Re: Testimonies from 2003 - Dr. Ernest Lykissa

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Bless his precious heart, he is a darling. He is a friend of our Dr. Blais.

We have many Angels helping us, especially in this group...love...Lea

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Testimonies from 2003 - Dr. Ernest Lykissa

>

> Dr. Lykissa - My HERO - Rogene

> ----------------------

>

> 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.<

> /P>

>

> 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.

>

>

>

>

>

>

>

> Opinions expressed are NOT meant to take the place of advice given by

> licensed health care professionals. Consult your physician or licensed

> health care professional before commencing any medical treatment.

>

> " Do not let either the medical authorities or the politicians mislead you.

> Find out what the facts are, and make your own decisions about how to live

> a happy life and how to work for a better world. " - Linus ing,

> two-time Nobel Prize Winner (1954, Chemistry; 1963, Peace)

>

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