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United States. Congress. House. Committee on Gover.

FDA regulation of medical devices, including the status of breast implants : joint hearing before the Subcommittee on Human Resources and Intergovernmental Relations and the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs of the Committee on Government Reform and online

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Online LibraryUnited States. Congress. House. Committee on GoverFDA regulation of medical devices, including the status of breast implants : joint hearing before the Subcommittee on Human Resources and Intergovernmental Relations and the Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs of the Committee on Government Reform and → online text (page 24 of 32)
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a breast implant.

[The prepared statement of Ms. Russano follows:]

Prepared Statement of Jama Kim Russano, Children Afflicted by Toxic

Substances

Dear Subcommittee Members, Thank you for allowing me to address the commit-
tee. It seems appropriate for me to be the last speaker today, for the children have
been the last on the list when it comes to the relationship of silicone.

I speak before you; representing hundreds of thousands of children froin teenagers
who were implanted with breast implants to infants bom to mothers with silicone
and saline breast implants. I would like to show you the snowball effect of the man-
ufacture's negligence in totally discounting proper research; falsification of labora-
tory animal tests; lack of manufacturing quality control; suppression of information
and a flagrant irreverence to be forthcoming with Congress and the FDA. I want
to point out how the medical community never recognized or addressed the effects
of silicone's composition and derivatives used in breast implants. There were no
human studies relating to pregnancy, breast feeding or documentation during the



151

development of a young girls body. Misinformed, the FDA and consumers could not
make a valid decision regarding safety and efficiency of the breast implants.

My name is Jama Kim Russano. I live In Northport, NY, and have been married
for 15 years. I had a breast implant at age 14. During my 22 years of implantation
of 2 Dow Coming implants, Silastic I and Silastic II, I gave birth to 2 beautiful boys,
now ages 9 & 12. I have had 20 years of experience in sales and marketing with
various consumer product companies. Additional personal information as well as my
health history is provided in written testimony.

My children suffer some of the same symptoms as I, particularly a rare disease.
Esophageal Dismotility. Questioning the relationship of causation to my silicone
breast implant and my children's health problems, I realized there was very little
information as well as very few studies answering my question, "Is there a correla-
tion between the mother's experience with silicone breast implants, miscarriages, in-
fertility, birth defects and childhood illnesses?"

In 1992, I felt it was vital these questions be answered and I founded a not-for-

grofit foundation. Children Afflicted by Toxic Substances (CA.T.S. for short).
iA.T.S. was designed to spearhead the evaluation and research necessary to an-
swer these compelling questions. C.A.T.S. developed a questionnaire, centralizing
medical information in a database. In three short years we have heard from 5,000
families reporting the health status of their children.

Our research has assisted Dr. Jeramiah Levine and Dr. Norman Dlowite to author
the January 19, 1994. JAMA article, "Sclerodermalike Esophageal Disease in Chil-
dren Breast Fed by Mothers with Silicone Breast Implants . This small study com-
pared the health of 11 "implant" children (8 breast-fed, 3 bottle-fed) to that of 17
children whose mothers did not have implants, but who had similar gastrointestinal
complaints. Their findings?: 6 of the 8 breast-fed children sufTered esophageal
dysmotility. The continuation of this study in larger numbers shows a consistent
pattern.

This study was criticized by the implant manufacturers. But the fact remains that
it is the only study that has been performed on children exposed to breast implants.
The Hydrocephalic Shunt study, reference Lancet Journal — 1992, Volume 340, pes.
510-613, also produced an immune response and its safety is still an issue. But the
material is "Solid" and does not seem to migrate through the lymph system to other
organs as the silicone and secondary chemicals in breast implants. In addition to
the difference in medical necessity between women receiving a silicone breast im-
plant and children Hydrocephalic, the difference in material between gel and the
solid material used in silicone shunts makes any comparison between the two ex-
tremely difficult.

The manufacturers of silicone and breast implants have had 40 years to conduct
proper studies. However, only recently did Dow Coming, Plastic Surgeons, and
other Breast Implants manufactures helped fund studies from the Mayo Clinic and
Harvard. Those studies did not ask the right questions. They did not look at the
children's issue of birth defects, childhood illness, miscarriages, ruptures or infertil-
ity. Researcher's rely on industry for research funding. This makes one concerned
that there is an impact on the results, including the type, of questions' one may ask
in an epidemiological study.

Studies concerning effects on reproductive performance and the fetus were initi-
ated by Dow Coming in the 1960*8. I reference Dow Coming Wright Silastic Gel Sa-
line Mammary Implant H.P. and Silastic MSI Gel Saline Mammary Implant H.P.
PreMarket Approval Application for the record. Teratology tests of PDMS include
four studies in the rabbit and three in the rat employing do th dermal and subcuta-
neous routes of exposure. "Regarding fetal abnormalities, there was a significant in-
cretise in skeletal defects following dermal treatment with PDMS".

In the 70's, a study using a similar chemical make up as Silicone Silastic Gel
showed the chemicals transcended the placental barrier, working their way to the
pituitary gland and passing the liver, kidney and spleen. It has also been found to
atrophy the reproductive organs of test animals. The same chemical application is
used as an insecticide for roaches.

The question. Were these tests repeated on the "new, better Silastic II Gel, or was
it assumed that the response would be the same? If the manufactures were so con-
fident bearing children and breast feeding with silicone implants did not cause prob-
lems, why was the subject not addressed in their literature? If breast implants was
such a small and unprofitable part of their business, why did they continue to con-
duct business without proper studies or research? Are Dow Coming and Dow Chem-
ical protecting over 1,000 or more patents they hold on other silicone products? An
executive of Dow Coming recently stated "Dow's philosophy was to ignore the prob-
lem and it will go away". I have news for them; we are not going away!



152

CA.TS. recently published a preliminary report of 250 mothers with silicone im-

Elants and the health of 151 children bom before and the health of 362 children
om after implantation. There is a significant pattern of complaints with children
that are breast-fed over bottle-fed. Children that are bom to mothers with an im-
plant of 5-6 years or older (at the time of birth) are displaying more symptoms.
There are strong suggestions from the old data and new data that children may be
adversely affected. Dr. Levine's work and CA.T.S. data comprise the largest study
to be done on the children of implanted mothers.

Every day, questions are being asked of the Medical Community, mostly consist-
ing of Plastic Surgeons, Pediatricians, Lactation Specialist and Le Leche League, "Is
it safe to have a baby and to breast feed?" Today this "YES" is used freely, and still
there is no documentation by the Pediatric Society of the Manufactures. TTiey do not
acknowledge that there have not been proper tests on childbearing or breast feeding.
The medical conmiunity based this information on pure "hearsay", fueled by an erro-
neous endorsement of the manufactures sales representatives who quoted a report
which was admittedly fictitious. The Human Milk Banking Association, a nonprofit
organization that administers breast milk banks to US Hospitals, now screens for
women with implants. They issued a directive in March 1994 that stated, "Mothers
with silicone breast implants will not be accepted as donors." A Tylenol bottle has
more information pertaining to breast feeding and pregnancy than the package in-
sert of a breast implant.

Unfortunately, as a non-profit organization, we rely totally on donations. Since we
are contra to manufactures, there is no source of their funds. In addition, research
we attempt may be considered biased as we are a benefited party. However, WHO
is going to fund the research and collect the data to fully understand the effects if
these products to insure future generations be bom healthy and that Government
and Taxpayers are not burdened with their medical costs.

Women and children rely on the safety and fair treatment of elected officials. Our
laws serve as a bulwark protecting the weaker against the stronger and promoting
the common good (in this case the health and safety of all Americans) against those
who would sacrifice it to their quest for personal and corporate gain. We work hard
for a decent living and rely on our system of laws and justice to protect ourselves
and our children from unsafe products, corporate greed and dishonesty.

Due to the Bankruptcy of Dow Coming and the lengthy time it will take for
women and children to get needed medical care, we ask this subconmiittee to
strongly consider issuing immediate emergency funding for research programs relat-
ing to this issue as well as an explant fund that is so desperately needed.

I would be happy to expand on the numerous topics at hand today and I would
like to thank you for your valuable time expression of concerns for women and chil-
dren.



Children Afflicted by Toxic Substances Research Study Program
clinical history vl\ questionnaire

Methods

Randomly Selected (n=250)

Children bom to mothers before implants (n=151)
Children bom to mothers with breast implants (n=352)

Background

DOCUMENTED DISEASES IN WOMEN WITH SILICONE IMPLANTS

Possible second generation affects

• Incidence of associated diseases

• Disease patterns in affected children

• Specific type of implant



153



V



Results — Women: n=250 Average Age=37



Gel



Polyuretliaiie Ooubl* Lumen



Type of implant:

Health of women:

Fair

Poor

Miscarriages



64%


9%


27%


11.5 yrs


3 yrs


7 yrs


27%


16%


18%


23%


29%


32%


50%


55%


50%


28%


2%


2%



Results — Children Bom Before Implant (n=151)

Health





Sllicane Gel


Polyuretliane


Double Uirnen


Fair


84%
16


91%
9



76%
24


Poor















Most frequent diagnosis: ear infections, allerjies, asthma.

Results — Children Bom After Implants (n=352)

Age: &-10 Years

Age of Implant at Birth: 5-6 Years



Gel



Polyurelhane Double Lumen



Method of feeding:

Breast fed ...

Bottle fed ....
Health:

Fair

Poor



65%


64%


78%


35


36


22


23


39


52


33


18


30


44


43


18



Results — Specific Symptoms

Symptoms Gel Polyureltiane Double Lumen

Gastrointestinal:

Abdominal pain 81% 61% 51%

Esophageal 41 36 9

Rheumatologic 35 25 24

Siaa 49 28 7

Fatigue 6 Weakness 53 43 27

Renal 4

Lymphadenopathy 25 32 17

Rashes 34 21 17

Most common complaints: Allergies, Upper Respiratory Inlections, Abnormal bone growth, muscle weakness, Leukemia, Precocious puberty.

81% of chiUren bom to Silicone implants are reporting symptoms.

47% of chiWren bom to Double Luman are reporting symptoms.

50% of chiUren born to Polyurelhane are reporting symptoms.

CONCLUSIONS — MORE STUDIES ARE NEEDED

Motility Disorder:
Abdominal pain
Esophageal symptoms

Neurologic:

Are children's fatigue/weakness due to neuropathies? How does ADD fit in?

Rheumatologic:

Are children following the same pattern as the mothers?



(



154



Renal:

Stenosis of urethra & frequent bladder infections are common in boys.

Rasfies:

Rashes come and go. Are children displaying an allergic reaction?

Mr. Shays. Thank you very much.

I'm somewhat in a quandary on how to proceed, because not only
do we have pros and cons, but we have people who have very per-
sonal experiences, and we have experts who have spent their lives
studying these issues.

I guess I would like to start out — Dr. Sergent, you started in the
beginning. I would like you, if you wouldn't mind, to just comment
on some of the testimony you have heard that followed you and
your kind of reaction with the different testimony that you heard.

Dr. Sergent. With regard to the last comment, the Harvard
study that was referred to, that was a preliminary report, and it
was not 200,000 patients; it was 200,000 person-years. A person-
year is determined by taking the number of people in the study
and multipljdng it by the number of years that they have been fol-
lowed.

The final Harvard study had well over 1 million person-years,
and it clearly showed no — as a matter of fact, the patients with im-
plants had a slightly decreased incidence of rheumatoid arthritis,
although not statistically different, and nobody would make any-
thing of it. But that was a preliminary report, and it is certainly
not the complete data.

With regard to the doctor at my lefl, I would say that I'm very
disturbed by people who make no effort to try to look at the global
picture. There's no question that women are sick. There's no ques-
tion that women with implants have rheumatic diseases. The issue
is, are these diseases occurring at an increased frequency?

With regard to the so-called new disease that he spoke of, I
would say that both the Mayo Clinic study, the study from Har-
vard, £ina the very interesting study from the University of South
Florida all looked at a variety of musculoskeletal symptoms, and
they were looking at it specifically to see if some new disease that
was nondefined might be appearing in this population. And in all
of those studies the answer was, no, there is no new disease ap-
pearing in the breast implant population.

Mr. Shays. Dr. Shanklin, I feel like, in a way, it's a description
of the economists, the lefl and the right. I was hoping that all of
you would solve our problem here, but you obviously have much
disagreement. Bottom line: How did you get into this issue, and
what has given you such an impetus to proceed the way you are
proceeding? Because I get the sense that you are not in the main-
stream.

Dr. Shanklin. Well, I don't know. I may be the future.

Mr. Shays. Well, the mainstream isn't necessarily the future.

Dr. Shanklesi. Well, I don't know about that. I'm a pathologist.
I look at the tissues when they come out. I performed an autopsy
on a woman who died of direct complications of her implants. I
know of eight other similar deaths. The FDA has records of some
sort on 52 deaths. They have not even shared the details of these
with the medical profession in summary or specific form. I would



155

like very much to know what they have. I don't even know if they
have in their records the ones that I have.

There is a cellular toxicity and a tissue toxicity of silicone. That
has been shown clearly. There have been deaths which have fol-
lowed directly upon injection of silicone into the body. That's why
silicone injections were banned a long time ago, and they are
against the law in cer£ain States because of the inherent danger of
that.

There is very little difference, in terms of the toxic load in the
body, between something that is injected by a syringe and that
which comes there because a device ruptures. As a matter of fact,
you get a lot more of it in the body when a device ruptures. We're
talking about, oh, say, two average sized implants, if they both rup-
ture in a woman, we're talking about 1 pound of silicone gel that
is released into her body. And the body does respond to it. It re-
sponds to it when it bleeds out of the envelope.

Mr. Shays. Let me ask you, if this is a man-made device and
man-made material, how do you find out what will happen in the
fiiture. Obviously, in this case, this device was already in people's
bodies, and we can go backwards.

Dr. Shankun. Yes.

Mr. Shays. But, in general, any man-made device, my challenge
is, how would you know the effect 50 years from now or 40? I
mean, it seems to me then you would basically put an end to every
type of device development.

Dr. Shanklin. Well, the point is well-taken, Mr. Chairman.
There is an imponderability over that period of time. As a con-
sequence of that imponderability, a variety of animal research has
to be done, on a broad enough scale, over a long enough time to
give an indication relative to life span of given animals.

The amount of work that was done and published in the medical
literature up until, roughly, 1980 was rather minuscule. There was
a lot of work done by industry which they never brought to the
public light, which has come to our awareness only because of liti-
gation.

It's a long-term problem. The consequences over time are difficult
to estimate, I grant you.

Mr. Shays. Are you involved in any litigation yourself?

Dr. Shanklin. I have been in the past. I have nothing active at
the moment. I have one case in mediation; I don't really know
what's happening to it.

Mr. Shays. Dr. Gabriel, you speak with a tremendous sense of
confidence in your study and the results of it, and you're sharing
your study. How would you transfer your study into other areas?
Does this lead you to just have total confidence in silicone not
being a problem, or does it just lead you to believe that your study
shows in this instance?

Dr. Gabriel. I think my confidence stems from looking at all of
the data, not just my study. I have a lot of confidence in our meth-
ods and the way we did the study, and I stand behind that. But
the confidence that I expressed was due to the totality of the data
of the controlled studies, and I think that's reallv the most impres-
sive thing is that all of the well-done, controlled, epidemiologic



156

studies done tx) date are all negative. And that's what has im-
pressed me.

Mr. Shays. So it's not just your study, but when you continue to
look at other studies, you get reinforced with your position.

Dr. Gabriel. Right. Exactly. All the case control and cohort stud-
ies.

Mr. Shays. Dr. Connell, you have been involved in this process,
and I was intrigued by trjang to figure out your position until the
end. And your position is that it should be resolved. Do you have
the same confidence level that Dr. Gabriel has?

Dr. Connell. I do. I have thought so often, in recent years I
wish we had had her data when we were meeting in November
1991 and February 1992. As John Sergent pointed out, we antici-
pated, when I returned and he joined us in 1992, that we were
going to see a lot of very negative, very dangerous information
forthcoming. We were, I think, all of us, quite disappointed — actu-
ally, rather delighted that this was simply not the case.

I think it's critical to look at then and at now. At that point, we
made judgments based on anecdotal information and case reports.
Today would be very different.

Mr. Shays. If I could interrupt, the point is that you made a de-
cision earlier on, and it has been reinforced, as well, by the studies.

Dr. Connell. We've been absolutely delighted to see these stud-
ies come out because they answered many of the questions that we
had. And we felt very discomforted that we couldn't answer them
at that time. That's the reason we said there's a public health need,
that women get them with informed consent, and let's get some an-
swers.

Mr. Shays. My only regret in this hearing is that we've had no
votes, because, if we had, I would have loved to have taken Tara
on the floor of the House. I can do that if she's my daughter, and
I would have adopted her for a short period of time. But evidently
we won't have a vote before you all leave.

I'm just interested to know if you have any additional comment
based on other points that were made, or if Tara does, before you
all catch your plane, which you have rescheduled.

Mrs. Ransom. We had to, yes. Basically, I think that everyone
needs to remember that there are two types of implants. One type
goes into a nonhealthy body. It controls the problem, much like an
insulin, has its own problems, maybe, maybe not. But you are
weighing one direction against another. In Tara's case, it's very
simple: life or death.

The other thing is when you choose to put an implant into a
healthy body. What does an oyster do to a seed of sand? It makes
a pearl. Bodies are not designed — they are very hostile environ-
ments, basically — they are not designed to have implants. It's going
to fight against it. Somebody may have a problem. I'm not saying
that they do or they don't. I don't know. I'm not a scientist. But
what I ao know is that for some people it is the only alternative.
You can learn to deal with the problem if you get to tomorrow, but
that's what we need to do.

Mr. Shays. We're going to continue with other questioners. I'm
going to go to Mr. Barrett. I just need to say that if any witness



157

does need to leave, obviously, you are free to. I don't want you to
all get up and leave, but we will be going on a little bit more.

Mrs. Ransom. I think I will let Tara go back to the room.

Mr. Shays. I sure understand that.

Mrs. Ransom. Thank you. Did anyone have a question for her be-
fore she left?

Mr. Shays. Yes. Let me just say to any Member who would like
to ask Tara a question or her mother, let's do that, and then I will
come right back to you.

Mr. Barrett.

Mrs. Ransom. I can stay. It's just Tara.

Mr. McIntosh. Mr. Chairman, no question, but just a comment.

Thank you very much for coming today.

Mr. Barrett. I'd like to know from Tara who her favorite char-
acter is in Wizard of Oz?

Mr. Shays. That is a very good question.

Mrs. Ransom. Who's your favorite character? Tell him.

Mr. Shays. You have to answer a Member of Congress.

Mr. Barrett. Who's your favorite?

Mr. Shays. Maybe the question is, do you have a favorite?

Mrs. Ransom. She has to think. It's all the books.

Mr. Shays. You're just convincing me that you're a young lady
who's 8 years old.

Mrs. Ransom. Dorothy.

Mr. Barrett. Thank you very much.

Mrs. Ransom. She brought a rabbit with her that has a little
gingham dress. Tara doesn't want to write her story, but Dorothy
Rabbit is going to write her story about going to Congress.

Mr. Barrett. That sounds very good.

Mr. Shays. I would love to see that story if you would send it
to me. Thank you very much.

Mrs. Ransom. We'll try.

Mr. Shays. Thank you very much, Tara.

I'm going to ask Mr. Barrett, you have questions, and you can
ask any the other witnesses who their favorite ones are, too.

Mr. Barrett. Ms. Green, I was interested in a comment that you
made sort of at the tail of your testimony, when you talked about
what appeared to be your disagreement with the FDA in terms of
the effectiveness of the trial mechanism they have for women to re-
ceive implants. If you could comment on that further.

Ms. Green. Right. Well, the trials are restrictive in some regard.
First of all, a woman's doctor has to indicate that this would be the
very best implant for her, so she can't be a candidate for saline or
some of the other method, and that she would need the silicone to
get the best result. So there is a restriction there.

Second, you have to go to a doctor who is part of the trials. And
people who are part of HMO's and I believe some of the military
gproups do not have a plastic surgeon who is part of the trial. So,
therefore, a woman would not have access to them.

Our own medical advisors, several who are plastic surgeons, have
told me most of them, even though they prefer the silicone implant,
are using saline just because of the difficulty in guaranteeing
whether a woman can get a replacement down the road or that her



158

hospital is concerned on using silicone implants because of the cli-
mate in the legal system.

So they really aren't as available. And besides, just the overall
media frenzy, you know, adds that little bit of doubt.

Mr. Barrett. OK

Ms. Green. And also — one thing I forgot — ^that basically they are
not going to be available. I think there are enough to complete
some of the trials now, but if there are no manufacturers in the
business — they are not open-ended studies. As soon as the product
is gone, so are the studies.

Mr. Barrett. OK, Ms. Ransom, have you had difficulty in get-
ting the shunts for Tara? I understand, obviously, where your con-
cern lies,

Mrs. Ransom. Not yet. Tara's last surgeries were when she was
3V2. She's 8 now. Ajid extended life on a shunt is somewhere
around 8 years. They fail because of growth. They fail because the
brain tissue invades them. I've got one in my purse, if you'd like
to see it later, that literally the brain tissue invaded the end of it.



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