talking into the mike. When you look this way we don't pick you
up as well.
Ms. Lloyd. It seems to me that if we're talking about the safety
of silicone gel, why could it be bad only for women's breasts, why
not some of these other devices that we have listed here.
Ms. MoRELLA. I guess what I'm trying to get at is, can we have
these silicone gel implants now under certain — can anybody have —
if they get into a trial?
Ms. Lloyd. I can have them, but as far as I know, women cannot
have them that want to have cosmetic surgery. And there again,
I think this is a real put-down for women that other people can de-
cide whether — they need or should have an implant.
Ms. MoRELLA. Well, that it is part of choice, I would agree with
you in that regard. Thank you. Thank you, Mr. Chairman. I really
have no other questions.
Mr. Shays. I thank the gentlelady.
Mr. Fattah, you have the floor.
Mr. Fattah. Thank you, Mr. Chairman. And let me ask former
Congresswoman Lloyd a question, since you served in this body
and were involved in this issue in a number of different ways. We
seem to be having a debate about the validity of research con-
ducted by the private sector. Have there been, and what is your
view point about. Federal efforts to do research on this issue so
that we could find some objective information on which to base,
say, informed consent or some further ruling by the FDA in this
matter?
Ms. Lloyd. Congressman, I think we should listen to the advice
of our knowledgeable medical community, from our scientists and
our doctors. I don't think that the opinion of junk scientists should
come into play.
Mr. Fattah. But my question is whether there has been feder-
ally sponsored research on this question?
Ms. Lloyd. Oh, yes. A lot of very fine doctors and scientists work
for the Federal Government. As you know, when I was a Member
of Congress, I worked very hard to increase the funding for more
research, and certainly I hope the Federal Government will con-
tinue fiinding needed research and I hope the FDA will act respon-
sibly.
What we need is more research, but until we do find a cure, all
we have is time.
Mr. Fattah. It seems though that this phenomena related to im-
plants seems to leave out, at least most of the research that I've
seen, any real reference to minority women. And I note that breast
cancer has a disastrous effect in terms of its impact upon minority
women in this country.
Ms. Lloyd. I'm glad you bring out this point, because there are
more minority women — especially Hispanics — that develop breast
cancer and die because they did not receive timely treatment. And,
again, all we have is time, and all we can do is try to educate more
women to take control of their body, to do their monthly exams and
have check-ups. It's one of the reasons that the Congressional
Women's Caucus has called for having mammograms paid for by
50
Medicaid. We must have our mammograms for at-risk women fi-
nanced annually.
So I would hope you would continue as a Member of this Con-
gress to fight for Federal research dollars for women's health, with
special attention to needs of minorities.
Mr. Fattah. Well, I intend to, and thank you very much for your
very compelling story. I'm glad that the chairman arranged for you
to De here.
Let me move now to Congressman Traficant. I think it's fascinat-
ing that we could have Members of the Congress now be concerned
al^ut making statements that could impede the integrity of institu-
tions, given all of the statements that have been made in this Con-
gress over the last several months that are absolutely irrespon-
sible.
But I think that your point, having served on a number of uni-
versity boards and particularly related to our health care institu-
tions in Pennsylvania, it is not irrelevant, that a major grant would
be made at the time that supposedly objective research was being
conducted. And any university or ooard thereof should be con-
cerned if such an offer were made of such a significant amount.
I'm glad that you've raised it, and we need to find out whether
it's true, because I do think that it does rise to the level of signifi-
cant questions about what the impact of such research would be.
Mr. Traficant. Yeah. Just let me Just respond, because I think
you've touched that point very well. But I think more importantly,
everybody is overlooking the fact is we're talking about more re-
search. I m not so sure the Congress of the United States has seen
all of the research on this issue.
That's what my goal is. What was withheld from the Congress
of the United States. What documents were not submitted. Was
there in fact scientists who performed certain studies that also had
a monetary link to those with vested interests.
We have — I don't think anybody more than the chairman there,
Mr. Shays, has looked at an issue relative to tobacco where for
years tobacco was completely safe and much of the research was
generated from that industry. And you'll get still scientists today
on the payroll of those tobacco companies tell you how safe they
are.
BotJi my parents died of complications directly attributed to
smoking. They were always wondering good, bad, indifferent, like
many Americans. Much of the study performed in that 1994 Har-
vard Study, none of it dealt with women who had had breast im-
plants after 1990. Much of it was done on women that had a short
experience with breast implants.
Now, if we looked at a 25-year old sample of American people
and looked for health-related issues from tobacco and health, I
don't think we'd find that many. But you start looking at 55, 60-
year-olds and what I'm saying is that is something I believe Dow
Coming has, in my heart, they haven't shared with us.
I'd like Congress to say, look, give us the truth, give us the facts.
Mr. Fattah. Let me just ask the final member of the panel a
quick question. Congressman, is there' any medical reason why —
and I'm going back to the question that was asked by former Con-
gresswoman Lloyd — one would be concerned about this material in
51
a breast implant but not concerned about it in these other — ^in the
shunts or in other ways that this material is used?
Dr. Ganske, Well, the silicone gel material has been used in
penile implants and in testicular implants, but hasn't generated as
much interest as this.
But let me, if you would, respond to Mr. Traficant's statement
about this recent study that has come out from Harvard on silicone
breast implants and the risk of connective tissue disease.
In an effort to be up front, the authors noted at the beginning
that in a prior study they had received grant money from Dow, but
this study was funded by the NIH. And furthermore, if you read
how the methodology of this study was done, specifically it says
that researchers who entered data on implant history were blinded
to information about medical histories of the women.
So, in other words, there were proper precautions taken to avoid
bias in this study, and furthermore, the reason the study was done
with a cutoff in 1990, was to eliminate bias in a study related to
all the publicity that has surrounded this subject. And the follow-
up in fact on the average was 9 to 10 years plus minus 3 to 4
years. So it's a pretty good study and I think it is unbiased.
Mr. Fattah. Are you satisfied that there is enough research on
this issue that an informed opinion can now be made on this ques-
tion?
Dr. Ganske. Yes. I believe that the American College of
Rheumatology for instance has looked at all of this, and they are
much more expert in rheumatology than I am by any means. They
have looked at all of the evidence to date on this, and have basi-
cally said that they see no connection between silicone gel implants
and connective tissue diseases. And so I think that informed con-
sent should be sufficient to allow these implants to be used.
Mr. Fattah. Thank you very much, Mr. Chairman.
Mr. Shays. I thank the gentleman.
Mr. Fox.
Mr. Fox. Thank you. Chairman Shays. Congresswoman Lloyd,
we do appreciate your testimony today and you're coming here with
your very poignant account of what has happened in your life and
now it affects many women across the country. We're very hopeful
that as a result of your testimony and your support and leadership,
that we can make some changes in the country which are beneficial
to all women and we in Congress are certainly appreciative of your
efforts. I'm sorry I didn't get a chance to serve with you, but we
certainly are continuing by working together here at this stage.
In your opinion, how should the FDA have weighed the fact that
many women avoid or delay cancer detection screening due to the
fear of a disfigurement in the agency's assessment of the risks and
benefits of silicone gel breast implants?
Ms. Lloyd. Well, certainly, it's my opinion as I stated earlier,
that the moratorium did more harm than implant could have done.
As Dr. Ganske stated we don't have any evidence that the implants
have done any harm.
But I truly believe that if we had just moved ahead as the first
FDA advisory panel had suggested to the FDA, and they had al-
lowed women to look at all the evidence and then make the deci-
sion for themselves, I think it would have been a much wiser
52
course of action. And I think that should still be the woman's deci-
sion, and I think that she has the information available to her that
she should make this for herself and her family. It's a tough choice.
Mr. Fox. Well, women do have access to the implants, but it is
a special exception, this creates an uncertainty about safety. Was
the uncertainty because the FDA has failed to act to discourage
women from seeking treatment, in your opinion?
Ms. Lloyd. Well, Congressman, frankly, I think the whole thing
for the past 4 years has been so blown out of proportion that at
the present time, most women that go in to have a mammogram
are scared to death, and they aren't having the regular screenings
that they should have.
And look at the women who have had them removed unneces-
sarily, they spent thousands of dollars having them removed. So,
yes, I think great harm has been done, and I think that we should
move ahead and put the facts before the women of this countiy and
let them make their decision with their doctor on what is rignt for
them.
Mr. Fox. This question would probably be for you and Congress-
man, Dr. Ganske, and what I've learned from testimony from Sher-
ry McManus who is with us today is that there has been a great
deal of paperwork required in order to get the excejption, and I
wondered whether you found in your studies and the involvement
that it might take a physician as much as 1 day or more to fill out
the paperwork that's connected with this procedure. Doctor?
Dr. Ganske. Well, I think there is a lot of paperwork, but that
doesn't particularly bother me. I mean, I personally used three or
four forms, including ones that have been, of course, put out by the
FDA. And that to me is just part of informed consent and I don't
mind. I didn't mind going through that. If you had to go through
it two or three different times, it was all right.
Mr. Fox. Did that cause a burden for you, Congresswoman?
Ms. Lloyd. I felt informed consent when I received my implant,
yes.
Mr. Fox. What would you have the FDA do now at this point?
Ms. Lloyd. What?
Mr. Fox. What would be your course of action if your words
today could be a single message to the FDA, what would they be?
Ms. Lloyd. I would allow all women who want to have an im-
plant to have them with an informed consent. She and her physi-
cian would have all the valid information before her, that it would
be her decision based on sound research. I think it's very patroniz-
ing for women that the FDA can decide whether or not they de-
serve an implant.
Mr. Fox. Very good. Thank you, Mr. Chairman. Thank you
panel.
Mr. Shays. I thank the gentleman.
Mr. Barrett, welcome to the committee. You've been here for a
while and I appreciate your patience.
Mr. Barrett. Thank you, Mr. Chairman. Maybe, Mr. Traficant,
I C£m follow-up on the question that was just asked of Congress-
woman Lloyd who it's nice to see back here. You heard her say
that she would like to see the FDA have a policy of just informed
consent. What is your response to that?
53
Mr. Traficant. Well, I think, No. 1, that we should get all the
facts out, review it veiy carefully. And I believe, if in fact, what we
have found in some of the studies, that neither has talked about,
that it usually takes 8 to 15 years before you can really define
whether or not there has been £iny damage to the autoimmune sys-
tem, that at least there should be a warning.
That, if in fact, the Grovemment of the United States, after re-
viewing all these documents in evidence believes that it is the
woman s choice, that there could be certain risks related, cite what
those risks are purported at least to be, and let the woman have
enough information so that she could make a decision.
I certainly don't want any woman to die from cancer because
they were afraid that they would be disfigured by going in and
frnding out the truth. But on the second hand, let me say this, if
there are related health risks, that Congress can at least come with
a policy that says, OK, there are certain risks. Whether or not this
side is right amd this side is right, there is enough smoke here to
say, there is a possible risk, here is what the risks are, and in fact,
mandate that those risks be known to women.
And if women are then going to go forward, that would be their
choice. So I am not here trying to stop Marilyn that opportunity,
I really mean that. I am here about lying, withholding, shredding
documents on or about the time where an individual, a vice presi-
dent testified before this same subcommittee in 1990, in 1990, Mr.
Chairman.
And if I could just maybe close with this, Mr. Barrett, the spe-
cific incident occurred on Friday, December 14, at 5:15 p.m., Greg
Tyse a senior litigation attorney in the corporate legal department
approached Marianne Woodbury a research scientist of my staff in
her office. He asked that she destroy all copies of a memo she cir-
culated 2 days previously.
The memo contained a data analysis of a recent National Center
for Health Statistics survev of surgical device, et cetera. This was
submitted bv the company s corporate medical director to the com-
pany's ethic s committee that felt that their whole operation would
be compromised by some executive coming down and asking them
to destroy documents.
Now, I don't know what the truth is here. I'm not trying to stop
women from breast implants. But I want women to know the truth
of this issue, and I'm not satisfied from what I've seen that they're
getting that truth.
Mr. Barrett. Congressman Ganske, how satisfied are you?
Dr. Ganske. I think that with informed consent, with the studies
that have been done, not just in the last couple of years, but have
been ongoing for 20 years, showing that implants are safe, that no
medical device is without some risk of complication, that when you
balance the benefits, I believe that it comes down in favor of being
able to utilize these devices.
And I must say that gel implants were used as opposed to saline,
because many people thought that they were better implants. And
practically speaking, at this point in time, gel implants aren't avail-
able because of the litigation problem.
Mr. Barrett. You referred to the litigation problem, how con-
cerned are you with their safety when you look at the lawsuits that
54
have been settled? How does that factor into your analysis? In
other words, as a person who is not a medical person at all, if I
saw that there were billions or millions or whatever the figure is
in lawsuits, I would think, well, maybe it's not just a spurious law-
suit.
Dr. Ganske. I think there are a lot of examples of litigation in
the past where over the years the science has proven that there
was minimal to no risk. We can go into the instances of anti-nau-
sea medicine for women in pregnancy and so whether the science
is valid or not Euid that the risk is exceedingly small, that doesn't
necessarily mean that you're going to ignore a litigation problem in
terms of whether you use or do not use a medical device.
I think it really does affect whether these devices are available
or not.
Mr. Barrett. And I understand that in terms of the wide array
of different procedures and devices on the market, but specifically
with respect to this one, are you comfortable enough with the liti-
gation to say, OK, there's no problems?
Dr. Ganske. I am personally comfortable enough with my review
of the literature that these devices are safe.
Mr. Barrett. Congresswoman Lloyd.
Ms. Lloyd. I believe the scientific information supports my belief
that they are safe, and as I stated earlier, we must do all we can
to encourage women to see their physicians and have regular
checkups. They should have their self-examinations and do all they
can to be knowledgeable. And we should never forget there is no
cure for breast cancer. All we have is time.
Mr. Barrett. Let me ask you if I could to make sure, because
I'm new on this issue. With the moratorium, if a woman has had
a mastectomy, can she have the implant following that? What is
the FDA rule on that? Does that fall into cosmetic or not? I hon-
estly don't know. Do any of you know?
Dr. Ganske. Let me answer that. A woman can use, obviously,
silicone saline implants are available, but this is a matter that is
coming up for additional FDA review. The silicone gel implants are
available, but you need to get — enter a patient into a registry and
go through a number of things, and I think that as I said before,
practically speaking, because of the litigation situation, just a lot
of plastic surgeons just will no longer use them.
Mr. Barrett. OK. Thank you very much.
Mr. Shays. Mr. Gutknecht, do you intend to ask questions?
You're welcome to do so.
Mr. Gutknecht. I'd like to, Mr. Chairman, if I could, ask one
quick question of Representative Traficant. Do you have any con-
cern — and one of the things that I've heard, and we have a lot of
research and medical technology companies up where I come
from — and one of the big concerns that I hear from many of the re-
searchers and the companies is that because of the litigation and
some of the things that have gone on, many of the maior compa-
nies — particularly the major chemical companies— don t want to
offer things like Dacron and simple component products that would
go into some of these new technologies.
Does that concern you at all?
55
Mr. Traficant. Absolutely. I think that there has been litigation
in the past, it was designed in fact to cause problems. It has. I
have great concern over a fine, large company that employs an
awfiil lot of Americans where a technology is being, many times,
from what I hear now, exported overseas. And I'm the No. 1 guy
in the Congress probably to oppose those types of phenomenons.
But I don't see that as the crux of this issue. I see full disclosure
and that's my purpose here. I think you should be able to make a
decision predicated on all the facts not just that that has been
force-fed to you. And I have doubts, and I believe I have submitted
in documents evidence now that will prove that those doubts really
exist.
Let's get it all on the table. I am most likely in agreement with
both of my co-panelists here. But I believe there is more of a risk
than what has been stated and the reason why we're not getting
all that risk is because of the tremendous amount of litigation that
is there and what are the costs implications.
Now, that's unfortunate because I'm not concerned about the
costs in the litigation process, but what is the valid health situa-
tion of the American women. Do they have all those facts as a 30-
year and say, look, when you're 40, 55 years old, there is a possible
link to rheumatoid arthritis, et cetera, and do they have all those
facts.
And so I think that is more or less what my purpose is here. Did
they withhold documents? Did they lie to us? Did they shred docu-
ments that spoke to salient points that could give us the truth of
this issue? Are they in fact driving the litigation process by denying
facts? We've only seen the studies that support their positions.
That's all I'm saying. I'm saying, get all of the facts.
When we get all the facts, I'm sure we will make a good decision.
Mr. GUTKNECHT. Thank you, Mr. Chairman, I yield back.
Mr. Shays. I thank the gentleman. All three of you have been
excellent witnesses.
Mr. Towns. Mr. Chairman, excuse me. Let me ask one question
just before you close out.
And I just sort of really — something you said is sort of — ^it's on
my mind. Congressman Traficant, are you suggesting that Con-
gress should require manufacturers of silicone implants to issue
warnings similar to those issued on cigarette packaging?
If so, unlike the case of with cigarettes, most women receiving
the implant would never see the packaging. How could Congress
act to ensure that women are adequately informed of safety con-
cerns? Am I understanding you correctly?
Mr. Traficant. Mr. Towns, I used the tobacco issue as a co-rel-
ative issue that has spoken to years of research driven by vested
interests. And it took the Congn'ess years to come to some position
where the Congress mandated certain warnings for cause.
Now, I'm not saying that every breast implant should have a tag
put on it and say the Congress of the United States warns every-
body this could be dangerous to your health. But I think in some
process — I'm first saying, get all of the facts, afler we do, I believe
that women should be — ^have the total truth objectively fi-om all
parties.
56
Maybe Dr. Ganske is right. Maybe the industry is right. Maybe
there are no complications here, no safety risks. But I have some
real doubts when people shred documents withhold evidence, do
not submit reports, and then we find things in files. I'm saying get
that and then we construct a policy. I'm not trying to withhold any-
thing, but so that women would know the truth.
I question the truth at this point on this whole issue, and I think
it's driven by the industiy, and I think Congress is incumbent upon
us to get to the bottom of it and get all the facts.
Mr. Towns. Thank you very much, Mr. Chairman, I yield back.
Mr. Shays. I'd like to again thank all three witnesses. You have
been extraordinarily helpful in serving the ball into play and giving
us — I tJiink a very balanced view of the differences. We really ap-
preciate you being here and in terms of your point, Mr. Traficant,
all of the facts won't be heard today and we're not going to be get-
ting into some of the facts.
In deference to corporate funding of studies, I just make the
point to you that in some cases the FDA requires corporations to
do studies, ask institutions to do them, and ask them to fund it.
And so I just want to provide that information as well.
Dr. Ganske, Mr. Traficant, and Congresswoman Lloyd, thank
you.
We call on our second panel. It is comprised of Dr. Kessler and
he brings with him Bruce Burlington, and if you have anyone else
that you choose to come and assist you in answering questions. Dr.
Kessler, we'll swear them in as well.
Let me just say that if there is anyone else that you may call to
answer a question, even if thev are sitting behind you, I would
want them to be sworn in. So if anyone who might assist you and
so on, and we welcome as well. So any of those who will be, in fact,
testifying, if they would rise at this time to be sworn in.
[Witnesses sworn.]
Mr. Shays. I will affirm that everyone has answered in the af-
firmative. If we could, Dr. Kessler, just those who have stood up,
if they could introduce themselves and we'll start with you, Joseph
Levitt and if you would just explain who you are and vour job.
We'll just go through the introductions so we know who is here.
Mr. Levitt. My name is Joseph A. Levitt. I am the Deputy Direc-
tor for Regulations and Policy in FDA's Center for Devices in Radi-
ological Health.
Mr. Shays. Thank you. Bruce Burlington, if you would introduce
yourself.
Dr. Burlington. I'm Donald Bruce Burlington. I'm a physician,
and for 2 V2 years I have been the Director for the Center of Devices
in Radiological Health at FDA.
Dr. Merkatz. My name is Ruth Merkatz. I am a nurse and I am