADATION
SHELL STRENGTH - THICKNESS
STERILIZATION/CONTAMINATION
TESTING
TISSUE
REACTION
FDA: FDA inspects Dow Corning Wright's plant from January 13 to March 2 and finds various examples of MDR reportable silicone
breast implant complaints that were not reported to the Food and Drug Administration.
Examples include leaking mammary envelopes, ruptured mammary implants, implant deflations, capsular contracture complaints,
inflammatory reactions, infections, gel bleed, an inadequate program in place for monitoring and controlling the levels of
microbial and particulate matter in the controlled rooms, improper validation of the envelope curing oven, inadequate calibration
program and MDR reports not filed in a timely manner.
CITE: M 780802 - 780813.
Dow Corning Trial Exhibit List Abstracts
Document #538
03/09/92
COHESIVENESS
- LIQUID COMPONENT OF GEL
FRAUD/MISREPRESENTATION
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE
TISSUE
REACTION
Lutz, Dow Corning, memo to Clary, McClintick, Klykken, Rigas, Roghhaar and Zellner regarding position statement on gel
bleed and D4 - review and comments. Comments regarding bleed include bleed of silicone fluid is commonly associated with mammary
implants and has long been recognized by surgeons as a characteristic of silicone gel-filled breast implants. The amount of
bleed is largely dependent on the molecular weight of the silicone material. The comments regarding D4 include that it is
contained in minute quantities in the silicone gel-filled mammary implant and Dow Corning and other manufacturers believe
D4 is safe for use in its intended applications and in no way affects the safety of silicone mammary implants.
CITE: KMM 452997 - 453002, Exhibit 44 to Zimmer Deposition.
Dow Corning Trial Exhibit List Abstracts
Document #540
03/13/92
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
RUPTURE
SHELL STRENGTH
– THICKNESS
TESTING
FDA: The FDA cites deficiencies in Dow Corning, Mentor and McGhan's PMA test data on chemical extraction studies, in-vitro
gel cohesivity, valve competence, joint integrity, tear resistance, and tensile strength. Include internal FDA memos dated
03/13/92 and 03/18/92 from Lawrence Coyne explaining in detail the reasons for the PMA denials.
CITE: FDA 12567 - 12607. NOTE/ FDA 12519 - 12535 may be an attachment to this document.
Dow Corning Trial Exhibit List
Abstracts
Document #541
02/13/92
COHESIVENESS - LIQUID COMPONENT OF GEL
KNOWLEDGE OF GEL BLEED
RUPTURE
SHELL STRENGTH
- THICKNESS
TESTING
FDA: The FDA, in a summary of safety and effectiveness data, cites deficiencies in Dow Corning's, Mentor's, and McGhan's
PMA test data on chemical extraction studies, in-vitro gel cohesivity, valve competence, joint integrity, tear resistance,
and tensile strength.
CITE: FDA 12519 - 12535. NOTE: May be an attachment to FDA 12567 -12607.
Dow Corning Trial Exhibit List Abstracts
Document
#549
12/31/92
ACKNOWLEDGEMENT OF NEED FOR TESTING
CONCEALING FROM FDA
FRAUD/MISREPRESENTATION
GEL MIGRATION
KNOWLEDGE
OF GEL BLEED
KNOWLEDGE OF LIQUID SILICONE DANGERS
KNOWLEDGE OF SYSTEMIC DISEASE
MISCELLANEOUS
MISCELLANEOUS -
LOBBYING
RUPTURE
TESTING
TISSUE REACTION
The Committee on Government Operations (John Coyners, Chairman, Henry Waxman, et al.) writes a report which includes a
scathing critique of the FDA's failed regulation of silicone breast implants while ignoring their own scientists recommendations
and the manufacturers' failure to do any long term safety studies. Silicone breast implants should have been banned due to
lack of safety evidence in all manufacturers PMA's. The article covers all areas of this issue.
CITE: PSSC Medical Articles CD, J 3968 - 4022.
Dow Corning Trial Exhibit List Abstracts
Document #557
09/01/93
TESTING
KNOWLEDGE OF GEL BLEED
KNOWLEDGE OF SYSTEMIC DISEASE
Malczewski, Woolhiser, Mudget, Duwe, Galbraith, Nash and Klykken, Dow Corning, report on "A Humoral Adjuvancy Study In
The Rat Of Dow Corning Silicone Gel (Q7-2159a) Preparations And Mammary Gel Bleed." All three sheared mammary gel/BSA preparations
demonstrated comparable antibody responses to the positive FCA/BSA control and were significantly greater than that of the
non-adjuvant control at 4, 6, and 8 weeks post-immunization. The ability of sheared silicone gel preparations to elicit an
adjuvant response does not appear to be a preparation-dependent phenomenon under the conditions of this assay. The adjuvancy
potential of mammary gel may not be primarily dependent on the preparation technique. Mammary gel bleed did not elicit an
adjuvant response following i.m. administration. The antibody levels generated from this group were equivalent to the non-adjuvant
control at all time points measured.
CITE: OOT 48639 - 48655, Exhibit 9 to Klykken deposition in Harris County.
Dow Corning Trial Exhibit List Abstracts
