AIMBE recognizes that revision of FDA regulatory practices is controversial and
complicated. A well-functioning FDA provides assurance to both the public and to
The public benefits by knowing that life-enhancing and life-saving prod-
ucts arriving at the marketplace are safe for their intended use. Industry benefits
from oversi^t by meeting world-class standards in product development. It is im-
portant that any reorganization of federal authority result in a process that has the
confidence of both the public and industry, and embodies the following philosophical
• product accessibility must be promoted by prompt regulatory action.
• technologies must be safe in the context of the disease process being treated.
• medical devices must fulfill their intended performance as described by labeling.
A. SHORT TERM LEGISLATIVE REFORM
1. Place oversight responsibility and authority for limited preliminary or inves-
tigative trials with duly-constituted institutional review boards (IRBs), not in the
FDA. This action would increase the level of peer review in the scientific aspects
of device development, and free up FDA resources for other oversight responsibil-
2. Drop barriers (i.e., no FDA preapproval) to the exportation of U.S.-made medi-
cal devices (except for banned devices) to industrialized nations, providing that their
import is not in conflict with the laws and practices of the receiving country. This
action would serve as a stimulus for compames to keep manufacturing jobs and cap-
ital within U.S. borders, as well as increase the trade surplus of the medical device
industry by making U.S. products available in those nations which have a market
demand for them.
3. The newly evolving tissue engineering products cannot be regulated either as
standard devices, as traditional biologies, or as conventional drugs. To allow timely
introduction of these new technologies into medical practice requires that the FDA
promptly implement a new approval pathway for this class of products.
4. Establish a third-party certification system by which medical device manufac-
turing facilities are inspected and product conformance is confirmed according to
processes controlled by international standards. These third-party experts would be
subject to FDA registration approval. This action would free up FDA resources while
promoting international harmonization of good manufacturing standards.
5. Make public and transparent all FDA guidance documents used in the review
of 51(Xk)8. This will provide manufacturers with the essential information that will
promote better and mster compliance with federal standards. FDA guidance docu-
ments should be developed jointly with input from industry and the clinical commu-
6. For setting testing and material requirements the FDA should utilize standard-
setting organizations such as the American Association for Medical Instrumentation,
the American Society for Testing Materials, and the International Standards Orga-
nization. These groups have assembled the appropriate standards for device and
material testing with appropriate input from the clinical, manufacturing, and regu-
7. Allow FDA to use third-party review of 510(k) submissions so they can meet
the mandated 90 day time period, and establish a system for all third-party review
of 510(k) submissions not acted on within the mandated 90 day time period. Such
actions will increase FDA flexibility to use peer review mechanisms, as well as pro-
vide immediate attention to those applications that are not reviewed in a timely
8. Facilitate reclassification procedures for preamendment class III devices, espe-
cially mature products with demonstrated satisfactory performance in human use.
Decades of successful clinical use, even for high risk devices, can provide sufficient
proof for reclassification to a lower risk category.
9. Allow products under premarket approval to be commercially marketed as soon
as the PMA and a postmarket surveillance plan are approved. Currently many
months, if not years, pass after FDA approval of a PMA and the ultimate conamer-
cialization of the product. This would allow for controlled marketing of such devices
and the early generation of post-market surveillance data.
10. All FDA records with respect to a company should be made available to the
company on request. Companies should be informed if they are put in an excra sur-
11. Withdraw the previous FDA draft policy statement on industry supported sci-
entific and educational activities that will prohibit American industry support of
clinical conferences where off label uses of products are discussed.
12. In addition to these recommendations for implants and life-sustaining or life-
supporting devices, AIMBE supports certain changes for all class I and class II de-
vices, as follows:
a) exempt all class I devices from the premarket notification process (510K)
b) re-review all class II devices in terms of risk assessment and the
postmarket surveillance requirements of the Safe Medical Devices Act to reclas-
sify those devices with an established record of safe performance.
c) provide guidelines which allows manufactures increased options with re-
spect to the need to file 510(K) submissions for product modifications.
B. LONG-TERM LEGISLATIVE REFORM
Fundamental long-term regulatory reform is also required in order to maintain
U.S. competitiveness in the medical device technology industry. In the long term,
this must be accomplished by developing a regulatory process that is responsive to
changes in science and in the increasingly competitive global economy. Recent
changes in European law serve as a model for new regulatory approaches in the
United States. AIMBE believes that several hallmarks of European device regula-
tion warrant further study and incorporation, as appropriate, in U.S. law. Hall-
marics of the European approach include:
• Efficacy is a medical not a regulatory determination.
• Technical definition of "essential recruirements" for all devices as also detailed
in ISOA'R 14283, which was approved and published March, 1995. The Inter-
national Standards Organization has defined essential requirements" as the nec-
essary minimum requirements for labeling, preclinical and clinical testing, and the
safe manufacturing of devices to allow conunercialization. Legislatively mandated
classiflcation of products by risk. A regulatory process based on international stand-
• Independence of institutional review boards.
• Regulatory process implementation by independent third party accessors accord-
ing to mtemational standards.
• Unified electronic patient data collection systems. Postmarket surveillance by
authority (not by mandate). Mutual transnational recognition of approved products
which conform to global harmonized regulatory process.
AIMBE advocates a new approach to todays regulatory and liability conundrum
focusing UDon accessibility of technolo^ as well as relative safety and mtended per-
formance. New medical device legislation must be written to sanction true and com-
plete harmonization with the European medical device system. Without legislative
reform, large device companies with international capabilities will continue to move
their dinical trials, research, development, and manufacturing outside the United
States. Smaller companies will continue to perish. Harmonization and mutual
transnational recognition is the optimum solution — one that benefits American pa-
tients, researchers, physicians, manufactures, and ultimately our nation. Each of
these groups deserve, contribute to, trust in, and expect new technology.
Thank you for providing me the opportunity to testify. I would be happy to answer
any questions you may have.
Mr. Shays. Thank you, Dr. Schultz.
We have kind of hodgepodge here Mr. Benson, you represent a
lot of different companies that are in the same field that Dow Cor-
ning is in, but you represent other companies.
We obviously have a specific instance with your company, Mr.
Hazleton, of actually settling a case and getting out of the business.
I have to tell you, I wasn't surprised that you settled, but I was
concerned that you might have settled before it was really deter-
mined whether you were truly responsible.
And this may be a side question, but was the judgment of Dow
Coming that it was, in fact, responsible, or did they just decide,
based on the legal process, that ultimately it would have to settle?
If you would just refresh my memory, very briefly.
Mr. Hazleton. It was clearly a judgment that had a lot of busi-
ness content to it. And I would agree with you that we settled —
participated in the settlement — before there was any clear resolu-
tion of the legal responsibility and what the science was saying
about that, and how the science that has come through is being
played out in the legal process.
We felt we had no choice in that respect, because, in the space
of 3 years time, from the end of 1991 to the end of 1994, we got
to the point where we faced 20,000 lawsuits. And the financial li-
ability, much less the physical ability to manage that kind of a liti-
gation load, became such that it was just not possible to continue.
We have participated in trials. We've won as many cases as
we've lost. When the evidence is all presented, juries do a reason-
ably good job, I think, of trying to sort out very complex scientific
issues. But 20,000 is a lot of lawsuits to try to work your way
Mr. Shays. How many cases actually were heard before you
made a settlement?
Mr. Hazleton. Before we made the settlement, there had been,
I think, about half a dozen that came to trial.
Mr, Shays. And the same basic evidence was presented in each
trial but with different conclusions?
Mr. Hazleton. Well, it varies from case to case as to the specific
circumstances, Mr. Chairman, but the basic issue of causation was
very oflen common, yes.
Mr. Shays. Now, you got out of the business. I mean, mavbe it's
an obvious question, but why did you get out of the business/
Mr. Hazleton. Well, we got out of the business because, again,
the litigation situation, even with the settlement — and as we've
seen, the global settlement which we're talking about has not
proved to be successful in resolving the issue — so, from a business
judgment and viability point of view for my company, it was our
conclusion that we could no longer participate in that business.
But it was also our judgment, based on the way things developed
after the FDA moratorium, that there was not going to be a viable
business for silicone breast implants, at least for the foreseeable fu-
Mr. Shays. How much did breast implants contribute to your
Mr. Hazleton. About 1 percent.
Mr. Shays. About 1 percent.
Mr. Hazleton. That s right.
Mr. Shays. Ninety-nine percent of your revenue came from other
Mr. Hazleton. That's right. About 3 percent of our revenue, in
total, comes from our participation in the medical field, the kinds
of devices that we've talked about today, and materials for uses in
those devices. And breast implants, as a subset of that, when we
were in the business, was never more than 1 percent.
Mr. Shays. Would a larger company, then, make a logical deci-
sion simply not to get in this area? I think of you having a factory
that operates, and 3 days out of a year the plant operates only to
make breast implants.
How much of your total operation was involved in breast im-
Mr. Hazleton. It would depend on how you measure, but it
would be roughly — it's a very minuscule part; your point is cer-
Mr. Shays. OK So the bottom line is, there is no economic incen-
tive for you to stay in that business or for future manufacturers to
get into certain kinds of businesses like this, if it represents such
a tiny part of their total revenue.
Mr. ELazleton. I think that's certainly correct. If we had known
30 years ago, when we first got into the business, to the breast im-
plant business, what would develop out of this, no economic judg-
ment would have made sense to participate in that business.
Mr. Shays. Does a business that chooses to get into this area
have to separate from another business and start out as a small,
independent organization that would have what I'd call limited re-
Mr. Hazleton. Perhaps either Mr. Benson or Mr. Schultz is bet-
ter qualified to answer that. What I would say is that, from my
knowledge of the situation, I think it is an ironic fact that, at the
time when many consumer activists are saying we need to be sure
that there's a lot of high-quality research on these things, the only
companies that are able to go into these kinds of businesses and
see the risks are those that are small, thinly capitalized, startup
kinds of companies.
Mr. Shays. Doesn't the possibility that you had a settlement give
validity to those who think that silicone is, in fact, a dangerous
Mr. Hazleton. Certainly that has added to that perception.
That's one of the reasons that it made it a very difficult decision
for us. If I could just add a point to that, and it goes to the question
of what research did we do and what didn't we.
I was interested in Ms. Goldrich's point in response to the ques-
tion of future research. And if I paraphrase her wrongly, I apolo-
gize, but I think I caught what she said, "What do we do if the cur-
rent research, or the new research, replicates the previous fraudu-
lent research?" by her characterization.
Now, if, in fact, the current studies and the current science con-
cludes the same things that we have been saying about these prod-
ucts for 30 years, then if you believe that what we've been saying
about them for 30 years is fraudulent, you reach her conclusion
that there must be something fraudulent, I guess, with the current
There is an alternative suggestion, or possibility, and that is that
if the current information is valid, it challenges the question as to
whether the previous research was fraudulent or not. And I'm very
willing to have the safety of my company's products and our rep-
utation stand on what the science says today and what inferences
people may draw about what our behavior and science, the quality
of that, was in the past.
Mr. Shays. We had three basic reasons — or four questions that
we, as a committee, wanted answered, and the last one is, finally,
what standards should guide the FDA in the quantification and
evaluation of the benefits and risks of new medical devices and
You were here for most of the day, and are you of the same opin-
ion that a number of us are, that we're never going to come to a
conclusion if we continue the way we are, as it relates simply to
Mr. Hazleton. Well, I think the question that has been asked
many times with breast implants — and you could apply it to other
things — is, when is enough enough, and will we ever get to enough,
given the way the process works?
Mr. Shays. Well, I'm asking something more than that.
Mr. Hazleton. I'm sorry.
Mr. Shays. I'm asking really a question of— does the FDA have
an incentive to try to find a conclusion and resolve this issue, or
is allowing the system to just continue, ad infinitum, almost the
mind-set of an agency like the FDA?
Obviously, you have to interact with them in other ways, and I'm
not looking to have you criticize the FDA. I mean, they have
enough critics. I'm just trying to understand how we could change
the statutes or change the agency's attitude to bring resolution to
Mr. Hazleton. Well, I think you spoke to it well in the com-
ments you made in your interaction with Commissioner Kessler
this morning, Mr. Chairman. And I would agree, there is a mind-
set issue. And I'm not trying to just score points with the FDA, but
I would honestly say that it's not just with the FDA. I think there's
something in our whole — I don't know — the gestalt of how we're
dealing with this whole situation.
I was interested in a couple of things that Dr. Kessler said, and
I tJiink some of this testimony has referred to it, as well, when he
said that he felt it was important that the FDA stay out of the liti-
gation situation. Well, first of all, I can certainly understand why
ne would want to do that. Second, it is not, in my view, the FDA's
responsibility to resolve litigation situations.
But he gave a couple of examples. He gave, as Mr. Benson has
indicated, a pretty strong endorsement to the safety of the
Norplant product. And Dr. Burlington gave us a good chemistry
lesson, which I'm glad I didn't have to, on the difference in dif-
ferent kinds of silicones.
Mr. Shays. Let me say I'm going to have to interrupt you.
Mr. Hazleton. I'm sorry.
Mr. Shays. Just because I do feel that I'm going over my time,
and Mr. Barrett and others — I think we're going to have a vote
soon, and I'd just like you to conclude your point.
Mr. Hazleton. OK. He made a strong endorsement of Norplant,
and it's a different kind of silicone. As we meet today, the same
plaintiffs' lawyers who destroyed the breast implant situation are
now marketing the same kind of fear with respect to Norplant. And
they are not making the distinction that the Commissioner made
about different kinds of silicones.
Mr. Shays. Point well taken.
Mr. Barrett. Thank you, Mr. Chairman.
Mr. Benson, in your testimony you cite a number of products in
which silicone is used: deodorant, sun tan lotion, toothpaste, and go
on to state that the safety of silicone is tried and true. But isn't
the form of silicone used in those products different from the gel
that we're talking about here today?
Mr. Benson. Well, there are a variety of different types of sili-
cone. Again, I think the chart summarizes it very nicely. Basically,
three types: oil, which loses its fluid; gel, which is, just as the name
implies, a gel; and then the strongly cross-linked product known as
a solid. And a variety of those, also combined with other ingredi-
ents, go into making various products.
The point I wanted to make is that the very same basic material
that we are so concerned about on the one hand, you know, is like
the air we breathe and the water we drink on the other.
Mr. Barrett. But they are different products?
Mr. Benson. Well, they are different forms of the same product.
Mr. Barrett. So are you implying that the dangers that we were
seeing in the marketplace because of silicone gel are dangers we
can expect to see with respect to toothpaste or deodorants?
Mr. Benson. No, I would turn it and say just the opposite. I
think the dangers — I don't think we're seeing dangers with silicone
gel. I don't think we're seeing risks
Mr. Barrett. I'm talking about the marketplace reaction, your
reaction, the reaction of Dow.
Mr. Benson. Unfortunately, I think that may well be a function
of the fear that gets markets, that Mr. Hazleton referenced a
Mr. Barrett. Do you honestly think that Dow Chemical or other
companies that make products with silicone in them are going to
take them off the market?
Mr. Benson. I'm sorry?
Mr. Barrett. Are they going to take them off the market?
Mr. Benson. They are — other materials that go into medical de-
vices have been taken off the market.
Mr. Barrett. But I'm not referring to medical devices; I'm refer-
ring to toothpaste, deodorants, the things that you mentioned in
Mr. Benson. I don't know. I don't know. My point was not to stir
that fear but rather to point out that silicone is ubiquitous.
Mr. Hazleton. If I can just add to that, I would say that I cer-
tainly would hope that common sense would kick in somewhere
along the line on this. But, frankly, that's something we've been
concerned about, because 3 percent of our business is in the medi-
cal business, but if the whole thing is tainted, that's a concern for
all of us.
And if I may also just correct you on one point, which I suspect
was inadvertent, we're Dow Coming; we're the people that make
silicones. Dow Chemical is one of our shareholders, and they are
not in the silicone business.
Mr. Barrett. I understand. I apologize for making the mistake.
Mr. Hazleton, if we could turn to the settlement. So I have a bet-
ter understanding, there was a $4.25-billion settlement. Your con-
cern, as you stated it, was that — and you had plaintiffs outside the
class who continued to file lawsuits — ^you entered bankruptcy pro-
ceedings at that time. For those who are members of the class, are
they protected now that you're in bankruptcy?
Mr. Hazleton. Well, Congressman Barrett, I'm learning a lot
about the bankruptcy laws as we go.
Mr. Shays. Could we, for the record, just state, your liability is
$2 billion of this?
Mr. Hazleton. Our commitment to the original global settlement
agreement was to pay $2 billion into the total $4.25 billion.
Thank you, Mr. Chairman.
Mr. Shays. OK.
Mr. Hazleton. There are a lot of complex possibilities as to how
this will work out. There are now difficulties, as you may be aware,
with the global settlement itself that are independent of the fact
that we're in the Chapter 11 process. So how all of that is going
to play out together, and how all of that situation is going to be
resolved, has a lot of uncertainties to it at this point.
Mr. Barrett. OK But from your testimony, I inferred that the
reason that you did was because of — we can call them the inde-
Mr. Hazleton. Yes.
Mr. Barrett. But it sounds to me now you're saying that there
are no assurances that the women who were part of that original
settlement are ever going to get their money; is that correct?
Mr. Hazleton. Excuse me. I was not trying to imply that.
Mr. Barrett. I inferred that. I'm not saying
Mr. Hazleton. What I'm saying is that there are a lot of uncer-
tainties about what will happen. Our intention, in our bankruptcy
process now, is to still try to find some resolution, including some
kind of a global settlement, a modification of the original one, per-
haps something different, but something which fairly and equitably
deals with all of the claims that are valid, of all women, those that
were members of the settlement class and those who are outside
Mr. Barrett. OK You talked about other products that Dow
Corning has sold, the shunt patients, heart valves, kidney dialysis,
insulin production. One that you didn't mention was the TMJ de-
vices. If you could just bring me up to date on the marketing life
of that device and what happened with that one.
Mr. Hazleton. Yes, let me try to, very briefly, both for reasons
of time and because I'll get way over my head on the biomechanics,
if I don't.
TMJ stands for temporomandibular joints. They are a medical
device that's used to correct deformities or other problems with the
jaw, and they are involved in load-bearing physics between the var-
ious parts of the jaw. And a number of materials have been used
Silicones have had some part in that, historically. We have never
recommended them for any device where they would be part of a
load-bearing with a lot of stress on it, because that is not one of
the properties of silicone that it can stand up to loads, and there's
danger of it bearing down.
There have been some few instances where doctors were using
those kinds of materials, along with others, that have resulted in
some product claims and lawsuits. It's a relatively small number
that silicone is involved in, and there are some controversies over
some of the other materials that have been involved in that.
Mr. Barrett: Mr. Hazleton, you seemed to indicate that, from
your standpoint at least, your frustration seems to be more with
the plaintiffs' bar than FDA; is that correct?
Mr. Hazleton. Yes, I think that's a fair characterization.
Mr. Barrett. And yours seems to be more with the FDA, your
frustration; is that correct?
Mr. Benson. I wouldn't say the frustration is with FDA; I would
say the frustration is with the whole system that we're facing in
the raw materials area. This thing you just brought up on TMJ
was responsible, in no small way, for causing DuPont to withdraw
from the raw materials market.
And I wanted to mention that, when Mr. Hazleton was talking
about getting out of the business, there are really two businesses
that I think Dow Corning is considering getting out of. One they