Note-. Estlmatas compiled from Medicare/Medicaid records, federal records (wkere available), and input from physicians, manufacturers, and
rtfulatory representatwes Current prwate sector statistics are generally not tracked and are difficult to obtain. Figures may be understated.

Mr, Shays. I thank all three of our witnesses. We will proceed
with some questions, but I'll ask a witness who was not sworn in,
Mr. Kyi, evidently you have some individuals you would like to in-
troduce. Do you have a statement as well that you want to make?

Mr. Kyl. Mr. Chairman, I don't have a statement. I simply want-
ed to make brief comments in the way of an introduction of the wit-
nesses youll hear this afternoon.

Mr. Shays. That would be very nice. We welcome you.

Mr. Kyl. Would you like for me to be sworn to give the introduc-
tion?

Mr. Shays. No, not for that.

Mr. Kyl. Well, Mr. Chairman, if I could proceed at this time,
then, I appreciate your courtesies. Two of you — well, about four of
you know that this was a committee on which I sat when I was
in the House of Representatives, and it's a pleasure for me to be
back at this committee today, and also to be with Marilyn Lloyd.

I worked with Marilyn on issues relating to breast cancer when
I was in the House with Jim Traficant, who has been aptly de-
scribed as a friend and someone who is very courageous. And Dr.
Ganske who has just presented, I think, some extraordinarily im-
portant testimony. My comments will bear on what he has just
said.

I very much appreciate the opportunity to appear at this hearing
this morning. And as I noted, I'm not here as a witness, but to in-
troduce two remarkable women from my State of Arizona. The first
is Tara Ann Ransom. She's a very young woman, just 8 years old.
She's an exceptionally bright and active third grader. She jumps
rope, roller skates, and is the top student in her class at the Mag-
net Traditional School in Phoenix.

She reads on the sixth grade level and has recently finished all
14 books of the Wizard of Oz series. She scores in the — and she'll
talk to you more about that. She scores in the 99th percentile on
national academic achievement tests.

Tara is a hydrocephalic child. She can do all the things that a
normal 8-year old can do and more with the help of a little piece
of plastic silicone very much like this. It's a little smaller, but it
looks almost exactly like this. And I think she'll show that to you
this afternoon.

This plastic tube is called a shimt, and it drains excess fluid from
her brain. Without the shunt the pressure on her brain would in-
crease, causing severe disability and ultimately death. She wants
us to make sure that when she outgrows her current shunt she will
be able to get a new one.

Unfortunately, there is a real danger that the companies that
produce the raw material for shunts will stop supplying it because
of product liability concerns and FDA regulatory overreach. I
learned about Tara from her mother Linda, a devoted mother who
is fighting for her daughter's life. She's also fighting for the lives
of all of the approximately 50,000 citizens in Arizona and all over
this country who depend on silicone plastic shunts.



42

It is important to note that more than 7 million Americans have
some kind of implants made of silicone. She has my support and
the support of the senior Senator from Arizona Senator McCain,
and I hope she'll have yours. In May, the Senate passed S. 565 the
Product Liability Fairness Act. This bill contains a provision that
would limit the liability of suppliers of the raw materials that are
manufactured into medical implant devices.

The House passed Product Liability Bill H.R. 956 as a similar
provision. But regulatory reform is also needed. That is the pur-
pose of this hearing, to determine whether the FDA has gone so far
in trying to protect some Americans that it has in fact jeopardized
the lives of others like Tara.

Mrs. Ransom and Tara will testify this afternoon, but I'd like
just to read one paragraph from a letter that Tara wrote to me,
"Some issues, like the life of a child — " excuse me, Mrs. Ransom
wrote this letter to me. "Some issues like the life of a child seem
so basic, but as you know all too well they are anonymous statistics
to many bureaucrats. There has to be a solution to this problem.
Tara will die without a shunt. What more can be said?"

And Mr. Chairman, members of the committee, I hope that you
will be moved by the testimony of Tara and Linda Ransom this
afternoon. I believe that they have entered the hearing room this
morning, and if they are here I wonder if they would at least stand
and be recognized.

Mr. Shays. It's very nice to have both of you here, you bless our
company with your presence and we look forward to both of your
testimonies. And I thank you, Senator, for taking the time to come
and introduce them.

Mr. Kyl. Thank you again for your courtesies, Mr. Chairman.
With your leave, I will absent myself now, unless there are any
questions.

Mr. Shays. Well, you're very kind to come here to introduce two
people and thank you very much. It's very important you did that.

I open now — our witnesses are invited to respond to some ques-
tions and I would ask Mr. dinger if he has a question or two for
the witness.

Mr. Clinger. Thank you, Mr. Chairman. I just have one com-
ment and a question. I just want to commend all three of the wit-
nesses for very compelling testimony and delighted to see our
former colleague Ms. Lloyd here today and hear her testimony and
Jim Traficant our good friend and Dr. Ganske. I think you have all
done yourselves very well in this testimony.

I have one question I wanted to ask you, Jim, and it has to do
with the French study which you referred to, the French morato-
rium which you referred to. My question is, that study or that mor-
atorium or taking it off the market was not precipitated by any
study that showed that there was a chemical problem or a causa-
tive problem with cancer or any sort of tissue-related diseases; is
that your understanding?

Mr. Traficant. Yes. My understanding, though, and the reason
why I brought up that whole incident -regarding the French deci-
sion is Dow Coming used extensively in their advertisements as
documentation and further support for the safety of their silicone



43

gel breast implants that France and Britain had in fact accepted
those products and found them to be safe.

Some 2 weeks after a lot of that extensive advertising campaign,
France in fact banned totally the manufacture or sale of all of those
products.

Mr. Clinger. But I believe that there is a moratorium pending
further study, not a permanent condition, as I understand it.

Mt. Traficant. Yeah. The French Minister of Health noted that
silicone breast implants — this is their exact statements — "Expose
women to the risk of rupture with spread of silicone and that sili-
cone can be associated with local and systemic complications."

Let me just say sitting here between these two, a great former
Member and certainly a dynamite young Member, Im not here
today totally about the safety of this issue. I think Congress must
get to it. What I am here putting on the record was there documen-
tary evidence withheld, knowingly and with intent, by Dow Cor-
ning.

Did Dow Corning in 1990 knowingly and willingly within intent
to deceive the Congress of the United States withhold certain par-
ticular salient points from the Congress. Did thev lie to Congress.
Did they ever comply with the 1990 request of Cnairman Weiss to
give us all the documentation of the claim that they made that
their product was risk-free.

So I'm not talking about this device. I support them. I'm not talk-
ing about all these other devices. I'm not a scientist, but I'm talk-
ing about the silicone breast implants and did in fact our govern-
ment get all the information it could have from the private sector
driven research, much of it conducted by those with vested interest
in such research.

Mr. Cljnger. In reference to the study that was done as a result
of Congressman Weiss's inquiry. There was a report put out at that
time, it was controversial because it was not— it was never ap-
proved by the committee, it was actually issued by the staff and
never had the imprimatur, as you would say, of the committee it-
self. So I think it has some basis to question that.

Mr. Traficant. Well, I believe then that we could check the re-
port of that language. My language basically — the information that
I have says that the report clearly notes, "That Dow Coming subse-
quently refused to provide the documents."

Now, I'm sure we could look at the report language and the re-
port of that subcommittee process.

Mr. Clinger. Thank you.

Mr. Shays. I thank the gentleman.

Mr. Towns.

Mr. Towns. Thank you very much, Mr. Chairman. Let me begin
by thanking all the witnesses for their testimony and of course Mr.
TVaficant and of course Dr. Ganske and Congresswoman Lloyd.

What I would like to do is just basically ask you, Congresswoman
Lloyd, what action would you encourage the FDA to take in the
near future with respect to the regulation of silicone breast im-
plants. What would you suggest?

Ms. Lloyd. I think they should do as I called for when I was a
Member of Congress, to allow women to make — and I cosponsored



44

legislation to this and I believe Mrs. Morella did also — to allow
women to make an informed consent decision.

It should be her decision alone, and I think that this is the way
that we should have moved ahead instead of providing this terrible,
terrible moratorium. As I said, it's cost the lives of many women.
You know, I think it's very important. Congressman Towns, that
we listen to the respected medical community. And that's really all
I ask of this committee today.

If you're interested in why the French Government made the de-
cision they did, I think you should ask the French Government. I
think if you want to know if there is any problem with implants,
I think it should come from the medical community, and to the in-
formation available to me at the present time, there is no informa-
tion from the respected medical community, the New England
Journal of Medicine reports here on the table, that indicates in any
way that silicone gel implants are unsafe to women if they are han-
dled properly.

This is my opinion. You know that science can never prove nega-
tive propositions entirely, but I do think that we've harmed many,
many women with the decision to move ahead as we have. And I
hope that this committee will shed further light on it and review
the harm that has been done. Thank vou.

Mr. Towns. Thank you very mucn. Let me just conclude, Mr.
Chairman, by saying I think that when we have people in the Con-
gress like Dr. Ganske who has had a tremendous amount of prac-
tical experience in terms of dealing with many issues, to come and
to testify, I think that that is very, very important in terms of what
we have to do in terms of documenting and making a decision in
terms of the future.

Also, good for you, Mr. Traficant, in terms of the fact that you
want to make certain that if there is any information out there
that we need to have, we need to — we 'want to make certain that
we do have it.

Let me just say that in terms of 1990, as I remember what hap-
pened, some of the things that happened was that Congressman
Weiss became ill and someone else was actually filling in as the
chair of the committee, so — and I understand tnere was a break-
down there in terms of information sort of flowing the way it
should have. So I think that was also part of the problem.

So the 1990 situation is something that was not clear, because
of the fact that the chairman became very ill and was not able to
follow through on many of the issues that were raised during that
time.

Thank you very much. I yield back the balance of my time.

Mr, Shays. I thank the gentleman.

Mr. Mcintosh.

Mr. McIntosh. Thank you, Mr. Chairman. I've got essentially
two questions. First, Con^esswoman Lloyd, thank you for coming
today. I remember very vividly your testimony around the time of
your treatment in which you were in between having had the mas-
tectomy and having had the opportunity to have an implant.

I remember it very vividly and it was very moving at the time
and I appreciate your willingness to put your personal story into
the public record that way about a very emotional and trying issue.



45

Let me ask you this. It's my understanding that all sorts of orga-
nizations, including the National Cancer Institute, the Society of
Surgical Oncology, and prominent physicians have all indicated
that they believe that women will be less likely to either submit
themselves to mammography or other procedures for detection of
breast cancer because of the fear that they will not be able to take
care of the disfigurement that may occur should they have that dis-
ease.

Ms. Lloyd. That's the point that I was trying to make. You
know, the only thing we have in the fight in breast cancer is time.
That's the reason I had my surgery done immediately. All you have
is time. And if you wait 6 months, many times it can be fatal.

So we must do more to educate women and to let them know —
you don't have to go through life wearing an uncomfortable pros-
thesis, you don't have to go through life lopsided, that we do care
as a country and we are going to have the treatment that you need.

Mr. McIntosh. And isn't it true that women often will find ex-
cuses to put off going in for a mammography? My mother, when
I asked her whether she had received one recently said, "No,
they're terribly uncomfortable. I don't want to do that." And don't
we need to do everything possible to encourage that type of screen-
ing?

Ms. Lloyd. This really, in a woman's mind, marks the final stage
of her recovery. You go through chemo, you go through radiation,
you go through the wig bit, but you're always looking forward to
that day when you can say it's behind me.

Mr. McIntosh. Which is 5 years?

Ms. Lloyd. That's right.

Mr. McIntosh. Let me also turn to Mr. Ganske, and I appreciate
you coming and sharing your expertise as a doctor who has treated
patients. I wanted to know, was it your experience when you were
practicing as a physician that your patients did try to avoid either
detection of breast cancer or treatment and that you often had to
work hard to persuade them to move forward with those two proce-
dures?

Dr. Ganske. I was not infrequently referred patients who had a
diagnosed breast cancer who had told their general surgeon that
they would not proceed with a mastectomy, which for their particu-
lar circumstances was probably the best treatment, unless they
could have a breast reconstruction.

Mr. McIntosh. So the ability to have a reconstruction was criti-
cal for their decision to be treated?

Dr. Ganske. Absolutely.

Mr. McIntosh. And let me ask you a hypothetical question, Dr.
Ganske, and that is to put yourself in the position of Dr. Kessler
as head of FDA, given the 17 studies that you're aware of, would
you be able to approve finally with certainty the use of silicone
breast implants in the cases of women who had breast cancer?

Dr. Ganske. I want to answer in a little bit more detail. I believe
that Dr. Kessler's first decision in which he ignored the advice of
the first advisory panel was ill-advised. His first advisory panel ba-
sically said there is no substantial proof that there is a problem
with implants.



46

Yes, let's proceed with some additional studies, but I believe that
he overreacted. And I believe on the basis of the subsequent science
that has come out, that breast implants either saline filled or gel
filled are safe.

Now, I want to say one thing. There is no medical device that
is 100 percent free of'^any complications. Hip prostheses will break.
Finger prostheses made of silicone can break. They need to be re-
placed occasionally. There is no surgical procedure that you can do
that is 100 percent free of complications.

Any time you place a knife to the skin, there is a small chance
of infection, there is a small chance of bleeding, there is a small
chance of excess scar formation, but those are things that are dis-
tinct from a medical device in relationship to the complications of
surgery. And if we're going to use any medical devices at all, we
have to weigh the benefits versus the small acceptable risks of com-
plication. That is a cost benefit analysis that I think this Congress
needs to be involved in.

Mr. McIntosh. Thank you. Dr. Ganske. And specifically, the tes-
timony that Dr. Kessler will give us later in written testimony indi-
cates that there is not a general risk of the autoimmune disease
but there is a small and perhaps significant risk that they mav in-
crease certain types of diseases, mainly because it's never been
disproven.

Dr. Ganske. You cannot prove the negative.

Mr. McIntosh. In all of this. Would you be willing to advise your
patients that those small risks are worth the potential benefits of
having an implant?

Dr. Ganske. When I, as a physician, talked to a patient, I do as
Congresswoman Lloyd has suggested, you lay out what the possible
complications are, and then the patient should have the right to
make an informed decision.

Mr. McIntosh. Thank you. Dr. Ganske. I have no further ques-
tions for this panel.

Mr. Shays. Mr. Peterson.

Mr. Peterson. Thank you, Mr. Chairman. I want to thank the
panel for their testimony.

Congressman Traficant, I'm aware that you've sent several let-
ters to Attorney General Janet Reno requesting that the Justice
Department investigate whether Dow Corning knowingly mislead
Congress and withheld information on the sa^ty of silicone breast
implants.

What has been the Justice Department's response to your re-
quests?

Mr. Traficant. We have not had a specific response, but we
have cited the circumstances why we believe that it should at least
be looked into.

And I think that is part and parcel of what we're discussing here
today. I am not in disag^reement with many of the things that Dr.
Ganske has stated and testified to, nor Marilyn Lloyd, but I think
the record is quite clear that there has been an awful lot of with-
holding of information and what I consider to be worthy of inves-
tigation, lying to Congress.

But everybody is predicating what is we're hearing on this 1994
study. And one of the reasons why I've asked for such an informa-



47

tion is that I want to know if three of the studies authors were ei-
ther personally receiving moneys from breast implant manufactur-
ers or had already agreed to act as paid consultants for a breast
implant manufacturer while they were conducting that study.

I also want to know if Dow Coming contributed $7 million to
Brigham and Women's Hospital, the institution conducting this
study while this study was in progress. Let me say this, I don't
want to see any of these devices withheld.

Mr. McIntosh. Excuse me. Would the gentleman yield? I have
a question for the witness. Are you impugning the integp*ity of that
university?

Mr. Traficant. No, I'm not.

Mr. McIntosh. What was the purpose of pointing out the fact
that they received a contribution?

Mr. Traficant, I want to know if Dow Corning made a $7 mil-
lion contribution.

Mr. McIntosh. But are you stating that that would affect the
University in their scientific study?

Mr. Traficant. Whether or not it would have, I know this, if
they received $7 million at about the time they were in fact per-
forming that study, from a company that had concerns about the
study wiey were performing, I just want to know if in fact that is
the case. Those are reports that I have had.

Mr. McIntosh. But it may be an irrelevant fact.

Mr. Traficant. If it is, then they can certainly explain that. Con-
gressman.

Mr. McIntosh. Unless you're implying that they've been influ-
enced by that?

Mr. TIlAFlCANT. If it is, they could certainly explain that.

Mr. McIntosh. I don't think that Dow Coming would be able to
explain that. I think the University whose integrity is at stake here
would be the one that you would question about that.

Mr. Traficant. Then let me rephrase my answer to you. If in
fact the research is coming out of an institution, and a company
with a tremendous problem at stake has made a sizable contribu-
tion to that institution, I'm not saying that it in fact impacted the
decision, but that seems to be a very timely donation of sig^nificant
amounts and I want to know.

Let me also say to this Congress, you have an industry that has
agreed to the largest settlement in American history of over $4 bil-
lion. Now, I'm just a regular lay taxpayer here. I'm not a doctor.
I haven't had one of these devices. But I'll tell you this, if I was
a major corporation that had a completely safe product, I'm not so
sure that I would have in fact agreed to such a settlement then
filed bankruptcy.

Was the filing of the bankruptcy — did Dow Corning and Dow
Chemical in fact collude to in fact make a settlement then file the
bankruptcy? The only final point I'm making to you is this, I am
not necessarily here to stop silicone breast implants, but my God,
if there is a safety risk associated with it, it shouldn't be the advice
of a good conscientious doctor that says there mav be a risk.

Congress took upon themselves to warn people the health haz-
ards of tobacco, and if there is a potential health risk, my Grod, let's
get all the facts in. Did they keep those facts from us?



48

Mr. Shays. Let me just say for the record Mr. Peterson has the
floor, and I didn't hear you say yes, and I didn't jump in soon
enough. I apologize to the gentleman.

Mr. Peterson. Oh. That's fine. I think we are all learning from
these exchanges.

One final thing. I was just wondering if you're aware of any of
the documents that support your claim that Dow Coming know-
ingly mislead Congress, whether they have been introduced into
evidence in any of the cases that are currently pending against
Dow Coming?

Mr. Traficant. I don't know if they've been submitted into evi-
dence. I'm sure they probably have, but I have submitted all the
documents that I was able to uncover, and I placed them before you
and your committee. And in such a short period of time, I did not
go into many of them. I'd advise that somebody be assigned to go
through and distill and digest all of those reports. That's the only
advice I'll make to the committee.

Mr. Peterson. Thank you. Thank you, Mr. Chairman.

Mr. Shays. I thank the gentleman.

Ms. Morella, you have the floor, and you've been very patient.

Ms. Morella. Thank you very much. I want to thank our three
witnesses' very eloquent testimony given very passionately, because
you all in your own areas of expertise believe strongly, and I appre-
ciate that very much.

I just have one question, perhaps to Congresswoman Lloyd, and
I think it will be the kind of question I'll probably direct to Dr.
Kessler on the next panel, because what I'm curious about is, is it
true that breast cancer survivors do have access under certain cir-
cumstances to silicone breast implants? I mean, it seemed to me
that there was some element of choice, maybe it isn't very clear,
if they are involved with a clinical trial or — I think there was some
stages — are you aware of that?

Was anyone telling you about that, Congresswoman Lloyd, or do
you think it's not adequate? I wanted to get your response.

Ms. Lloyd. No. When I received mine, I had to take part in a
clinical study, and there is a certain element of fear in this. Connie,
I think it would have been much better, as I stated earlier, if we
would allow women when the issue came up after the Connie
Chung story, if we could have had an informed consent decree for
women.

But I would just like to remind you one more time, that more
women died because of this moratorium than could ever be killed
with silicone gel implants.

Ms. Morella. Because of the anxiety, the concern?

Ms. Lloyd. We went about it in the wrong way.

Ms. Morella. So you think of course informed consent, but at
this point, we'll find out from Dr. Kessler whether there is a way
that women can still get the silicone gel implant.

You think it's too complicated?

Ms. Lloyd. Is silicone only harmful in women's breasts? Why did
we pick women's breasts as a topic for use of silicone? Why didn't
we pick up some of these other medical devices made of silicone?



49

Mr. Shays. Excuse me, Marilyn. Could you make sure you're