Tom Talcott was a scientist who used to work for Dow Corning. He resigned in the 70's or early 80's (not sure which) because they would not heed his warnings about the lack of the saftey of breast implants. He then became one of our best friends and tried to warn the government and other scientific communities that these products were unsafe & should not be implanted in a human body.

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I N T R O D U C T I O N

The following "Wanted" article by Tom Talcott, was presented at the San Francisco Silicone Education Conference on Saturday, July 19, 1997. This conference was co-sponsored by ImPart, Inc. of the San Francisco Bay Area and by C.O.S.S. of Denver Colorado.

Mr. Talcott has generously given ImPart, Inc. permission to transcribed and reproduce this article. All rights are reserved. Please contact Mr.Talcott at the following address for further permission to reproduce his work:

Thomas D. Talcott

Thomas Talcott Consulting

26941 Cabot Road, Suite 133

Laguna Hills CA 92653

InPart would like to join the hundreds of thousands of men women, and children harmed by silicone breast implants in giving our heartfelt thanks and gratitude to a man of extraordinary integrity and courage. In a time Of incredible pressure to conform to the policies and politics of the corporate gods, Mr. Talcott has proven to be a man of conscience. He has been motivated by an unlimited compassion for those suffering from the horribly disfiguring and chronic systemic illnesses related to silicone poisoning. He has paid a high price in both his personal health and career. We understand, recognize and acknowledge what he has given and what he has sacrificed on our behalf. We give him the only thing we have left; our highest honor, respect and gratitude.

May God richly reward and bless you Mr. Talcott for telling the truth about silicone and the subsequent human tragedy. With your indomitable faith and spirit and others like you, we will be able to bring consumer safety and corporate accountability into the new millennium. We will be victorious! Just as the tobacco companies are now being held accountable, the manufacturers of silicone breast implants will also be held accountable, assuring that generations to come will not fall prey to the lies and deception of inhumane corporate profiteers.

Sincerely yours,

Ruby Rahn IMPART, INC.

3377 Deer Valley Road

P.O. Box 174, Antioch, CA 94509

415. 512-7730

rubyr@slip.net

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- W A N T E D -

Several Journalists To Function As Investigative Reporters To Study and Publicize The Real Science of Silicones Thomas D. Talcott BSChE Materials Consultant 1997 Tom Talcott. All rights reserved. Presented at the Silicone Education Conference San Francisco, July 19, 1997 A Pulitzer Prize is awaiting a responsive journalist.

During the last few years the journalists and media producers of the country have shifted from the viewpoint that silicone breast implants are a national health disaster to the view that silicones have not been proven To be causative of any disease. They imply that silicones are safe for any implant use. This change encouraged by epidemiological studies and other specific statement as in the PBS Frontline program "Implants on Trial" by many well respected health professionals in highly respected positions GIVES THE PUBLIC AND MANY IMPORTANT DECISION MAKERS (IN CONGRESS AND THE COURTS) A FALSE IMPRESSION ABOUT THE SAFETY OF SILICONES.

Marcia Angell M.D., Executive Editor of the New England Journal of Medicine has summarized and attempted to justify the conclusions of medical science as reported by many journalists in her book "Science on Trial", published by W.W. Norton & Company. The errors, misunderstandings, poor interpretations of materials science and lack of apparent awareness of important immunological studies are many. The publisher might want to consider recalling this book because of serious liability in the "guarantee" made to current and potential implantees that silicone is safe.

The current public misconceptions about the science and toxicology of silicone materials created by journalists, the media and prominent health professionals is causing dangerous, wrongful actions by many parties. Judges have in the past few months made decisions that are preventing Women and children from obtaining proper justice in breast implant and other litigation concerning solid silicone implants such as chin implants. This includes new confidentially rulings on biocompatibility testing documents which if available to health professionals would give new understanding of how rapidly toxins or poisons in silicone are administered as toxic drugs. Congress has introduced a new Biomaterials Access Assurance Act which will improperly allow manufacturers to produce toxic silicones for use in medical implants intended for human use.

Many journalists and health professionals in the media appear to have been convinced by efforts of large public relations organizations hired by Dow Corning to publicize that silicones are safe for use in medical implants. This reversal of opinion about silicone safety is encouraging the continuation of the very large HUMAN EXPERIMENT concerning silicone implants. Many health professionals apparently have committed their opinions without any attempt to understand the world of materials science. In general, good science in any field is based on a study of cause and effect relationships, which has yet to be completely agreed upon by the parties involved.

Some would have us believe that only greedy lawyers and women are at fault for the current mass of litigation. In reality, the women discovered at a 1988 FDA Hearing that there were thousands of injured women. The Connie Chung show also alerted the world about the hazards of silicone. The attorneys were simply very pleased, for a fee, to assist women in recovering damages.

Additional Background

There should really be no controversy about silicones or silicone breast implants causing disease today. Safety and efficacy should have been proven three decades ago by the manufacturers and the Plastic Surgery Community. Safety and efficacy should have been assured before mass marketing. Unfortunately one of the manufacturers, Heyer-Schulte Corp., introduced a liquid type gel implant in 1972. The plastic surgeons had been asking for such a device to obtain a more natural appearing results after augmentation. Acceptance of this new product by surgeons was essentially instantaneous without waiting for long term results. The early false success of this product was due in part to a lower profile design which took longer for the scar capsules around the implant to give a typical spherical contracture (a contracture of scar tissue around the implant to form a sphere and accompanied by painful chronic inflammation). Dow Corning in 1975 proceeded with the development of a fluid gel implant based on Heyer-Schulte's success without knowing of the high rupture rates occurring with the product. A large number of anecdotal problems persisted to the extent that the Congressional Hearing, entitled "Is the FDA Protecting Patients from the Dangers of Silicone Breast Implants" Ted Weiss chairman, was held in December of 1990.

At that hearing I warned about the similarity of the bleed from breast implants to the outlawed use of liquid silicone injections. I also discussed the fluid consistency of the silicone gel and the tendency of the more fluid gel to cause rupture. The lack of immediate removal of the spilled gel by surgeons was because they had been misled into believing that the fluid gel was not toxic. I demonstrated an accelerated test for determination of the extent or amount of silicone bleed that was allowed to mix with tissue. This type of testing still is not being used in lot testing of devices.

Also at that hearing Frank B. Vasey, M.D., Professor and acting Chief of Rheumatology, at the University of South Florida testified about his experience and his success of implant removal helping in the resolution of serious disease symptoms. In a summary paper published in August 1994 (1) he reports during an average follow up of 22 months after implant removal 24 women improved clinically, 8 did not change and one worsened.

He and his 6 co-authors believed that the series supports a relationship between silicone breast implants and rheumatic disease signs and symptoms.

In Table 3 of this paper he points out that 11 other papers report a total of over 51 women showing improvement after implant removal. Dr. Angell feels this is simply a placebo effect. It is my under- standing that a placebo effect is usually only a temporary resolution of symptoms.

These hearings were preceded by an FDA General and Plastic Surgery Advisory Panel Hearing, on the safety of silicone breast implants, in November of 1988. The presentations given by knowledgeable attorneys, engineers and women with very disfiguring multiple surgeries and systemic illness symptoms gave vivid warnings that serious problems existed in the use of silicone gel filled breast implants. The relatively large number of women injured by physical disfigurement and sever systemic illness symptoms encouraged the victims to organize and publicize their plight. This activity has only been partially successful.

It should not be surprising that attorneys were anxious to help the victims for a contingency fee. It should be noted that many plaintiffs attorneys are having serious financial problems at this time financing their activities while the defense attorneys are paid very lucrative hourly fees.

One early lawsuit, the 1984 Stern vs Dow Corning case ended with a 1.7 million jury award. It is my understanding that in this trial a witness discovered fraud concerning one of the animal (dog) studies. The important happening was that a copy of a document the witness had studied before trial did not have the identifying dog numbers as did the copy presented At trial. It was suggested that the witness study the documents overnight. The next morning the defense attorney said they did not wish to continue questioning on this document at which time the judge questioned the witness, contributing to the juries decision to convict Dow Corning of fraud. It is most unfortunate that in accepting a reduced award the plaintiff and the attorneys firm agreed to a confidentially order on all of the scientific studies presented at trial.

These documents and others critical to understanding the real science of silicone did not become available to the FDA until a few days before Dr. Kessler declared a moratorium on the use of silicone gel filled breast implants It appears that the proponents of silicone implants have never properly studies those, and additional documents made available in the discovery concerning breast implants and other silicone litigation.

Recently I have come to understand that situations are exactly as one should expect. To believe they should be difference, better or less controversial in the case of silicone is unrealistic considering the total inputs or lack thereof by Victims, Medical Science, Materials Science & Technology, Immunological Science, Attorneys, FDA Personnel, Congress, Public Relations Firms, Manufacturers and the Courts.

There has been very little cooperation or attempt to understand the position of the proponents or opponents of silicone safety by the opposing sides. We have a highly polarized situation that we all helped to create by gross statements and lack of real interdisciplinary scientific investigation to obtain the truth about silicone.

It should be pointed out here, that the much touted Peer Review Process" to give credibility to scientific endeavors has failed to date and will continue to fail until a much broader interdisciplinary science approach is started.

Could Medical Science Be Wrong About Silicone Breast Implants Not Causing Serious Disease?

Dr. Angell states in her book (p. 196) "Although it is certainly possible that new studies might find a small association (to disease), enough is already known to say that a strong association is extremely unlikely. At most breast implants could be a very weak risk factor of disease." Angell is obviously convinced that the studies are not flawed in some basic manner to make them completely invalid.

A study by this author indicates that at least ONE FATAL FLAW that makes all epidemiological studies of silicone breast implants invalid. This flaw is because implants can not relate to disease, only toxic materials or toxins that migrate from the implants can cause disease.

The dosage of chemicals that migrate from silicone implants and other solid devices have not been properly considered. These chemicals vary widely in composition type and amount. As a consequence the studies do not have a single universe of exposure that is required to consider using statistical methods to interpret the results.

As one example, the early Cronin breast implant contained polychlorinated bi-phenyls (PCBs). (2) These chemicals as contaminates in the environment are known to adversely affect the reproductive system of birds. There should therefore be some consideration of breast implants containing poly-chlorinated bi-phenyls to be related to causing the second generation effect claimed by some victims of breast implants.

I am aware that two women who have children with serious health problems were implanted with implants containing PCBs. It should not be surprising when the group of women exposed to high amounts of PCBs between 1963 and 1969 were lumped in studies with all other implantees through 1992 that no effects about damage to reproductive systems or off-spring were noted due to the dilution effect. I am not sure questions about the second Generation effect or reproductive difficulties or affected children were even asked.

A second example is one of dosage of small silicone molecules. Jack Carmichael, (3) a Dow Corning scientist, in 1966 demonstrated and published that equilibrium polymerization of silicone polymers produce silicones containing small cyclic and linear molecules. A change to a stronger catalyst in the manufacture of medical grade silicone fluids by Dow Corning about 1965 appears to explain a high concentration of such species that led to poor device performance as follows.

The minutes of Dow Corning's task force, that was charged with the rapid development of a new breast implant in 1975, indicated that a high bleed rate batch of devices were produced. Experimental efforts at that time could not produce a duplicate batch. This result remained a mystery until Dow Corning admitted they changed the process for the manufacture of medical grade silicone fluid for injection. The new process was described in discovery documents in a lawsuit concerning injuries from the FDA and the Plastic Surgery Association (ASPRS) approved clinical trials of injectable silicone fluid in 1978 for the single use to correct facial atrophy.

Based on Carmichael's work it was obvious that proper control of the fluid would be impossible using a very fast equilibrium catalyst. The swelling of the breast implant envelope is dependent upon the size of the fluid molecules to which it is exposed. Fluids containing a high concentration of small molecules swell the envelope to a greater extend that standard fluids causing a higher bleed rate and a higher dosage of the toxins to the victim.

A quality of MDX-4-4011 injectable grade silicone fluid was obtained from defendant Dow Corning, analyzed and found to contain 28 percent small molecules (4). In a paper (5) published in the American Medical Journal written by Dr. Bennett for the AMA Committee on Scientific Affairs, it was disclosed that Dow Corning only analyzed in a gas chromatography column capable of detecting only the smaller molecules of up to DP 20. A DP of 20 has 20 repeating Dimethysiloxane units in a molecule. In both Carmichael's 1966 work and the above analysis, polymer sizes of up to DP-40 were obtained. The high bleed rates were the result of the extra swelling to make the envelope more porous.

To summarize, this information means that the amount of silicone contamination to a womans tissue and immune system is unknown in every woman presented in all epidemiological studies. Therefore there can be no single universe for a proper statistical evaluation of any epidemiological study.

I can sympathize with the statisticians for continuing to make this error as I had the same experience in the early 1950s. In searching for the reason erroneous results in my work using statistics on production quality problems, I found the answer in "Statistical Quality Control" by Grant (6). Grant points out that "in the application of statistics to other fields than industrial quality control, standard errors of averages are often calculated for measurements which if tested by Shewhart techniques, would show lack of control. Even writers of textbooks on statistics sometimes make this mistake." He continues in footnote 1 "There seem to be two reasons why the standard error is so frequently misused in applications outside the field of quality control in manufacturing.

One reason is Shewhart's contributions to statistical theory, originally applied in manufacturing, are not so well known as they ought to be to statisticians in other fields. The other reason is that statisticians in other fields are not subject to the immediate check on the accuracy of the predictions which are so common in manufacturing. In many other fields, if a statistician, by computing a standard error where none is justified, gives a false assurance of the accuracy of a given average, it is likely everyone will have forgotten about it by the time subsequent facts show that he (or she) was wrong."

If epidemiologists would like to perform a more valid study they could compare:

Patients with low bleed devices that have not ruptured (the low level of dosage) with all other devices that have not ruptured (moderately high and high level of dosage) and devices that have ruptured (the highest level of dosage).Unfortunately there are other details such as toxic metal catalyst and solvent contamination that will invalidate studies that can never be defined because of improper testing and record keeping by the manufacturers.Can Good Valid Science Prevail and Provide Justice for the Victims of Silicone Poisoning? Before this can happen the new valid materials related science needs to be publicized so that people in many fields can be aware of the information and understand the big picture. In Marcia Angell's book "Science on Trial" in addition to her blind faith in faulty epidemiological studies she fails to even mention other important scientific efforts. Some point to the metabolites of silicone interacting with the immune system. Garrido (7), (8), (9) and co-workers using nuclear magnetic resonance have shown the formation of silicates and silica from silicone in distant parts of the human bodies.

Medical scientists must eventually realize that this large group of metabolites combined with the silicone and other toxic chemicals migrating from the implants are the cause of a wide variety of symptoms and multiple diseases in humans.

Dr. Angell has also failed to mention other important scientific findings related to the interaction of these hundreds of chemicals in the immune system. She makes no mention of the work of Shanklin and Smalley (10), (11) showing cell mediated immune response to the migratables from breast implants. Her staff has apparently not searched sufficiently to find some of the most recent results in the form of poster sessions. Smalley, et al (12) have shown that combinations of silicone and silica cause extreme lymphocyte proliferation when testing the lymphocytes of women exposed to silicone implants.

Smalley and Shanklin have also shown that 45 of 45 patients (13) exposed to saline filled silicone breast implants have stimulations indices similar To those exposed to gel filled implants. Should saline filled breast implants still be allowed unlimited use for augmentation? The women with symptoms of silicone disease caused by saline filled implants are having extreme difficulty in finding attorneys to take and prosecute their cases. The work by Drs. Wolfe,, Ezrailson (14) et. al., and Garry (15) who've defined and successfully tested for antibodies has been improperly ridiculed by many, including the courts.

It should be mentioned that the FDA has drafted a document entitled "Immunotoxicity Testing Framework". This document makes recommendations For using immunological testing on materials for medical devices.

A letter written by Drs. Smalley and Shanklin concerning P. P. Narinis article "Repeated Exposure to Silicone Gel Can Induce Delayed Hypersensitivity" was published in the October 1996 issue of Plastic and Reconstructive Surgery (Vol. 98, No. 5, p 915). His references are a good source of additional information on the subject of immune response. HE CONCLUDES "NOW IS THE TIME FOR FURTHER INVESTIGATION IN AN EFFORT TO INHIBIT THE INAPPROPRIATE STIMULATION OF T CELLS AND THE IMMUNE SYSTEM."

New Information Concerning The Causation of Silicone Disease

Tissue engineering is a new field that involves the growth of human tissue for subsequent use as implants. Examples are artificial skin and cartilage. At a recent American Society of Testing and Materials Workshop on Tissue Engineering, May 6-7 in St Louis, Missouri, Eugene Bell. PhD., CEO and President of Tissue Engineering, Inc of Boston, Massachusetts, who apparently is the father of this exciting new field revealed that growth factors were required to be present for the cells to demonstrate the proper growth.

He indicated that these growth factors were interferon's and cytokines. His detailed explanation indicated that the growth factors are the same and some similar to the cytokines released by macrophages after the ingestion of silicone. Other animal work was reported where the addition of growth factors to encourage bone growth caused remodeling of bone at distant sites. It seems reasonable that this mechanism is responsible for the excessive scar tissue which forms around breast implants.

About a month before this meeting Dr. S.W. Balkin, DPM lectured at an American Medical Writers Association meeting in Huntington Beach, California about his experience using injected silicone in the feet of diabetics to assist in healing serious debilitating ulcers. It seems that the cytokines being released by macrophages that had ingested silicone were directing the cells to deposit tissue to heal the ulcers. To me this is an unexpected benefit of silicone injection and for some reason he found no systemic complication from this use.

The mechanism also explains lung function loss when the cells are instructed to increase collagen structures of the lung or other organs. The mechanism explains the death of some women due to lung problems including the lady in British Columbia whose husband wrote me about her final days. Deaths are another factor not mentioned in any epidemiological studies. The deaths reported to the FDA should make a good analytical study by themselves.

Conclusion and Suggestions

There appears too be sufficient evidence that the immune system is involved with silicone related diseases that would seem advisable to use the new immunological testing on the experimental human users of silicone implants since 1992. It may be that manufacturers, unknown to the public, have decreased the amount of migratable silicone and other toxins to a level that immune reactions do not occur.

It would be very worthwhile for the women who are considering implants and the world to know.Since silicone appears to be unique with its interaction to form metabolites that interact with the immune system, the manufacturers of more easily oxidized organic polymers for use in medical devices may not need to worry about causing serious disease problems.

They should not interact as badly with the body or its immune system and could be easily checked by extraction and immunological testing in animals. If interactions with the immune system are shown in the experimental women implanted since 1992, these results could end the experiment on hundreds of thousands of men women and children.

This immunological testing could also define new silicone materials that will not allow leaching of migratable silicones to interact as badly as the migratables from current silicone formulations that are causing disease. To make silicone elastomers and gels with near zero, extremely low levels of migratables does appear to be a difficult if not impossible task. There are organic polymers that would appear capable of making much safer implants.

1. Vasey, Frank B. et al, Clinical Findings in Symptomatic Women With Silicone Breast Implants Seminars in Arthritis and Rheumatism, Vol. 24, No 1, Suppl. 1, pp 22-28, August 1994

2. PCBs are from the 2, 4 Dichlorobenzoyl Peroxide.

It has only recently been shown that extremely high temperature oven cures are required to remove these toxins Re: Norplant Litigation Discovery.

3. Carmichael, Jack B. et. al.

Analysis of Large Linear and Cyclic Methysiloxanes and Computer Calculation of the Chromatographic Data Journal Gas Chromatography 1996 Vol. 4, No. 9, pp 347-349

4. Talcott, Thomas D. Silicones Used in Long-Term Implantable Devices and Resultant Disease International Journal of Occupational Medicine and Toxicology, Vol 4, No. 1, pp 113-126

5. Bennett D.R., Council on Scientific Affairs, American Medical Association, Silicone Gel Breast Implants JAMA 1993; 270: pp 2602-2606

6. Eugene L. Grant "Statistical Quality Control" First edition, Seventh ImPression 1946 McGraw-Hill Publ., New York

7. Leoncio Garrido, Bettina Pfleiderer, Bruce C. Jenkins, Carol A Hulka, Daniel B. Kopans Migration and Chemical Modification of Silicone in Women With Breast Prostheses Magnetic Resonance in Medicine, Vol 31, No. 3, March 1994

8. Leoncio Garrido, Bettina Pfleiderer, Mikhail Papisov, Jerome L. Ackerman In Vivo Degradation of Free Silicone Magnetic Resonance in Medicine, Vol 29, pp 839-843, March 22, 1993

9. Bettina Pfleiderer, Jerome L. Ackerman, Leoncio Garrido Migration and Biodegradation of Free Silicone from Silicone Gel-Filled Implants After Long-Term Implantation Magnetic Resonance in Medicine, Vol 30, pp 839-843, July 7, 1993

10. Smalley, D.L., Puckett, D.H., Osborne, S.H., Hall, M.F., Stevens, M.V., Shanklin, D.R. Immunologic Stimulation of Lymphocytes in Silicone Gel Breast Implant Patients Presented at the 7th AnnuaL Meeting of the Assoc. of Medical Laboratory Immunologists, Boston, MA July 14, 1994

11. Smalley, D.L., Osborne, D.H., Puckett, D.H., Hall, M.F., Stevens, M.V., Shanklin, D.R., Retention of Cell Mediated Immune Response in Silicone Gel Breast Implant Patients Following Explantation Presented at the 7th Annual Meeting of the Assoc. of Medical Laboratory Immunologists, Boston, MA July 14, 1994

12. Smalley, D.L., Talcott, T.D., and Shanklin, D.R. Response Enhancement in T Lymphocyte Memory Testing by Triphasic Combination of Silicaceous Mitogens ASBMB, ASIP, and AAI (Experimental Biology 96, Part 2, June 6, 1996, New Orleans, Louisiana

13. Shanklin, D.R. and Smalley, D.L. Differential Capsulopathy in Silicone Implant Type Laboratory Investigation 74:24A, 1996 (Abstract No. 123)

14. Wolfe, L.E., Lapp, M., Peterson, R.D., and Ezrailson, E.G. Human Immune Response to Polydimethylsiloxane : Screening Studies in a Breast Implant Population FASEB J Vol. 7pp 1265-1268

15. Garry, R.F., Tenenbaum, Scott A., et al Use of Anti-Polymer Antibody Assay in Recipients of Silicone Breast Implants Lancet: Vol. 349, No. 9050, pp 449-54, February 15, 1997

Thomas D. Talcott has been involved with the silicone breast implant situation for many years.
After graduating from Purdue University with a BSChE in Chemical Engineering he worked for Dow Corning until February of 1976 then American Heyer-Schulte Corp. until July of 1978.
He was involved in the Research and Development of silicone breast implants at both companies.
He resigned at both companies because of poor research and management.
He then went to Borehinger Mannheim Corp. where a low bleed gel was patented but not produced other than for a few clinical trials.
He has been working since 1982 in a major attempt to make the world aware of what silicones really are and their relationship to disease.

Date: 2004-05-15 18:45:13 PST
Thanks toPam Dowd for sending the following from the evidentiary files of breast implant litigation. . .
Myrl BMS00071088/1142 Thomas 0. Talcott Consultant, 17 Pacific Crest, Laguna Niguel, CA 92677

Journal of Nutritional & Environmental Medicine; Abingdon; Dec 1998; #2

More Letters to the Editor:

Sirs: In order to better understand the complexity of silicone gel-filled breasts implant a short history is indicated.

Johann Berzelius, a Swedish chemist, isolated the element silicium or silicon in 1824. The first organosilicon compound was made in 1863. Frederick Kipping of England cast the term silicone by fusing silicium and ketone. In 1963 plastic surgeons started to introduce this man-made polymer in the form of a breast implant. At that time no laws controlled the use of liquid silicone or any implantable devices. In 1965 the Food and Drug Administration (FDA) of the USA declared liquid silicone a drug and forbade its parenteral use in humans. In 1976 a public law 94-295 was passed that required classification of all implantable devices. Because of pressure and intimidation by the manufacturers, the FDA was negligent by failing to classify the silicone gel-filled implants into Class III which required the manufacturers to give clear and documentable proof of the safety and efficacy of their product.

The FDA did so only in 1992 after the Courts found the manufacturers guilty of fraud. To this date the manufacturers still have not given such required proof.

The silicone gel-filled breast implant is a heterogeneous combination of polymers, mineral fillers, catalysts, accelerators, stabilizers,lubricants, stripping agents, plasticizers, inhibitors, fillers and solvent residuals. 52-95% of the silicone gel is liquid silicone,contained within a three-dimensional network of cross-linked silicone chains. It consists of a mixture of cyclic and linear chains of various molecular weights with different cytotoxic and immunotoxic effects. The elastomer envelope, fortified with 30-volume % amorphous, fumed silica, is a lattice with microscopic openings. Thus, the 15 chemical precursors used in making a gel-filled breast implant are released into the woman's body over a lifetime. The highly toxic ethylenoxide is used for gas sterilization and is partially absorbed by the silicone gel and later diffuses into mammary tissues. An implant rupture simply accelerates and intensifies the dispersion of its contents.

We are dealing with a drug delivery system, the drug being liquid silicone. Injectable liquid silicone and liquid silicone from silicone gel are identical. They diffuse into the human body in the form of microdroplets measuring 0.1-10 microns. One cubic centimeter of liquid silicone dispersed into billions of microdroplets has a tremendous contact surface with human cells. The dissemination occurs through phagocytosis by macrophages and direct migration into the lymphatic and vascular system.

Presently, there is no proven method by which liquid silicone can be removed from vital organs such as the brain, spleen, liver, bone marrow and the heart muscle. This is an irreversible process!

The symptoms caused by silicone gel-filled breast implants are local, regional and systemic. Plastic surgeons have removed several thousand silicone gel-filled breast implants. Ninety percent of local symptoms disappeared and in 70% of patients systemic symptoms improved. A re-implantation of implants in 2 women, 4 months after explantation, immediately brought back all symptoms, illustrating Robert Koch's principle of cause and effect.

[1] Ericsson AD. Syndromes associated with silicone breast implants: a clinical study and review. J Envir Med 1998; 8: 35-51.
[2] Varapath S, Salyers K and Plotzke K. Non-regulated study: identification of major metabolites of octamethylcyclotetra-siloxane (D4) in rat urine, Dow Coming Internal Memorandum (August 26, 1997), 1-72.
[3] Barrett J. Textbook of Immunology. St Louis, MO: C. V. Mosby Company 1988: 36>2.

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Sirs: As a casualty of silicone gel leakage/disease who is conversant with studies on both sides of the argument, as well as with the accounts of many fellow sufferers, I offer my response to the full Independent Review Group (IRG) Report in a lay capacity. I suggest that the Report displays a general failure to weigh the data and assess the evidence with proper scrutiny.

For example, in the website details of the Report, manufacturers' information is described as sometimes 'patchy' and the exact nature and source of materials being tested `was not always possible from data provided'. Standards of processing had, therefore, to be 'assumed' to be adequate. Are these imprecisions compatible with scientific rigour?

When the panel finds insufficient evidence from the slides provided by Professor Shanklin, this is taken to detract from the credibility of his silicone-unsafe opinion. When, on the other hand, the panel receives insufficient data from the manufacturers, this is not taken to detract from the silicone-safe opinion.

A point of great concern has been the dominant influence of the Medical Devices Agency (MDA) during the review period. This is manifestly apparent in the Report. An example can be seen in the Histopathology section, website, page 1, para. 4, where Professor Shanklin's work is interpreted with MDA aid. Another is seriously evident in the Immune Response website section. This is introduced by congratulations to the MDA from the IRG on the methodology of the MDA's earlier Independent Expert Advisory Group (IEAG) review. On the strength of this, the panel is content to exclude from its assessment any studies which pre-date 1994 when the IEAG review was published.

The MDA has been committed to the silicone-safe stance from the outset of and throughout the review period. When this was questioned we were told that the MDA was acting as secretariat; but should a partisan body have been employed as secretariat? Has not the MDA by far exceeded the secretariat role? Does this not block any fresh-eyed approach essential to an independent review?

In the Summary Report, page 21, the Role of Epidemiological Studies to Assess Risk, the drawbacks of cohort study, case study and meta-analysis are honestly admitted. So where do we go from here? Should not an open-minded but skilful consultation with reported casualties be high on the agenda?

In the Summary Report, pages 19 and 20, the studies of Ellis and Young et al. are selected as worthy of further exploration. Elsewhere, the sense of inconclusiveness with regard to the evidence of the disease link is manifest. How can the panel feel at ease in allowing this to be interpreted as safe-to-continue?

Professor Sturrock, the chairman of the IRG, and Baroness Jay prided themselves on having invited written and oral accounts from patients. During the review Professor Sturrock commented on the enormity of the response. We know from our own feedback from helplines and the representations we made to the panel on behalf of those who had contacted us that substantial numbers submitted anecdotal evidence on the silicone/disease link. Nowhere, in either the Summary Report or the website details, were these patients' accounts given any analysis, assessment or mention.

Sirs: American corporations have long been known to "dump" outdated, faulty and dangerous medications and devices overseas. Silicone breast implants fit well into this category.

After being marketed with no proof of safety for 30 years in America, the Food and Drug Administration (FDA) finally removed these known defective devices from the market in 1992 when no silicone manufacturer could prove its product "safe". Today, over 150,000 ill and injured women have written to the FDA with serious adverse complications and others are too sick or too dead to voice their outrage.

The inappropriately named "Independent Review Group" came to conclusions in July 1998 that read like a manufacturer's public relations piece.Indeed, their slick brochure has become a marketing tool for the British plastic surgeons who assure their patients that silicone is "safe" and "inert." This is based on wishful thinking, their pocketbooks, and the support of the Medical Devices Agency-not facts.

Rupture, which is a devastating event often requiring multiple invasive surgeries, is all but dismissed because these reviewers found "little information on the overall rupture rate." The Lancet (11/22/97) clearly detailed rupture of up to 95% within 20 years. Other journals report similar high rates. Silicone has been located in the brains, spinal cords, livers, uteri, lymph system and children of implanted women. The Mayo Clinic describes 36% of postmastectomy women-who ironically can still receive silicone gel in America-having to have further surgery within just the first 5 years! What possible definition of "safe" is described here?

British women describe being treated worse than lepers as their medical doctors have no cure and cannot clearly define the illnesses. This impotency appears to induce them to walk these women out of their offices untreated, or worse, to mock them for their illnesses. Caring doctors who try to report failed implants are left frustrated with no means to record the damage to their patients. Because the cover-up of the true dangers has been exported from America to Britain, implant removal (explantation) is not properly done and women are left with residual scar capsule and silicone free floating in their bodies.

In America, women don't fare much better, as the silicone wars rage on in the courtrooms and science, medicine and the implanted women are the victims.

Daily I communicate with thousands of implanted and explanted women who are trying to deal with this human tragedy which is often tearing their families apart. Autoimmune diseases are extremely prevalent in this group of women, and many have experienced 1030 implant related surgeries. Their viewpoints on "local complications" sound nothing like the mild, minimized descriptions of the IRG.

Dow Coming commissioned a study and has known since 1975 that silicone crossed the placenta yet chose to hide this important study. What pediatrician ever asks the mother of a child with swallowing problems,allergies, or autoimmune conditions whether or not she has implants? This second generation issue must be rigorously explored.

We implore the British Government to re-visit this issue, away from the political manipulations and the bottom lines of the plastic surgeons, and protect its women and their offspring.

PAID WOMEN TO KEEP SILENT ~ Anne Lowder's Testimony 2000
~ I question why I was being paid to be quiet ~ I had saline implants

Excerpt: "I purposefully have not named the manufacturer of my particular implants.

The reason you don't hear as many of these stories as you could is because six years ago now the manufacturer that was involved with me decided to pay me while I was still involved in the global settlement, and my part in that was I had to sign an agreement, a contract not to disclose and not to repeat what was in the contract or anything about my story. I had to remain silent. I could not tell anybody the nightmare that I had gone through or that this manufacturer was paying me $3,300 a month, and they did for four years...... I question why I was being paid to be quiet. I had saline implants. I had the same saline implants that they've had a number of problems with, a lot of problems with."

READ HER STORY:

MS. LOWDER: Good morning. Thank you for this opportunity to speak to each one of you.

I wish my experience had been like the last lady and the letters she read, but mine was not. In 1984, I chose to have saline breast implants put in in Charlotte, North Carolina, after my plastic surgeon told me unequivocally that they would last a lifetime, and I did question. Actually I had not been there for implant surgery. I had been there due to an accident and needed a scar revised, and he brought it up, and consequently I ended up -- it was my choice.

But informed choice I think is one of the key components here.

After I was implanted in 1984, in July of 1984, it didn't take but a few months and I was in the hospital in very serious condition, and that was the beginning of what has been a downward spiral for the last 23 years.

I have been in the hospital for untold surgeries. I have gone through a hysterectomy. The implants were removed in 1984 shortly after the discovered a chest wall tumor just above the left one, and they finally agreed with me that there was a problem. I was leaking a grayish-black matter, and then the doctor got in there, he discovered that I had fungus and large black particulate matter.

Now, I'm not saying that every implant has this kind of a problem. I don't know, but I do know and I can tell you that I experienced it, and what ensued, what happened after that was a nightmare.

I ended up with a total hysterectomy the same day that they removed the implants. They discovered that I was filled with tumors that I had not had before.

I need to backtrack a little bit right now. I had been an Olympic contender ice skater. I was a dancer, ballerina. I was an equestrian. I played the piano. I was a very happily married woman with two very young boys, very active, healthy boys. I had whatever in this world wants. I had a loving home and a family.

That surgery on December 5th, 1984, where they removed the implants and the hysterectomy, was just obviously just prior to Christmas. On Christmas morning, the two boys and I were waiting at the Christmas tree for my husband to come downstairs, and he came down with one bag in his hand, and he said with regret that he was really sorry, but he just didn't want the responsibility anymore. He didn't want to be married to somebody who was so sick. So he left.

I have gone through countless surgeries. It's too many to even go through. I, in fact, go home from here to have a couple more tumors removed from my abdominal area and for a third time a cell tumor out of my hand.

The seizures, the MS-like condition can only be handled where morphine -- I take 60 milligram os morphine daily just to get through. Fortunately my boys are now grown, and they've been educated, and they're on their own, and I thank God for that because I don't think I could go through it again.

My experience was not what you hear some of these women sharing about, oh, the wonderful side of implants, and maybe there is a wonderful side. I can't address that. I didn't experience it, and the women I talked to on almost a daily basis have not experienced it.

I was not informed. I don't know what it would take to have doctors explain what the real problems can possibly be or what people can expect from implants, but what I do know is that it is an elective surgery, and until we have an assurance that people like myself are not going to go in expecting nothing but good things and come out with a total disaster, maybe it is chemical sensitivity. I don't know, but I think we need more answers before we can just unequivocally, indiscriminately open the doors and say anybody that wants an implant, come get it because there are too many that are unsuspecting like I was.

Today I am in total financial ruin. I lost my home. I had to close my business that I loved.
Excuse me. (Patty's note: She was crying here...)

I was a commercial designer. Not too many people you talk to can honestly say they love what they do, and I did. I loved every moment of it, but the day that I was -- pardon me -- driving from Sandy Springs in Georgia to Cumming, Georgia to meet with a builder on a major highway, I had a seizure. The neurologist and my other doctors had been trying to convince me that it was time to back away from my career.

Well, that day I had no choice. When I said that I thank God that my boys are grown. They were robbed. They were robbed of a mom that was a happy, healthy, well adjusted person. Instead what they have to remember is a mom not knowing whether or not when they came home from school I was going to be in the hospital, whether I was going to be in bed or whether I would be able to cook dinner for them that night.

When I say this has been a nightmare, it really has, and I don't think you people sitting up here want to open that can of worms or continue to allow it to be open until there is some recognition of what has and what is going on.

There are too many people. I hear the same stories day after day after day. I have what is typically known as ANDS. It's like MS, along with a whole host of other things, and they're too long to even go into.

I wrote them all down, and I thought that sounds like a laundry list. There's no point in getting up here and reading off to you what's wrong with me today. I hate it. That much I can tell you.

I came to know a woman by the name of Kathy Keithley Johnston with Toxic Discovery Network going on three years ago now. She had started from pure love in her heart a nonprofit organization to help women who were and had gone through situations like I've had, and she's been there, And she has continued to be there for me.

As I close, I want to read a statement from Kathy who has had to close the doors of TDN, but before I do, one other thing I want to mention to you. I purposefully have not named the manufacturer of my particular implants. The reason you don't hear as many of these stories as you could is because six years ago now the manufacturer that was involved with me decided to pay me while I was still involved in the global settlement, and my part in that was I had to sign an agreement, a contract not to disclose and not to repeat what was in the contract or anything about my story. I had to remain silent. I could not tell anybody the nightmare that I had gone through or that this manufacturer was paying me $3,300 a month, and they did for four years.

They stopped paying me in November two years ago now. My father, my brother, and my oldest son are helping me stay afloat. That's a hell of a note for somebody who was as proud as I've always been.

I'm sharing that story with you because, about the manufacturer, for one reason. I question why I was being paid to be quiet. I had saline implants. I had the same saline implants that they've had a number of problems with, a lot of problems with.

I'm not going to be their conscience. The story will come out, but I'm not here today to try to run them into the ground. I'm here to talk to you, the FDA, about a product that I don't think is safe.

I just want to close with a comment from Kathy Johnston who has selflessly given of her time, their money, and her love. Kathy is an R.N. and president and Medical Director of Toxic Discovery Network, and she wanted me to read this quote, and her comment was, "I want it read loud and clear."

The right to choose is meaningless without the right to know, and I think that's pretty poignant.

And with that I thank you for giving me the time.

CHAIRMAN WHALEN: Would you entertain a question, Ms. Lowder?

DR. BURKHARDT: Hi. I have two questions. The first is that you referred to the global settlement in relation to your saline implants. It was my understanding that the global settlement had to do with The silicone gel implants, but you had saline implants, and you were part of the global settlement?

MS. LOWDER: That is correct.

DR. BURKHARDT: The second question is that you've obviously had an enormous amount of difficulty for which I think any of us must feel great empathy and sympathy, but it was not really clear in your presentation to me why you related that to your implants.

MS. LOWDER: Because it has been directly tied together. I have, and I apologize that I didn't tie it together.

I have silicone -- even though I had saline implants, I have silicone in my lymphatic system, in my brain, in every tumor that has been removed that they have checked since 1994. I have silicone, and my first question was: well, how can I have silicone when I had saline implants?

The answer to that is the outer casing is silicone.

DR. BURKHARDT: Thank you very much.

MS. LOWDER: Thank you.

The next speaker, and I apologize if I mispronounce your name, is Dr. Joseph Bubinak.

DR. BUBINAK: Thank you, Mr. Chairman and all members of the advisory panel. I answer no to all four questions. I am a board-certified hematologist and medical oncologist. My undergraduate training led to degrees in mechanical engineering and science. I retired from active practice two years ago.

One year ago, a former patient with a history of ruptured breast implant and a low platelet count called and said she was told that she was, quote, full of platinum, unquote. Excessive platinum was found in skin, subcutaneous tissue, blood, urine and subsequently bone marrow. This interested me because I have treated patients with platinum-based chemotherapy since 1976. A low platelet count is a frequent side effect. The first chemotherapy agent was cisplatin, which is also mutagenic, carcinogenic, leukemogenic and teratogenic. Platinum has been found in the milk of patients treated with platinum compounds.

There is little information in the medical literature regarding an association of platinum with breast implants. Unfortunately, not everyone has a good result. Information obtained from many sources, including interviews with patients, physicians and researchers, reveal that some implant patients develop a variety of systemic complaints including malaise, hair loss, peripheral neuropathy which is sometimes disabling, loss of short-term memory, rash and other allergic manifestations, respiratory systems, constipation and anorexia, just to name a few. In short, these are the same side effects people treated with cisplatin cytotoxic chemotherapy experience. Increased intensity of systemic complaints commonly follow gross rupture of the implant.

I was astounded to learn that the catalyst used to manufacture the silicone for silicone gel and silicone elastomer for both gel-filled and saline-filled implants was platinum chloride, a highly reactive molecule and precursor to the chemotherapy agent cisplatin. The chemistry of the polymerization process says that the platinum in ideal proportions is reduced to its inactive elemental form. This, however, does not correlate with the amount of platinum found in tissues both proximate and distant from the implant site.

Two independent researchers now have found platinum in excessive concentration in tissues. Capsule formation around the implant, a frequent complicating event, tells the world that this device is not inert. Even without considering the seepage of low molecular weight silicones, the migration of reactive platinum alone can explain capsule formation.

One package insert states that the literature suggests that radiation therapy may increase the likelihood of capsular contracture, necrosis and extrusion. I have witnessed this first hand. In this regard, you should understand that platinum-based chemotherapy is commonly used explicitly to sensitize the target tissue to the effects of radiation therapy.

In conclusion, systemic systems do matter and must be listed as potential side effects in the package insert when patients are expected to give informed consent. Likewise, reports of symptomatic improvement in patients following explantation must also be included. Despite almost 40 years of clinical experience, there is not one good, solid, prospective epidemiologic study available. The largest study that I saw was a retrospective study, just last year, and that study showed increased risk for respiratory and brain cancers, and a non-significant increased risk for leukemia of various types.

Analysis for platinum DNA must be made available if other critical questions are to be answered. Long-term ex vivo testing of implants, subjected to realistic stresses while immersed in physiologic biologically active media at 37 degrees, are needed.

Last, from a pure engineering perspective, considering the failure and complication rates, I wonder what reasoning could have led to the approval of these devices. Reasonable assurance of safety and effectiveness--no one would argue against the beneficial psychological effects a positive body image will give. Safety means unhurt, secure from any harm.

I urge this panel to approve only products that are truly safe and effective for all who desire them. Thank you.

DR. WHALEN: Thank you, doctor. Any questions??

[No response]

Dr Ernest Lykissa’s Testimony F D A Advisory Panel Medical Devices October 2003

DR. LYKISSA: Good morning. My name is Ernest Lykissa. I have been involved in the last--oh, since the years '89, '90 with silicone breast implant research. Presently, I am involved in forensic and clinical toxicology in the city of Houston.

When I was affiliated as a professor of clinical and forensic toxicology with Baylor College of Medicine in Houston, I was able to do extensive research with these particular devices.

Oh, I forgot--my affiliations are that the National Organization of Women paid my ticket to fly up here and also paid for my stay last night in this hotel.

In this Power Point that I present for you, I just summarize in the first four pages some research that was performed with mice at Baylor College of Medicine. In order to remind you, this particular work was done at the time when we were told that silicone was inert, that there was no toxicity associated with it. We were able to prove that there is an LD-50 associated with cyclosiloxanes. We were able to prove, in our paper in Analytical Chemistry, that both the silicone and the platinum catalyst that is included in the low molecular weight silicone oil in order to polymerize that mixture and make it a good fill for the envelope so that it can be implanted in a human being, that material was passively leaking out of the porous envelope. We were also able to show that there were toxic effects in the mice to the point where we also had death due to fatal hepatic and liver complications--hepatic and liver, I am sorry, I mean hepatic and pulmonary complications with the mice

As I said, in the second paper that I have there, we are showing also that platinum was being released in a very significant manner from those implants. What we were saying was that the devices were depolymerizing with aging. Remember, we worked not with brand-new, shiny implants. We worked with devices that had been explanted from women after they had been in situ for a period of up to ten years, sometimes more.

It seems that these devices, when they were manufactured, had convinced the manufacturers that they were a good device. And, I agree with them. They were looking at something very shiny, off the show room. The problem is once you put it in a human body, once you subject it to the rigors that those ladies that were being implanted were subjecting them to, those devices were coming very quickly to a very high failure rate.

I am not talking about ruptures now. I am talking about where optically you can look at the device and you see nothing wrong with it. Of course, you see some small tears. If you put it under the microscope you see a lot of different things happening. The fact that the capsule is formed by the body shows you a very strong reaction of the body. It is rejecting it like a cyst. It is encapsulating it like it was a cyst.

So, we know that from day one that the body is not reacting very well. In the old days the plastic surgeons were known to literally hit the women in the breast with a two by four literally to break the capsule because they would get hard. Women obviously didn't want their breasts to be hard.

After Baylor College of Medicine, in the laboratory, was able to test women that had been implanted and had been explanted, we were able to test their blood, their urine, hairs, nails, sweat and so on and so forth, and what we found was that there was still silicone. Obviously, the silicone that had migrated in their body, in small foci throughout their body, was still releasing D4s, D3s, D5s, D6s, D7s, and so on and so forth. These are the low molecular weights that get polymerized with the introduction of the catalyst of platinum and put in a gel form from the oil.

So, once we had that situation, we found that these materials were still present in their bodies. Some of them were worse than others. Let's don't forget that it is not one breast implant out there, there are a lot of models. There are a lot of batches. When they were manufacturing them, if the batch did not gel properly according to the formulation, they went in and sprinkled a little more hexachloroplatinic acid or whatever else they needed.

So, we are talking about a little bit of alchemy here. We are not talking about chemistry; we are not talking about a controlled science. Remember, these devices were not produced under strict controls. I am talking about the early days. Slowly, as we saw the symptoms being developed, as we saw women complaining, they went back and they used that as quality control.

Of course, they attacked everything the scientists were trying to do by saying we have financial--you know, obviously I am not a millionaire and I am not going to make my living doing this, but what I am here to tell you is that my research has shown that these particular devices, with time they are like tires. They have enough mileage on them and once they get enough mileage on them they will fail.

So, I implore you, in your decision-making that you take that into consideration--that you ask the manufacturers to provide you with data that they have done stress testing on these devices. I implore you, like you do with aspirin and like you do with vitamin pills, put an expiration date on these devices. Demand that the manufacturer puts an expiration date on these things. Just tell them, based on their studies, based on your decisions, I implore you that you do that because, if you don't do that, your names will be known to many of these women and somebody will be testifying against you. Remember that. You are handling here human lives. I took an oath to cause no harm--I don't know about you--and I uphold that. In the last conclusive evidence that I am going to give you here so I can let other people talk to you about more important things, I think the recipients of these devices should be forewarned of the increased risk of the systemic toxicity with prolonged implantation past those expiration--

DR. WHALEN: Doctor, would you conclude, please?

DR. LYKISSA: I am done, sir.

MS. GILBERT: I have a question. You don't have page numbers, but in the platinum in samples of women with silicone gel or silicone saline implants and their children, how long out did you do your studies? I mean, how far away were the women from implantation and what about children?

DR. LYKISSA: As I said, you have to remember that these were not every case that we tested. At the time we tested it, it was a custom case. I mean, it was not like some type of--to answer your question, I will say that we tested these women with their implants, we tested them for a period of about two months to three months in vitro in order to see what they were releasing in our laboratory under the conditions that simulated the human body. When we tested them, as I said, with the saline implant we did not find any toxicity to talk about that was, you know, very significant. But with silicone breast implants, I can guarantee you.

The Germans have confirmed our research. So, I can stand up here and tell you that our research is valid and you can look at it with scientific criteria that has been published in Environmental Health Perspectives, American Journal of Pathology, Analytical Chemistry. So, we are not talking here about, you know, something that came out of somebody's closet.

DR. MILLER: Can I ask you a question also? Could you tell me about ExperTox? How long has ExperTox, Inc. been a company?

DR. LYKISSA: ExperTox, as I said, is a clinical and toxicology laboratory and has been in practice now since the year 2000.

DR. MILLER: What percentage of your studies are done related to silicone problems?

DR. LYKISSA: I would say less than five percent.

DR. MILLER: So, you do toxicology testing--

DR. LYKISSA: We just do toxicology, sir. We just have ICPMs, DCMs, LCMs, all the best technology. You give me the samples; I give you answers.

DR. MILLER: And one other question, you know, you list a lot of toxic appearing things and you say that the longer the implant is in, the increased is the risk of toxic, you know, systemic effects. Yet, we have no epidemiologic data that suggests there is a linkage between systemic illness and the implants. So, how do you square these epidemiologic studies and the questions raised by this kind of information?

DR. LYKISSA: Well, the epidemiologic studies were not our concern. We were testing patients, individual patients. Obviously, the patients that had problems came to us. The patients that did not have problems, they had no use for ExperTox. The people that I see in my laboratory, sir, they are all suffering from some kind of toxicity most of the time. The best news you can get out of my laboratory is that I found nothing and that happens very rarely, unfortunately. In these particular cases, the patients that I tested, they had been seen by rheumatologists, dermatologists. They were suffering from silicone deformities. They had sores on their bodies. I mean, a very obvious disease state had established itself in their bodies for a long time.

So, how do I square it off? Believe me, I have seen enough people and enough sickness to tell you that I am so convinced of this, and I am very hard to convince, I promise you that--the people that I have seen have been sick, and I know that the fact that we have hexachloroplatinic acid release from those devices, which is an alchemist's product--it is platinum treated with aqua regia, for crying aloud, from the 1400s. You know, we have this material released from the body. I know that is the reason for the sensitizations and I know that the silicone, when it starts being released in the body, just adds to the burden and that is what breaks the camel's back.

DR. MILLER: Thank you.

DR. LIEBERMAN: I have a question. You clearly have this data and clearly there is a lot of variation in the symptoms--

DR. LYKISSA: Oh, yes.

DR. LIEBERMAN: So, I wondered if you could help us to think about what factors might influence whether a woman has symptoms or not.

DR. LYKISSA: Okay, I will start by telling you that since all my graduate work up in Montreal, in medical school and following my graduate work with a Ph.D. and all these other things, what I learned was let's not forget the DNA. Let's not forget the genetics here. So, we have predispositions from the genetic factors.

Number two, which makes it very complicated for any one of us in this room to have a clear understanding of what is going on, there were multiple models of breast implants. There were the Dow Corning; there were the McGhan; there were this; there were that. There were batch variabilities. We went in and we tried to make ends meet. So, this is another factor, what is the device you are talking about?

We are all standing up here like, you know, the monkeys in 2001, trying to tell you that we know what the fact is. We don't know what it is. These are devices that were manufactured under different conditions. So, these are the factors you want to look at.

Then, number three, and very important, is the life of the woman. What is she going to do with her body? Where is she going to live? Is she going to live in a cold climate? We found out that as you turn the temperature up these materials depolymerize a lot faster. So, if she is going to live in Florida with her breast implants versus Upstate New York, we are going to have different factors there.

Also, we found out that lipophilicity--you know, the pores on the envelopes seem to allow this migration and depolymerization in the presence of stearic acid, for example, which is the human adipose tissue. Also, unsaturated fatty acids seem to help that material.

So, I can stand up here and tell you that I know but, you know what, I really don't know. I wouldn't want your job. Thank you.

DR. LIEBERMAN: I have one more question.

DR. WHALEN: I am afraid that is all we have time for right now. We will try to maybe come back to it if we can, because we have multiple other speakers that are coming.

I do want to let the audience know, especially the people who have spoken who wonder why different people get different periods of time, we have tried to make that announcement in advance but we weren't able to at that particular time. But one of the subsequent speakers did donate five minutes of their time to the doctor.

"FRIDAY, MARCH 31, 2000"

"(202) 514-2007"

"TDD (202) 514-1888"

" JUSTICE DEPARTMENT FILES SUIT TO RECOVER FEDERAL

EXPENDITURES IN TREATING INJURIES OF SILICON

BREAST IMPLANT CLAIMANTS"

"WASHINGTON, D.C. --The Department of Justice today filed suit against six major corporations to recover government expenditures in treating injuries incurred by silicon breast implant claimants. The suit was filed against Baxter International, Inc., Baxter Healthcare Corp., Bristol-Meyers-Squibb Co., 3M Co., Union Carbide Chemical and Plastics Co. and Union Carbide Corp. in the pending litigation brought by women who allege they were injured by silicon gel breast implants."

"The government's claim in the case is based on the Medicare Secondary Payer laws, which ensure that Medicare is reimbursed when it pays for treatment that should have been paid for by a third party, and the Medical Care Recovery Act, which permits the government to recover the cost of providing medical care to persons injured as a result of the wrongful acts of a third party."

"The lawsuit was filed today in U.S. District Court in Birmingham, Alabama after the breakdown of several years of negotiations with the implant manufacturers over the government's claims."

"Although the complaint does not seek a specified amount of damages, the government believes it is owed millions of dollars. The complaint also seeks to enjoin disbursement of additional settlement funds related to treatments funded by the government until the government's rights are resolved."