The Bleeding Edge Page #2

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I felt it go into my tube.

I remember hearing the clicking noises.

I felt it expand.

Um, it was pretty intense.

After the procedure,

I was running fevers a lot.

The bleeding was almost continual.

There may be a day or two

during the month when I wasn't bleeding.

The sharp, stabbing pain on my left side

was getting more and more intense.

So I made an appointment to go in

and have an exam.

The doctor ordered an ultrasound.

He came in and he looked at the screen

and just said, "Oh, it looks likeone

of her Essure devices is in her uterus."

And I was kind of in shock.

So he says,

"You know, we need to get these out."

And I agreed.

Woke up and the doctor said,

"Everything went good."

You know. "Go home and heal and rest

and you should feel better."

But after the procedure,

I started having problems again.

The bleeding started picking up.

My husband had gone with me

to the hospital

and we're in a room,

and I've got the IV in...

and just blood exploded out of me.

Like, it looked like a horror scene.

And there were large clots

all over the floor.

And he went out in the hallway

and just screamed for someone to come,

and they all just came in.

They threw me on a gurney, and off I went,

stretcher down the hallway.

I was scared.

I was really thinking about...

"What's gonna happen to my kids

if I don't wake up?"

The old-time medicine man

would sell his snake oil

by positively guaranteeing

it would cure any and every disease

known to man and beast.

Fortunately,

this form of quackery in medicine

is gradually being eliminated

by our food and drug laws,

but there's still another form,

equally dangerous

and far more difficult to control.

Phony machines and devices,

which are supposed to diagnose

and treat disease.

Unlike new drugs,

therapeutic devices do not have to be

proved either safe or effective

before they are sold or used.

The history

of medical devices is odd.

There was an explosion in the 1920s

and '30s and '40s of fraudulent devices

that pretended to put sound waves

into the body to cure cancer

or any number of these weird devices.

Some were dangerous, such as ones

that had radioactive qualities.

There are some as phony

as a three dollar bill.

Like this Zerret Applicator, for example,

which has claimed to cure arthritis

with Z-rays.

There are no Z-rays.

Investigate before you invest

in health services or products.

Help stamp out quackery.

This has been

a public service announcement

from the Food and Drug Administration.

For many years,

devices just came onto the market

with the anecdotes

of doctors who used them,

who would say, "Well, I think it works."

It was only with

the Medical Device Amendments of 1976

that devices came under control of FDA.

At that point, industry argued,

"We don't want to have to test everything

we're already using,

pacemakers and other devices."

And the FDA said,

"Okay, you can grandfather in

anything that was on the market

prior to 1976.

The regulation of medical devices

has always been less than ideal.

Since 1976, the complexity of devices,

the number of devices,

the types of devices,

just rapidly expanded.

So we have the same framework

that was imposed, you know, 40 years ago

for a device world that is much more

complicated today.

Dr. Kessler,

please proceed when ready, sir.

Mr. Chairman, Americans rightfully expect

public health decisions...

to be made in their interest

and to be based on the best science

and medicine.

I was appointed as FDA commissioner

by the first President Bush

and asked to stay on by President Clinton.

FDA is the most important

consumer protection agency in the world.

It regulates virtually everything

that comes in contact with the body.

FDA is organized by centers.

So there's a center for foods.

There's a center for drugs,

there's a center for biologics

and there's a center for medical devices.

And FDA does a credible job

with the vast majority of products.

The problem we have...

is that, when it comes to medical devices,

we built a system that doesn't work.

Before I went into medicine,

I worked as a bike mechanic.

I always have loved taking things apart

and putting them back together again.

I grew up in Alaska.

Both my parents were physicians.

So I had a lot of knowledge

about medicine in general.

He's probably the most genuine person

you'll ever meet.

He's very caring, giving,

honest, and his patients love him.

That head now is ceramic.

The stem is titanium alloy, same as...

The first operation I ever saw

as a third-year medical student

was a hip replacement.

And I loved it. Very mechanical.

Something's broken and you fix it.

And it's... it's the simplicity of it.

He was having

a lot of degenerative hip issues himself.

And, on the one side,

the pain was more prevalent

and persistent.

It was starting to limit his bike riding.

The hip was getting

progressively more painful.

I realized,

doing the 100-Mile Winter Race,

that I could never do that again

unless I got the hip replaced.

The most critical fundamental

about hip replacement

is what are the materials of the parts

and pieces that rub together?

The most commonly used combinations

are ceramic-on-ceramic,

ceramic-on-plastic, metal-on-plastic,

and metal-on-metal.

The metal is almost exclusively

chrome cobalt.

Cobalt is used in a lot of machine alloys,

because it's made very, very hard.

It's one reason

that we use it in joint replacement.

I was swayed

to the metal-on-metal ASR hip

because that particular device

had been marketed

specifically

to exceptionally active individuals.

Within six weeks after my operation,

I did a 200-mile road race

without a lot of difficulty.

I... I thought it was great.

Most people probably believe,

when they get a medical device implanted,

be it a pacemaker or a joint,

that those medical devices

have undergone appropriate testing

to demonstrate that they are safe

and effective

before they came on the market

and doctors started using them.

But for most moderate

and high-risk devices,

that is not the case.

Originally, Congress intended

that almost all new devices

go through pre-market approval.

A PMA is similar

to a new drug application,

in that a manufacturer

must test it first in humans,

compile all this data,

and then present that to FDA scientists,

who will approve the device

if in fact it is safe and effective.

Industry argues, "We're innovating,

we're changing products every year

and that costs a lot of money, to test

each of those iterations in humans.

So Congress established

the 510 process.

For the 510 pathway,

all the manufacturer needs to demonstrate

is that their device is substantially

equivalent, is the regulatory term,

to another device

that's already on the market.

That provision,

which was meant as an exception,

in essence, a little loophole...

That exception became the rule.

So the vast majority of devices today,

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