Dr. Pierre Blais Testimony before the FDA Advisory Panel - 2000

[Guest guest]

Dr Pierre Blais Testimony before the FDA Advisory

Panel 2000

DR. BLAIS: Thank you very much.

I differ from the other speakers inasmuch as I am not

a U.S. citizen. I'm here on invitation. I'm not a

member of the association, nor, for that matter, of

any advocacy association.

I do not derive income from the breast implant trades,

neither through implantation, explantation, health

care, diagnostic, marketing, sale, or whatever.

I am here at my own expense. I have never received

funding from any source with respect to this program.

I'm a former Canadian official with a position very

similar to our colleagues here from the FDA. I had a

similar role in Canada. I'm responsible for what may

be the largest breast implant or, for that matter,

general deep, long term implant study ever taken

worldwide. It has lasted now 25 years to this day.

The part I wish to report today is a very small

segment of this study. It concerns 250 specimens from

a very large cohort of explanted devices collected

between about 1989 to almost the present. Out of

these, there were only a few that were suitable for

the type of study according to our protocol.

The type of protocol that we had targeted was one

where we would look for contamination in implants that

had not failed. This is a minority of implants that

are removed, and they also included a review of the

mechanical issues surrounding the fabrication of

implants.

We have heard today about many things. We have heard

about how beneficial the implants can be

psychologically, how beneficial they will be to cancer

patients, the fact that they are liked by individuals

who have had deformity and so on. This may be so I

could agree with it. I applaud the studies. They're

very worthwhile.

My interests, however, are much more mundane. I'm a

scientist, and I'm also a technologist. I've studied

those devices now for far in excess of 25 years. I go

back to the '60s, and I have personal direct

recollection from the ph Kennedy hearings. Those

of you who are my age will remember that.

Now, what I wish to impress on you is that the mention

of science in the study, the retrospective study is

one thing, and that may be so, but the mention of

science in the context of fabrication and engineering

of the implant is not here. I have never seen any

evidence of intelligent engineering or science in the

design, the fabrication or, for that matter, the post

explantation analysis of these devices. They are

articles of commerce of very low grade. They belong to

technology. They do not belong to science.

Those of you who still hold the view that these things

are scientific need only look at a few. I have some

here. I won't bore you with that they are like, except

to mention the part that I wish to draw attention to.

Virtually anything we have pulled out of patients over

the last years that have not been outright broken

amongst the salines were all septic, septic to a level

which is unprecedented in studies on scientific

implants. They were visibly contaminated with all

types of flora, something that by itself should be a

sobering thought for any physician who puts them in

and who takes them out.

What I want to draw your attention to is a very small

segment of our study which has concerned saline

implants. Two hundred and forty-two implants that fall

into a certain category, a subclass of saline

implants, 74 that fulfill criteria of being " intact "

in the surgical sense of the word, six of the users

reporting problems prior to removal, such as

deflation, a few of them claiming systemic

complications -- I'm not competent to discuss it --

three users only involved in litigation.

Out of these 74, 12 were very old implants, what we

call the Mark I, which is a unique implant

introduced in 1968 with a very coarse and, by the way,

highly secure valve system. These are the ones that

habitually are removed without rupture. It's an

interesting observation.

The others, 62 of them, bearing the same type of

valve, this is what we call a forward valve or an apex

valve. Those of you familiar with the trade will know

what this symbols is. It is simply a hole with a

diaphragm at the bottom and a plug at the top to cap

it.

The early ones, the , were quite secure. The

second generation which was introduced in '76 is not,

nor is it designed to be, as best as I can figure out.

This type of implant is designed to leak intentionally

to support a claim of control of contracture. It is by

itself an engineering misrepresentation. It is not a

single product. It is made by nearly everyone in the

trade. More than 18 different manufacturers have made

it. The values all share the same process, the same

problem because they all come from the same place.

They are a commodity. They are an article of commerce

marketed by a single manufacturer, sold to others.

Now, the other part of importance in this sub-study is

that not only were the values of this design not

terribly good in terms of manufacturing, but they did

not even fit. The parts were not mated correctly. To

put it in very vulgar terms, it was like having a cork

on a wine bottle which is about five millimeters

smaller than the hole, so that if you put the cork in

the bottle, it falls to the bottom.

Now, I ask you as a technologist, as a scientist, as a

physician, as an administrator, as a layman, as a

user, what would you think of a company that presents

to you with an elaborate pre-market submission

claiming elaborate studies and good science and good

engineering, who cannot manufacture an object to the

right dimensions? What credibility will the PMA have?

Now, there are many things. I've made a formal

submission, and I'm very grateful to Dr. Krause for

accepting it. It will be given to you.

Unlike many others, it involves 20 recommendations on

what the committee has no option but to consider if

they ever find that one of the submissions complies

with the terms of the requirement. I'm not saying

there are any. I have yet to find one, but there could

be one.

If such an implant ever appears in your files and

you're required to give it assent as an approved

product, then you have no option but to consider

implementing the 20 recommendations that are made

there, and many of them are quite surprising. They're

also very old because the same recommendations are

culled out of meetings that took place incidental to

classification panels in 1978 right through to about

1983 and were reiterated again in the late '80s when

the gel implant issue arose.

I'll just point to a few of them. If you wish to have

further elaborations, I can do that personally, if an

invitation.

One of the main issues that I have is that the FDA

must address retrospectively warnings for users of the

implants. They are exposed to risks which have never

been made clear to them and have been denied. Yet they

are undeniable in the light of laboratory findings.

The other issues have to do with disclosure and the

clearing up of issues that are called possibilities,

remote risks as opposed to inevitable, time dependent

certainties.

These implants are literally replete with certainties.

They are not probabilities.

And then finally I have to deal with the issue of

breast feeding. In the light of any reasonable person

who is briefed about breast physiology and in the

light of the laboratory findings that we are getting

from saline implant, there is no basis in any science,

any technology, not even in psychology, that would

justify breast feeding, and as surprising as it

sounds, it has nothing to do with the offspring. It

has to do with the very principle on why implants are

put in in the first place.

If you attempt breast feeding with an implant, you

will have a good chance of bringing the breast back to

its pre-implantation condition, breast involution.

It's all over medical texts.

The issue of the so-called selfishly oriented

recommendation against breast feeding is absolute. It

is a cosmetic issue and also one of risk.

Now, the issue of the offspring is secondary, but it's

just as important in the ethical sense because we now

have implants that are not secure in terms of

integrity, which are known to be colonized by a broad

range of microorganisms which have access to the

breast, and the breast is fully engorged and

responsible for distribution of milk precursor product

to the implant.

Therefore, the implant constitutes a direct channel

for transmission of an infective vector to the

offspring. This concept is so old that you will find

it in European texts in 1965.

Contrary to opinions expressed this morning, the

saline implant is not a 1968 discovery. It's a 1960

discovery, and to make it even more embarrassing, it's

a Canadian one at that. It is my Breton who has

foisted this on you. It is older than the gel implant.

It's been known since the beginning that they

constituted a microbiological hazard that would

preclude absolutely any recommendation for breast

feeding.

Finally, to conserve and try to establish a record of

being timely, the issue of radiography must also be

addressed. It is also transparently obvious these

devices, the very shell is structured and is

radiopaque. As such, the uniqueness of the shell, its

structure and its peculiarities, preclude any form of

meaningful radiodiagnostic oncology aspect. The

implant is not just a confusing factor. It is capable

of generating both false positive and false negatives.

Therefore, there should be an FDA recommendation with

respect to deemphasizing any value of radiographic

assessment for tumors.

Then last of all, I have the issue of cost. How and

why did Canada governments become interested in breast

implants? It had nothing to do with the health of the

user, the offspring, the safety, or the cosmetic

aspects, what we call efficacy. It had to do with

cost.

Some of you know that Canada operates under a medicare

system. In the early days of this debate, which is the

late '70s, I performed a study on health care cost,

which is easy to do. It's only a computer issue in

Canada, as we have the record, and a very strong

outcome came.

Anyone implanted consumed four times our health care

resources of a corresponded age adjusted individual. I

haven't done the study since. I'm scared.

Now, this has enormous implications. If you do a

macroeconomic analysis of this phenomenon, you will

observe that both primary and secondary health care

costs of some states and incidental to

Medicare/Medicaid, which does operate in some states,

you find that it exceeds in some cases the actual

promotion studies, the cost of promoting the

technology.

Now, as a result of this, everyone, whether or not

they have implants, are affected. They are affected in

the sense that third party insurers, HMOs, and

everyone else who is in the health care funding

business is looking at breast implants with much

concern for good reasons, because they attract health

care procedures,a nd they attract health care costs.

One doesn't have to be the rocket scientist to figure

this out.

Finally, the issue, the last issue, I made a small

omission in disclosing conflict. It may not be a

conflict. I have consulted for everybody, the breast

implant industry, the breast implant professionals,

the attorneys for defense, attorneys for plaintiffs,

third party insurers, governments, you name it. I have

done it, but I have not derived a living from it.

And finally, I do have an involvement as a witness,

and it's a witness in Canada called a material witness

incidental to a criminal investigation of the Canadian

government surrounding wrongdoings in the approval

process of medical devices.

Thank you very much.

CHAIRMAN WHALEN: Dr. Burkhardt

DR. BURKHARDT: Is it Dr. Blais?

DR. BLAIS: Yes, it is, sir.

DR. BURKHARDT: Thank you.

A couple of things that I couldn't understand. I'm

just a little dense about this stuff, the thing that

you said. You said that you had removed 74 intact

saline implants.

DR. BLAIS: They're out of a group --

DR. BURKHARDT: I'm not finished yet.

DR. BLAIS: I'm sorry. I apologize.

DR. BURKHARDT: You removed 74 intact implants. Then

you commented that the valve looked like it had been

made to leak, and I don't understand whether the

implants you removed were intact or deflated or what.

What was the relationship there?

DR. BLAIS: They were intact in the sense of the word

that you would use in your own operative report, Dr.

Burkhardt.

DR. BURKHARDT: But were they deflated?

DR. BLAIS: They were fully inflated. Many of them were

even over inflated.

DR. BURKHARDT: So they had not leaked.

DR. BLAIS: Correct. However, this is not true --

DR. BURKHARDT: That was the answer to my question. I

just wanted to understand that.

Now, in terms of transmitting an infected vector to

the offspring, it's my understanding, and we have an

expert here who might be able to help us, that about

95 percent of lactating mother's milk is contaminated

with staff epidermatis. It's a normal organism in the

milk, and this is the predominant organism that is

recovered from around implants.

So it's not clear to me why you think that the implant

itself is a vector in transmitting that.

DR. BLAIS: Yes, it's three questions actually that you

have directed, and I'm familiar with the microbiology

of the breast. In fact, it's not limited to

stapholocci. It includes also propioni bactiacne and

many other things, the natural flora of the

contaminated functional breast.

However, the organisms in those implants were not of

this genus. They belonged to the mycobacteria family

for reasons I can't go into, but now I show you the

diagram of this valve again, and I tell you that it is

not secure.

Even though the implants were inflated, which puzzled

us for a time, our modeling studies showed that the

valve functioned as a pump. It would take

extracellular fluid occupying the intracapsular space

and through the user's habitual movements, this would

produce cyclic compression, and it drive fluid within

the implant.

Therefore, the implant leaked not just one way,b ut in

both directions and --

DR. BURKHARDT: Thank you very much.

DR. BLAIS: -- therefore, whatever is in would get out

into the breast.

DR. BURKHARDT: Thank you.

DR. BLAIS: Thank you.

CHAIRMAN WHALEN: Yes, Dr. Dubler.

MS. DUBLER: On the very last page of your handout, you

have a comment on publication.

DR. BLAIS: Yes.

MS. DUBLER: And how difficult it is to get these sorts

of negative data published.

DR. BLAIS: Yes.

MS. DUBLER: Has the government of Canada -- has your

report in any way been submitted formally and accepted

by any agency of the Canadian government?

DR. BLAIS: No, Doctor. The report that you have in

your hand was finished yesterday. You are privileged

to have its first copy, or either cursed with having

its first copy.

MS. DUBLER: Thank you.

DR. BLAIS: I have published many things. I have not

and deliberately avoided publication in this area as

it has been painfully difficult to collect clinical

material, and that could be the object of another

presentation, but it has no place here.

CHAIRMAN WHALEN: Thank you.

I'm making a statement on behalf of Dr. Arthur C.

Sehalski (phonetic) of the University of Southern

Illinois. He's a scientist, an immunologist and could

not be with us this afternoon.

The statement is confined to issues of the structural

integrity within the human body of the shell of

prothesis known as silicone gel breast implants and

saline filled breast implants.

The statements quoted during the next five minutes

come from two sources, namely, one, the 1999 National

Academy press publication titled " Safety of Silicone

Breast Implants, " and, two, the 1999 published, peer

reviewed paper by Dr. Eugene P. Goldberg and

co-authors, titled " Silicone Gel Breast Implant

Failure and Frequency of Additional Surgeries. "

Analysis of 35 studies reporting examination of more

than 8,000 explants. In the executive summary of the

Institute of Medicine's 1999 publication, the

following statement appears in the second paragraph of

page 3. " Precise frequencies of the rupture of gel

filled or the deflation of saline filled implants are

not available. The properties of these devices can

affect rupture or deflation and have changed markedly

over time, and particularly in the case of gel

implants. It has not been possible to reliably

diagnose and study rupture in an unbiased

cross-section of implanted women. "

Continuing, " rupture frequencies in the past have been

considerable, and the rupture rate of current models

has yet to be measured over the relevant periods of

time. "

Assuming the accuracy of the statement, of the

sentence just quoted, and given the absence since this

statement by the IOM committee was made of evidence to

the contrary, why is the advisory committee even now

considering a pre-market approval application for

saline inflatable breast prosthesis.

It is not the labeling information available to the

prospective saline implant recipient that establishes

or certifies safety. Labeling information merely

informs the prospective recipient of risks. What it

does not do and cannot do is provide substantial human

based evidence on the duration of the integrity of the

sell within women. Is this not obvious?

Are saline inflatable breast implanted women again to

serve as a test population to determine safety, to

determine rate of rupture? Doesn't the evidence from

the studies conducted at the University of Florida's

Biomaterials Center and the Tampa Bay Cranial-Facial

and Plastic Surgery Center show a direct and suitable,

significant correlation of implant duration with

percent shell failure?

And don't the studies of Goldberg and co-workers

credibly reveal a failure rate of 30 percent at five

years, 50 percent at ten years, and 70 percent at 17

years?

In 1993, the AMA Council on Scientific Affairs

suggested that the shell failure rate was four to six

percent, and is this not true that the FDA itself has

stated that five percent rupture is " not a safety

standard that the FDA can accept " ? Has the FDA now

changed its mind?

We would hope not.

Thank you.

CHAIRMAN WHALEN: Thank you

[Guest guest]

Rogene, thank you for posting these articles. AS you know, I have been back and forth on breast feeding my next child, it is a very hard decision I have been trying to make, knowing the pro's of breast milk, versus our formulas. However, being implanted, at one point and for so long, has made me unsure. And i couldnt breastfeed Tyler while implanted and now feel good that I couldnt. I think God was protecting us surely!

After reading this, and also the platinum article on breastfeading, I have just now offically opted against ever breast feeeding this baby. Im not risking anything to the health of this child, without long term knowledge due to lack of any studies-long term or otherwise, of how these certain toxins that may or may not be within breast tissue, and how it can affect breast feeding and its milk long term. I refuse to risk giving toxic milk to my baby especially at such a low immunity time in their life- do we know if platinum is still lodged within tissues, only to be expelled in breast milk?We know that fat tissues, especially the breasts are higher in risk for cancers, as the toxins store themselves within these fat cells. Do we know if silicone particles are still within the milk, to be dispersed to a tiny baby, and what harm could that cause? Could myco infections still be lurking there?

I am greatly saddened that implants, yet again have affected my life in a negative light. But, at least I have the knowledge from this group to control any harm to this child. I have power in that! Rogene, again thank you for all you do and I love you so much! And this group. I simply dont know where I'd be.

>From: Rogene S <saxony01@...> >Reply- > < >, SiliconeKids <siliconekids > >Subject: Dr. Pierre Blais Testimony before the FDA Advisory Panel - 2000 >Date: Wed, 4 May 2005 19:48:33 -0700 (PDT) > >Dr Pierre Blais Testimony before the FDA Advisory >Panel 2000 > >DR. BLAIS: Thank you very much. > >I differ from the other speakers inasmuch as I am not >a U.S. citizen. I'm here on invitation. I'm not a >member of the association, nor, for that matter, of >any advocacy association. > >I do not derive income from the breast implant trades, >neither through implantation, explantation, health >care, diagnostic, marketing, sale, or whatever. > >I am here at my own expense. I have never received >funding from any source with respect to this program. > >I'm a former Canadian official with a position very >similar to our colleagues here from the FDA. I had a >similar role in Canada. I'm responsible for what may >be the largest breast implant or, for that matter, >general deep, long term implant study ever taken >worldwide. It has lasted now 25 years to this day. > >The part I wish to report today is a very small >segment of this study. It concerns 250 specimens from >a very large cohort of explanted devices collected >between about 1989 to almost the present. Out of >these, there were only a few that were suitable for >the type of study according to our protocol. > >The type of protocol that we had targeted was one >where we would look for contamination in implants that >had not failed. This is a minority of implants that >are removed, and they also included a review of the >mechanical issues surrounding the fabrication of >implants. > >We have heard today about many things. We have heard >about how beneficial the implants can be >psychologically, how beneficial they will be to cancer >patients, the fact that they are liked by individuals >who have had deformity and so on. This may be so I >could agree with it. I applaud the studies. They're >very worthwhile. > >My interests, however, are much more mundane. I'm a >scientist, and I'm also a technologist. I've studied >those devices now for far in excess of 25 years. I go >back to the '60s, and I have personal direct >recollection from the ph Kennedy hearings. Those >of you who are my age will remember that. > >Now, what I wish to impress on you is that the mention >of science in the study, the retrospective study is >one thing, and that may be so, but the mention of >science in the context of fabrication and engineering >of the implant is not here. I have never seen any >evidence of intelligent engineering or science in the >design, the fabrication or, for that matter, the post >explantation analysis of these devices. They are >articles of commerce of very low grade. They belong to >technology. They do not belong to science. > >Those of you who still hold the view that these things >are scientific need only look at a few. I have some >here. I won't bore you with that they are like, except >to mention the part that I wish to draw attention to. > >Virtually anything we have pulled out of patients over >the last years that have not been outright broken >amongst the salines were all septic, septic to a level >which is unprecedented in studies on scientific >implants. They were visibly contaminated with all >types of flora, something that by itself should be a >sobering thought for any physician who puts them in >and who takes them out. > >What I want to draw your attention to is a very small >segment of our study which has concerned saline >implants. Two hundred and forty-two implants that fall >into a certain category, a subclass of saline >implants, 74 that fulfill criteria of being "intact" >in the surgical sense of the word, six of the users >reporting problems prior to removal, such as >deflation, a few of them claiming systemic >complications -- I'm not competent to discuss it -- >three users only involved in litigation. > >Out of these 74, 12 were very old implants, what we >call the Mark I, which is a unique implant >introduced in 1968 with a very coarse and, by the way, >highly secure valve system. These are the ones that >habitually are removed without rupture. It's an >interesting observation. > >The others, 62 of them, bearing the same type of >valve, this is what we call a forward valve or an apex >valve. Those of you familiar with the trade will know >what this symbols is. It is simply a hole with a >diaphragm at the bottom and a plug at the top to cap >it. > >The early ones, the , were quite secure. The >second generation which was introduced in '76 is not, >nor is it designed to be, as best as I can figure out. >This type of implant is designed to leak intentionally >to support a claim of control of contracture. It is by >itself an engineering misrepresentation. It is not a >single product. It is made by nearly everyone in the >trade. More than 18 different manufacturers have made >it. The values all share the same process, the same >problem because they all come from the same place. > >They are a commodity. They are an article of commerce >marketed by a single manufacturer, sold to others. >Now, the other part of importance in this sub-study is >that not only were the values of this design not >terribly good in terms of manufacturing, but they did >not even fit. The parts were not mated correctly. To >put it in very vulgar terms, it was like having a cork >on a wine bottle which is about five millimeters >smaller than the hole, so that if you put the cork in >the bottle, it falls to the bottom. > >Now, I ask you as a technologist, as a scientist, as a >physician, as an administrator, as a layman, as a >user, what would you think of a company that presents >to you with an elaborate pre-market submission >claiming elaborate studies and good science and good >engineering, who cannot manufacture an object to the >right dimensions? What credibility will the PMA have? > >Now, there are many things. I've made a formal >submission, and I'm very grateful to Dr. Krause for >accepting it. It will be given to you. > >Unlike many others, it involves 20 recommendations on >what the committee has no option but to consider if >they ever find that one of the submissions complies >with the terms of the requirement. I'm not saying >there are any. I have yet to find one, but there could >be one. > >If such an implant ever appears in your files and >you're required to give it assent as an approved >product, then you have no option but to consider >implementing the 20 recommendations that are made >there, and many of them are quite surprising. They're >also very old because the same recommendations are >culled out of meetings that took place incidental to >classification panels in 1978 right through to about >1983 and were reiterated again in the late '80s when >the gel implant issue arose. > >I'll just point to a few of them. If you wish to have >further elaborations, I can do that personally, if an >invitation. > >One of the main issues that I have is that the FDA >must address retrospectively warnings for users of the >implants. They are exposed to risks which have never >been made clear to them and have been denied. Yet they >are undeniable in the light of laboratory findings. >The other issues have to do with disclosure and the >clearing up of issues that are called possibilities, >remote risks as opposed to inevitable, time dependent >certainties. > >These implants are literally replete with certainties. >They are not probabilities. > >And then finally I have to deal with the issue of >breast feeding. In the light of any reasonable person >who is briefed about breast physiology and in the >light of the laboratory findings that we are getting >from saline implant, there is no basis in any science, >any technology, not even in psychology, that would >justify breast feeding, and as surprising as it >sounds, it has nothing to do with the offspring. It >has to do with the very principle on why implants are >put in in the first place. > >If you attempt breast feeding with an implant, you >will have a good chance of bringing the breast back to >its pre-implantation condition, breast involution. >It's all over medical texts. > >The issue of the so-called selfishly oriented >recommendation against breast feeding is absolute. It >is a cosmetic issue and also one of risk. >Now, the issue of the offspring is secondary, but it's >just as important in the ethical sense because we now >have implants that are not secure in terms of >integrity, which are known to be colonized by a broad >range of microorganisms which have access to the >breast, and the breast is fully engorged and >responsible for distribution of milk precursor product >to the implant. > >Therefore, the implant constitutes a direct channel >for transmission of an infective vector to the >offspring. This concept is so old that you will find >it in European texts in 1965. > >Contrary to opinions expressed this morning, the >saline implant is not a 1968 discovery. It's a 1960 >discovery, and to make it even more embarrassing, it's >a Canadian one at that. It is my Breton who has >foisted this on you. It is older than the gel implant. >It's been known since the beginning that they >constituted a microbiological hazard that would >preclude absolutely any recommendation for breast >feeding. > >Finally, to conserve and try to establish a record of >being timely, the issue of radiography must also be >addressed. It is also transparently obvious these >devices, the very shell is structured and is >radiopaque. As such, the uniqueness of the shell, its >structure and its peculiarities, preclude any form of >meaningful radiodiagnostic oncology aspect. The >implant is not just a confusing factor. It is capable >of generating both false positive and false negatives. >Therefore, there should be an FDA recommendation with >respect to deemphasizing any value of radiographic >assessment for tumors. > >Then last of all, I have the issue of cost. How and >why did Canada governments become interested in breast >implants? It had nothing to do with the health of the >user, the offspring, the safety, or the cosmetic >aspects, what we call efficacy. It had to do with >cost. >Some of you know that Canada operates under a medicare >system. In the early days of this debate, which is the >late '70s, I performed a study on health care cost, >which is easy to do. It's only a computer issue in >Canada, as we have the record, and a very strong >outcome came. > >Anyone implanted consumed four times our health care >resources of a corresponded age adjusted individual. I >haven't done the study since. I'm scared. > >Now, this has enormous implications. If you do a >macroeconomic analysis of this phenomenon, you will >observe that both primary and secondary health care >costs of some states and incidental to >Medicare/Medicaid, which does operate in some states, >you find that it exceeds in some cases the actual >promotion studies, the cost of promoting the >technology. > >Now, as a result of this, everyone, whether or not >they have implants, are affected. They are affected in >the sense that third party insurers, HMOs, and >everyone else who is in the health care funding >business is looking at breast implants with much >concern for good reasons, because they attract health >care procedures,a nd they attract health care costs. >One doesn't have to be the rocket scientist to figure >this out. > >Finally, the issue, the last issue, I made a small >omission in disclosing conflict. It may not be a >conflict. I have consulted for everybody, the breast >implant industry, the breast implant professionals, >the attorneys for defense, attorneys for plaintiffs, >third party insurers, governments, you name it. I have >done it, but I have not derived a living from it. > >And finally, I do have an involvement as a witness, >and it's a witness in Canada called a material witness >incidental to a criminal investigation of the Canadian >government surrounding wrongdoings in the approval >process of medical devices. > >Thank you very much. > >CHAIRMAN WHALEN: Dr. Burkhardt > >DR. BURKHARDT: Is it Dr. Blais? > >DR. BLAIS: Yes, it is, sir. > >DR. BURKHARDT: Thank you. > >A couple of things that I couldn't understand. I'm >just a little dense about this stuff, the thing that >you said. You said that you had removed 74 intact >saline implants. > >DR. BLAIS: They're out of a group -- > >DR. BURKHARDT: I'm not finished yet. > >DR. BLAIS: I'm sorry. I apologize. > >DR. BURKHARDT: You removed 74 intact implants. Then >you commented that the valve looked like it had been >made to leak, and I don't understand whether the >implants you removed were intact or deflated or what. >What was the relationship there? > >DR. BLAIS: They were intact in the sense of the word >that you would use in your own operative report, Dr. >Burkhardt. > >DR. BURKHARDT: But were they deflated? > >DR. BLAIS: They were fully inflated. Many of them were >even over inflated. > >DR. BURKHARDT: So they had not leaked. > >DR. BLAIS: Correct. However, this is not true -- > >DR. BURKHARDT: That was the answer to my question. I >just wanted to understand that. > > >Now, in terms of transmitting an infected vector to >the offspring, it's my understanding, and we have an >expert here who might be able to help us, that about >95 percent of lactating mother's milk is contaminated >with staff epidermatis. It's a normal organism in the >milk, and this is the predominant organism that is >recovered from around implants. > >So it's not clear to me why you think that the implant >itself is a vector in transmitting that. > > >DR. BLAIS: Yes, it's three questions actually that you >have directed, and I'm familiar with the microbiology >of the breast. In fact, it's not limited to >stapholocci. It includes also propioni bactiacne and >many other things, the natural flora of the >contaminated functional breast. > >However, the organisms in those implants were not of >this genus. They belonged to the mycobacteria family >for reasons I can't go into, but now I show you the >diagram of this valve again, and I tell you that it is >not secure. > >Even though the implants were inflated, which puzzled >us for a time, our modeling studies showed that the >valve functioned as a pump. It would take >extracellular fluid occupying the intracapsular space >and through the user's habitual movements, this would >produce cyclic compression, and it drive fluid within >the implant. > >Therefore, the implant leaked not just one way,b ut in >both directions and -- > >DR. BURKHARDT: Thank you very much. > >DR. BLAIS: -- therefore, whatever is in would get out >into the breast. > >DR. BURKHARDT: Thank you. > >DR. BLAIS: Thank you. > >CHAIRMAN WHALEN: Yes, Dr. Dubler. > > >MS. DUBLER: On the very last page of your handout, you >have a comment on publication. > >DR. BLAIS: Yes. > > >MS. DUBLER: And how difficult it is to get these sorts >of negative data published. > > >DR. BLAIS: Yes. > > >MS. DUBLER: Has the government of Canada -- has your >report in any way been submitted formally and accepted >by any agency of the Canadian government? > >DR. BLAIS: No, Doctor. The report that you have in >your hand was finished yesterday. You are privileged >to have its first copy, or either cursed with having >its first copy. > > >MS. DUBLER: Thank you. > >DR. BLAIS: I have published many things. I have not >and deliberately avoided publication in this area as >it has been painfully difficult to collect clinical >material, and that could be the object of another >presentation, but it has no place here. >CHAIRMAN WHALEN: Thank you. > > >I'm making a statement on behalf of Dr. Arthur C. >Sehalski (phonetic) of the University of Southern >Illinois. He's a scientist, an immunologist and could >not be with us this afternoon. > >The statement is confined to issues of the structural >integrity within the human body of the shell of >prothesis known as silicone gel breast implants and >saline filled breast implants. > > >The statements quoted during the next five minutes >come from two sources, namely, one, the 1999 National >Academy press publication titled "Safety of Silicone >Breast Implants," and, two, the 1999 published, peer >reviewed paper by Dr. Eugene P. Goldberg and >co-authors, titled "Silicone Gel Breast Implant >Failure and Frequency of Additional Surgeries." > >Analysis of 35 studies reporting examination of more >than 8,000 explants. In the executive summary of the >Institute of Medicine's 1999 publication, the >following statement appears in the second paragraph of >page 3. "Precise frequencies of the rupture of gel >filled or the deflation of saline filled implants are >not available. The properties of these devices can >affect rupture or deflation and have changed markedly >over time, and particularly in the case of gel >implants. It has not been possible to reliably >diagnose and study rupture in an unbiased >cross-section of implanted women." > >Continuing, "rupture frequencies in the past have been >considerable, and the rupture rate of current models >has yet to be measured over the relevant periods of >time." > >Assuming the accuracy of the statement, of the >sentence just quoted, and given the absence since this >statement by the IOM committee was made of evidence to >the contrary, why is the advisory committee even now >considering a pre-market approval application for >saline inflatable breast prosthesis. > > >It is not the labeling information available to the >prospective saline implant recipient that establishes >or certifies safety. Labeling information merely >informs the prospective recipient of risks. What it >does not do and cannot do is provide substantial human >based evidence on the duration of the integrity of the >sell within women. Is this not obvious? > >Are saline inflatable breast implanted women again to >serve as a test population to determine safety, to >determine rate of rupture? Doesn't the evidence from >the studies conducted at the University of Florida's >Biomaterials Center and the Tampa Bay Cranial-Facial >and Plastic Surgery Center show a direct and suitable, >significant correlation of implant duration with >percent shell failure? > >And don't the studies of Goldberg and co-workers >credibly reveal a failure rate of 30 percent at five >years, 50 percent at ten years, and 70 percent at 17 >years? > >In 1993, the AMA Council on Scientific Affairs >suggested that the shell failure rate was four to six >percent, and is this not true that the FDA itself has >stated that five percent rupture is "not a safety >standard that the FDA can accept"? Has the FDA now >changed its mind? >We would hope not. > >Thank you. > >CHAIRMAN WHALEN: Thank you > > > > >

[Guest guest]

When is the baby due? Is it getting close? We better get pictures!!

Hugs

kathy

>

[Guest guest]

July 8th! You will! Love

>From: "mikat828" <mikat828@...>>Reply- > >Subject: Re: Dr. Pierre Blais Testimony before the FDA Advisory Panel - 2000>Date: Fri, 06 May 2005 03:25:00 -0000>>>>>When is the baby due? Is it getting close? We better get pictures!!>Hugs>kathy>>>>>>>> >>>>>>

[Guest guest]

,

I'm really sad that you don't feel comfortable breast

feeding your baby. However, I'm sure you're doing

what's best for your baby. Unless there is way to be

sure your milk is 100% safe, it's really the only safe

choice.

The more I see of this situation regarding the

children, the more dismayed I am at how it could go on

so long!

What is your OB-GYN doc saying about implants these

days? . . . Is he seeing any problem among the

implanted women or their children?

It seems that, in my own off-line world, I'm hearing

about more sick women and children daily! It's all so

sad!

Love,

Rogene