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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a device before they disappear.

My husband Jerry and I wish we had never heard of hydrocephalus and a shunt,
but wishes aren't reality. We want both Lindsey, our 10-year-old daughter, and Tara
to have the same opportunities to grow up, get an education, and eventually have
their own families.

When I became aware of the current problem involving raw materials for medical
devices, I was frantic. I still am very frightened, though 1 have tried to educate my-
self to the issues and help find solutions. I immediately wrote to all 538 Senators
and Congressmen on the ust. I had 12 replies and my first lesson in political proto-
col. I have worked closely with Arizona Senators John McCain and Jon Kyi, as well
as Congressman Ed Pastor. Although they are not from my district, I am also re-
ceiving support and encouragement from Congressmen John Shadegg, J.D.
Hayworth, and Matt Salmon.

I had more success contacting the chemical companies, having received replies
from each letter that I wrote. In fact, Mr. Richard Hazelton of Dow Coming person-
ally called me to reassure me of their commitment to make life-saving raw materials
available. Unfortunately, the Chapter 11 filing may make that impossible.

I have also been invited to speak as a patient representative on a panel entitled
"Medical Science and Device Industry Put Tort Law on Trial" sponsored by the
American Institute for Medical and Biological Engineering and endorsed by the
American Association for the Advancement of Science Section on Engineering and
Society for Biomaterials in Atlanta, Georgia in February, 1995. Participating with
me were Mr. Bruce Burlington of the FDA, Mr. Richard Hoover of Dow Coming,
and Mr. James Benson of HIMA (Health Industry Manufacturers Association). In
May, 1995 I spoke at a conference entitled "Tough Decisions II: Risk-Free Medi-
cine?" sponsored by the Memorial Blood Centers of Minnesota in Minneapolis. Dr.
Susan Alpert of the FDA sat next to me on the same panel and I met Ms. Barie
Carmichael of Dow Coming who participated with a different group.

Only my actual expenses were reimbursed. I have never been paid for anything
related to my activities. I have spoken to many people and no one yet can guarantee
that a shunt will always be available when Tara needs one. I will not stop until
I have that assurance. Saving Tara's life is our only motivation.

Surgery is scary for all of^us, especially for Tara, but it is our only hope today.
We at least need that chance for ner. The risk of complications is not really an
issue. We've dealt with them before, and we'll deal with them if they occur again.
If we cannot replace her shunt as often as she needs one, we all lose our future.
The increasing pressure in her brain will cause progressive retardation, paralysis,
blindness, and aeath. If things continue and silicone is removed from the market,
shunts could disappear — and so would our hope.

We do not want to put some untested proauct into Tara's brain. A contaminated
shunt could kill her. But so can the lack of any shunt! We would risk an experi-
mental device if the alternative was death.

Some perspective and reason needs to be put back into the research and approval
of medical products. What dilTerence does it make to know if a device could poten-
tially cause cancer in 20 years if your life expectancy without it is days or months?
You can deal with the complications if you are still alive! I think it is reasonable
to put different testing requirements on different product usages. Life-enhancing
and life-saving devices should have different criteria. Decisions related to product
availability need to be based on scientific research.

No one wants unregulated devices flooding the market. In Tara's case, the shunt
is implanted directly into her brain. Of course, we want a sterile, safe device. How-
ever, when people start dying because regulations and politics interfere with the
availability of life-saving devices, something needs to be quickly and radically

Also, rather than punish companies and institutions for their attempts to advance
medicine, they should be encouraged to participate with products and talent.

History is full of failed attempts before success is finally achieved. How many
years and inventions preceded the first successful airplane flight? Medical strides
nave been just as tenuous — successes and failures. We don't want Tara to be part
of an experiment, but we are not willing to let "nature take its course" either.


Progress today in all fields of science is being made faster than any agency can
evaluate. Maybe what needs to be regulated is the research institute, not the spe-
cific device, and have certified peer review committees to evaluate the science and
testing procedures. Yes, there needs to be responsibility from the medical industry
and scientific community, but there also needs to be legislative and regulatory re-
sponsibility. Patients also need to accept that not every product will have the same
outcome for every patient. We do not ban penicillin and aspirin because patients ex-
perience allergic reactions. Don't aUow the silicone to be taken from Tara.

Can you look at Ttira today and guarantee that a shunt will be available when
she needs one? I can't tell you if shunt failure will occur in a few hours or a few
years. Medically, Tara is stable now. The only thing I know for sure is that the far-
ther away we are from her last surgery, the closer we are to the next.

Can you even guarantee that the silicone from which the shunt is made is ^oing
to be available for medical uses tomorrow? This shouldn't be a legal or busmess
issue. It shouldn't be a political issue. It should be a medical issue. Tara is not a
Democrat or a Republican. She is a child. She could be your child, grandchild, or
even yourself. Shunts are simply used to treat head injuries and tumors when some-
thing interrupts the normal flow of fluid from the brain.

We appeal to you to use common sense in evaluating the legislation in this very
critical area. Congressman John Shadegg was quoted in the Arizona Republic on
July 20, 1995 following a day of the Waco testimony as saying "I think it's frustrat-
ing. We've spent 80 percent of the day on red herrings that have nothing to do with
the purpose of this hearing." Don't be sidetracked from the real issue; the availabil-
ity of raw materials and implants necessary to preserve the lives of very real people.
Today's regulations will not insure implant availability for tomorrow.

There are approximately 50,000 shunt-dependent hydrocephalics is this country.
You are talking numbers equivalent to the Vietnam battle deaths. They would never
get a wall, but they would leave just as many devastated families.

We need you to recognize what the impact of any new legislation, or the failure
to provide real reform, will have in your life and that of your family. Don't take hope
away from either yourselves or Tara. She sits before you today. Put Tara before you
when you make decisions.

Miss Ransom. Hello. My name is Tara Ransom, I'm 8 years old.
My favorite book is the Wizard of Oz. I like to jump rope, bike ride,
and run. Fm going to be in third grade this year.

I have a shunt. It is this bump on my head. I have a shunt be-
cause I have hydrocephalus. The shunt goes into my brain. The
tube goes down my head and neck, down my chest, down into my
tummy. I got the hydrocephalus when I was a baby. I can't do gym-
nastics or stand on my head, but I can do lots of other things.

I need a shunt to live. The shunt is made of silicone plastic, I
need you to save the plastic shunts to save the people.

[The prepared statement of Miss Tara Ransom follows:]

Prepared Statement of Tara Ransom, Phoenix, AZ


My neune is Tara Ransom,

I am 8 years old.

My favorite book is the Wizard of Oz. I like to jump rope, bike ride, and run. Fm
going to be in 3rd grade this year.

I have a shunt. It is this bump on my head. I have a shunt because I have hydro-
cephalus. The shunt ^oes in to my brain. The tube goes down my head and neck,
down my chest, down into my tummy.

I got the hydjx>cephalu3 when I was a baby.

I can't do gymnastics or stand on my head. But I can do lots of other things.

I need a shunt to live. The shunt is made of silicone plastic. I need you to save
the plastic shunts to save the people.

Mrs. Ransom. And Tara wrote that herself.

Thank you.

Mr, Shays, Thank you, Tara.

Mrs Groldrich, you're on.

Ms. GOLDRICH, Thank you for the opportunity to be here today.


I am a bilateral mastectomy patient. I was offered breast im-
plants. I accepted breast implants in 1983. Breast implants were
removed because they called me a breast implant failure. I don't
believe I failed; I think the product failed.

In 1988, I had a hysterectomy and bilateral salpingo-
oophorectomy. Silicone was found in my uterus, my ovaries, and
mv liver. I have been an activist in making sure that women get
adequate information to make an informed decision to get or not
get breast implants. I was reconstructed with a new technology
called a flap operation, which is formidable but doable, for cancer
patients. So there are alternatives for some cancer patients that
don't require the use of a medical device.

And I must tell you that I would defend the right of a child or
any human being to a life-saving device, just as I will defend my
daughter's right to have absolute truth about the product that they
may have to choose, whether they want to or not, because they are
at greater risk of developing breast cancer because I had breast

So today I offer you five suggestions to how we might be able to
solve some of these problems. In 1976, Congress left a loophole in
the Food, Drug, and Cosmetic Act when it grandfathered this de-
vice into place. And it wasn't until many, many vears later, prob-
ably about 30 years later, that women became alarmed and came
forward with problems.

I can't understand why a manufacturer, who had 30 years or
even from 1976 to 1983 to come forth with adequate data to prove
this product safe, which they knew was the standard from day one,
and they haven't done it. Where are they? They should have had
the studies already. They have been given borrowed time.

When David Kessler came on the scene, he stopped a regulatory
stance that allowed women to be used as human guinea pigs. Be-
fore Dr. Kessler came, we had diethylstilbestrol and we had the
Dalkon Shield. I know you will agree that none of us want to see
that period in our history, our meoBcal history, repeated.

The current FDA and current scientific ethical and legal stand-
ard for medical devices is that they be proven safe and effective.
Proven not unsafe, and proven not ineffective is not the standard.
It never was the standard and should never be the standard. And
the manufacturers of these products knew that all along.

Products made of silicone — this is my second suggestion — should
be made available in life-and-death situations only when the recipi-
ents are fully informed of all risks and benefits. Tara has been in-
formed. I was not informed.

In the case of breast implants, full disclosure would require that
patients be advised that Dow Coming tampered with the early sili-
cone studies and was later found guilty twice of fraud. Those cases
are, for your reference, Stern v. Dow Corning and Hopkins v. Dow
Corning. The Hopkins v. Dow Corning fraud was upheld by the Su-
preme Court of the United States, and during those trials, causa-
tion was proven using the Daubert standards for scientific accu-

It seems to me that some of these companies — ^you asked Dr.
Kessler so many times why all these companies are not coming for-
ward with studies. They don't come forward because they don't


have them, and they knew they were required to have them. People
in foreign countries come here for redress for products that are
made by companies in the United States. That's unfortunate. We
don't get a great reputation out there. Nobody wins from that kind
of sale.

When silicone can make a difference between life and death for
a patient, a lack of long-term data may be irrelevant. But where
anything less than life is at stake, it's important that the long-term
effects of a product should be known, because otherwise the patient
is committed to life imprisonment without the possibility of parole.

My third suggestion is that you limit tort reform as it deals with
medical devices. At this point, it seems that Congress wants to pro-
vide further protection lor industry and to limit consumer protec-
tion. At the same time, it is attempting to guide the scope and re-
sponsibility of the FDA to move faster.

Last year, the U.S. Senate failed to pass the Sunshine In Litiga-
tion Act; it failed by one vote. That would have allowed people to
know when a court case had information in it that would affect
pubHc health, that that information would be made available to
people. Instead, they have sealed these documents with secrecy or-

So, in 1983, when Maria Stem won her case about causation of
silicone problems for her autoimmune disease, I was having my
first breast cancer surgeries, and I wasn't told that because the
court sealed it. So please pass that kind of legislation so that we
can be forthright with people who need to know.

It might be a good idea to reform the bankruptcy laws to make
it difficult and even impossible for manufacturers to hide in bank-
ruptcy only to leave the citizens and taxpayers to pick up the tab
for product liability and corporate wrongdoing. People who are in-
jured by these products, by breast implants, have been waiting a
long time for the resolution of the case and certainly the resolution
of the science, which is definitely not forthcoming.

The financial burden will fall on local governments and will fall
on medical programs sponsored by the States, and will also require
Social Security disability for those women who are severely dis-
abled. Once again, the taxpayers are going to pay the bill for a cor-
porate bailout, because they had the opportunity to come forward
with the science in the first place.

It was Dow Corning that wanted those records sealed in the
Stem case. It was Dow Coming that tampered with those studies,
for which they were found guilty of fraud. The best tort reform will
come when everybody serves on jury duty and we don't have all of
these massive jury verdicts to change the structure of who has and
who has not any money in this country.

When corporate executives are given — and doctors and lawyers —
are perhaps given a tax credit for serving on juries, we woula prob-
ably have a more meaningful effect than passing maior laws about
tort reform, because you would then hear exactly what the people

Manufacturers whine about the costs of litigation and the legal
aspects of medical device production, but for every plaintiffs lawyer
they cite as making tons of money with contingency fees, there is
a defense firm racking up millions, on an hourly basis, paid up


front and regularly. The defense bar has a disincentive to find
quick resolution for product liability cases. By the way, Dow Cor-
ning has spent $200 million on their legal fees.

My last two I will do very quickly. Please don't release a product
before it's appropriately tested. We must remain mindful of the pri-
vacy needs of patients, but perhaps, when a medical device is is-
sued, the person should appear on a registry of sorts. And informa-
tion, information, information; it must be free-flowing and correct.
It must not be weighted and manipulated, and it must be readily
available in language that is understandable.

The Pope asked Michelangelo when he would be finished with
the Sistine Chapel. I can't recall the name of the movie at the time,
but it was Rex Harrison who asked whoever was playing Michelan-
gelo — ^the Agony and the Ecstasy. The Pope said, "When will it be
done?" And Michelangelo said, "When it is finished." So that's what
I would like to see done with the science, appropriately, this many
years after the product was released on the market.

Thank you.

[The prepared statement of Ms. Goldrich follows:]

Prepared Statement of Sybil Niden GSoldrich, Command Trust Network

Mr. Chairman and Members of the Committee: I speak to you this morning as
the co-founder of Command Trust Network, the largest information clearinghouse
and advocacy group for women with breast implants. And I speak to you, this morn-
ing, as a cancer patient who had bi-lateral mastectomies and who was reconstructed
in 1983 and 1984 using seven implants that failed and an innovative reconstructive
surgery that succeeded: the trans abdominal island flap. I have survived my cancer
for thirteen years but I have been plagued with problems arising from migrating
silicone and decomposed polyurethane foam since 1983.

My medical records describe me as "an implant failure". I do not accept that de-
scription because it was breast implants that failed me by leaking and spreading
silicone gel throughout my body. I have had a total abdominal hysterectomy, bi-lat-
eral salpingo oophorectomy and liver biopsy with silicone being detected in rep-
resentative slides of my uterus, ovaries and liver. I have had five tumors removed
from my ankle, thigh and wrist respectively. Tumors such as these are frequently
found to form around mass collections of silicone but, at this point I ask my sur-
geons only if the tumors are benign or malignant because there is no known way
of removing silicone from the body; there are ways to treat a person for cancer.

If it were not bad enough for people like me to have been sold a product that was
inadecruately proven and released for sale prematurely, now we are inundated with
after-tne fact, scientific studies claiming to prove that breast implants were safe all
along. Manufacturers of these unsafe devices are pouring money into research
projects designed, however poorly, to provide evidence for courtroom confrontations.
Alas, for already injured patients and patients who need silicone based products to
help manage matters of life and death, there is not now, nor will there ever be an
answer that can be trusted. Where the silicone is contained in a product that can
make the difference between life and death for a patient, the absence of long-term
answers may be irrelevant. But where anything less than life is at stake, the lack
of information is a term of life imprisonment with no possibility of parole.

Thirty years after the release of breast implants on the market there are no valid
scientific studies to prove the product safe. The scientists who developed breast im-
plants and other silicone based products committed fraud in their basic research.
This finding of fraud is cited in Stern v Dow Corning and in Hopkins v Dow Cor-
ning. Evidence admitted in Hopkins v Dow Corning withstood the rules cited in
Daubert (the case that defined the standards for scientific evidence). Further, the
Hopkins case was taken to the Court of Appeals in California and the Supreme
Court of California and the fraud count was upheld. The Supreme Court of the Unit-
ed States, by allowing the decision to stay, affirmed the fraud count against Dow

Scientific findings emanating from fraudulent basic science can never be proven
and certainly can never be taken seriously. Once there is fraud, there is no con-


sress-person, physician, scientist, government regulator, or medical ethicist who can
dispute that.

Please accept the following five suggestions as a way to avoid another medical de-
vice debacle:

LATIONS IS ESSENTL\L. Congress did a good thing by passing the 1976 Food,
Drug, and Cosmetic Act Amendment. However, they left a loophole that in many
instances denied Americans the chance to have implantable medical devices that
were proven to be safe and effective. It was Congress that allowed products to be
"ffrandfathered" into the marketplace. Few, if any, congress-people are scientists.
But, Congress is not exclusively to blame. It was a weakly run FDA, seduced by
medical device lobbyists and plastic surgeons, who made sure that breast implants
were not re-examined until women began to report iniuries en masse. It was not
until David Kessler came on the scene that anyone took seriously the fact that the
FDA's weedc regulatory stance had allowed more than a generation of women to be
used as human guinea pigs. Before Dr. Kessler, we had Diethylstilbestrol (DES) and
the Dalkon Shield. I would venture that nobody would ever want that period in
America's health history repeated. Dr. Kessler has made great strides toward main-
taining the scientific, ethical and legal standard that medical devices must meet the
safe and effective scientific threshold. Not proven unsafe and not proven ineffective
is not the standard, never was the standard and should never be the standard.

loved ones can then perform their own risk benefit analysis. Only after that infor-
mation is provided them can there be true informed consent which is a choice made
freely and aft«r consideration. Then manufacturers of such products could be pro-
vided immunity from suit. As an extension of this process, eiTorts to develop alter-
native and safe products to improve the risk/benefit ratio must be supported.

gress is attempting to provide further protection for industry and strip consumers
of protection at the same time as it is attempting to limit the scope and reach of
responsibility by the FDA. If there is to be reform, then reform the bankruptcy laws
to make it difficult, if not impossible, for manufacturers to run to hide in bank-
ruptcy only to leave the citizen/taxpayer to pick up the tab for corporate wrong-

If our system of compensation via the judiciary is further limited, people who are
irnured will not have enough money to care for their expanded medical needs. They
will increasingly turn to local government for medical assistance and to the Federal
Government lor Social Security disability. And once again, taxpayers will foot the
bill for a bailout of enormous proportions.

Lobbyist groups welcome former FDA employees into their midst with enthu-
siasm. There should be a waiting period for all former government employees to join
lobbying groups and trade associations. Even the most honorable FDA employee
who is planning to become a lobbyist has a mixed agenda. In this case, the appear-
ance of impropriety is impropriety itself because it impugns the integrity of the FDA
as an institution.

For every plaintifPs lawjyer that tort reformers cite as earning tons of money,
there is a defense firm making much more money on a regular basis and up front.
As a member of the Tort Claimants Committee for the Dow Coming Bankruptcy,
I can assure you that Defense law firms have billed Dow Coming for well over thir-
ty-six million dollars. Plaintifl's attorneys haven't collected a dime and may never
collect a dime. In the past two years, defense firms have billed $190 million in costs
to implant manufacturers. This fact was placed in record during the bankruptcy
hearings of Dow Coming before Judge Arthur Spector of Michigan.

The standards of the FDA are that a product must be proven safe. Not Proven Un-
safe is decidedly diiterent. It is important to the healtn and safety of every Amer-
ican that you and the lobbyists who approach you remain mindful of this basic
truth. That standard — to be proven safe — must never be altered. We are entitled to
that security. A product/recipient registry would make for easy recall of a faulty

5. INFORMATION, INFORMATION, INFORMATION. It must be correct and free
flowing. It must not be weighted and manipulated. It must be readily available in
language that is understandable. Without it, consumers of medical devices are
doomed. Their doctors are doomed by the liability of failure to inform. Manufactur-
ers are doomed by failure to inform and breaches of responsibility. Dow Coming
stated the risks of auto-immune disease in their 1985 package insert — more than
twenty years after the development of their silicone product. They did so only after


losing Stem v Dow Coming, a case where a woman proved causation of autoimmune