are facing.
And I would just like to submit for the record, Mr. Chairman, a
comprehensive list of many of the medical devices that are im-
pacted by today's hearings. Thank you, sir.
Mr. Shays. Without objection. Any testimony that the Members
wish to submit will be submitted for the record without objection.
[The information referred to follows:]
Potentially* Affected Temporary Implants
litit than 30 dayt)
Product BuRiaterial (Ganeric Polymer)
Auto Transfusion:
Chest Drainage Unit urethane
Other polyester, sABS, polycarlwnate
Balloons:
Intra-aortic silicone
Other polyester, urethane, polycartxmate
Blood Filters polyethylene, nylon, polyvinylchloride, polyester
Blood Pumps polyester, silicone
Bl^ Pressure Transducer Attch polycartwnate
Blood Temperature Monitors acrylic
Bone Growth Stimulator (Implantable) silicone
Breathing Circuit Connectors polypropylene
Cannulac:
Coronary silicone
Femoral polyurethane
Inducer polypropylene, polycarbonate, polyethylene, ABS
Other polyvinylchloride
Cardiac Insulation Pads polyethylene
Cardiac Jackets polyurethane
Catheter:
Angioplastic polyester, polyethylene, nylon, polyurethane
Cardiovascular silicone, polyvinylchloride, urethane, polyamidc, ABS
13
Potentially* Affected Temporary Implants — Continued
[Lm tb«« 30 days]
Product
Biomatwial (GtMric PolyMtr)
Chotongiography silicone
Coronary Laser PTFE, polyurethane, epoxy
Diagnostic polyester, polyethylene, nylon, polyurethane
Dilatation polyethylene
Epidural PT7E, nylon
Epistaxis silicone
External CFS Drainage silicone, polypropylene
Foley silicone, polyurethane, PTFE-coated
Gastrointestinal silicone, polyester elastomer, polyvinyichloride
Guiding polyester elastomer. PTTE, polyamide. urethane, aramid fitwr,
ABS
Nephrostomy silicone
PCTA Balloon polyester
Peripheral Laser PTFE, polyurethane, epoxy
Vascular PTFE, polyvinyichloride, polyurethane
Venous PTFE, silicone, polyurethane, polycartxMiate, PVDF, polymethyl
pentaene, polyphenyleneoxide
Other PTFE, polyester, polyurethane, silicone, polyvinyichloride,
polyacetal, polycartionate
Catheter Introducer Kits polypropylene, FEP, polyamide
Catheter Shafts polyester, polyethylene
Covers:
Blood Filter polyester yam
Sterile PETG, polyethylene
Dialators polyethylene
Dialyzers polyurethane, polyethylene, polyurethane, polysulfone
Disposal)le Temperature ProtMS polyvinyichloride
Drainage Products:
Drainage Tulws polyurethane, polyethylene
External CFS Drainage & Monitoring System polyethylene
Wound Drainage Set polyvinyichloride, silicone
Drapes polyethylene
Ear Wicks merocel, polyurethane
Electrodes:
Fetal Scalp polyethylene
Vaginal silicone
Embolic Device n-Butyl cyanoacrylate
Esophageal Stethoscopes polyvinyichloride
Fracture Fixation Device polyethylene
Gloves polyvinyichloride
Guide Wires PTFE, silicone
Hemofiltration Device polysulfone, polycartwnate, polypropylene, polyurethane, sty-
rene aciylonitrile
Hubs polyurethane, polyethylene, polyvinyichloride
Intra-Arterial Blood Gas Sensor silicone, polycarbonate, urethane, PTFE, urethane adhesives
Intracardiac Suction Device polyester, polyvinyichloride
Intrauterine Pressure Device:
Ruid Filled polyethylene
Transducer Tipped polypropylene, silicone, polyurethane, polycarbonate
Leads:
fteuro (& aaessories) silicone, PTFE, polyurethane, polyacetal, nylon, sunoprene
Pacing polyethylene, silicone, polypropylene
Lead Inducers:
Cardio PTFE
Lead/Catheter polyethylene, PTFE, polypropylene, polystyrene
Nasal Septal Splints silicone
Nasal Tampons polyurethane
Needles silicone coated
Ophthalmic:
Glider polyethylene
Lacrimal (DCR) silicone
Sealant n-Butyl cyanoacrylate
Orthopedic Implant Si2e Testers acetal
14
Potentially* Affected Temporary Implants — Continued
(IMS tkan 30 days]
Prodyd Bmnatehal (GMtric Potymar)
Oxygenators:
Dialyttr polycartwnate. polyurethane, polyethytene
Long Term silicone
Surgical Membrane silicone
Other polyester, silicone defoamer, polypropylene
PAP Brush polyvinylchloride, nylon
Patient ID Bands homopolymer acetal, polyethylene, polyester, vinyl, poly-
styrene, tyvek
Periodontal ?\ba Adhesives 2-octyl cyanoactylafe
Pessary polyurethane, polyvinylchloride
Prosthesis;
Hip polyethylene
Knee polyethylene
Retention Cuffs (Enema Tip) silicone elastomer
Sets:
Electrolyte Testing polyvinylchloride, ABS, PCS
Infusion polyvinylchioride, PCB
Peresis polyvinylchloride, silicone, nylon, polyethylene, ABS
Reinfusion polyvinylchloride, ABS
Thoracostomy polyvinylchloride
Sheeting silicone
Staples/Clips PTFE, silicone coating
Stomach Ports silicone
Surgical Instruments PTTE, silicone, polyacetal, FEP, polyethylene, polypropylene,
polysulfone, nylon, polyester foam
Transducer Protectors PTFE
Tubes:
Blood Line silicone, polyvinylchloride
Gastrointestinal polyvinylchloride
Reservoir Bags silicone
Stomach Feeding silicone, polyurethane
Tipptnostopy (Ear Implant) silicone
Tracheal polyvinylchloride, polyurethane
Other silicone
Ureteral Stents silicone, polyethylene, polyurethane
Vaginal Contraceptives silicone
Valves:
Holder polyacetal
Sizer polysulfone
Other silicone
Vascular Vessel Clamps acetal homopolymer, nylon
Vessel Loops silicone
Water and Saline Bottles polyethylene
*At tkis tima tha poientlal Impact of a biomaterials ambarjo on temporary implants is uncertain.
Biomaterials Embargo: Potentially Affected Permanent Implants
[More than or equal to 30 days]
Product Blomaterial (Generic Potymer)
Acetabular Cups polyethylene
Annuloplasty Ring polyester, PTTE
Aortic/Coronary Locators silicone
Artificial Pancreas PTFE, acrylic
Batteries: >
Defibrillator PTFE
Pacemaker PTFE, polyimides, ETTE, FEP
Bone Cement PMMA, n-Butyl Cyanocrylate
Breast Implants silicone
Cardiac Materials:
Fabrics polyester
Felts polyester. PTFE
15
Biomaterials Embargo: Potentially Affected Permanent Implants — Continued
[Mora thtii or equal to 30 dtys)
Product
Biom«tari«l (GtMrk PolyMtr)
Mesh polyester
Patches (vascular repair) polyester, PTFE
Catheters:
CAPO silicone
Central Venous polyester, polyurethane
Chest silicone
Intra-Skomal Corneal Ring PMMA
Peritonea) Dialysis silicone, polyester
Other polyester, silicone, polyethylene terepthalate
Catheter Introducer Kits polypropylene, FEP, polyamide
Cement Spacers PMMA
aips:
Aneurysm polyester
Ligation polyacetal
Vena Cava polyester, PTFE
Cochlear Implant silicone
Contraceptive silicone
Defibrillators PTFE, polyester, ETFE, silicone, polyimide, polyurethane
Embolic Device n-Butyl Cyanoacrylate
Frekote Lubricant (general) PTFE
Generators: >
Defibrillator pulse PTFE, nylon
Pacemalier pulse silicone, polyurethane, parylene C
Other epoxy, silicone
Grafts:
A-V Access silicone, polyester
Intra-aortic polyester
Valve polyester, PTFE
Vascular polyester, PTFE, silicone
Implantable Pumps silicone, nylon, polyacetal, polyimide, polypropylene, PTFE,
polyester, polyvinyl idene fluoride
Impotence Implant silicone, PTFE, polyacetal
Incontinence Implant silicone, PTFE, polyacetal
Intraocular Lens PMMA
Leads:
Cardio PTFE, polyester, FEP, silicone
Defibrillator polyester, silicone, polyurethane
Pacemaker polyester, silicone, polyurethane
Vagus Nerve polyester, silicone
Lead Adapters silicone, polyurethane
Lead Connectors silicone, polyurethane
Mokled Components (Catheters, etc.) silicone
flasal Button silicone
Ort)(tal Implant silicone
Orthopedics:
Finger Prosthesis silicone elastomer
Fracture Fixation Device polyethylene
Hip Joint polyethylene, PMMA
Knee Joint polyethylene, PMMA
Partial/Total Ossicular Replacement polyethylene, silicone, PTFE
Plug (hip fracture stem) silicone
Shoulder Joint polyethylene, PMMA
Spinal Systems polyethylene
Tibia Insert polyethylene
Pacemakers polyimide, PTFE, FEP, ETFE, silicone, nylon
Patellar Buttons polyethylene
Penile Implant silicone
Pledgets PTFE
Ports:
Infuswn silicone, polyethylene, polyurethane
Injection acetal
Osteoport silicone
Vascular access silicone, polyacetal, polypropylene, polysulfone
16
Biomaterials Embargo: Potentially Affected Permanent Implants — Continued
[More than or tqual to 30 days]
Product Bjoaiattrial (G«Mric Polyi«*r)
Other silicone, polyurethane, PVDF
Prosthetic Heart Valves polyurethane, polyester, silicone, polysulfone, polyacetal, PTFE
Sheeting (Scar tissue prevention lininj) silicone, PTFE
Shunts:
CNS silicone, polypropylene
Dialysis PTTE, silicone
Hydrocephalus silicone, polypropylene
Peritoneal silicone, PTFE. polypropylene
Other silicone, polyester
Stimulators:
Bone Growth Implant silicone
Functional Electrical silicone elastomers, polyester, epoxy, PTFE
Neuro (& Accessories) PTFE, polyacetal, silicone, polyurethane, hysol epoxy, parylene
C
Sutures polybutester, polyester. PTFE. nylon, polypropylene, silicone
Tutws:
Myringotomy silicone, PTFE, polyethylene
Otological Ventilation silicone
Vent silicone
Umtxlical Tape polyester
Valved Conduits polyester, PTFE
Vascular Access Device silicone elastomer, polyester mesh, polysulfone, acetals
Vascular Stents polyester
Liitiiif wdadM dcvicM that ara ioipacted, will be impadad, mIiM or niiM Ml U inpaciad.
PMM A p otywatliytiiiethaciylata
FEP — tluorwatad «lhy<m< propyletw
ETFE — athylaaa-talrafluroelliylene copolymar
ABS — acrilonllrila butadieM styreae
sABS— stabHoad ABS
PVDF — potyviiylldena fluoride
PCB — piolyckloriaatad biphenyl
■— polyacetal/acetal
PTFE— -polytttraflvoraathyieRe
PET— potyatMMe terephthalate(poVa(ter)
PFTG — PET with (lycol additwe
> CoitaiMd ia device: *«t directly exposed to skia.
Mr. Shays. Mr. Fox or Mr. Tate, do you have a statement? Mr.
Fox.
Mr. Fox. Mr. Chairman, thank you. And I thank vou and Mr.
Mcintosh for your efforts today and in organizing toaay's hearing
on the Food and Drug Administration's regulation of medical de-
vices, including the status of breast implants.
We all know that the Food, Drug and Cosmetic Act authorized
the FDA to regulate the safety and effectiveness of medical devices
before, during, and after marketing. The FDA is therefore respon-
sible for evaluating the safety and the effectiveness of medical de-
vices prior to marketing and sale.
Americans want safe medical devices, they want a strong FDA
that will keep unsafe products off the market, but I believe they
want to see more emphasis on the value of giving patients a choice
and access to accept risks for the treatments they so desperately
need.
By illustration, let me speak of the 20 million diabetics in the
United States many of whom need to take insulin injections to sur-
vive. In effect, diabetics are supposed to measure their blood sugar
levels several times a day to determine the amount of insulin they
need at a given time. Currently, Mr. Chairman, the only approved
method is to stick the finger and apply blood to a test strip several
times a day. Because the pain associated with the frequency of this
17
procedure, many diabetics refuse to test themselves, thus leading
to medical problems which include diminished eye sight, organ de-
generation, and wounds which often lead to amputations.
The knowledge exists now, Mr. Chairman, which would allow
diabetics to test themselves without experiencing the pain associ-
ated with the needle-stick method. Research in this noninvasive
medical device has been going on since 1986, and there are 20 dif-
ferent companies trying to get devices on the market. However, no
one has been successful because the FDA continues to require addi-
tional testing. Meanwhile, people continue to live in pain without
being given the choice to take advantage of a necessary product.
Through my illustration this morning we explore the case of sili-
cone breast implants which will allow us to study the questions as-
sociated with risk assessment and the government's role in permit-
ting or denying patients' access to medical devices.
We have impressive panels of witnesses, Mr. Chairman, before
us today. The issue of today's hearing will invoke a strong degree
of emotion; however, we look forward to hearing from each witness
as we seek a balanced discussion on such an important health care
issue.
Thank you.
Mr. Shays. I thank the gentleman. Mr. Tate.
Mr. Tate. Thank you, Mr. Chairman. I'd like to thank the chair-
man as well as the chairman of the other subcommittee, Mr.
Mcintosh, for their interest in this issue. I'll keep my remarks
brief, because I think it's more important that we hear from the
witnesses today than myself.
I'm here to find out the answers. Women deserve the right to
know the effects, the benefits, the costs of these sort of procedures,
and that's the hope that I have from these committees, is just to
find the answers. I'm here to learn, to listen and to find out, and
that's the hope of the people of my district and the hope of the peo-
ple of this country.
And I look forward to getting started with the debate.
Mr. Shays. I thank the gentleman and, again, I want to thank
the witnesses. To be helpful to panel 3, it's my judgment we will
probably not come to you until somewhere between 12:30 and 1:30.
So I would just say to panel 3, if you need to do something else
in the meantime, you have our permission certainly.
At this time I will swear in our witnesses and thank Marilyn
Lloyd, a former Member of Congress, and James Traficant and
Greg Granske, Dr. Greg Ganske. All three of you, we swear in all
our other witnesses, so we feel it's appropriate to swear in Mem-
bers and former Members as well.
[Witnesses sworn.]
Mr. Shays. For the record our witnesses have answered in the
affirmative. All three of you have very important statements to
make and this isn't going to be pro forma where we get you in and
out. You're free to make your statements and make your points,
and we welcome all three of you here today. Thank you for coming.
We're going to go in the order that you're seated and we'll start
with you, Congresswoman Lloyd and it s nice to have you back.
[The prepared statement of Hon. Gene Green follows:]
18
Prepared Statement of Hon. Gene Green, a Representative in Congress
From the State of Texas
Mr. Chairman, I would first of all like to express my appreciation to you for hold-
ing these hearings on such an important subject. It is of vital importance that we
provide ourselves and the American people with the necessary information on the
approval of all medical devices especially silicone-gel breast implants. Thousands of
women have experienced a variety of medical problems as a result of these implants
and we owe it to them as our wives, mothers, sisters and daughters to assure these
problems will cease to be overlooked. Every person in this country should feel a cer-
tainty and confidence in their doctor and tneir judgement. This hearing will help
to bring this assurance to our constituents. With the testimonies of our panels today
we can hopefully bring to light where improvements can be made in our approval
process of medical devices and in effect reauce, and hopefully eliminate, future med-
ical problems caused by any device or implant.
STATEMENT OF HON. MARILYN LLOYD, A FORMER REP-
RESENTATIVE IN CONGRESS FROM THE STATE OF TEN-
NESSEE; HON. JAMES A. TRAFICANT, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OHIO; HON. GREG GANSKE,
A REPRESENTATIVE IN CONGRESS FROM THE STATE OF
IOWA
Ms. Lloyd. Thank you. Thank you very much, Chairman Shays,
Chairman Mcintosh, Chairman dinger, Mr. Towns, Mr. Peterson,
Connie Morella, all my good friends. It's good to be here, and be-
lieve me, it's good to sit on this side of the table.
I speak to you today as a former Member of this House, as a
former chair with oversight responsibilities and jurisdiction of the
FDA, and I come to you as a woman, a 4-year survivor of breast
cancer and after 2-years the recipient of a gel implant.
I don't suppose there is anyone here with a greater personal or
professional interest in this hearing than I have, so thank you so
very much for inviting me today.
I suppose my personal story began in June 11, 1991, when I par-
ticipated with other women in front of the Capitol on the Breast
Cancer 2000 Rally. The purpose of the rally was to educate more
women about this deadly epidemic, to bring it to our Nation's con-
science, to educate more women on the reality of disease, and at
the same time to create a greater awareness of the need for more
funding to find a cure for breast cancer.
But in all reality, Mr. Chairman, that rally saved my life, be-
cause I was determined that week, when I went back home to Ten-
nessee, to have a mammogram, which I did on the following Fri-
day. This mammogram revealed a very suspicious lump. The fol-
lowing morning, Saturday, I had surgery for a biopsy, and I in-
formed my surgeon that if he found a malignancy, not to awaken
me but to go ahead and do a mastectomy.
When I awakened the malignancy was gone and so was one
breast. This shock was beyond description, out I was resolved to
get on with my life. My plans were to have chemotherapy and radi-
ation followed by my reconstruction. And in surgery through
chemo, I only missed 2 weeks away from Washington. I worked
very hard for recovery.
But I was looking forward to the day that I wouldn't have to get
up in the morning and look at my disfigured body and I would not
have to wear an uncomfortable prosthesis. Silicone gel implants
19
were my choice. To me and for other women, they might mark the
final stage of recovery from breast cancer.
Cancer was not my choice. Implants were. But before my sched-
uled reconstruction surgery, the FDA under Dr. David Kessler's di-
rection restricted my access to a product that my personal physi-
cian and I agreed was right for my full recovery. And the tragic
part of this story is the FDA acted without adequate data to war-
rant this very unnecessary decision.
The decision was based on fantasy and not science. There is no
scientific evidence to support the decision to withdraw silicone im-
plants. This is a quote from Dr. John E. Woods, vice chair of the
Department of Surgery at Mayo Clinic, "So instead of protecting
the health and concerns of women, this moratorium caused undue
stress and anxiety for women with implants and women who want-
ed them around tne world."
But the point I want to make to you all this morning is that real
women, mothers, daughters and wives died because of this tragic
decision and the FDA knows this. Since my surgery, I have tried
to help women who have been diagnosed with the disease and I try
to speak out on awareness. And I know it is a fact that there is
a fear among women to have an exam when they know that they
might find a problem.
And because of the work that I've done and other women who are
survivors, many women say that they have found the courage to go
ahead and to act responsible. And I can tell you that without the
prospect of reconstruction and the thought of facing life disfigured
and wearing an uncomfortable prothesis such as this for the rest
of their lives, many women are going to put off a check-up imtil
it is too late.
Remember, time is all we have. We don't have a cure.
I'd like to look at some numbers. Last year there were 182,000
new cases of breast cancer in women. Two years ago it was
170,000. But if 1 in 100 victims finds the prospect of going through
life disfigured too dismal to bear, and they wait an extra 6 months
before they see a physician, that's 1,820 women that will go unde-
tected. If it's 1 in 1,000, that's 182 women that will die needlessly.
We don't know the exact numbers, but the numbers are there
and we know that they're real, and we know that a lot more
women died because of this mandate than could ever be killed by
silicone.
Dr. Kessler, in defending his imdefensible decision, repeatedly
said that his first obligation as a physician was to do no harm.
Well, Dr. Kessler has done harm, considerable harm to thousands
of women around this world.
I try to make it my business both professionally and personally
to be as infor..ied as possible and not to have a biased attitude. Mr.
Chairman, these are the facts as I see them today. The moratorium
did more harm than an implant. There was not then, nor is there
now any scientific evidence that implants are imsafe for women.
The decision was based on unsubstantiated claims and not good
science.
Two, women who had implants were terrified, and even though
the FDA said they didn't need to, they had them removed unneces-
20
sarily. Three, other women sadly did not have a breast exam in
time because of fear and many of them died as a result.
The United States lost it's biomedical silicone industries. Bio-
medical research which depends upon silicone has declined. Four,
health costs have increased, and six, lawsuits have been filed by
the thousands.
Well, this is history and we can't change the past, so you say,
well, why are you here this morning. Well, I'm here this morning
because I care. I care about the women and families who must
make the tough decisions that I had to make. They should have the
most advanced care and treatment that we as a Nation can provide
for them. And the choices should be theirs alone, with the very best
scientific information available and not the opinion of junk sci-
entists.
And I care about our research community. We should do all we
can as a Nation to foster the finest research facilities and medi-
cines that can be produced. We should encourage our good doctors
and scientists and not continue to put these unnecessary controls
and restrictions on their efforts to develop new products and medi-
cines.
So I hope that by being here today that I have done a very small
part in helping to rein in a misguided and inept FDA, who, in my
opinion, is more interested in promoting itself as a regulatory agen-
cy than listening to the respected medical community and protect-
ingthe lives of women.
Thank you, Mr. Chairman.
[The prepared statement of Ms. Lloyd follows:]
Prepared Statement of Hon. Marilyn Lloyd, a Former Representative in
Congress From the State of Tennessee
I speak to you today as a former member of this House, a former chair of a sub-
committee with jurisdiction and oversight responsibilities for the FDA, and I come
to you as a woman who is now a four-year survivor of breast cancer and, after two
years, a recipient of a silicone breast implant. I doubt anyone here has a greater
personal and professional interest in this hearing. I deeply appreciate the invitation
to testify this morning.
I suppose my personal stoiy began June 11, 1991 when I participated in a Breast
Cancer 2000 rally in front of the Capitol. I was there that day with other women
Members of Congress and women from every state in the Union as a means to bring
the breast cancer epidemic to our nation's conscience — to educate more women on
the reality of the disease and to create a greater awareness of the need to provide
more funding for research for a cure. Perhaps this rally saved my life. I decided to
schedule a manomogram for myself for the following Friday in Tennessee. The mam-
mogram revealed a suspicious lump. The next morning, Saturday, I had surgery for
a biopsy. I instructed my surgeon not to awaken me if he found a malignancy, but
to do a mastectomy. When I awakened, the malignancy has been removed and so
was one breast. The shock was beyond description. But I resolved to get on with
my life. My plans were to have chemotherapy and radiation followed by reconstruc-
tion. From surgery through chemo I missed only two weeks awav from Washington
and worked hard for recovery. I looked forward to the day I would not have to Took
at my disfigured body each morning and would not have to wear an uncomfortable
prostnesis. Silicone gel implants were my choice — to me, they marked the final stage
of my recovery from cancer. Cancer was not my choice, but implants were.
But before my scheduled reconstruction surgery, the FDA, under Dr. David
Kessler's direction, restricted my access to a product that my personal physician and
I agreed was right for me for a full recovery. The tragic point of this story is that
the FDA acted without adequate data to warrant this unnecessary and senseless de-
cision. The decision was based on fantasy — not science. There was not scientific data
supporting the decision to withdraw silicone implants. This is a quote from Dr. John