both you and the other chair of the joint subcommittees. I do serve
as a member of the other subcommittee, though I have missed
these proceedings this morning because I'm in tne concluding day
of the Waco hearings, which I'm pleased are concluding.
Mr. Shays. Thank you for your work there.
Mr. Shadegg. It is a privilege to introduce both Tara Ransom,
who is 8 years old and who will be testifying before this panel
today, as well as her mother, Linda Ransom. Both are residents of
Phoenix, AZ, which is a part of my district, though they are not my
constituents; they are constituents of Congressman Ed Pastor.
Linda, Tara's mother, is a patient advocate on behalf of families
who have been affected by hydrocephalus shunts, including her
daughter Tara. Tara is 8 years old, and she received a hydro-
cephalus shunt shortly afler her premature birth. She requires this
shunt for the balance of her life, in order to drain fluid from her
Linda Ransom and, of course, Tara are deeply concerned that the
controversy, and it is an important controversy that you are look-
ing into today, will somehow, and already has to some degree â€” and
you will hear this in their testimony â€” reduced the availability of
other implants made from silicone.
Materials such as silicone, teflon, and the plastics that are used
in sutures, pacemakers, artificial valves and joints, and many other
applications are key to the survival of patients all across America.
Makers of those products, in many instances, have either stopped
or are contemplating stopping the production of the materials used
in the manufacture of those oiomaterials because of their concern
about possible liabilitv implications.
Whenever we legislate, Mr. Chairman, we deal very much with
the law, which never gets discussed, of imintended consequences.
That is the issue here. In our efforts to deal with the direct prob-
lem that is before us, we need to be certain that we do not, through
an unintended consequence, place people like Tara, whose life is
truly dependent upon these materials, in jeopardy.
I simply would also further like to mention that Senator John
McCain has introduced legislation on this issue, trying to make
sure that there will be a continuing availability of materials for
these types of medical devices, including the type of brain shunt
that Tara wears. His legislation is, hopefully, moving through the
Senate and making progress.
I would call upon my colleagues on this committee to, please, as
you would all witnesses, listen carefully to the testimony of Tara.
1 think you will find it compelling. She has written it herself and
edited it herself I urge you to listen to both Tara and Linda.
I welcome, Tara, you and your mother, Linda, to this committee.
Thank you very much, Mr. Chairman.
Mr. Shays. Thank you for your comments.
Now, I would like all the witnesses to stand.
Tara, we're going to swear in all the witnesses. Legally, we can't
swear you in, out we're more than happy to have you participate
in this process, and then I'm going to be asking you a question
If all the witnesses would stand up and raise their right hands.
Tara, we're giving an oath of office about speaking the truth.
Mr. Shays, I note for the record, everyone has answered in the
The one thing I am absolutely certain of, Tara, is that you know
the difference between the truth and something that's not true.
That's why we don't need to swear you in.
We're just going to go right down. We're going to ask vou to keep
your words fairlv concise. We don't have as many Members asking
questions, but there will be a number of questions. So feel free to
use your 5 minutes, and then we will have some good questions
and answers, hopefully. We will certainly have some good answers.
STATEMENT OF JOHN S. SERGENT, M.D^ VANDERBILT UNI-
VERSITY; DOUGLAS R. SHANKLIN, M.D., UNIVERSITY OF TEN-
NESSEE, MEMPHIS; SHERINE E. GABRIEL, M.D., MAYO CLIN-
IC; ELIZABETH B. CONNELL, M.D., EMORY UNIVERSITY;
LINDA RANSOM AND TARA RANSOM, PHOENIX, AZ; SYBIL
NIDEN GOLDRICH, COMMAND TRUST NETWORK; SHARON
GREEN, Y-ME; AND JAMA KIM RUSSANO, CHILDREN AF-
FLICTED BY TOXIC SUBSTANCES
Dr. Sergent. Thank you, Mr. Chairman.
I'm John Sergent, chief of medicine at St. Thomas Hospital and
professor of medicine at Vanderbilt University in Nashville. In
1992-93, 1 was president of the American College of Rheumatology.
When Dr. Kessler called for the voluntary moratorium on silicone
gel breast implants and reconvened the FDA panel in 1992, I was
one of two rheumatologists asked to be on that expanded panel.
Like most rheumatologists, I was familiar with the reports of
rheumatic diseases following breast implantation, and when Dr.
Kessler called for the moratorium, I assumed that we were going
to hear new and convincing evidence that there truly was some re-
lationship between breast implants and rheumatic diseases. How-
ever, the only clinical reports we heard were anecdotal series by
rheumatologists and others whose views were well-known and
whose patient referrals included large numbers of women referred
by lawyers. There was no epidemiologically sound evidence pre-
The reason that good epidemiology was required to answer this
question is that out of the million or so women that the FDA esti-
mates had breast implants, one would expect to see 10,000 to
20,000 cases of rheumatoid arthritis develop over the years, along
with several thousand cases of lupus and the other connective tis-
sue diseases. Fibromyalgia, a symptom complex consisting pri-
marilv of diffuse aches and pains, could be expected to occur in
even higher numbers.
All of these would be expected in any population of a million
women, with or without silicone implants, and represent the back-
ground noise which can only be sorted out by good epidemiology.
In 1992, at the time of the implant hearings, there had been no
solid scientific studies done to look at this problem.
However, beginning that year and extending through last month,
there have been a number of large studies using a variety of epi-
demiologic techniques. Some of the medical centers which nave re-
ported studies on this issue include Johns Hopkins, the University
of Pittsburgh, M.D. Anderson, the Universitv of Michigan, the
Mayo Clinic and Foundation, the University of South Florida, and
All of these studies reached the same conclusion: There is no in-
crease in musculoskeletal symptoms or in any rheumatic disease in
women with breast implants. So, from a scientific standpoint, the
issue is resolved. I disagree with Congressman Ganske and with
Dr. Kessler. The negative has been proven. As Dr. Shaun Ruddy,
the current president of the American College of Rheumatology,
put it, the only thing keeping this issue alive is litigation, not sci-
But the litigation, fueled in part by the FDA moratorium, has
had effects that go far beyond the issue of silicone implants. Grood
scientists, from outstanding universities, have been narassed by
plaintiff lawyers, and they and their universities have been injured
in the process. A distinguished editor of the New England Journal
of Medicine has been similarly harassed for expressing her views.
This will surely make doctors reluctant to get involved in answer-
ing similar questions in the future.
The FDA moratorium and the explosion of litigation will also
have long-term repercussions in the whole field of implantable
medical devices, as has already been discussed today. The United
States has been the acknowledged leader of the world in this area.
I wonder how enthusiastic U.S. companies will be about new prod-
uct development in the years to come.
Finally, I would like to comment on the process the FDA used
to examine this issue. The panel on which I served was called pri-
marily to answer the question of whether FDA action was called
for in light of the reports of various rheumatic diseases occurring
in women with implants.
I maintained publicly at the time that the panel was almost
uniquely unqualified to answer such a question. It contained only
two rheumatologists. Dr. Nate Zvaifler and myself, neither of whom
is an epidemiologist. The only epidemiologist on the panel had no
apparent familiarity with the diagnostic difficulties involved in
complex rheumatic diseases, as was also true of the panel's only
Others on the panel were already on record as opposing implants
for a variety of reasons, most having little or nothing to do with
rheumatic diseases. For example, one panel member, in explaining
her vote to restrict implants, stated that she decided to change her
vote after a confrontation by the director of women's studies at her
The question before the FDA in 1992 was this: Is there an in-
creased incidence of any rheumatic disease following silicone breast
implantation? That fundamental epidemiolo^c question can only be
answered one way, by good science. Good science is not decided by
voting in a media-charged atmosphere such as the FDA hearing; it
is decided by careful inquiry. In the case of breast implants and
rheumatic diseases, all of the solid science shows that there is no
The primary responsibility of the FDA is to protect the public,
but that public protection should be carried out with respect for the
principles of good science and honest inquiry, not the junk science
of poorly designed and unconfirmed laboratory tests, and anecdotal
reports from doctors whose practice consists largely of women re-
ferred by plaintiff lawyers.
The FDA moratorium on silicone breast implants was an enor-
mous error. Unless the fundamental process of decisionmaking by
the FDA is changed, we can only expect more of the same in years
[The prepared statement of Dr. Sergent follows:]
Prepared Statement of John S. Sergent, M.D., Vanderbilt University
I am John Seraent, Chief of Medicine at St. Thomas Hospital and Professor of
Medicine at Vanoerbilt University School of Medicine, both in Nashville, TN. I am
a clinictd rheumatologist, and in 1992-93 I was President of the American College
of Rheumatology. After Dr. Kessler called for the voluntary moratorium on silicone
gel breast implants and reconvened the FDA panel, I was one of two
liieumatologists asked to be on that expanded panel.
Like mo^ clinical rheumatologists, 1 was familiar with the Japanese articles
which had appeared in the 60s and again in 1980s, and I was also familiar with
a few anecdotal reports by physicians reporting various symptoms in patients with
breast implants. At that particular time, scleroderma, a potentially fatal disease,
had been reported in women with implants, especially in the Japanese papers.
Again, like most rheumatologists, I thought there might be something to this as-
sociation. We already had evidence that drugs and environmental factors can cause
clinical features that resemble scleroderma.
When I read that Dr. Kessler had called the moratorium, and then was asked to
be on the panel, I assumed that we were going to hear new and convincing evidence
that there was truly some relationship between breast implants and rheumatic dis-
I was very disappointed by what occurred at the FDA panel. The only clinical ma-
terials presented were anecdotal series by physicians who had publicly stated that
there was a relationship between breast implants and rheumatic diseases. It was
clear that the pattern of referral of these physicians was based almost entirely on
the fact that their views were widely known, and much of it was from plaintiff law-
yers. I was disappointed that none of these physicians had made any attempt to
look objectively at their data in an epidemiolo^c way.
At this point, I think I need to explain to you a little bit about the rheumatic,
or connective tissue, diseases. The major rheumatic diseases bringing people to
rheumatologists' oflices, roughly in order of frequency, are as follows:
1. Fibromyalgia â€” this is a poorly defined symptom complex that consists primarily
of aches and pains, sometimes with poor sleep patterns and other symptoms. It is
extremely common, although no exact incidence ligures are available. It is estimated
by some rheumatologists uiat as many as 40% of their patients have this disease.
It is also said to be the most common cause of a rheumatology consultation in the
countiy. Virtually all of these patients are women, usually between ages 25 and 50.
2. Rheumatoid arthritis â€” this disease afFects between 1 and 2 percent of the popu-
lation, or about 10-20,000 cases per million people. Approximately 70% of the pa-
tients are women, and the peak age of onset is about 40, although it is seen at edl
3. Systemic lupus erythematosus â€” this disease occurs at a frequency of about 1
case per 1-2,000 women, and approximately 90% of the patients who have the dis-
ease are women. Most of the cases occur between age 15 and 45.
4. Scleroderma â€” this is much less frecpent, with about one new case per year per
100,000 people. It is also more frequent m women.
The other systemic inflammatory connective tissue diseases, including inflam-
matory muscle diseases, are also seen at a higher incidence in women than in men,
although they are much less frequent.
Therefore, the reason that good epidemiology is required to answer questions in
rheumatology is that out of the million or so women that the FDA estimates had
breast implants, one would expect to see 10-20,000 cases of rheumatoid arthritis de-
velop over the years, along with several thousand cases of lupus and the other dis-
eases. Fibromyalgia could be expected to occur in much higher numbers. All of these
would be expected in any population of a million women, with or without silicone
implants, and represent the "background noise," if you will, which can only be sort-
ed out by good epidemiology.
In 1992, at the time oithe implant hearings, there had been no solid epidemio-
logic studies done to look at this problem. The first, later that year, was a retrospec-
tive look at a large population oi patients with scleroderma at Johns Hopkins and
the University of Pittsburgh. Out of 741 women with scleroderma 7 had undergone
breast implantation, and tne overall incidence of implantation prior to scleroderma
was 0.6%, a figure not different from estimates of the incidence of breast implants
in the population at large.^
Since tnen a number of important epidemiologic studies have been performed, and
all have shown no increase in any rheumatic disease among implant recipients.
Briefly summarized, the following are among the most important:
1. A study comparing women with silicone breast reconstruction after cancer sur-
gery, compared to women who underwent breast reconstruction using their own tis-
sues.' This study showed no increase in any rheumatic disease due to silicone.
2. A large study from the Mayo Clinic^ which looked at 749 women with silicone
implants and compared them to controls without implants. Thev also found the
same incidence botn of rheumatic diseases and of various musculoskeletal symptoms
in the two groups.
3. A large study from Australia^ whidi found no relationship between silicone im-
plants and scleroderma.
4. Finally, a Harvard study'' looked at 121,000 women, and found 448 cases of
rheumatic diseases. There was no association between silicone implantation and any
liieumatic disease, nor were musculoskeletal symptoms reported with increased fre-
quency, which would make it extremely unlikely that silicone had caused a new pre-
viously undeflned, disease.
In addition, in a unique approach a group from the University of South Florida*
examined women who had had silicone breast implants and compared their symp-
tomatology to women who had undergone other forms of plastic surgery not involv-
ing silicone. There were no significant differences in their musculoskeletal symp-
toms, again refuting the emergence of any new disease due to silicone.
So, from a scientiflc standpoint I believe the issue is closed. As Dr. Shaun Ruddy
of Richmond, the current President of the American CoUege of Rheumatology, put
it, the only thing keeping this issue alive is litigation, not scientiflc inquiry.
^Wigley FM, Miller R, Hochberg MC et al: Augmentation mammoplasty in patients with ays-
temic sderoeis: data fix)m the Baltimore Scleroderma Research Center and Pittaburgh
Scleroderma Data Bank. Arthritis Rheum 35:S46, 1992 (abetr).
'Schusterman MA, Kroll SS, Reece GP et al: Incidence of autoimmune disease in patients
after breast reconstruction with silicone gel implants versus autogenous tissue: a preliminary
report. Annals Plast Surg 31:1-6, 1993.
^Gabriel SE, OTallon WM, Kurland LT, et al: Risk of connective tissue diseases and other
disorders after breast implantation. N Engl J Med 330:1697-702, 1994.
^Englert HJ, Brooks P: Scleroderma and augmentation nnammoplasty â€” a causal relationship?
Aust NZ J Med 24:74-79, 1994.
"Sanchez-Guerrero JS, Colditz GA, Karlson EW et al: Silicone breast implants and the risk
of connective- tissue diseases and symptoms. N Enal J Med 332:1666-70, 1995.
'Wells KE, Cruse CW, Baker JL, et al: The health status of women following cosmetic sur-
gery. Plast Reconstr Surg 93:907, 1994.
But the FDA moratorium has had effects that go far beyond the issue of silicone
implants. Good scientists from outstanding universities have been harassed by
Slaintiff lawyers, and they and their universities have been injured by the process.
, distinguished editor of the New England Journal of Medicine has been sunilarly
harassed for expressing her views. This will surely make doctors reluctant to get
involved in answering similar questions in the future, especially if there is a great
deal of pending litigation.
/Uad while I Know little of the process involved in making implantable medical de-
vices, I know something of the devices themselves. They are used for such things
as artificial joints, heart valves, pacemakers, eye lenses, and various shunts, just
to mention a few. The United States has been the acknowledged leader of the world
in this area. One can't help but wonder if the result of the FDA panel won't have
major repercussions in the area of new product development for many years to
Finally, I would like to comment on the process the FDA used to examine this
issue. The panel on whidi I served was called primarily to answer the question of
whether FDA action was called for in light of tne reports of various rheumatic dis-
eases occurring in women with implants. I maintained publicly at the time, and be-
lieve even stronger today, that the panel was almost umquely unqualified to answer
such a (niestion. It contained only two rheumatologiats, Dr. Nate Zvaifler and my-
self, neither of whom is an epidemiologist. The only epidemiologist on the panel had
no apparent familiarity with the diagnostic difficulties involved in complex rheu-
matic diseases, as was also true of the panel's only inununologist.
TTien that group was mixed with additional people who were already on record
as opposing implants for a variety of reasons, most having little or nothing to do
with rheumatic diseases. For example, one panel member, in explaining her vote,
Eublicly stated that she had been confronted by the director of women's studies at
er university because the original FDA panel, on which she also sat, had favored
The question before the FDA in 1992 was this: Is there an increased incidence
of any rheumatic disease following silicone breast implantation. That fundamental
epidemiologic ouestion can only be answer one way: by good science. Good science
is not decided by voting in a media-charged atmosphere such as the FDA hearing.
Indeed, the argument could be made that the FDA panel, and all the publicity, have
made it more diflicult to do good prospective epidemiologic research. The conclusion
the FDA reached was flawed, and it was flawed because the fundamental process
of decision-making was flawed.
Mr. Shays. Doctor, thank you very much.
Dr. Shanklin. Thank you, Mr. Chairman.
I'm Radford ShankHn. I've been a physician for 40 years. And as
a physician and pathologist who used to be in chnical practice, I've
seen many unusual and marvelous things. Over this time, however,
I've not seen anything quite so distinctive as the tissue changes
which are found actually in the women who have problems arising
as a result of their implants.
I think there is another transportation vehicle that should be in
the metaphor of the morning's hearing. There is another vehicle â€”
whether it's a jet airplane or a truck on the parallel highway, we
will find outâ€” but that is the impetus given by basic clinical prob-
lems these women have, which have been reflected in both clinical
and basic laboratory research. As a pathologist, I'm qualified to
speak to that.
One of the things that is very impressive to me about the tissue
diseases that they actually show is, in fact, the consistency that the
findings appear to be from woman to woman, and the duration and
consistency that they stay with that particular woman over many
I view the hearings today as not only the inheritor of the 1990
hearings, but, as I have indicated in my printed remarks, of the
1936 hearings of the 74th Congress on the Gawley Bridge disaster
in West Virginia, which was an industrial disaster with an ac-
knowledged death toll of nearly 500 people, due to what we would
call today accelerated silicosis.
The reason for mentioning that is very clear. The chart has been
taken down, but it showed filler in the elastomer which is on the
outside of the shell of the implant. That filler is amorphous silica
and accounts for about 25 percent of the physical mass of that de-
vice, at that level.
There has been some talk about and some claims about amor-
f>hous silica being nontoxic. That is not true. There is an abundant
iterature, dating from the 1950's, showing that amorphous silica
has similar reactions in the body to so-called crystalline silica, and
we see tiiat, certainly, in the pathological material that I have been
privileged to examine over the last 10 years.
In addition to that, we recently made a presentation on the T-
memory cell response to the various forms of silica, which was pub-
lished m a FASEB journal in March of this year. It was a presen-
tation, in abstract form, at their national meeting in Atlanta in
April. All of these forms of silica are part of these products.
In addition to that, the basic chemistry indicates very clearly
that the silicone can redegrade back to silica through the medium
of silicate formation and tnen recondensation. The tnermodynamics
and the physics are very clear that this will happen, and we see
I brought some photographs to show the committee, but we're not
able to do so. However, the staff does have my notebook, which I
sent through, which shows similar pictures illustrating many of
these lesions. We're talking about a real thing here, Mr. Chairman.
Not only that, in deference to my colleague to my right, he is es-
sentially correct. The classical diseases of autoimmune type are not
being seen with any increased frequency. This is a new disease, be-
cause this is a new substance that the human species has come
into contact with. We have referred to it, in some of our writing,
as an alien disease. It's actually sort of a wry joke, because its
man-made. Silicones do not occur in nature.
These things come together in my mind, as a basic scientist, be-
cause I see them in the tissues, and they cause a profound reaction
which has immunological consequences. Some of the studies have
indicated that there is not sufficient information about the atypical
forms of disease. We have done peptide tests on the serum of
women with so-called silicone disease, and their peptide profile is
different from that of classical autoimmune processes.
Accordingly, the study by my colleague on my left is correct in
that regard, but there is good evidence beginning to evolve in lab-
oratories all over the country. Witness was given to this by the
hearing, or rather, workshop, more correctly stated, at NIH in
March, at which a number of basic researchers came forward and
presented their material.
There was a consensus out of that that the products bleed gel
into the tissues and that gel causes an immunological reaction. We
have published work on that. The reaction or positivity rate is up-