173

search institutions that also show no link between the implants and immune dis-
ease. The consistency of these results has led some researchers to declare that if
it weren't for the hype on this issue, this case would be closed from a scientific per-
spective.

Breast implants do carry some well documented risks of local complications. Many
women with invpltrnts, for example, may develop a fibrous capsule around the de-
vice. In some ofthe cases, the capsule may become hard and painful requiring fur-
ther treatment to break the capsule. In the last state-of-the-art implant that Dow
Coming had developed before we permanentlv withdrew from the implant business,
our people had nearly eliminatea this problem. Rupture is another complication,
whicn has been reported to us in less tnan 3% of the implants we manufactured.
Both of these complications — rupture and fibrous capsules-— deserve attention.

But the absence of a link between imj^ants ana disease means that neither of
these complications are life-threatening. They can be dealt with by an implant pa-
tient and her physician who are in the test position to balance the benefits of breast
implants with the complications.

That is the science and the data regarding breast implants risks as we know it
today. But even research from institutions like Harvard Medical School, The Mayo
Clime, Johns Hopkins and others cannot compete with the public health scare that
was burned into the national consciousness in early 1992. Instead, those highly re-
spected institutions have found their very ethics attacked by those who actually
claim that any funding from manufacturers — no matter how remotely connected to
the actual research — inevitably compromises their work. Does anyone seriously be-
lieve that a prestigious medical institution would risk its reputation, act unethically,
or commit fraud tor the funding of studies? Ironically, these same critics also vilify
companies like Dow Coming for allegedly not funding enough research. Frankly, I
find these allegations cynical and preposterous. In truth, they are nothing more
than a poorly disguised tactic to focus on anything but what the science says.

So far I've described a pretty bleak picture. But I hope and believe there can be
a solution to this madness.

It starts by ensuring that public policy is driven by scientifically based risk as-
sessment and that our public nealth institutions serve as a firewall that withstands
the sometimes enormous power of those who specialize in made-for-the-media scare
mongering. Put another way, should plaintifls' attorneys — who stand to gain lit-
erally bUlions of dollars by the mass marketing of fear — determine whether a prod-
uct is safe or should regulatory and research institutions like the FDA, NIH, Har-
vard, Mayo and Johns Hopkins? The answer should be obvious, but our experience
would suggest otherwise.

More specifically, let me close by suggesting the following three recommendations
for improving the process for evaluating risk in medical devices:

1. Guidelines must clearly establish what degree of risk is acceptable before a de-
vice can become available. If all devices must be totally risk-free, then informed con-
sumers will no longer have any role in deciding for themselves what risks they are
willing to assume. The government will make that decision for them and the num-
ber 01 devices available to consumers will be severely reduced. If devices can have
a reasonable level of risk, what is the standard of evidence that must be met that
both protects the consumer and maintains their right to decide for themselves what
risks they are willing to take? What are the standards that determine when enough
scientific evidence is enough?

2. When the guidelines and standards change for evaluating the risk of a device,
the manufacturers should be aware of those changes before they are implemented.
By definition, science and standards evolve. What is state-of-the-art today will not
be state-of-the-art tomorrow. Manufacturers not only understand this, they most
often drive these advances. But if you are competing in the high jump and the bar
is raised after you started your jump, then the incentive to even enter the contest

auickly goes away. This is especially true when the consequences of falling short of
lie rising bar can literally put well meaning companies out of business cased on
unproven allegations alone.

3. There is an ureent need for tort reform, particularly in the area of medical ma-
terials used in medical devices. The end device manufacturer or supplier must con-
tinue to be responsible for assuming the safety and performance oi their products.
However, continuing to allow medical materiel suppliers to be lawsuit targets sim-
ply because they have deep pockets will only have one result . . . the continued
withdrawal of those materials from the marketplace.

I want to conclude with a few comments to those who are convinced that they
have been harmed by our company. It is very discouraging to me, and to every one
of my fellow employees at Dow Coming, that this issue has generated so much
anger and mistrust between some women and ourselves that it is very difficult for



174

UB to listen to each other and have much of a constructive dialogue. But despite the
anger and mistrust, I hope that they will accept the sincerity of our intention to
fairly and equitably address their claims. My deflnition of a fair and equitable reso-
lution is one that does recognize what the scientiflc evidence says, but one that is
also viewed by at least most women with implants and the world at large as respon-
sible and honorable.

Thank you for inviting Dow Coming to share its thoughts on this most important
subject.



Response to Written Questions Submitted by Hon. Ed Towns to Richard A.

Hazleton

Question 1. During the Congressional hearings in 1990, the Committee Chairman
at that time, the late Congressman Ted Weiss, asked Dow (Coming) to produce cer-
tain documents that contained trade secrets. Were these documents given to the
Committee and if not, can you share with us the problem in not making them avail-
able?

Answer. Dow Coming believes that all documents requested by the Committee
have been produced through requests from the FDA, the Justice Department and
through the MDL (multi-mstrict litigation) data base. If there are specific docu-
ments in which you have a particular interest or which you believe were not dis-
closed, I would be happy to identify where they have been provided or expedite pro-
cedures to make them available to you.

Question 2. Early studies show that Dow Chemical conducted animal research on
silicone and its effects. Why then is Dow Chemical not being held accountable along
vdth Dow Coming?

Answer. Dow Coming was founded in 1943 at the request of the U.S. Government
to supply silicone materials, not available anjrwhere else in the world, for the war
effort. Both Dow Chemical and the then Corriing Glass Works, provided technology
needed to start the company. Since its founding, Dow Coming has operated as a
separate independent entity from its two shareholders. During the early years of the
company, Dow Coming was too small to have either the facilities or the trained per-
sonnel to conduct sophisticated toxicological studies. We, therefore, as is common
gractice in industry and government, contracted work with outside laboratories who
ad the capabilities. Dow Chemical was one of several outside laboratories utilized.
Dow Chemical did not design, test, or manufacture breast implants. Those activi-
ties are solely the responsibility of the Dow Coming Corporation. I believe deep
pockets, not facts, are the basis of attempts by plaintiffs attorneys to bring Dow
Chemical into breast implant litigation.

Question 3. The medical difficulties of children bom to women with breast im-
plants has not been well publicized. First, does Dow (Coming) acknowledge that
there have been health problems for these children? And, second, how can funds be
found for the needed research and treatment of children affected by these implants?
Answer. There is no credible scientific evidence to suggest increased medical dif-
ficulties in children of mothers with breast implants. The single published study by
Levine and Ilowite, claiming "Esophageal Disease," has been largely discredited due
to gross selection bias leading to skewed results. The British Department of Health's
evaluation of this work follows:

There are, in fact, a number of significant deficiencies in the study which pre-
vent any vaJid conclusions being drawn. These include the use of a highly se-
lected group of patients with bias evident at each stage of selection, inadequate
controls in terms of numbers and matching, inadequate numbers investigated,
inaccuracies in clinical correlations, lack of evidence that abnormalities were
clinically significant, lack of corroborative evidence, the effect of any anesthetic
agents used on esopha^al motility, inappropriate statistical methods and lack
of any evidence that silicone was present in milk or ingested. In spite of the
widespread publicity generated by this paper, it is of no value in assessing the
healtn effects of silicones.
Nonetheless, because of the fear such studies generate, Dow Coming is sponsoring
third party epidemiology work to address the claims being hypothesized. However,
I feel it is unconscionable that children are now being used by some as a pawns
in the breast implant litigation debate. Before we once again scare women and the
families of women with breast implants, as we allowed to happen with unfounded
claims of cancer, scleroderma and lupus, I hope we will require more than hearsay
and anecdotes before raising an unfounded health scare for children.

Mr. Shays. Thank you, Mr. Hazleton.



175

Mr. Benson,

Mr. Benson. Thank you, Mr. Chairman.

I also want to thank you for inviting me to be here today. Like
you said, it's been a long day, but I tnink much information has
come out, and I think even more is yet to come. As requested, I
have submitted my written testimony, and I would like here to
summarize that testimony.

My name is Jim Benson. I'm senior vice president for technology
and regulatory affairs at the Health Industry Manufacturers Asso-
ciation. In my comments today I want to stress three points:

First, one of the most essential materials in medical implants,
silicone, has been widely accused of being unsafe, though a growing
volume of evidence suggests otherwise. Second, the vilification of
silicone is one of the primary causes of current shortages of many
raw materials used in medical products. And third, these shortages
present a threat to patients because technology manufacturers may
not be able to develop countless new technologies.

Though much of this hearing has addressed the issue of breast
implants, my remarks today will not. As former Acting Commis-
sioner of FDA and former director of the Center for Devices and
Radiological Health, I am precluded by law from discussing propri-
etary information. I want to use my brief time today to address
questions of FDA risk assessment and science that hold even
broader implications for patient care.

Let me begin by focusing on risk assessment at FDA. The FD&C
Act requires FDA to find a reasonable assurance of safety and ef-
fectiveness before approving a new product. To meet that standard,
medical technology companies perform a variety of tests on their
devices. These include clinical trials in humans; animal studies;
mechanical, structural and chemical tests; and mathematic or com-
puter modeling.

Yet, even the most rigorous testing does not and cannot yield as-
surance of absolute safety. That's because science itself rarely, if
ever, yields absolute answers. By its very nature, science is open-
ended; it's ongoing; it's never complete. No matter how thorough
the testing, one can always ask one more question, study one more
patient, seek one more statistic.

Congress clearly recognized the nature of science when it con-
cluded, in the 1976 medical device law, that the agency should not
seek absolute assurance of safety and effectiveness of*^ medical de-
vices but a reasonable assurance. That means FDA must examine
the risks and the benefits of devices, then make its judgment on
the balance between the two.

The job of FDA is not to hold up a product indefinitely while de-
manding evidence that exceeds the standard of reasonable assur-
ance. If that happens, product approvals at FDA will stop com-
pletely, and patients will be harmed. At that point, the quest of ab-
solutes in protecting public health will, in itself, have become a
threat to public health.

Ultimately, the agency has ignored the dictates of Congress, pre-
ferring instead this "absolutist' mentality, this insistence that data
prove, with total certainty, that a product will or will not have a
specific effect. Let me give you an example. In recent months, some
17 or 18 epidemiological studies have all reached the same conclu-



176

sion: They do not find a link between breast implants with silicone

fel and connective tissue diseases. These are studies that have
een done by some of the world's leading institutions, such as Har-
vard University and Mayo Clinic.

In addition, FDA's counterpart agencies in such countries as the
United Kingdom, Australia, and New Zealand, have conducted
their own analyses and literature reviews. None of these countries
is finding a link between silicone and connective tissue diseases.
Yet, despite this growing body of evidence, FDA continues to argue
with these findings.

I would like to digress here just a moment and acknowledge that
Dr. Kessler said this morning, if I heard him correctly, that this
body of evidence does point toward no link between silicone and
tvpical connective tissue disease. We need to hear what he said
there very carefully, and I look forward to examining the record
more closely.

This is especially surprising since silicone is one of the most
ubiquitous substances in our society. Each of us uses and ingests
it every day. We use it in deodorants, suntan lotions, pain reliev-
ers, toothpaste, lip balm, shaving cream, soft drinks, and even
french fries, to name just a few.

The everyday, routine uses of silicone combined with its long suc-
cessful history in medical use, especially implants, represents an
enormous body of empirical data. If any significant danger existed
from silicone, it would have become obvious a long time ago.

Yet, this perception of silicone as being unsafe, together with
FDA's unwillingness to acknowledge studies of the highest caliber,
is having an increasing harmful impact on patient care. Unsub-
stantiated allegations about the safety of silicone have become the
centerpiece of widespread product liability litigation and publicity
in this country. This type of litigation has led many suppliers of
vital raw materials for medical devices to simply leave the device
market, thus creating growing shortages.

With due respect to the CDRH staff who were here this morning,
and they have been working with us toward finding substitutes for
some of these raw materials that have been withdrawn, we remain
deeply concerned that new raw material suppliers will not enter
the market. These are shortages that directly threaten patient
health. Again, I'm hopeful that Dr. Kessler's comments about the
relative safety of silicone this morning will positively affect these
shortages.

Countless medical technologies depend upon such raw materials,
including, to name only a few: heart valves used by 35,000 patients
annually; vascular grafts, 300 patients annually; and certain types
of surgical tools which are used to treat millions of patients every
year.

Though these products I've mentioned are comprised of a variety
of biomaterials, many devices depend upon silicone, in particular,
and they include hydrocephalus shunts, which we've heard a lot
about today; arthroplasty devices, such as artificial knees and hips,
600,000 patients a year; and catheters which are used in about a
million patients a year. Some of these products are displayed here;
others are demonstrated on Mr, Towns' chart.



177

Let me stress, Mr. Chairman, that the shortages our industry
faces today in raw materials can be traced directly back to the ab-
solutism of FDA. The roots of the problem lie in the obvious con-
tradiction that, on the one hand, convicts silicone before all the
facts are in, but on the other, refuses to exonerate silicone in the
face of growing proof of its innocence. It is this attitude which
unleashes a chain reaction that ultimately restricts the raw mate-
rials our industry that we need to improve lives.

We believe that four steps are necessary to alleviate this crisis:
First, we urge Congress to pass biomaterials legislation now con-
tained in House and Senate-passed product liability bills. This leg-
islation would limit the liability of raw material suppliers.

Mr. Shays. Mr. Benson, let me just ask you, just so you don't
lose me here. How much longer is your testimony?

Mr. Benson. I have two more pages.

Mr. Shays. OK That's fine.

Mr. Benson. Thank you.

The biomaterials legislation would limit the liability of raw mate-
rial suppliers to instances of genuine fault, thus reducing the likeli-
hood of unwarranted lawsuits. In effect, this bill would encourage
biomaterial suppliers to remain in medical device markets, but it
would not, in any way, diminish the existing and future liability of
device manufacturers which use these materials in their products.

Second, we believe FDA must reverse its course on silicone. It
must accept the growing volume of respected evidence that is show-
ing the unsubstantiated allegations about silicone to be wrong.
FDA must, once and for all, stand up and reassure the public of
the safety of silicone and the use of silicone in all of its forms.
Again, Dr. Kessler took a step in that direction this morning. I
hope we hear more.

Third, we recommend that FDA abandon absolutism in risk as-
sessment. Absolutes are not achievable, and the quest for absolutes
holds the potential to harm patients.

Finally, we believe FDA must view product approvals as a key
element in consumer protection. Getting new, safe, and better
treatments to the bedsides of patients can be just as critical in pro-
moting better health as keeping unsafe products off the market.
The fact is, we need both.

There's no question, Mr. Chairman, that FDA has a clear obliga-
tion to assess potential risks when evaluating products. Patients
have a right to know. But if the agency is to truly protect public
health, it must use an even-handed, objective, and rational ap-
proval process that ultimately rests upon sound science, reasonable
assurance, and common sense.

Thank you.

[The prepared statement of Mr. Benson follows:]

Prepared Statement of James E. Benson, Senior Vice President, Technology
AND Regulatory Affairs, Health Industry Manufacturers Association

introduction

Mr. Chairman, my name is James S. Benson. I am senior vice president for tech-
nology and regulatory affairs of the Health Industry Manufacturers Association
(HJMA).



178

I appreciate this opportunity to testify on the risk assessment standards used by
FDA in evaluating medical devices. In my testimony today, Mr. Chairman, I want
to leave this Subcommittee with three points:

• First, one of the most essential materials in medical implants, silicone, has been
unfairly accused of being unsafe, though decades of successful use and a growing
volume of research substantiates the appropriateness of its use in the body.

• Second, the vilification of silicone is one of the primary causes of the current
shortages of many raw materials which are essential to the development of new
medical products;

• Third, these shortages present a threat to the health of hundreds of thousands,
perhaps millions, of patients because technology manufacturers may not have the
materials they need to develop countless life-saving technologies.

I recognize, Mr. Chairman, that the focus of much of tnis hearing will be on
breast implants. But, for two reasons, my remarks today will not focus on these
products — nor on the companies that produce them: First, as former Acting Commis-
sioner of the FDA and former Director of the Center for Devices and Radiological
Health, I am precluded by law and by ethical considerations from discussing propri-
etary information. But in addition, I want to use my brief time today to address
some of the deeper guestions of risk assessment and science at the agency that I
believe hold implications for patient care and health that go well beyond the breast
implant controversy.

fflMA REPRESENTS MEDICAL DEVICES, DIAGNOSTICS, mS

For those members of the Subcommittee who may be unfamiliar with HIMA, let
me explain who we are and who we represent.

HIMA is the national trade association of the medical technology industry. It rep-
resents more than 700 manufacturers of medical devices, diagnostic products, and
health information technologies.

During the past 20 years, these medical technologies have revolutionized medi-
cine. Thanks to achievements in such iields as flberoptics, imaging, electronics, and
biotechnology, today's medical technologies are faster, more efficient, and more pro-
ductive than ever. But most important, such products — be they lasers, scalpels,
MRIs, home diagnostic tests, pacemakers, or a myriad of other products — have sub-
stantially improved health care for patients.

As I noted, many of these medical devices depend upon a variety of biomaterials,
including silicone — which is one of the most pervasive of all synthetic materials ana
is used widely in various forms (solids, liquids, gels) in countless medical and non-
medical products. It is used, for example, in such products as toothpaste, soft
drinks, deodorants, and pain relievers, as well as in a range of medical products,
including catheters, artificial joints, and shunts. Were it not for substances like sili-
cone and other biomaterials, much of the progress in medicine that each of us takes
for granted would not have occurred.

RISK ASSESSMENT AT FDA

Your chosen topic of risk assessment at FDA, Mr. Chairman, is of significant in-
terest to virtually every manufacturer of medical products.

All of the technologies developed by our industry must be reviewed by the Food
and Drug Administration or must otherwise adhere to the rules and pohcies estab-
lished by FDA. As such, our members are fully familiar with FDA procedures and
requirements regarding risk assessment. As former Acting Commissioner of FDA
and Director of the Center for Devices and Radiological Health — the office respon-
sible for device review at the agency — I, too, am familiar with FDA procedures on
risk assessment.

I commend your Subcommittee for examining this issue because I believe FDA's
risk assessment policies — in many important ways — lie at the heart of the problems
I noted a moment ago.

Let me begin by providing a baseline for understanding just what risk assessment
at FDA is and what it means. As members of the Subcommittee may be aware, the
Federal Food, Drug, and Cosmetics Act (FFDCA, Section 513(aXlXC) and Section
515(dX2)) requires that FDA must find a reasonable eissurance of safety and effec-
tiveness before approving a new product. Note that the term Congress chose was
reasonable, not absolute, not perfect, but reasonable.

To meet that standard, medical technology companies perform a variety of tests
and studies on their products. Depending on the type or nature of the product; how
it is intended to interact with the body; the disease or condition it is intended to
diagnose or treat; or how it will be used, where, and by whom; those tests might
include:



179

• Bench tests, in which the products are put through a range of mechanical, struc-
tural, and chemical examinations.

• Mathematical or computer modeling, in which the product is simulated to under-
go a variety of conditions which mimic virtually any human environment.

• Animal studies, in which the product or component material is tested in animals
in which certain biological responses are physiologically similar to those of humans.

• Long-term or short-term clinical trials, in which the product is studied over a
period of time in human subjects.

• And tests to determine now devices directly affect the tissues they contact and,
conversely, how the tissues and body fluids affect the device.