to working with you and again commend you for convening this
hearing. We have some very outstanding witnesses, some that we
served with in the Congress and of course had great respect for in
the Congress and have great respect for them now they're out of
the Congress and of course some that are still with us in the Con-
gress and it's a pleasure to have them and all the witnesses here.

So at this particular time I would yield back and look forward
to hearing from the witnesses.

[The prepared statement of Hon. Edolphus Towns follows:]

Prepared Statement of Hon. Edolphus Towns, a Representative in Congress

From the State of New York

Mr. Chairman, thank you for convening this hearing which continues the Human
Resources Subconmiittee s oversight of the Food and Drug Administration. The sub-
ject of today's hearing — FDA regulation of medical devices, and more specifically, sil-
icone breast implants — is a public health issue of fundamental importance. Given
that over 1 million wonien have breast implants, and a sizable portion of them have
reported problems, we must ensure that these devices are both safe and effective.



When the Human Resources Subcommittee last focused its attention on this issue
in 1990, we knew far less about the safety of silicone breast implants than we know
today. At that time, few scientific studies had been conducted, and speculation about
the safety of the implants was rampant.

As a result of scientific uncertainty, and amid suggestions that silicone breast im-
plants led to connective tissue disorders such as lupus or rheumatoid arthritis, the
FDA issued a moratorium on the use of silicone breast implcmts until science could
substantiate their safety.

Since that time, numerous scientific studies have been conducted that put to rest
a number of prior safety concerns. These studies have found no significant increased
risk for connective tissue disorders resulting from the use of silicone breast im-
plants.

At a minimum, these findings should prompt the FDA to review its position with
respect to the regulation of silicone breast implants. These findings should not how-
ever, be looked upon as conclusive in this debate over safety. There are still a num-
ber of outstanding safety issues not addressed in these stuaies, and I would counsel
caution until these issues have been resolved.

Beyond the issue of breast implant safety, this hearing speaks to the much larger
issue of risk assessment within the FDA. From our previous oversight hearings, the
picture has emerged of an agency that is tremendously risk-averse. While I applaud
the agency's eiTorts to provide an assurance of safety for products and devices it reg-
ulates, it is impossible to expect these products to be completely and absolutely risk-
free. The FDA should not keep pxjtentially life saving products off the market for
fear that some extremely remote hazard will be realized. We cannot have an FDA
whose duty is to protect public health and safety, being the primary obstacle be-
tween a patient in need and a life-saving device.

In addition, there is a concern that the FDA's actions in the past with respect
to silicone implants, and concerns over liability, threaten to lead to the withdrawal
of numerous products from the market. I have with me a list of such products.

I ask, is this a course that we wish to follow?

In light of these concerns, I welcome the FDA and all of the witnesses and I look
forwara to hearing their views on the issues raised. Mr. Chairman. As you well
know, I am committed to working with you, and again, I commend you for conven-
ing this hearing.

Mr. Shays. Thank you. At this time I'd like to call on the chair-
man of the National Economic Growth, Natural Resources, and
Regulatory Affairs Subcommittee, Mr. Mcintosh, and then we^l
hear from the ranking member and then we'll invite Mr. dinger,
the chairman of the committee to make a statement.

Mr. McIntosh. Thank you. Chairman Shays. And I appreciate
you holding this hearing today. I think it's of vital importance to
all Americans.

This morning we will be addressing a matter that is of vital im-
portance to all Americans, the process by which the Food and Drug
Administration approves medical devices for use by the public. Spe-
cifically, the process the FDA has used to review the safety of sili-
cone breast implants in cancer patients.

The issue today is whether FDA is killing women, specifically, is
FDA causing more women to die of breast cancer because its fail-
ure to reach a conclusion about the relative safety of artificial
breast implants for women who suffer with that disease.

Let me say at the outset this is not only a women's issue, it is
also an issue for which men must share responsibility. After all, we
all have mothers, wives, sisters, and other loved ones who may al-
ready or may someday in the future suffer from breast cancer. 'To-
day's statistics show 1 in 8 women in America are likely to suffer
from breast cancer, and the chances are getting worse every day.

Let me also say that this is a personal issue. When I started dat-
ing my wife Ruthie, who is here today, her mother Sherry
McManus was diagnosed with breast cancer. Sherry is also here



today. She is a survivor. And I'd like both of them to stand and be
recognized. [Applause.]

At the time Sherry had her surgery, which included reconstruc-
tion of her breast with an implant, Dr. Kessler scared the living
daylights out of women across America by telling them that such
procedures could be risky or even fatal. And on top of this, there
is the very real fear that the cancer may reoccur and they may be
untreatable.

My mother-in-law chose to go forward with her procedure, but I
shudder to think of the women who chose not to go forward or who
hesitated to have surgery or were even fearful to have a mammo-

fram because they didn't know the awful truth, that they might
ave breast cancer.

Reconstructive surgery has done wonders to help women who do
have breast cancer receive treatment and live with dignity. Yet
tens of thousands of women die each year because they do not act
quickly to do everything to detect and eradicate their own breast
cancer.

FDA's failure to act promptly to allay their fears about breast
implants contributes to those needless deaths. Mastectomies and
lumpectomies coupled with chemotherapy have cured millions of
women of breast cancer. The procedure can also disfigure a woman
and potentially have debilitating and life threatening side effects.

Yet every day, people elect to accept the real and high risks asso-
ciated with that treatment, because it offers them a chance to live.
Many times, however, patients and doctors are robbed of this
choice. Instead, the Federal Government specifically the FDA pro-
hibits them from accepting risk for treatments they need. The gov-
ernment should not be allowed to make such critical decisions for
American women, but the FDA does.

As a result, the FDA is depriving women from access to nec-
essary treatments which they desire to try and see whether they
will succeed in spite of the risks. This morning we will examine a
case of silicone breast implants which will allow us to study the
questions of risk assessment and the government's role in permit-
ting or denying patients' access to medical devices.

The FDA has ag^reed that scientific research performed to date
tends to show there is no connection between silicone implants and
connective tissue diseases, which has been the main medical con-
cern about silicone implants.

In fact the scientific research is much more conclusive. A June
1995 study in the New England Journal of Medicine states, "We
found no evidence of an association between silicone breast im-
plants and either connective tissue diseases defined according to a
variety of standardized criteria or signs of symptoms of connective
tissue disease."

In spite of this, the FDA has refused to go further. Afler so many
years and so many studies, I want to know why. I also want to
know if the FDA shares my concern that until we put the breast
implant controversy to rest, there will be those who choose to with-
hold or withdraw life saving products from the market and there
will be women who choose to put off mammograms and delay or
forego mastectomies and who ultimately die needlessly.



8

I want to welcome all of our witnesses, and especially Dr.
Kessler, who has done his own risk assessment and concluded that
the benefits of being here today outweigh the risks.

This hearing entails difficult and complex questions and a great
degree of emotion. I hope we will focus on the science and that we
will answer women's questions and concerns about breast implants.
But I also hope we will examine the difficult questions of how risk
is measured, what level of risk is acceptable, and who should deter-
mine if the benefits of medical treatment outweigh the risks.

Thank you very much, Mr. Chairman, for holding this hearing.

[The prepared statement of Hon. David M. Mcintosh follows:]

Prepared Statement of Hon. David M. McIntosh, a Representative in
Congress From the State of Indiana

This morning we will be addressing a matter of vital importance to all Ameri-
cans — ^the process by which the Food and Drug Administration approves drugs and
medical devices for use by the public.

Everyone in this room agrees that drugs and medical devices must be "safe." But
I'm not sure we all agree on the definition of "safe."

"Safe" should not mean that there are no risks associated with a drug or device.
We know that there are very real risks associated with some of the most important
and necessary medical products available today.

For some devices or arugs, the risks are so high that they outwei^^ the benefits —
so high that the government must prohibit them from the market. They simply are
not "safe."

But, for many devices or drugs, a high level of risk is appropriate and necessary.
Chemotherapy has cured millions of people of cancer. It also haa debilitating and
life-threatening side effects. Every day, people elect to accept the very real and high
risks associated with that therapy because it offers them a chance to live.

Many times, however, patients and doctors are robbed of this choice. Instead, the
federal government, specifically the FDA, prohibits them from accepting risks for
treatments they need. The government should not be allowed to maJce such critical
decisions for the American people, but it does. As a result, the FDA is depriving
Americans from access to necessary treatments which they desire to try in spite of
the risks.

The FDA restricts the availability of new products to patients who want and need
them. Many Americans are forced to travel abroad to access drugs and new proce-
dures that can help them. When the Subcommittee on Regulatory Affairs held a
field hearing in Pennsylvania in June, we heard testimony from David Samowitz,
a young man who has suffered from epilepsy all his life. In order to obtain the only
two medications that will curb his disease and allow him to lead a relatively normal
life, David must go to extreme lengths and have them shipped from a pharmacy in
London. If the shipment does not arrive in time, or if there is a problem with cus-
toms, David is left without the medicine he must have to survive.

This morning we will examine the case of silicone breast implants which will
allow us to study the questions of risk assessment and the government's role in per-
mitting or denying patients' access to medical devices.

The FDA has agreed that the scientific research j>erformed to date tends to show
that there is no connection between silicone implants and connective tissue dis-
eases — which has been the main medical concern about silicone implants. But it has
refused to go any further. After so many years and so many studies, I want to know
why.

I also want to know if the FDA shares my concern that until we put the breast
implant controversy to rest, there will be those who will choose to witnhold or with-
draw a life-saving product from the market.

I want to welcome all our witnesses, and especially Dr. Kessler, who has done his
own risk assessment and concluded that the benefits of being here today outweigh
the risks.

This hearing entails diflicult and complex questions and a great degree of emo-
tion. I hope we will focus on the science that will answer women's concerns about
breast implants. But, I also hope we will examine the difficult questions of how risk
is determined, what level of risK is acceptable, and who should determine if the ben-
efits of medical treatments outweigh the risks.



Mr. Shays. Thank you, Mr. Chairman. And I just want to say
that all witnesses here todav are very welcome and we appreciate
that they're here today. And at this time I ask Mr. Peterson if he
has a statement for the record.

Mr. Peterson. Well, thank you, Mr. Chairman. I appreciate your
calling this hearing and your leadership on this issue.

What I hope we can determine today are four fundamental is-
sues, what is the FDA's current view of the safety of silicone as
biomaterial and specifically silicone breast implants. Second, when
will the agency be able to reach final conclusions on the safety and
efficacy of these devices. What impact has the FDA's approach to
the regulation of silicone breast implants had on the development
of new medical devices and the availability of biomaterials, and fi-
nally, what standard should guide the FDA in risk assessment of
new medical devices and biomaterial.

So I hope that, Mr. Chairman, we can get some answers and
some insight into these four fundamental issues. I will concluded
with that, because we have a number of witnesses that we want
to hear. I again appreciate your leadership in calling this hearing
and look forward to hearing the testimony of the witnesses.

Mr. Shays. I thank the gentleman. Those are excellent questions
that need to be asked, and at this time I would ask the cnairman
of the full committee, Mr. dinger if he has a statement.

Mr. Clinger. Thank you very much, Mr. Chairman. I am very
pleased to have the opportunity to participate in this joint sub-
committee hearing today on this important issue of FDA regulation
of medical devices, and to look at the breast implant issue and the
safety concerns that swirl around this.

It is my hope that this hearing will shed light on some of the dif-
ficult issues surrounding breast implants. I am sympathetic toward
the women who are faced with these difficult decisions, those that
have breast implants, and those who must make decisions in the
future.

We're going to be hearing testimony from many different points
of view on this issue today. One of the hardest things about this
issue is, quite frankly, the lack of information. Since 1992, the FDA
has declared a moratorium on silicone implants for other than re-
constructive purposes because of insufficient information. But the
FDA has yet to assess the studies and make a judgment regarding
the safety and efficacy of the implants.

The FDA has been far too slow in helping us gain a full under-
standing of the issue of both the risks and the benefits. The sooner
the FDA can provide the necessary information to the public in
some definitive form, the better off everyone will be in terms of
making these hard decisions.

Decisions should not be based on anecdotal or piecemeal informa-
tion. Without some definitive guidance, we are simply taking a
walk in the dark down a very rugged path. The information we are
seeking includes: What are the risks? Are the risks any higher for
developing autoimmune diseases with the implants? Are the risks
so high that no one should have silicone breast implants? What are
the DKBnefits of silicone implants? Once the risk factor is known
should we allow individuals to make their own choices? Since the
moratorium has been in effect, what has the FDA done in evaluat-



10

ing the known studies and when do they plan to issue their opin-
ion?

We need to get some answers to these questions now. The an-
swers have been much too slow in coming. How much longer will
it take?

So, Mr. Chairman, I look forward to the testimony of our wit-
nesses today on this very critical issue affecting the lives of thou-
sands of women. Thank you, Mr. Chairman.

[The prepared statement of Hon. William F. dinger, Jr., follows:]

Prepared Statement of Hon. William F. Cunger, Jr., a Representative in
Congress From the State of Pennsylvania

I am pleased to have the opportunity to participate in this joint Subcommittee
hearing today on the issue of FDA regulation of medical devices, and to look at the
breast implant issue and safety concerns. It is my hope that this hearing will shed
light on some of the difficult and painful issues surrounding breast implants. I am
svmpathetic towards the women who are faced with these difficult choices, those
that have breast implants and those who must make decisions in the future. We
will be hearing testimony from many different points of view on this issue today.

One of the hardest things about this issue is the lack of information. Since 1992
the FDA has declared a moratorium on silicone implants (for other than reconstruc-
tive purposes) because of insufficient information, but the FDA has yet to assess the
studies and make a judgment regarding the safety and efficacy of the implants. The
FDA has been too slow in helping us gain a full understanding of the issue — ^both
the risks and the benefits. The sooner the FDA can provide the necessary informa-
tion to the public in some definitive form, the better off everyone will be in terms
of making these hard decisions. Decisions should not be based on anecdotal or piece-
meal information. Without some definitive guidance, we are simply taking a walk
in the dark down a very rugged path.

The information we are desperately seeking includes: What are the risks? Are the
risks any higher for developing autoimmune diseases with the implants? Are the
risks so high that no one should have silicone breast implants? What are the bene-
fits of silicone implants? Once the risk factor is known snould we allow individuals
to make their own choices? Since the moratorium has been in effect what has the
FDA done in evaluating the known studies and when do they plan to issue their
opinion?

We need to get some answers to these questions now. The answers have been
much too slow in coming. How much longer will it take?

I look forward to the testimony of our witnesses today on this critical issue affect-
ing the lives of thousands of women.

Mr. Shays. Do other Members have statements? Mr. Souder, do
you have a statement?

Mr. SouDER. No.

Mr. Shays. Mr. Fattah.

Mr. Fattah. In the interest of time, Mr. Chairman, I'll forego an
opening statement.

Mr. Shays. Thank you. It will be submitted for the record, if you
have one.

Ms. Morella.

Ms. Morella. Yes. I'd like to give just a brief statement, Mr.
Chairman. First of all, to thank you for scheduling this hearing on
FDA regulation of medical devices, specifically as we focus on
breast implants today.

In anticipation of this hearing, I've been provided with materials
from a variety of individual groups and companies, ranging from
those critical of the FDA response to the breast implant issue who
point to the data from recent studies, to those who believe that the
FDA took appropriate action and that the risks associated with sili-
cone breast implants continue to be significant.



11

I have received letters from women who have suffered from auto-
immune diseases and other health problems linked with breast im-
plants who contend that these implants were rightfully banned and
the FDA, while agreeing that recent studies are providing helpful
data, believes that the evidence of silicone breast implant safety
continues to be inadequate.

So I approach today's hearing, Mr. Chairman, with the hope that
we can learn from this experience and apply these lessons to our
efforts to improve and streamline the FDA approval process. As
many of us have discovered over the past several months, risk as-
sessment is a very tricky business.

I strongly believe that we have a responsibility to protect the
health of our citizens and to continue to provide careful analysis of
medical devices before approving them for use by the public, and
at the same time we cannot allow a cumbersome approval process
to prevent lifesaving devices from reaching the market in a timely
fashion.

So I look forward to hearing from our witnesses today. I particu-
larly want to thank and bid a strong, warm greeting to Marilyn
Lloyd, with whom I had the pleasure of serving in Congress and
on the Science Committee and our two incumbent Members of Con-
gfress, Congressman Traficant and Congressman Ganske.

Thank you very much, Mr. Chairman.

[The prepared statement of Hon, Constance A. Morella follows:]

Prepared Statement of Hon. Constance A. Morella, a Representative in
Congress From the State of Maryland

Mr. Chairman, thank you for scheduling this hearing on FDA regulation of medi-
cal devices, speciiically focusing on breast implants.

In anticipation of this hearing, I have been provided with materials from a variety
of individuals, groups, and companies, ranging from those critical of the FDA re-
sponse to the breast implant issue who point to the data from recent studies to
those who believe that the FDA took appropriate action and that the risks associ-
ated with silicone breast implants continue to be significant.

I have received letters from women who have suffered from autoimmune diseases
and other health problems linked with breast implants, who contend that these im-
plants were rightiully banned. And the FDA, while agreeing that recent studies are
providing helpful data, believes that the evidence of silicone breast implant safety
continues to be inadequate.

I approach today's hearing with the hope that we can learn from this experience
and apply these lessons to our efforts to improve and streamline the FDA approval
process. As many of us have discovered over the past several months, risk assess-
ment is a verv tricky business.

I strongly believe that we have a responsibility to protect the health of our citi-
zens and to continue to provide careful analysis of medical devices before approving
them for use by the public. At the same time, we cannot allow a cumbersome ap-

ftroval process to prevent lifesaving devices from reaching the market in a timely
ashion.

I look forward to hearing from our witnesses today as we ponder these issues.
Thank you, Mr. Chairman.

Mr. Shays. I thank the gentlelady.

Mr. Martini, do you have a statement? Mr. Fox.

Mr. Martini. Yes. Thank you, Mr. Chairman. And just briefly,
I would also like to thank you, Mr. Chairman, and Mr. Mcintosh
for holding these hearings this morning.

In the context of this discussion, I'd like to just address my con-
cerns, really, Mr. Chairman, the medical device manufacturing
community in my opinion is currently standing at a crossroads. The



12



access for millions of Americans to lifesaving implantable medical
devices such as pacemakers, heart valves, hip and knee joints, and
artificial blood vessels are in serious jeopardy.

The litigation that arose from the breast implants scare has
forced the Nation's raw materials suppliers to restrict their sales
to medical device manufacturers. Recently, DuPont, Dow Chemical
and Dow Corning have announced that they would no longer sup-
ply biomaterials to medical implant manufacturers.

Medical device manufacturers represent about 1 percent of the
business for these large corporations but about 80 percent of the
litigation exposure. As we all know, Dow Coming has recently filed
for Chapter 11. Dow Corning is the Nation's leading supplier of sili-
cones for medical use, and silicone, as we know, is used in many
critical medical devices.

Without an adequate supply of this material, we will be severely
threatening the American peoples' access to vital medical devices.
If Congress fails to act swiftly and certainly, we are going to drive
the domestic medical device manufacturing industry out of the
United States.

Mr. Chairman, I believe this committee should commit itself to
exploring the full ramifications of the biological materials shortage.
And before I conclude my remarks, I would like to submit for tne
record a list of medical devices whose supply may be in jeopardy.
And I would urge my colleagues on the committee to examine this
list so that they may fully understand how serious a problem we