Dr. Blais Testimony to the FDA

Date: Thu, 30 Mar 2000 11:32:55 -0700

From: "Rogene" saxony02@netscape.net (by way of ilena@san.rr.com (Ilena Rose)

(thanks Rogene. just a note . . . all the speakers were asked to make their financial / disclosures at the beginning of their talks)

Beginning at page 242 . . .

CHAIRMAN WHALEN: Just so the three remaining individuals who are going to be talking to us know, we will be getting to them in time.

We have one remaining consumer group to hear from. Dr. Blais, Pierre Blais is from the Chemically Associated Neurological Disorders, and in view of Ms. Stansell's yielding of half of her time, would the timer please be set for 15 minutes?

DR. BLAIS: Thank you very much.

I differ from the other speakers in as much 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 Joseph 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 Jenny 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 Jenny, 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 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, and 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.

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