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

[Guest guest]

" 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. "

" 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. "

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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