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Good afternoon, everyone,
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and welcome to the Global Summit
for Medical Technology.
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Here in this room,
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many of you
have inspired generational leaps
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in medical technologies.
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You've created whole new fields
of medical advances.
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You've explored new horizons
and broken barriers.
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And everything we do is a means to the end
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of unleashing innovation
to improve and save lives.
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Watches and cell phones
that monitor blood sugar.
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3-D printers to create prosthetic limbs.
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Artificial intelligence
that today diagnoses melanoma.
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All of these things exist today.
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So let's pause for a minute
and take a look at the future.
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What if, by 2050,
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we have micro laboratories
implanted in our bodies
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that predict illnesses
before we ever get sick?
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What if, by 2050, we have 3-D printers
creating custom biomechanical organs?
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Or what if artificial intelligence
can be used to predict heart attacks
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before they even happen?
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If we succeed...
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imagine the impact we will have
on medical care.
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Let's continue to improve lives
by unleashing innovation.
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Everyone is intimidated by a shark. Become
a Card Shark AMERICASCARDROOM.COM
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Before you're born,
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they use medical devices to find out
when you're gonna be born.
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When you're born,
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they use medical devices
to find out how healthy you are.
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When you're growing up,
they oftentimes use medical devices
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to enhance what's going on with you.
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Medical devices are a way of life
in America.
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They are a way of life
in postindustrial society.
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They are a reason,
in some ways, for postindustrial society.
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They help us live longer.
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They give us better quality of life.
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And they're just about everywhere.
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There are devices
that are truly lifesaving.
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My husband has a pacemaker in.
I'm glad for it.
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It saved his life.
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I have a cataract lens in
that makes me see beautifully.
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It's everything from the very simple
little thing like a tongue depressor
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to breast implants,
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drug-eluting stents.
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There's such an array of devices.
It's pretty amazing.
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The medical device industry
is a 300 billion-a-year industry.
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This is big business.
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It's kind of a parallel
to the drug industry,
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and it isn't nearly as well understood.
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People think pharma's got power.
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No, no, no, no.
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The device industry
has much more power than pharma.
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The medical device industry has been
expanding faster
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than just about any other industry.
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And that's because technology
is just running away right now.
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And it's running away faster than we're
keeping up with the actual science.
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We're living
in a very highly technological society,
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and medical technology
is a... a wonder and a miracle.
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But because it's everywhere,
we have to be careful.
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I grew up in Western New York,
right between Rochester and Buffalo.
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I'm a mail carrier.
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And I work in the morning,
delivering mail to 70 mailboxes.
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I'm married.
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Hey, Bud. Do me a favor?
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I was engaged
to somebody else,
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and we broke up, and my friends threw me
a party to try to make me feel better.
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And, um, he was driving by,
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and one of my friends yelled out to him,
"Porch party!"
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A friend of mine invited me in,
and that's kind of where we met.
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What did you like about her?
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Everything.
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My daughter didn't have a father
in her life,
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and Pete's children lost their mother
when she passed away.
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So to come together
and all of us to just have each other,
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it was just a blessing.
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My last child was born in 2009.
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I was 37 when we became pregnant.
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We had decided,
you know, we wanted to have one together,
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but that was enough.
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So I went and spoke to my ob-gyn.
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And he talked to me
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about a new permanent birth control device
called Essure,
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which could be done right in the office,
and I could go back to work the next day.
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Put them in there. Yeah.
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Wow!
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You protect...
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...and prevent...
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...and even plan ahead.
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But what about your birth control?
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Maybe it's time to consider the proven,
permanent birth control of Essure.
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Essure is
a permanent sterilization device.
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It is made out of
little four-centimeter coils.
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It's inserted through the uterus
and placed inside of the fallopian tubes.
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It's intentionally designed
to cause an inflammatory response,
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which generates scar tissue.
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The scar tissue closes off
the fallopian tubes permanently,
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blocking the sperm
and the egg from meeting,
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therefore preventing pregnancy.
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The early studies that were done
to get this device approved
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suggested it's 99% effective
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in closing the fallopian tube
and causing sterilization.
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It originally was designed by Conceptus
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and then bought by Bayer.
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It was marketed as a better choice
than the traditional tubal ligation
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The Essure procedure does not require
any incisions.
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And because there are no incisions,
the procedure does not leave any scars.
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And when it comes to recovery
after the Essure procedure,
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women were typically discharged
from the medical facility
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within 45 minutes.
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It took no time out of my life.
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And there was no chance
of having to go under anesthesia.
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I was a nurse assisting
in the placement of Essure
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during the clinical trials.
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So I watched the procedure.
I thought it was simple.
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It was non-surgical, it was permanent,
and it was everything I was looking for.
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Seeing how easy it was to put it in,
I thought I should do it too.
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For us, we were now allowed
to have a type of intimacy...
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The company liked my story
because I was a nurse,
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I'd participated
on both ends of the product.
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So I was invited to be a spokesperson.
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I even went so far as I had my own website
called Ask Gaby.
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Patients would to me,
doctors would write to me.
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I told them all the benefits.
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I used to tell them that it took longer
to get your nails done
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than it did to get sterilized.
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Where's your headband?
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Oh, hi!
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How was school?
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- We had to do dance inside, but...
- Yeah?
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We were inside the whole time.
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I have a full-time job in a business firm.
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I am an account executive.
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I love my job.
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I have four daughters.
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And I enjoy every moment
with my kids.
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I want to go on Area 51.
You've got to try that!
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My husband and I had decided
that four kids was enough.
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So when I went to my doctor,
my doctor recommended Essure.
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Wait, let me take a picture
of all you winners.
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Smile!
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Okay.
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He said that it was easy.
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You come in the office,
you leave and you're good.
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You go back to your normal life.
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Thread the Essure device
through the introducer
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while you hold the hysteroscope.
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Slowly and steadily advance
the Essure delivery system
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into the fallopian tube.
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He said I shouldn't feel anything.
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Just two little devices
that I wouldn't even notice.
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But the moment
I stepped out of the doctor's office,
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I started feeling cramping.
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Then, in the first week,
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I started bleeding
more than I have ever bled
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in my whole life during a period.
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I called the doctor.
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He's like, "Those two little things
doesn't do anything,
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doesn't do all those changes
that you're telling me."
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So I just kept continuing to believe
that it was in my head.
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I went in for the procedure.
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I could feel the whole thing.
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I felt it go into my tube.
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I remember hearing the clicking noises.
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I felt it expand.
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Um, it was pretty intense.
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After the procedure,
I was running fevers a lot.
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The bleeding was almost continual.
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There may be a day or two
during the month when I wasn't bleeding.
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The sharp, stabbing pain on my left side
was getting more and more intense.
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So I made an appointment to go in
and have an exam.
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The doctor ordered an ultrasound.
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He came in and he looked at the screen
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and just said, "Oh, it looks like one
of her Essure devices is in her uterus."
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And I was kind of in shock.
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So he says,
"You know, we need to get these out."
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And I agreed.
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Woke up and the doctor said,
"Everything went good."
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You know. "Go home and heal and rest
and you should feel better."
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But after the procedure,
I started having problems again.
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The bleeding started picking up.
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My husband had gone with me
to the hospital
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and we're in a room,
and I've got the IV in...
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and just blood exploded out of me.
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Like, it looked like a horror scene.
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And there were large clots
all over the floor.
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And he went out in the hallway
and just screamed for someone to come,
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and they all just came in.
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They threw me on a gurney, and off I went,
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stretcher down the hallway.
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I was scared.
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I was really thinking about...
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"What's gonna happen to my kids
if I don't wake up?"
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The old-time medicine man
would sell his snake oil
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by positively guaranteeing
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it would cure any and every disease
known to man and beast.
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Fortunately,
this form of quackery in medicine
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is gradually being eliminated
by our food and drug laws,
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but there's still another form,
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equally dangerous
and far more difficult to control.
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Phony machines and devices,
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which are supposed to diagnose
and treat disease.
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Unlike new drugs,
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therapeutic devices do not have to be
proved either safe or effective
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before they are sold or used.
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The history
of medical devices is odd.
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There was an explosion in the 1920s
and '30s and '40s of fraudulent devices
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that pretended to put sound waves
into the body to cure cancer
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or any number of these weird devices.
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Some were dangerous, such as ones
that had radioactive qualities.
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There are some as phony
as a three dollar bill.
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Like this Zerret Applicator, for example,
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which has claimed to cure arthritis
with Z-rays.
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There are no Z-rays.
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Investigate before you invest
in health services or products.
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Help stamp out quackery.
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This has been
a public service announcement
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from the Food and Drug Administration.
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For many years,
devices just came onto the market
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with the anecdotes
of doctors who used them,
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who would say, "Well, I think it works."
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It was only with
the Medical Device Amendments of 1976
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that devices came under control of FDA.
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At that point, industry argued,
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"We don't want to have to test everything
we're already using,
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pacemakers and other devices."
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And the FDA said,
"Okay, you can grandfather in
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anything that was on the market
prior to 1976.
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The regulation of medical devices
has always been less than ideal.
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Since 1976, the complexity of devices,
the number of devices,
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the types of devices,
just rapidly expanded.
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So we have the same framework
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that was imposed, you know, 40 years ago
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for a device world that is much more
complicated today.
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Dr. Kessler,
please proceed when ready, sir.
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Mr. Chairman, Americans rightfully expect
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public health decisions...
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to be made in their interest
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and to be based on the best science
and medicine.
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I was appointed as FDA commissioner
by the first President Bush
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and asked to stay on by President Clinton.
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FDA is the most important
consumer protection agency in the world.
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It regulates virtually everything
that comes in contact with the body.
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FDA is organized by centers.
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So there's a center for foods.
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There's a center for drugs,
there's a center for biologics
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and there's a center for medical devices.
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And FDA does a credible job
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with the vast majority of products.
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The problem we have...
249
00:14:47,345 --> 00:14:52,975
is that, when it comes to medical devices,
we built a system that doesn't work.
250
00:15:19,043 --> 00:15:22,380
Before I went into medicine,
I worked as a bike mechanic.
251
00:15:23,172 --> 00:15:28,678
I always have loved taking things apart
and putting them back together again.
252
00:15:33,015 --> 00:15:34,267
I grew up in Alaska.
253
00:15:34,934 --> 00:15:36,811
Both my parents were physicians.
254
00:15:36,894 --> 00:15:40,773
So I had a lot of knowledge
about medicine in general.
255
00:15:42,942 --> 00:15:46,571
He's probably the most genuine person
you'll ever meet.
256
00:15:46,654 --> 00:15:49,866
He's very caring, giving,
257
00:15:49,949 --> 00:15:53,035
honest, and his patients love him.
258
00:15:53,536 --> 00:15:55,872
That head now is ceramic.
259
00:15:55,955 --> 00:15:58,624
The stem is titanium alloy, same as...
260
00:15:58,708 --> 00:16:02,253
The first operation I ever saw
as a third-year medical student
261
00:16:02,336 --> 00:16:03,588
was a hip replacement.
262
00:16:03,671 --> 00:16:06,174
And I loved it. Very mechanical.
263
00:16:07,133 --> 00:16:09,177
Something's broken and you fix it.
264
00:16:09,260 --> 00:16:11,345
And it's... it's the simplicity of it.
265
00:16:13,639 --> 00:16:16,934
He was having
a lot of degenerative hip issues himself.
266
00:16:17,018 --> 00:16:18,978
And, on the one side,
267
00:16:19,061 --> 00:16:21,272
the pain was more prevalent
and persistent.
268
00:16:21,814 --> 00:16:25,151
It was starting to limit his bike riding.
269
00:16:26,444 --> 00:16:29,780
The hip was getting
progressively more painful.
270
00:16:30,323 --> 00:16:33,701
I realized,
doing the 100-Mile Winter Race,
271
00:16:33,784 --> 00:16:37,079
that I could never do that again
unless I got the hip replaced.
272
00:16:37,872 --> 00:16:41,083
The most critical fundamental
about hip replacement
273
00:16:41,167 --> 00:16:44,629
is what are the materials of the parts
and pieces that rub together?
274
00:16:44,712 --> 00:16:49,091
The most commonly used combinations
are ceramic-on-ceramic,
275
00:16:49,634 --> 00:16:54,305
ceramic-on-plastic, metal-on-plastic,
and metal-on-metal.
276
00:16:54,847 --> 00:16:57,767
The metal is almost exclusively
chrome cobalt.
277
00:16:58,434 --> 00:17:03,731
Cobalt is used in a lot of machine alloys,
because it's made very, very hard.
278
00:17:03,814 --> 00:17:06,234
It's one reason
that we use it in joint replacement.
279
00:17:07,318 --> 00:17:10,905
I was swayed
to the metal-on-metal ASR hip
280
00:17:10,988 --> 00:17:13,491
because that particular device
had been marketed
281
00:17:13,574 --> 00:17:15,993
specifically
to exceptionally active individuals.
282
00:17:17,245 --> 00:17:19,664
Within six weeks after my operation,
283
00:17:19,747 --> 00:17:24,293
I did a 200-mile road race
without a lot of difficulty.
284
00:17:24,919 --> 00:17:26,462
I... I thought it was great.
285
00:17:30,550 --> 00:17:34,887
Most people probably believe,
when they get a medical device implanted,
286
00:17:34,971 --> 00:17:37,098
be it a pacemaker or a joint,
287
00:17:37,765 --> 00:17:42,687
that those medical devices
have undergone appropriate testing
288
00:17:42,770 --> 00:17:45,481
to demonstrate that they are safe
and effective
289
00:17:45,565 --> 00:17:48,442
before they came on the market
and doctors started using them.
290
00:17:48,526 --> 00:17:51,571
But for most moderate
and high-risk devices,
291
00:17:51,654 --> 00:17:53,155
that is not the case.
292
00:17:53,239 --> 00:17:56,075
Originally, Congress intended
that almost all new devices
293
00:17:56,158 --> 00:17:57,910
go through pre-market approval.
294
00:17:58,327 --> 00:18:01,414
A PMA is similar
to a new drug application,
295
00:18:01,539 --> 00:18:05,042
in that a manufacturer
must test it first in humans,
296
00:18:05,126 --> 00:18:07,044
compile all this data,
297
00:18:07,128 --> 00:18:09,171
and then present that to FDA scientists,
298
00:18:09,255 --> 00:18:12,341
who will approve the device
if in fact it is safe and effective.
299
00:18:12,425 --> 00:18:16,637
Industry argues, "We're innovating,
we're changing products every year
300
00:18:16,721 --> 00:18:20,391
and that costs a lot of money, to test
each of those iterations in humans.
301
00:18:20,516 --> 00:18:23,686
So Congress established
the 510 process.
302
00:18:23,769 --> 00:18:27,898
For the 510 pathway,
all the manufacturer needs to demonstrate
303
00:18:27,982 --> 00:18:31,569
is that their device is substantially
equivalent, is the regulatory term,
304
00:18:31,652 --> 00:18:34,113
to another device
that's already on the market.
305
00:18:34,614 --> 00:18:35,698
That provision,
306
00:18:36,699 --> 00:18:38,576
which was meant as an exception,
307
00:18:39,243 --> 00:18:40,995
in essence, a little loophole...
308
00:18:41,621 --> 00:18:43,706
That exception became the rule.
309
00:18:44,415 --> 00:18:46,959
So the vast majority of devices today,
310
00:18:47,043 --> 00:18:52,465
regrettably, are regulated
under this framework.
311
00:18:52,548 --> 00:18:54,091
This really can cause problems
312
00:18:54,175 --> 00:18:57,595
when one medical device is approved
on the basis of being
313
00:18:57,678 --> 00:19:00,014
substantially equivalent
to a previous medical device
314
00:19:00,097 --> 00:19:02,516
that was approved
because it was substantially equivalent
315
00:19:02,600 --> 00:19:04,560
to an earlier medical device than that.
316
00:19:04,644 --> 00:19:06,646
You end up
with what we call a daisy chain.
317
00:19:07,313 --> 00:19:09,231
And then, quite often what you found
318
00:19:09,315 --> 00:19:12,318
is that some of these predicate devices,
as they call them...
319
00:19:13,069 --> 00:19:15,821
have been recalled from the market
because they've been failing.
320
00:19:15,905 --> 00:19:18,366
I called the FDA and asked them,
321
00:19:18,449 --> 00:19:21,994
"How can you clear something
based on a predicate device
322
00:19:22,078 --> 00:19:23,913
that's already been shown to be dangerous?
323
00:19:23,996 --> 00:19:27,792
And they said,
"We don't judge what the prior device is."
324
00:19:27,875 --> 00:19:31,087
So even if the device was recalled
because it was dangerous,
325
00:19:31,170 --> 00:19:34,298
you can still use it as a predicate
and get your device cleared
326
00:19:34,382 --> 00:19:36,258
'cause it's substantially equivalent.
327
00:19:36,342 --> 00:19:39,387
So there's a lot of problems
with that 510 system.
328
00:19:39,470 --> 00:19:42,473
And that's how metal-on-metal hips
got on the market.
329
00:19:45,935 --> 00:19:48,854
A year and a half
after my operation,
330
00:19:49,188 --> 00:19:51,107
I started having a slew
331
00:19:51,190 --> 00:19:54,193
of health issues that I hadn't had before.
332
00:19:55,277 --> 00:19:58,406
I developed a tremor
in my non-dominant hand.
333
00:19:59,615 --> 00:20:00,991
His ears were ringing.
334
00:20:01,075 --> 00:20:04,453
He was starting to repeat himself a lot
335
00:20:04,537 --> 00:20:06,330
and explain things...
336
00:20:07,540 --> 00:20:08,541
over and over.
337
00:20:09,250 --> 00:20:14,547
As time went on,
those issues accelerated, and then,
338
00:20:14,630 --> 00:20:17,883
I... I had a psychological decompensation.
339
00:20:18,551 --> 00:20:21,846
He was attending a conference,
and I got a call.
340
00:20:22,680 --> 00:20:26,851
He had trashed a hotel room.
341
00:20:27,351 --> 00:20:29,228
He wrote all over the walls.
342
00:20:29,311 --> 00:20:31,188
He took pens, Sharpies,
343
00:20:31,272 --> 00:20:33,858
he wrote on the ceiling,
he wrote all over.
344
00:20:33,941 --> 00:20:36,193
And when that was done, he took soap...
345
00:20:36,819 --> 00:20:38,654
and he wrote on the mirrors.
346
00:20:38,738 --> 00:20:41,574
It was a full-on breakdown.
347
00:20:43,617 --> 00:20:45,828
You could see it in his eyes.
348
00:20:46,412 --> 00:20:47,246
And just...
349
00:20:47,705 --> 00:20:48,748
in turmoil...
350
00:20:50,124 --> 00:20:51,375
knowing full well...
351
00:20:52,126 --> 00:20:53,669
that he'd lost it.
352
00:20:54,837 --> 00:20:58,799
All the while, he's still thinking.
He's still connecting the dots.
353
00:20:59,967 --> 00:21:03,095
Eventually,
I started checking my blood and urine.
354
00:21:03,679 --> 00:21:09,101
And my levels of cobalt
were 100 times what I should have.
355
00:21:09,935 --> 00:21:13,189
I started calling up engineers at DePuy
356
00:21:13,272 --> 00:21:16,776
and salespeople, saying,
"Is anyone else talking about this?"
357
00:21:16,859 --> 00:21:18,152
The answer back was,
358
00:21:18,235 --> 00:21:20,529
"No, we've never heard
of that being a problem."
359
00:21:21,363 --> 00:21:25,075
But it was clear to me
that the hip would need to be redone.
360
00:21:25,576 --> 00:21:30,122
So I chose a different model
with a plastic socket and a ceramic head.
361
00:21:31,624 --> 00:21:34,710
When my doctor went in there
to revise my hip,
362
00:21:34,794 --> 00:21:38,172
he found a virtual crankcase
of metal sludge.
363
00:21:39,048 --> 00:21:43,761
And the critical ligaments, what we call
the hip capsule that holds a hip in place,
364
00:21:44,261 --> 00:21:45,846
that had just kind of liquefied.
365
00:21:49,934 --> 00:21:53,437
Within a month,
I had an incredible recovery
366
00:21:53,521 --> 00:21:58,067
in terms of my psychologic symptoms
and my ability to think.
367
00:21:59,735 --> 00:22:03,197
All the other symptoms
magically disappeared.
368
00:22:04,240 --> 00:22:05,491
I got my husband back.
369
00:22:06,784 --> 00:22:08,202
Come in.
370
00:22:09,078 --> 00:22:10,037
Hey, Rodney.
371
00:22:10,120 --> 00:22:11,163
Hello, Dr. Tower.
372
00:22:11,247 --> 00:22:12,289
A long time, no see.
373
00:22:12,373 --> 00:22:13,499
It's been a while.
374
00:22:13,833 --> 00:22:15,668
How was your drive?
375
00:22:16,043 --> 00:22:20,673
It was... The last 100 miles was snowy,
but it was a good drive before that.
376
00:22:21,423 --> 00:22:24,760
Unless I'd personally
experienced this myself...
377
00:22:25,427 --> 00:22:28,472
I wouldn't believe an orthopedic implant
378
00:22:28,556 --> 00:22:30,850
could cause neurologic problems.
379
00:22:31,517 --> 00:22:33,727
But with my experience,
380
00:22:33,811 --> 00:22:37,648
I started to notice problems
in my own patients,
381
00:22:37,731 --> 00:22:41,360
and it's not just metal-on-metal,
but metal-on-plastics, too.
382
00:22:41,443 --> 00:22:43,112
I was going blind.
383
00:22:43,195 --> 00:22:47,116
I was seeing stars,
constant stars in my eyes.
384
00:22:47,199 --> 00:22:48,868
I couldn't remember words.
385
00:22:49,493 --> 00:22:53,581
I'd start a sentence, then couldn't think
of the word that was supposed to go next
386
00:22:53,664 --> 00:22:55,207
Problems with memory.
387
00:22:55,416 --> 00:22:58,627
I was writing it off to, um, aging.
388
00:22:58,919 --> 00:23:01,630
I thought I had Alzheimer's or dementia.
389
00:23:02,423 --> 00:23:03,799
And that was really scary.
390
00:23:04,216 --> 00:23:07,303
Just diagnosed me with Parkinson's.
391
00:23:07,761 --> 00:23:11,599
My mind was... slowly slipping away.
392
00:23:12,433 --> 00:23:13,976
I've seen so much of this
393
00:23:14,059 --> 00:23:17,146
that now,
when a patient comes into the office,
394
00:23:17,229 --> 00:23:21,442
if they have an artificial hip
and I know it has a chrome cobalt piece,
395
00:23:21,942 --> 00:23:25,529
I routinely check
the level of cobalt in their urine.
396
00:23:26,071 --> 00:23:28,741
I've just been progressively
getting better and better
397
00:23:28,824 --> 00:23:31,869
since I had the hips both replaced.
398
00:23:32,202 --> 00:23:34,663
It's very hard
to convince people this problem exists,
399
00:23:34,747 --> 00:23:36,624
unless you show reversibility.
400
00:23:36,707 --> 00:23:39,251
Get rid of the cobalt,
the problem goes away.
401
00:23:39,376 --> 00:23:40,961
It's hard for people to argue with that.
402
00:23:41,545 --> 00:23:45,674
The real breakthrough
in the last 18 months
403
00:23:45,758 --> 00:23:50,012
has been the ability to actually image
the neurologic problem.
404
00:23:51,722 --> 00:23:53,766
Dr. Tower came down
to the Imaging Center
405
00:23:53,849 --> 00:23:55,851
to look at an MRI of the hip
406
00:23:55,935 --> 00:23:58,562
and we got into a discussion
about the symptoms
407
00:23:58,646 --> 00:24:00,648
of cobalt poisoning toxicity,
408
00:24:01,148 --> 00:24:03,275
and he mentioned cognitive issues.
409
00:24:03,359 --> 00:24:08,656
Dr. Bridges said, "Gee, yeah,
we ought to get an FDG PET brain scan
410
00:24:09,323 --> 00:24:13,077
on a patient that you think
is having the neurologic problems,
411
00:24:13,160 --> 00:24:14,787
because I bet we can see it.
412
00:24:15,371 --> 00:24:18,874
We have a tool that can
actually detect dementias like Alzheimer's
413
00:24:18,958 --> 00:24:22,461
years before they become clinically
evident on physical examination.
414
00:24:22,962 --> 00:24:27,299
Basically, what I'm looking at
is the slice through the basal ganglia.
415
00:24:27,383 --> 00:24:28,384
Blue is bad.
416
00:24:28,467 --> 00:24:32,388
Blue is bad. Those are the areas
of the brain that are most affected.
417
00:24:32,471 --> 00:24:34,723
By this scale, we're looking
at 2 to 3 standard deviation.
418
00:24:34,807 --> 00:24:37,935
At least greater
than two standard deviations below normal.
419
00:24:38,185 --> 00:24:40,938
The first patient came up very abnormal.
420
00:24:41,021 --> 00:24:43,857
So then he suggested we do another patient
421
00:24:43,941 --> 00:24:46,735
and then another patient,
and they all began to look the same.
422
00:24:47,528 --> 00:24:51,281
You've got the typical findings
on the brain scan
423
00:24:51,365 --> 00:24:53,742
that we're seeing
with the other 23 patients.
424
00:24:53,826 --> 00:24:55,369
So you're number 24.
425
00:24:58,414 --> 00:24:59,832
Doing a study on this
426
00:24:59,915 --> 00:25:03,293
is something that I feel
I'm morally obligated to do.
427
00:25:04,044 --> 00:25:07,214
But I don't think I should be the guy
who has to do that.
428
00:25:08,340 --> 00:25:12,261
This work really needs to be reproduced
with hundreds,
429
00:25:12,344 --> 00:25:16,849
if not thousands, of patients
to fully understand it.
430
00:25:17,516 --> 00:25:21,395
I think the CDC should be doing it.
I think the FDA should be doing it.
431
00:25:21,478 --> 00:25:23,439
And I've approached all those people,
432
00:25:23,522 --> 00:25:26,191
and just not getting
a lot of support there.
433
00:25:28,944 --> 00:25:32,448
I'm horrified because,
the more I'm looking at it,
434
00:25:33,574 --> 00:25:36,702
I'm beginning to wonder,
is cobalt the new mercury poisoning?
435
00:25:38,120 --> 00:25:40,664
Are these people being relegated
to the dustbin
436
00:25:40,748 --> 00:25:44,376
because they have what somebody
misperceives as dementia?
437
00:25:45,544 --> 00:25:46,920
How many people have been
438
00:25:47,004 --> 00:25:51,300
misdiagnosed
with a permanent disease process
439
00:25:51,383 --> 00:25:54,094
that actually have a reversible
disease process?
440
00:25:54,470 --> 00:25:56,180
That's the horror right there.
441
00:26:21,038 --> 00:26:22,998
Innovation lives here.
442
00:26:23,082 --> 00:26:27,669
It's the foundation of our legacy
and the backbone of our DNA.
443
00:26:28,420 --> 00:26:30,506
Our motto is never stop moving.
444
00:26:30,589 --> 00:26:35,135
And some of the words that are behind that
are just this relentless pursuit...
445
00:26:35,511 --> 00:26:39,640
of innovation that improves patient care.
446
00:26:46,188 --> 00:26:49,525
Industry likes to use the term
innovation, innovation, innovation.
447
00:26:49,900 --> 00:26:52,319
Innovation, to me,
means we've got something new,
448
00:26:52,402 --> 00:26:54,363
but we've got good evidence to support it.
449
00:26:54,446 --> 00:26:57,825
We've got good evidence about the benefits
and the harms.
450
00:26:57,908 --> 00:27:00,035
You're developing medicine,
you're bringing it forward.
451
00:27:00,119 --> 00:27:03,705
Without evidence, we don't know
whether it's really a development. It...
452
00:27:03,789 --> 00:27:05,499
You know? Who knows? You don't know.
453
00:27:05,791 --> 00:27:09,670
Surgeons and patients like the idea
that they're getting something new.
454
00:27:10,003 --> 00:27:13,090
I tell my patients
new equates to unproven.
455
00:27:13,924 --> 00:27:16,135
Companies can develop new products
456
00:27:16,218 --> 00:27:20,347
that may not be safer and more effective
than other products already on the market,
457
00:27:20,430 --> 00:27:22,724
but they will certainly
heavily promote them
458
00:27:22,808 --> 00:27:25,811
to doctors, to hospitals,
to drive up their profits.
459
00:27:26,395 --> 00:27:31,024
They wheel out patients and say,
"This person wouldn't be alive today
460
00:27:31,483 --> 00:27:34,486
if they didn't have
this innovative product."
461
00:27:34,903 --> 00:27:36,280
It's all very glossy.
462
00:27:36,363 --> 00:27:38,073
It's a slick machine.
463
00:27:38,657 --> 00:27:42,327
We've doubled life expectancy
in 150 years.
464
00:27:42,619 --> 00:27:44,580
And that's happened because of innovation.
465
00:27:45,289 --> 00:27:48,667
Just because you have a new technology
doesn't mean it's innovation.
466
00:27:48,750 --> 00:27:52,212
And, I think, too often I hear people say,
"Oh, you're gonna stifle innovation."
467
00:27:52,296 --> 00:27:54,256
They're not talking
about stifling innovation.
468
00:27:54,339 --> 00:27:58,552
They're talking about stifling, um,
putting untested devices on the market.
469
00:27:58,635 --> 00:28:00,095
That's not innovative.
470
00:28:07,311 --> 00:28:10,063
Before Essure,
the only times I was in the hospital
471
00:28:10,147 --> 00:28:11,773
was because I was pregnant.
472
00:28:13,567 --> 00:28:16,320
For the past three years
that I had the Essure,
473
00:28:16,403 --> 00:28:19,948
I've visited the hospital a lot
because of pain.
474
00:28:22,868 --> 00:28:26,079
I was working
and passed out 'cause of the pain,
475
00:28:26,455 --> 00:28:28,916
and I woke up
and I drove myself to the hospital.
476
00:28:30,042 --> 00:28:34,171
I'm more scared because,
if they have to admit me,
477
00:28:34,755 --> 00:28:37,341
I have to find someone
to take care of my kids.
478
00:28:38,050 --> 00:28:40,093
Especially because it's a school night.
479
00:28:40,802 --> 00:28:42,679
So I don't want them to miss school.
480
00:28:43,347 --> 00:28:44,723
Are you Ana Fuentes?
481
00:28:46,975 --> 00:28:49,478
After Essure,
my bleeding wouldn't stop.
482
00:28:50,437 --> 00:28:53,732
It came to the point that I had to start
wearing baby diapers.
483
00:28:54,399 --> 00:28:57,569
I couldn't even function
as a wife to my husband,
484
00:28:57,653 --> 00:28:59,821
and eventually, he ran away.
485
00:29:01,490 --> 00:29:03,450
One of the doctors that I had,
486
00:29:03,533 --> 00:29:07,871
he mentioned that most Latinas
have menstrual problems.
487
00:29:09,331 --> 00:29:10,832
So they thought it was...
488
00:29:11,416 --> 00:29:13,877
because I was Latina
that I would bleed a lot.
489
00:29:15,128 --> 00:29:18,215
But I'm like,
"I've been Latina since I was born
490
00:29:18,298 --> 00:29:20,050
and I became a...
491
00:29:20,133 --> 00:29:23,887
And my mom saw me grow up
and I never bleeded this much.
492
00:29:23,971 --> 00:29:26,682
So this doesn't have to do
with me being Latina."
493
00:29:43,615 --> 00:29:46,868
I've had a headache since 2011.
494
00:29:48,829 --> 00:29:50,747
Normally, the headache's about a four.
495
00:29:52,249 --> 00:29:55,002
And then at night, it starts spiking up.
496
00:29:55,627 --> 00:29:56,753
Seven, eight, nine.
497
00:29:57,421 --> 00:29:58,380
Sometimes ten.
498
00:30:07,222 --> 00:30:10,100
So this is my traction unit.
499
00:30:11,476 --> 00:30:13,520
It stretches my cervical spine,
500
00:30:13,770 --> 00:30:17,274
'cause the inflammation
gives me insane headaches.
501
00:30:21,737 --> 00:30:25,198
Before I had Essure put in,
I was really strong and really healthy.
502
00:30:26,658 --> 00:30:28,493
We went hiking, we went camping.
503
00:30:28,869 --> 00:30:31,288
I could do all the normal things
that moms do.
504
00:30:32,205 --> 00:30:34,499
It's hard for me
not to be doing those things.
505
00:30:42,215 --> 00:30:43,550
I did a little research.
506
00:30:43,800 --> 00:30:47,596
I didn't see too many people online
talking about Essure.
507
00:30:48,805 --> 00:30:52,934
And I said, "I have to warn my friends
and my family members,
508
00:30:53,018 --> 00:30:56,021
and I need to tell them
to stay away from this."
509
00:30:58,398 --> 00:31:00,359
So I started this little Facebook group
510
00:31:00,650 --> 00:31:04,071
called Essure Problems,
and I added all my girlfriends.
511
00:31:05,113 --> 00:31:07,282
I didn't really know
much about Facebook groups,
512
00:31:07,366 --> 00:31:11,453
but then slowly people that I didn't know
started commenting and saying,
513
00:31:11,536 --> 00:31:13,789
"Oh, my God,
this is what I'm going through."
514
00:31:14,498 --> 00:31:16,541
Just stories just started coming in.
515
00:31:19,628 --> 00:31:22,964
People just found me.
It just started snowballing.
516
00:31:23,048 --> 00:31:25,300
I remember hitting 65 people
517
00:31:25,384 --> 00:31:28,804
and going, "Wow, there's 65 people
that are having this problem."
518
00:31:29,429 --> 00:31:32,140
Every day, we had new people
joining the group.
519
00:31:33,100 --> 00:31:36,019
Women were telling their stories.
520
00:31:36,770 --> 00:31:40,232
The day that I was implanted,
I left the hospital
521
00:31:40,315 --> 00:31:41,691
and I was in pain.
522
00:31:41,775 --> 00:31:45,445
They told me to take some Ibuprofen
and it'll get better.
523
00:31:45,987 --> 00:31:52,119
Now I'm going to the OB this week to have
a full hysterectomy at 31 years old.
524
00:31:52,619 --> 00:31:56,206
Slowly, the progression of women
joining and having similar stories,
525
00:31:56,289 --> 00:31:59,251
um, we became a support group
for each other.
526
00:31:59,835 --> 00:32:04,047
And then we started finding information
about how the device was approved.
527
00:32:04,548 --> 00:32:06,758
We found out that Essure
went through something
528
00:32:06,842 --> 00:32:09,261
called the pre-market approval process,
or PMA.
529
00:32:10,720 --> 00:32:14,641
Pre-market approval
is the most stringent pathway
530
00:32:14,724 --> 00:32:16,268
to get a device approved.
531
00:32:16,351 --> 00:32:19,271
But even that process is not that strict.
532
00:32:19,479 --> 00:32:22,065
It's less rigorous
than the process for drugs.
533
00:32:22,816 --> 00:32:25,652
Most drugs had to have
two clinical trials,
534
00:32:25,735 --> 00:32:29,114
and they have to have large
numbers of patients.
535
00:32:29,197 --> 00:32:31,491
With devices, it's only one study.
536
00:32:31,575 --> 00:32:33,493
Those studies are often small.
537
00:32:33,577 --> 00:32:35,078
Sometimes it's 100 people.
538
00:32:35,162 --> 00:32:37,164
I've seen studies with 50 people.
539
00:32:37,622 --> 00:32:43,044
So the approval process
for the riskiest devices is not good.
540
00:32:44,629 --> 00:32:47,466
One of the members of the group
found the transcript
541
00:32:47,549 --> 00:32:49,551
for the 2002 approval meeting
542
00:32:49,885 --> 00:32:51,845
where the FDA approved Essure.
543
00:32:52,220 --> 00:32:54,848
I noticed at the bottom of the transcript
544
00:32:54,931 --> 00:32:56,933
that the entire meeting
had been videotaped
545
00:32:57,017 --> 00:33:00,061
by this video company,
and their phone number was there
546
00:33:00,437 --> 00:33:04,399
so I thought, "I should call them
and see if I can get a copy of that."
547
00:33:04,483 --> 00:33:06,776
And so I did, and they found it,
548
00:33:06,860 --> 00:33:10,489
and they said it was going to be
several hundred dollars.
549
00:33:10,572 --> 00:33:13,450
I put a post on the page.
I'm like, "I think we need this."
550
00:33:13,533 --> 00:33:18,121
And within 15 minutes, we raised $900
on the page, and I ordered those DVDs.
551
00:33:19,247 --> 00:33:21,958
All right.
Let's go ahead and get started.
552
00:33:22,042 --> 00:33:25,837
They approved this device
on such a small number of women
553
00:33:25,921 --> 00:33:28,089
that were followed
for such a short amount of time.
554
00:33:29,049 --> 00:33:31,718
The lead investigator
for the clinical trials
555
00:33:31,801 --> 00:33:34,012
who presented the evidence
556
00:33:34,095 --> 00:33:36,640
to the FDA
on the safety and efficacy of this device,
557
00:33:36,723 --> 00:33:39,392
he owned stock in this company.
558
00:33:39,476 --> 00:33:41,019
I have received compensation
559
00:33:41,102 --> 00:33:44,231
which now represents
a financial interest in the company.
560
00:33:44,940 --> 00:33:48,276
There was a paid spokesperson
that had Essure implanted herself.
561
00:33:49,110 --> 00:33:50,278
Gabriella Avina.
562
00:33:50,362 --> 00:33:52,197
They hired her to come and speak.
563
00:33:52,531 --> 00:33:55,742
It brought about a peace
to my life and to my relationship
564
00:33:55,825 --> 00:33:57,369
that I cannot express to you.
565
00:33:57,911 --> 00:34:02,374
And it was just mind-blowing
because they didn't have a lot of data
566
00:34:02,457 --> 00:34:04,668
for the questions
the panel members were asking.
567
00:34:05,001 --> 00:34:08,463
What would happen if you touched
the electrode to the coils?
568
00:34:08,547 --> 00:34:11,716
How much
uterine cavity will be compromised?
569
00:34:11,800 --> 00:34:14,886
The panel was not supplied with
a summary about compatibility testing.
570
00:34:14,970 --> 00:34:17,889
What about the tubal perforation issue?
571
00:34:17,973 --> 00:34:22,018
I don't know what happens to people
with metal sensitivity
572
00:34:22,143 --> 00:34:23,853
when you implant metals in them.
573
00:34:24,229 --> 00:34:28,066
They still approved it,
even with these open-ended questions.
574
00:34:28,149 --> 00:34:31,403
The device clearly met the criteria
of safety and effectiveness
575
00:34:31,486 --> 00:34:33,113
that are required for approval.
576
00:34:33,738 --> 00:34:36,116
At the end of the meeting,
577
00:34:36,199 --> 00:34:38,076
one of the panel members asked,
578
00:34:38,702 --> 00:34:41,663
"What are we gonna do
if we're seeing problems in ten years?"
579
00:34:42,330 --> 00:34:45,750
Private investigators would find
each of us, bring us back here,
580
00:34:45,834 --> 00:34:47,460
and ask us why we approved this.
581
00:34:52,215 --> 00:34:53,717
How could they joke about this?
582
00:34:53,800 --> 00:34:56,094
Like, they're joking about... us.
583
00:34:56,177 --> 00:34:59,514
You know, here we are, ten years later,
and all these problems...
584
00:35:00,015 --> 00:35:03,018
And... and, you know,
they approved it on... on a joke.
585
00:35:03,101 --> 00:35:07,230
If this is our FDA process
of medical device approval,
586
00:35:07,480 --> 00:35:10,108
then we have a big problem
in this country,
587
00:35:10,191 --> 00:35:11,943
because this is just one device.
588
00:35:16,948 --> 00:35:18,867
I'm from Nicholasville, Kentucky.
589
00:35:18,950 --> 00:35:21,703
Kind of a... Anywhere, USA.
590
00:35:22,829 --> 00:35:24,289
It's a small town.
591
00:35:24,372 --> 00:35:25,624
Great schools.
592
00:35:25,915 --> 00:35:27,876
Great people, wonderful church.
593
00:35:27,959 --> 00:35:30,337
I was in nursing.
594
00:35:30,837 --> 00:35:33,214
I did pediatrics, uh, children.
595
00:35:33,840 --> 00:35:36,009
And I just loved working with the people.
596
00:35:37,218 --> 00:35:39,679
My husband is a machinist
at General Electric.
597
00:35:39,971 --> 00:35:42,891
He works on the machines.
They're bigger than a house.
598
00:35:42,974 --> 00:35:44,309
He's my rock.
599
00:35:45,518 --> 00:35:47,270
Well, we met... Um...
600
00:35:48,271 --> 00:35:50,190
I was young and we were out partying.
601
00:35:50,690 --> 00:35:53,485
So, um, she was with a group of friends
602
00:35:53,568 --> 00:35:55,695
and I was kind of out on my own...
603
00:35:56,321 --> 00:35:58,698
um, looking for trouble, I should say.
604
00:35:59,616 --> 00:36:02,243
Ah... I found it!
605
00:36:03,411 --> 00:36:07,123
We've got a daughter
that's got a beautiful spirit.
606
00:36:07,749 --> 00:36:09,626
Very loving, very compassionate.
607
00:36:10,293 --> 00:36:12,837
Uh, make a great doctor one day,
if she chose to.
608
00:36:13,797 --> 00:36:15,924
I delivered my daughter at 41
609
00:36:16,299 --> 00:36:18,009
and I was working at the hospital,
610
00:36:18,093 --> 00:36:22,263
and when I would go to assist my patients
by transporting them from the bed,
611
00:36:22,347 --> 00:36:23,973
I would leak some.
612
00:36:24,057 --> 00:36:27,644
She started having some problem
with holding her urine.
613
00:36:28,228 --> 00:36:29,938
She went to the doctor to see about it.
614
00:36:30,730 --> 00:36:32,524
And, um, of course...
615
00:36:34,025 --> 00:36:36,736
they suggested some procedures.
616
00:36:36,820 --> 00:36:41,991
My doctor said, "We can take care
of that in a simple 45-minute procedure
617
00:36:42,075 --> 00:36:43,785
with this new thing called mesh.
618
00:36:44,494 --> 00:36:47,372
It's a simple, golden standard
outpatient surgery.
619
00:36:47,497 --> 00:36:50,750
It's better than sliced bread.
It's the new thing."
620
00:36:52,293 --> 00:36:57,882
Mesh is a polypropylene resin
that gets extruded into fibers
621
00:36:57,966 --> 00:37:00,635
and then woven and knit into a mesh.
622
00:37:01,219 --> 00:37:04,848
Johnson & Johnson saw that doctors
were starting to take hernia mesh
623
00:37:04,931 --> 00:37:08,977
and cut very little tiny pieces of it
to help support repairs
624
00:37:09,060 --> 00:37:13,189
where they felt they needed a little bit
extra because the woman's tissue was weak.
625
00:37:13,273 --> 00:37:15,108
So they said, "That's a great idea.
626
00:37:15,191 --> 00:37:18,153
Let's sell the hernia mesh
for pelvic floor treatments."
627
00:37:18,778 --> 00:37:22,115
As women get older,
and if they have several children,
628
00:37:22,198 --> 00:37:24,451
things start to bulge or drop.
629
00:37:24,534 --> 00:37:26,619
Patients come to us
and want things to be fixed.
630
00:37:26,703 --> 00:37:29,998
One approach is what's called
a native tissue repair,
631
00:37:30,081 --> 00:37:33,418
which is basically where we suture
things in place using stitches,
632
00:37:33,501 --> 00:37:34,586
suture material.
633
00:37:35,295 --> 00:37:41,176
Or, theoretically, one could use mesh
to augment the repair.
634
00:37:41,926 --> 00:37:44,053
The surgeon makes a cut in the vagina
635
00:37:44,137 --> 00:37:47,474
and then implants the mesh
to hold organs up in place.
636
00:37:48,224 --> 00:37:51,060
It costs about $25 to bring to market
637
00:37:51,144 --> 00:37:53,396
and they sell for about $2,000 a pop.
638
00:37:53,480 --> 00:37:58,401
I was told that it is superior to
the traditional surgery that's required.
639
00:37:59,152 --> 00:38:00,487
Very easy to place.
640
00:38:01,029 --> 00:38:03,072
Very, very few complications.
641
00:38:14,250 --> 00:38:17,962
I wish I could say that doctors
really understood
642
00:38:18,296 --> 00:38:20,799
the regulation of medical devices.
643
00:38:21,716 --> 00:38:26,304
But the fact is that's not what they do.
644
00:38:26,846 --> 00:38:29,265
That's not their area of expertise.
645
00:38:29,349 --> 00:38:33,853
We were surprised to see how little
surgeons knew, in our study,
646
00:38:33,937 --> 00:38:36,815
about the approval process for devices.
647
00:38:36,898 --> 00:38:40,902
Some of the surgeons seemed to think,
"Well, the FDA are taking care of this."
648
00:38:40,985 --> 00:38:43,446
That of course these devices
had been tested in humans.
649
00:38:45,949 --> 00:38:47,784
I came home from my surgery.
650
00:38:48,243 --> 00:38:51,079
I started having a lot of pain,
discomfort.
651
00:38:51,996 --> 00:38:55,458
I couldn't sit, I'd climb steps,
I felt like a 90-year-old woman.
652
00:38:55,542 --> 00:38:56,626
She had a bad fever.
653
00:38:57,377 --> 00:38:58,753
She was throwing up.
654
00:38:59,420 --> 00:39:02,423
We ended up going
to a few emergency rooms.
655
00:39:03,049 --> 00:39:05,718
We'd seen so many doctors.
656
00:39:06,302 --> 00:39:09,430
They didn't know what was going on
with her. They had no clue.
657
00:39:09,973 --> 00:39:11,808
Once you put mesh in,
658
00:39:11,891 --> 00:39:15,562
it is scarred into place,
permanently affixing it to the tissue.
659
00:39:16,354 --> 00:39:19,023
The scar tissue
causes the mesh to shrink up
660
00:39:19,107 --> 00:39:21,901
and as it shrinks, it starts to contract
661
00:39:21,985 --> 00:39:26,197
and pull against the adjacent tissues
that are in contact with the mesh.
662
00:39:26,281 --> 00:39:30,660
The scar tissue creates
a hard and flexible object in the pelvis.
663
00:39:31,744 --> 00:39:34,873
Around the vagina, around the bladder,
around the urethra.
664
00:39:34,956 --> 00:39:39,544
Structures that need to be able to move
in very subtle ways in order to function.
665
00:39:39,627 --> 00:39:43,089
Now you have this hard object in there,
and there's a cascade of problems.
666
00:39:44,591 --> 00:39:48,177
So eventually, I find this doctor
in Louisville.
667
00:39:48,761 --> 00:39:51,931
And he says,
"You've got a problem with your mesh
668
00:39:52,015 --> 00:39:53,516
and it needs to be removed...
669
00:39:54,142 --> 00:39:55,643
but I can't do it."
670
00:39:56,603 --> 00:39:59,564
I was never trained to take it out.
I've never took it out.
671
00:39:59,647 --> 00:40:01,900
We were just trained on how to put it in.
672
00:40:01,983 --> 00:40:03,484
Once it's scarred in place...
673
00:40:05,153 --> 00:40:06,029
that's it.
674
00:40:06,613 --> 00:40:09,240
Ain't coming out. Not in its entirety.
675
00:40:09,949 --> 00:40:12,994
I've been told
it's like removing rebar out of concrete,
676
00:40:13,077 --> 00:40:14,746
bubblegum out of your hair.
677
00:40:15,288 --> 00:40:17,415
Because of the position
that they're placed,
678
00:40:17,498 --> 00:40:19,667
they're in very delicate areas
679
00:40:19,792 --> 00:40:24,172
where it's almost impossible
to remove the mesh completely
680
00:40:24,255 --> 00:40:27,759
Once the scarring is complete,
the body doesn't want it to be there.
681
00:40:27,842 --> 00:40:30,970
So it keeps scarring and scarring,
keeps pushing and pushing,
682
00:40:31,262 --> 00:40:33,806
and sometimes it tries to push it
out of the body.
683
00:40:35,350 --> 00:40:37,352
So we do a partial mesh removal.
684
00:40:37,977 --> 00:40:39,520
Six to eight weeks of healing.
685
00:40:41,230 --> 00:40:45,485
My husband and I are trying to get back
to our sexual relations.
686
00:40:46,069 --> 00:40:47,612
I've set the stage, actually.
687
00:40:47,695 --> 00:40:50,323
I've got candles going,
I've got my daughter in bed.
688
00:40:50,406 --> 00:40:52,992
You know, I'm gonna feel
like a woman again.
689
00:40:53,076 --> 00:40:54,243
This mesh problem's gone.
690
00:40:55,536 --> 00:40:59,749
Very shortly into our intercourse,
my husband jumps up.
691
00:40:59,832 --> 00:41:01,084
When I penetrated her...
692
00:41:02,585 --> 00:41:04,128
I ended up getting a...
693
00:41:05,672 --> 00:41:06,547
cut.
694
00:41:07,006 --> 00:41:08,257
He grabs himself.
695
00:41:08,341 --> 00:41:10,176
He turns the light on.
696
00:41:10,259 --> 00:41:11,886
And I have cut...
697
00:41:12,428 --> 00:41:14,055
the top of his penis.
698
00:41:14,138 --> 00:41:17,016
I mean, like, what the hell?
You know? What's going on?
699
00:41:17,183 --> 00:41:19,852
And he's like, "Tammy,
you... you've cut me."
700
00:41:19,936 --> 00:41:21,771
She was confused about it.
701
00:41:22,939 --> 00:41:24,357
Just as well as I was.
702
00:41:24,816 --> 00:41:27,527
So I'm thinking in my head,
"Well, the rest of the mesh."
703
00:41:30,738 --> 00:41:32,365
As a woman, you're thinking,
704
00:41:32,448 --> 00:41:35,535
"Am I ever gonna be able to have relations
with my husband again?"
705
00:41:36,160 --> 00:41:38,287
Was he ever
gonna want to stay with me?
706
00:41:39,580 --> 00:41:42,917
At first, as she's going through
her illnesses and everything,
707
00:41:43,001 --> 00:41:44,585
you're not thinking about that.
708
00:41:45,336 --> 00:41:48,840
But then, you know,
we're talking an eight-year period...
709
00:41:49,924 --> 00:41:53,386
of not having relationships
with your mate.
710
00:41:54,637 --> 00:41:56,431
It can be really stressful.
711
00:41:57,640 --> 00:41:58,891
That was taken from us.
712
00:42:00,935 --> 00:42:02,603
I've had a major surgery...
713
00:42:03,187 --> 00:42:04,272
bladder repair...
714
00:42:04,772 --> 00:42:06,149
cervix removal...
715
00:42:06,524 --> 00:42:07,900
reconstruction.
716
00:42:07,984 --> 00:42:10,319
Your surgeries,
that's a grand total of how many?
717
00:42:10,403 --> 00:42:11,404
Oh, Lord.
718
00:42:11,487 --> 00:42:12,321
Eighteen?
719
00:42:13,239 --> 00:42:14,198
Nineteen?
720
00:42:14,866 --> 00:42:16,117
- Byonia?
- Yeah?
721
00:42:16,200 --> 00:42:17,493
What's today's surgery?
722
00:42:17,952 --> 00:42:19,954
I don't know. I've lost count.
723
00:42:21,748 --> 00:42:25,293
Byonia knows more about mesh
than a lot of doctors.
724
00:42:26,210 --> 00:42:28,212
She's been through every surgery.
725
00:42:31,549 --> 00:42:34,302
I want to be a good wife
and I want to be a good mother,
726
00:42:34,385 --> 00:42:37,847
and I still cannot do the things
I want to do with my daughter.
727
00:42:39,932 --> 00:42:41,976
- Slow up.
- Byonia, slow up.
728
00:42:42,268 --> 00:42:44,270
Yeah.
729
00:42:44,645 --> 00:42:46,272
Mommy can't keep up with you.
730
00:42:47,648 --> 00:42:51,444
I have a daughter that says, "I wish."
"Momma, I wish we could ride my bike.
731
00:42:51,527 --> 00:42:53,613
I wish that I could take your pain."
732
00:42:54,113 --> 00:42:56,199
The hardest one to hear is, uh...
733
00:42:58,618 --> 00:43:00,661
"Mommy, is it my fault you had mesh?"
734
00:43:03,122 --> 00:43:04,582
She's smart enough to know...
735
00:43:04,665 --> 00:43:06,000
She's heard women talk.
736
00:43:07,126 --> 00:43:09,670
That she knows it is a lot of it
from childbirth.
737
00:43:11,339 --> 00:43:13,633
That should never be in her heart
or her mind.
738
00:43:15,927 --> 00:43:16,886
That's my guilt.
739
00:43:20,223 --> 00:43:24,435
We take our responsibilities
as a leader in health care very seriously.
740
00:43:25,520 --> 00:43:27,522
We're fortunate to be in an industry
741
00:43:27,605 --> 00:43:30,817
where human health care
is the basis of our business.
742
00:43:31,901 --> 00:43:36,531
And we measure success by improving
the quality of people's lives.
743
00:43:37,949 --> 00:43:40,409
The CEO of Johnson & Johnson
is Alex Gorsky.
744
00:43:41,160 --> 00:43:42,703
Before he was the CEO,
745
00:43:42,995 --> 00:43:44,789
he actually was the head of Ethicon,
746
00:43:44,872 --> 00:43:48,000
the unit in the company
that these products were sold through.
747
00:43:48,626 --> 00:43:53,005
And on his watch, there was a flood
of information coming into the company...
748
00:43:53,923 --> 00:43:56,342
of women suffering
very severe complications.
749
00:43:57,093 --> 00:44:01,347
When did anybody first
make you aware that anybody in the world
750
00:44:01,430 --> 00:44:03,766
had a concern
about the safety of the Prolift?
751
00:44:04,350 --> 00:44:05,184
I don't recall.
752
00:44:06,310 --> 00:44:09,272
Before the pelvic mesh devices
even came to market,
753
00:44:09,355 --> 00:44:11,941
the surgeons who were developing
the prototypes...
754
00:44:12,650 --> 00:44:16,612
were telling Johnson & Johnson,
"This mesh is not safe."
755
00:44:17,446 --> 00:44:20,658
And the director of medical affairs
acknowledged it on the record
756
00:44:20,741 --> 00:44:22,118
when I took his deposition.
757
00:44:22,201 --> 00:44:24,245
You knew significant retraction
could occur?
758
00:44:24,328 --> 00:44:25,163
Yes.
759
00:44:26,914 --> 00:44:29,625
You knew
that a significant retraction
760
00:44:29,709 --> 00:44:31,878
could lead to pain for the patient,
correct?
761
00:44:31,961 --> 00:44:32,795
Yes.
762
00:44:36,632 --> 00:44:38,467
You knew it could lead
to the need
763
00:44:38,551 --> 00:44:41,554
to have subsequent invasive operations
to try to either...
764
00:44:41,971 --> 00:44:46,058
re... remove or revise
that contracted mesh, correct?
765
00:44:46,142 --> 00:44:47,059
Yes, sir.
766
00:44:48,019 --> 00:44:49,687
As you sit here now,
767
00:44:49,770 --> 00:44:55,318
are there any risks or adverse reactions,
adverse events connected to the Prolift
768
00:44:55,401 --> 00:44:59,614
that medical affairs at Ethicon know of
that were not known at the time of launch?
769
00:44:59,697 --> 00:45:05,411
No. There are no new adverse events that
we were unaware of at the time of launch.
770
00:45:06,245 --> 00:45:09,040
What they did
was willfully ignore the risks
771
00:45:09,123 --> 00:45:11,000
they were putting these women to
without telling them.
772
00:45:11,083 --> 00:45:13,211
And actually, not just not telling them,
773
00:45:13,294 --> 00:45:15,379
but telling them
how safe this was going to be
774
00:45:15,463 --> 00:45:17,590
and how wonderful
this was going to be,
775
00:45:17,715 --> 00:45:19,342
knowing they didn't have
a basis to say that.
776
00:45:21,219 --> 00:45:23,804
People who go to work
in medical device companies,
777
00:45:23,888 --> 00:45:26,682
they're scientists
who actually want to do the right thing.
778
00:45:27,099 --> 00:45:31,395
But if the science or the medicine
isn't jiving with the marketing,
779
00:45:31,729 --> 00:45:34,357
the marketing is always gonna win out,
always.
780
00:45:55,920 --> 00:46:00,091
So it is December 10th, Sunday.
781
00:46:00,800 --> 00:46:05,513
Um, two days before my lumbar puncture
spinal tap.
782
00:46:07,014 --> 00:46:11,269
My daughter, Rayne, is going to drive me
and stay with me there the whole day.
783
00:46:12,937 --> 00:46:15,898
I think they said they do the procedure
around 7:00 a.m.
784
00:46:16,816 --> 00:46:17,692
So, yeah.
785
00:46:18,401 --> 00:46:19,860
Yay, spinal tap.
786
00:46:20,361 --> 00:46:22,530
Coming up soon.Oneida.
787
00:46:26,242 --> 00:46:28,160
Have you ever had
any surgeries done?
788
00:46:28,244 --> 00:46:30,121
- Lots.
- What have you had?
789
00:46:30,204 --> 00:46:32,873
I had a medical device called Essure,
790
00:46:32,957 --> 00:46:35,710
- the new female sterilization.
- Oh, yeah.
791
00:46:35,793 --> 00:46:38,546
Those expelled and got migrated
in my uterus.
792
00:46:38,629 --> 00:46:42,091
I had surgery to remove those,
then I had to have a tubal ligation.
793
00:46:42,883 --> 00:46:44,468
- Um...
- So I guess you're not pregnant.
794
00:46:44,552 --> 00:46:47,430
No, because then, later,
I had to have a hysterectomy
795
00:46:47,513 --> 00:46:50,391
because of the fragments
from the devices that broke.
796
00:46:50,474 --> 00:46:51,475
Get out of town!
797
00:46:51,559 --> 00:46:55,229
Then I had two more surgeries
as I wasn't healing from the hysterectomy.
798
00:46:55,313 --> 00:46:57,732
So they had to repair the vaginal cuff
twice.
799
00:46:58,274 --> 00:47:00,067
- Holy crap!
- Yeah.
800
00:47:00,151 --> 00:47:01,986
Sorry, that's like...
801
00:47:02,069 --> 00:47:05,031
I've had three joint surgeries because...
802
00:47:06,032 --> 00:47:09,535
Essure removal
is the bane of my existence.
803
00:47:10,328 --> 00:47:13,664
We've seen the manufacturer
change the removal protocol,
804
00:47:13,748 --> 00:47:15,124
contradicting themselves
805
00:47:15,207 --> 00:47:18,169
and going back and forth on what's okay
and what's not okay.
806
00:47:18,461 --> 00:47:22,465
Because of that,
a lot of doctors are winging it.
807
00:47:22,965 --> 00:47:27,094
And, unfortunately, breaking them,
pulling them,
808
00:47:27,178 --> 00:47:28,763
cutting them, stretching them.
809
00:47:28,846 --> 00:47:31,182
'Cause If you pull them
or stretch them at all,
810
00:47:31,265 --> 00:47:33,601
it'll fragment and leave pieces behind.
811
00:47:34,935 --> 00:47:36,228
This is what happened to me.
812
00:47:36,312 --> 00:47:39,523
The device ended up breaking
and leaving me with fragments everywhere,
813
00:47:39,607 --> 00:47:41,776
which then set off
my immune system.
814
00:47:42,360 --> 00:47:45,821
Which then set off
a connective tissue disorder
815
00:47:45,905 --> 00:47:47,990
that started deteriorating my joints.
816
00:47:49,075 --> 00:47:51,869
Bayer has admitted that it causes
an autoimmune response
817
00:47:51,952 --> 00:47:53,704
in a small percentage of women.
818
00:47:53,788 --> 00:47:56,665
Um, however,
we don't think it's a small percentage.
819
00:47:58,000 --> 00:47:59,126
Women have all these problems
820
00:47:59,585 --> 00:48:02,380
that seem to have nothing to do
with their pelvic area.
821
00:48:03,214 --> 00:48:06,175
So we started
the Autoimmune After Essure group.
822
00:48:07,635 --> 00:48:09,387
What's just as crazy as that,
823
00:48:09,470 --> 00:48:12,890
we see a really high rate of women
that are becoming pregnant
824
00:48:12,973 --> 00:48:14,767
after being implanted with Essure.
825
00:48:15,518 --> 00:48:18,771
So we've started
a Parents of E-babies group.
826
00:48:20,272 --> 00:48:23,609
We're seeing patterns of health problems
with these babies.
827
00:48:24,819 --> 00:48:29,198
We have seen the device puncture
the amniotic sac and cause preterm labor.
828
00:48:30,324 --> 00:48:31,826
We've seen a lot of loss.
829
00:48:33,119 --> 00:48:36,288
I've seen women have to bury
premature babies.
830
00:48:37,748 --> 00:48:39,291
This is devastation.
831
00:48:39,834 --> 00:48:40,918
Life devastation.
832
00:48:50,261 --> 00:48:52,346
There's nobody paying attention.
833
00:48:52,430 --> 00:48:55,683
We are keeping those records
because nobody else is.
834
00:48:57,601 --> 00:49:00,104
We assume the FDA
has the data that they need
835
00:49:00,729 --> 00:49:04,942
to crack down on manufacturers
that have bad devices
836
00:49:05,025 --> 00:49:07,445
or to recall a product,
837
00:49:07,820 --> 00:49:08,988
and they don't have that.
838
00:49:09,071 --> 00:49:11,073
- They don't?
- They don't have that.
839
00:49:11,449 --> 00:49:14,869
There is a system
for reporting complications...
840
00:49:15,327 --> 00:49:18,914
but there's tremendous underreporting,
841
00:49:18,998 --> 00:49:21,542
because it's a voluntary system.
842
00:49:21,625 --> 00:49:26,672
The FDA has said, "If there's a problem,
just come back to us and let us know."
843
00:49:26,964 --> 00:49:31,051
Well, that reporting system
relies on self-reporting.
844
00:49:31,135 --> 00:49:35,347
There are huge problems
with self-reporting complications.
845
00:49:35,431 --> 00:49:39,560
If a physician observes an adverse event,
they do not have to report it.
846
00:49:39,643 --> 00:49:40,561
The only...
847
00:49:41,187 --> 00:49:45,149
bodies that are required to report
adverse events are the companies.
848
00:49:45,232 --> 00:49:47,610
And the industry is not interested
849
00:49:47,693 --> 00:49:51,071
in having problems with devices
become apparent.
850
00:49:51,947 --> 00:49:54,867
It's estimated
that only three to four percent
851
00:49:54,950 --> 00:49:56,660
of all adverse events...
852
00:49:57,036 --> 00:49:58,871
get reported to the FDA.
853
00:49:59,538 --> 00:50:02,833
A study found
that the worse the outcome was,
854
00:50:02,917 --> 00:50:06,587
the less likely it was
that they would report it to FDA.
855
00:50:07,129 --> 00:50:10,841
So we don't know
about the adverse effects of a new implant
856
00:50:10,925 --> 00:50:14,178
until months or years
after it's on the market.
857
00:50:14,261 --> 00:50:18,390
By then, that may have been put into
hundreds or thousands of people.
858
00:50:19,099 --> 00:50:21,769
Yes. That one.
859
00:50:24,563 --> 00:50:27,650
Here's some examples
of doctors putting in multiple coils.
860
00:50:27,733 --> 00:50:30,736
There's three coils here on this side
and one on this side.
861
00:50:31,779 --> 00:50:34,573
This one is way, way out
of the fallopian tube.
862
00:50:34,990 --> 00:50:36,659
Here's one with six devices.
863
00:50:37,451 --> 00:50:40,913
The doctors are told by the Bayer reps
that come in, who aren't doctors...
864
00:50:40,996 --> 00:50:43,040
Reps come into these rooms
to sell these devices,
865
00:50:43,123 --> 00:50:45,417
and they stand there
and watch you get implanted,
866
00:50:45,501 --> 00:50:48,671
and, if it misfires
and it just gets shot off into the uterus,
867
00:50:48,754 --> 00:50:51,632
they just tell the doctor
to load up another one and try again.
868
00:50:51,715 --> 00:50:56,512
So we're seeing women with five, six,
sometimes eight devices, inside of them,
869
00:50:56,595 --> 00:50:59,014
when you're only supposed
to have one per tube.
870
00:51:03,811 --> 00:51:07,606
Every year,
there's an annual ACOG convention.
871
00:51:07,690 --> 00:51:11,777
And ACOG is
the largest gynecological organization
872
00:51:11,860 --> 00:51:12,820
in the United States,
873
00:51:12,903 --> 00:51:17,074
so there will be thousands
of ob-gyn doctors
874
00:51:17,449 --> 00:51:20,119
at this ACOG convention.
875
00:51:20,911 --> 00:51:23,831
There are so many doctors
that still believe
876
00:51:23,914 --> 00:51:26,000
there are no problems with this device.
877
00:51:26,625 --> 00:51:30,129
Looking at the photos
I think changes their minds.
878
00:51:36,969 --> 00:51:39,847
- There's Holly.
- Hi! How's it going?
879
00:51:39,930 --> 00:51:42,766
I'm Janet, one of the main admins.
Nice to meet you.
880
00:51:42,850 --> 00:51:44,101
- I'm Eva.
- Nice to meet you, Eva.
881
00:51:44,184 --> 00:51:45,269
Oh, there's Angie.
882
00:51:45,352 --> 00:51:46,562
Hi!
883
00:51:46,645 --> 00:51:47,521
Oh, what's up?
884
00:51:47,605 --> 00:51:48,439
Nice shirt.
885
00:51:48,522 --> 00:51:49,481
Yeah, you like it?
886
00:51:49,898 --> 00:51:51,191
I love it. Love it.
887
00:51:51,275 --> 00:51:54,820
Bayer has no data!
Do you have malpractice?
888
00:51:55,279 --> 00:51:58,866
Bayer has no data!
Do you have malpractice?
889
00:51:58,949 --> 00:52:02,453
Bayer has no data!
Do you have malpractice?
890
00:52:02,536 --> 00:52:06,081
Bayer has no data!
Do you have malpractice?
891
00:52:06,749 --> 00:52:09,251
Make sure you tell Bayer
we're out here.
892
00:52:09,335 --> 00:52:11,462
- We're not going.
- Are you giving warning?
893
00:52:11,545 --> 00:52:13,631
What was the biggest problem with them?
894
00:52:13,714 --> 00:52:16,383
- Where do we begin? Chronic inflammation.
- Which part?
895
00:52:16,467 --> 00:52:19,345
Uteruses that are swollen,
two and three times the size.
896
00:52:19,428 --> 00:52:21,180
It's been in the market for...
897
00:52:21,263 --> 00:52:23,057
It's been
in the market 15 years.
898
00:52:23,140 --> 00:52:23,974
Oh, really?
899
00:52:24,058 --> 00:52:27,269
Like I said, I'm putting them in
less than I used to.
900
00:52:27,353 --> 00:52:29,772
- But for some...
- You should never put them in.
901
00:52:29,980 --> 00:52:33,192
You have two doctors here
who've been around long enough to know
902
00:52:33,275 --> 00:52:36,570
that there are complications that occur
all the time,
903
00:52:36,654 --> 00:52:38,864
- in all of medicine and surgery.
- Absolutely.
904
00:52:39,031 --> 00:52:41,283
And it's unfortunate.
I'm sorry you had to go through that.
905
00:52:41,909 --> 00:52:44,286
Are you aware
of all the side effects of Essure?
906
00:52:44,370 --> 00:52:46,789
No, if you do a good job,
you don't have any problem.
907
00:52:46,872 --> 00:52:49,083
- Even if they do a good job...
- No, no.
908
00:52:49,166 --> 00:52:50,376
All those women...
909
00:52:50,459 --> 00:52:51,543
See that sign?
910
00:52:51,627 --> 00:52:55,714
All those names are all hysterectomies
and surgeries and salpingectomies.
911
00:52:56,131 --> 00:52:58,550
It doesn't matter where they're implanted.
They move.
912
00:52:58,634 --> 00:53:01,303
- No, no, they don't.
- They... We have proof.
913
00:53:01,720 --> 00:53:03,722
What happens if there is a complication?
914
00:53:03,806 --> 00:53:08,394
Well, then it goes in the category
of people who have complications.
915
00:53:08,477 --> 00:53:09,937
You remove it, and that's it.
916
00:53:10,020 --> 00:53:11,271
How do you remove it?
917
00:53:11,647 --> 00:53:14,274
You remove it by hysteroscopy.
You put it...
918
00:53:14,358 --> 00:53:16,110
You... you pull it out?
919
00:53:16,235 --> 00:53:19,071
You put an instrument inside,
and you pull it out. You pull.
920
00:53:19,154 --> 00:53:20,572
You cannot do that.
921
00:53:20,781 --> 00:53:21,699
It breaks.
922
00:53:23,158 --> 00:53:24,034
You... you...
923
00:53:24,535 --> 00:53:26,620
You are not a doctor.
You are working...
924
00:53:26,704 --> 00:53:27,913
You are talking like nonsense.
925
00:53:27,996 --> 00:53:30,290
I have 33,000 women
in this group...
926
00:53:30,374 --> 00:53:31,250
No, no, no.
927
00:53:31,333 --> 00:53:32,835
...with over 9,000 surgeries.
928
00:53:32,918 --> 00:53:37,631
I can tell you that we've had fragments
that are unretrieveable.
929
00:53:37,715 --> 00:53:39,049
They cannot get them.
930
00:53:42,469 --> 00:53:43,512
Ah.
931
00:53:45,139 --> 00:53:47,349
Okay, guys, nice to talk to you. Okay?
932
00:53:47,641 --> 00:53:48,559
Good luck.
933
00:53:51,228 --> 00:53:53,689
There's a lot of uncertainty
in medicine.
934
00:53:54,314 --> 00:53:59,111
I think, as physicians, we're not very
good at saying, "We don't know," at times.
935
00:53:59,194 --> 00:54:02,781
It's fine for you
to shout about the benefits
936
00:54:02,865 --> 00:54:05,159
or overstate the benefits of a treatment.
937
00:54:05,451 --> 00:54:07,369
The minute you raise concerns
938
00:54:07,453 --> 00:54:10,372
that something might not be working
as well as it should,
939
00:54:10,456 --> 00:54:13,041
you are often criticized.
940
00:54:13,125 --> 00:54:16,587
You're told
you're unnecessarily scaring patients.
941
00:54:17,337 --> 00:54:22,468
It doesn't seem like doctors
are requiring a high level of evidence
942
00:54:22,551 --> 00:54:25,471
in order to implant a new device.
943
00:54:25,554 --> 00:54:27,806
Yet in order to abandon that device,
944
00:54:27,890 --> 00:54:30,601
they're requiring
a greater level of evidence.
945
00:54:30,851 --> 00:54:34,188
than it took them
to decide to implant the device.
946
00:54:34,605 --> 00:54:36,190
That's turning everything on its head.
947
00:54:37,024 --> 00:54:39,568
We attract good people
in health care,
948
00:54:39,860 --> 00:54:41,904
but there's this tremendous hunger
949
00:54:41,987 --> 00:54:46,533
to have the latest gadgets,
the newest technology,
950
00:54:46,617 --> 00:54:50,120
without the proper evaluation
of that technology.
951
00:54:50,871 --> 00:54:55,292
We shouldn't be surprised
when some of the health care goes wrong.
952
00:54:57,461 --> 00:54:58,587
If I knew this business...
953
00:54:59,505 --> 00:55:01,965
when I got into it X amount of years ago,
954
00:55:02,341 --> 00:55:03,801
I would have done something else.
955
00:55:04,635 --> 00:55:07,596
I worked for one of the largest
medical device companies in the world.
956
00:55:07,679 --> 00:55:12,142
My ultimate job was to make sure that
the surgeons used my implants in surgery.
957
00:55:12,643 --> 00:55:13,727
It's all about usage.
958
00:55:14,728 --> 00:55:18,023
So the more implants you use,
the more money they're going to make.
959
00:55:18,106 --> 00:55:20,275
It's gotten worse over time
because of greed.
960
00:55:20,359 --> 00:55:24,446
Most doctors do the right thing and
always will to the best of their ability.
961
00:55:24,530 --> 00:55:29,201
But some fraction of doctors
respond to the perverse incentives
962
00:55:29,284 --> 00:55:32,246
of getting paid more for the more you do,
963
00:55:32,329 --> 00:55:36,291
regardless of the appropriateness
of that medical care.
964
00:55:36,917 --> 00:55:41,797
There are kickbacks in the United States
today that are entirely legal.
965
00:55:41,880 --> 00:55:45,634
It doesn't have to necessarily be,
"Dr. Jones, I'm giving you money."
966
00:55:45,717 --> 00:55:47,928
It could be consulting,
it could be teaching.
967
00:55:48,512 --> 00:55:50,889
It could be providing money
for a fellowship program.
968
00:55:57,688 --> 00:56:00,649
There's some doctors that are good,
some doctors that aren't.
969
00:56:00,899 --> 00:56:02,943
I had one surgeon recently who said,
970
00:56:03,026 --> 00:56:06,071
"You make the best products,
but you don't do enough for me,
971
00:56:06,613 --> 00:56:08,991
so I'm using somebody else
because they do more for me."
972
00:56:10,033 --> 00:56:11,326
Welcome to the business.
973
00:56:16,456 --> 00:56:20,127
In days gone by,
surgery was all about blood and guts.
974
00:56:21,128 --> 00:56:24,381
In the future,
surgery will be about bits and bytes.
975
00:56:25,507 --> 00:56:27,467
Is the future already here?
976
00:56:29,011 --> 00:56:31,763
It's a blend of science fiction
and medical reality.
977
00:56:33,932 --> 00:56:35,851
The robot will see you now.
978
00:56:37,811 --> 00:56:39,771
Tonight, a story
from the cutting edge.
979
00:56:39,855 --> 00:56:42,024
The million-dollar Da Vinci system,
980
00:56:42,107 --> 00:56:45,110
a revolutionary tool
for surgeries of all kinds.
981
00:56:45,193 --> 00:56:48,530
The Da Vinci is a large,
fairly complicated robot
982
00:56:48,614 --> 00:56:54,536
able to bring a camera and instruments
in together through one small tube.
983
00:56:55,078 --> 00:56:57,122
The Da Vinci is able to reach anywhere
984
00:56:57,998 --> 00:57:00,667
Very exciting to think
where we get to go with this.
985
00:57:01,919 --> 00:57:04,630
Da Vinci allows us
to do remote surgery
986
00:57:04,713 --> 00:57:06,965
from about seven feet away
from the patient.
987
00:57:07,549 --> 00:57:11,595
We work in a remote control console,
sort of like a video game machine.
988
00:57:11,720 --> 00:57:15,015
We look on the screen,
at the image from inside the abdomen.
989
00:57:15,515 --> 00:57:19,144
And we can perform the operation
with remote control hands.
990
00:57:19,728 --> 00:57:24,816
Da Vinci, by Intuitive Surgical.
They're now in 64 countries.
991
00:57:24,900 --> 00:57:28,695
Intuitive is absolutely
the dominant market leader in this field
992
00:57:28,779 --> 00:57:31,698
with a turnover last year
of over $2 billion.
993
00:57:31,782 --> 00:57:33,784
We're an innovative company.
994
00:57:33,867 --> 00:57:36,203
We will continue to innovate,
put new products out.
995
00:57:36,286 --> 00:57:40,624
Intuitive is motivated by the opportunity
to invent new things, create the future.
996
00:57:40,707 --> 00:57:43,669
That is my vision for your future.
997
00:57:44,461 --> 00:57:46,004
Thank you.
998
00:57:54,304 --> 00:57:57,849
The story of how the robot
came into health care
999
00:57:57,933 --> 00:58:02,145
is the story of what's wrong with medicine
in America today.
1000
00:58:02,646 --> 00:58:07,567
Massive adoption of a new technology
with little evaluation of the outcomes.
1001
00:58:17,828 --> 00:58:21,373
The Da Vinci robot
was marketed with a strategy
1002
00:58:21,456 --> 00:58:23,667
of approaching doctors and communities
1003
00:58:23,750 --> 00:58:28,171
and telling those doctors,
"We can help drive business to you.
1004
00:58:29,589 --> 00:58:32,384
We can market you as the robot doctor."
1005
00:58:38,181 --> 00:58:41,101
The robot is better
for certain operations.
1006
00:58:41,643 --> 00:58:45,564
But in many situations,
it provides no benefit to the patient,
1007
00:58:45,647 --> 00:58:49,818
and it may add operation time
and it may add some risks.
1008
00:58:52,029 --> 00:58:53,780
"You need surgery."
1009
00:58:54,281 --> 00:58:56,366
Three words no one wants to hear.
1010
00:58:56,616 --> 00:59:00,787
This video will explain your surgical
options for a hysterectomy...
1011
00:59:01,329 --> 00:59:06,585
Hysterectomies are a very high-volume,
common procedure in the US.
1012
00:59:06,668 --> 00:59:11,131
About 500,000 women
have their uterus removed every year.
1013
00:59:11,882 --> 00:59:16,219
During a hysterectomy,
doctors remove part or all of the uterus,
1014
00:59:16,303 --> 00:59:20,265
the cervix, both fallopian tubes,
and both ovaries.
1015
00:59:21,558 --> 00:59:24,895
The surgeon then stitches
the internal opening closed.
1016
00:59:25,520 --> 00:59:27,606
If you're told you need a hysterectomy...
1017
00:59:28,231 --> 00:59:30,609
ask your doctor about Da Vinci surgery.
1018
00:59:33,195 --> 00:59:34,863
I had a biopsy,
1019
00:59:34,946 --> 00:59:38,950
and it came back positive
for, um, endometrial cancer.
1020
00:59:39,409 --> 00:59:43,246
I was having a lot of female trouble,
a lot of ovarian cysts.
1021
00:59:43,330 --> 00:59:45,624
They sent me for a vaginal ultrasound
1022
00:59:45,874 --> 00:59:48,835
because we couldn't figure out
why my blood counts were so low,
1023
00:59:48,919 --> 00:59:50,545
and I had a tumor.
1024
00:59:51,004 --> 00:59:53,799
I was diagnosed with uterine cancer.
1025
00:59:53,882 --> 00:59:55,967
I actually was kind of happy,
1026
00:59:56,051 --> 00:59:58,762
because I said,
if I have to have cancer anywhere,
1027
00:59:58,845 --> 01:00:02,516
that's the place to have it,
because I can have it taken out.
1028
01:00:02,766 --> 01:00:05,227
The doctor recommended a hysterectomy.
1029
01:00:05,310 --> 01:00:11,066
And the only type that he said he did
was the Da Vinci.
1030
01:00:11,149 --> 01:00:16,571
He said, "Well the best way to do this,
the fastest way and the quickest recovery
1031
01:00:16,655 --> 01:00:19,282
would be to use the Da Vinci robot."
1032
01:00:19,366 --> 01:00:22,661
It just sounded like the newest,
greatest thing,
1033
01:00:22,786 --> 01:00:25,580
and I had no reason to believe otherwise.
1034
01:00:39,636 --> 01:00:43,265
Originally,
Intuitive Surgical told the FDA
1035
01:00:43,348 --> 01:00:46,518
that a huge amount of training
would be provided
1036
01:00:46,601 --> 01:00:49,521
as part of the sale of the machine
to the hospitals,
1037
01:00:49,604 --> 01:00:53,275
but shortly after
the FDA gave permission to market,
1038
01:00:53,358 --> 01:00:57,571
Intuitive scaled back
all of the training requirements.
1039
01:00:58,155 --> 01:01:01,658
And the reason is,
if they said, "Your surgeons can use it,
1040
01:01:01,741 --> 01:01:05,996
but they need nine weeks of training,"
no one's gonna buy the machine.
1041
01:01:06,621 --> 01:01:09,958
So you have surgeons who
1042
01:01:10,041 --> 01:01:16,089
operate for half a day on pigs,
take a ten-question multiple-choice test,
1043
01:01:16,173 --> 01:01:20,719
and have a proctor, another surgeon,
watch them do two surgeries,
1044
01:01:20,802 --> 01:01:22,971
then they're turned loose
with the machine.
1045
01:01:23,597 --> 01:01:28,059
I was told that it takes ten cases
to get good at robotics.
1046
01:01:28,768 --> 01:01:30,937
But I know now, in retrospect,
1047
01:01:31,021 --> 01:01:33,773
that I didn't really start
to feel comfortable
1048
01:01:34,191 --> 01:01:36,568
until I was about 200 or 300 cases.
1049
01:01:37,444 --> 01:01:40,864
In other words, that area
where you'd call yourself proficient.
1050
01:01:41,489 --> 01:01:45,076
The surgical robot in inexperienced hands
1051
01:01:45,160 --> 01:01:49,581
adds complication or injury rates
to the patient.
1052
01:01:50,290 --> 01:01:54,544
A lot of surgeons
that shouldn't be using it are using it.
1053
01:01:55,212 --> 01:01:56,338
That's the problem.
1054
01:01:58,506 --> 01:02:02,052
So I had the hysterectomy, go home.
1055
01:02:03,220 --> 01:02:05,680
I'm thinking, "Wow, This is smooth, easy."
1056
01:02:05,764 --> 01:02:08,767
Within a day or two,
I was running up and down the stairs.
1057
01:02:09,351 --> 01:02:13,146
And then a couple of weeks later,
1058
01:02:13,230 --> 01:02:15,565
I started to not feel so great.
1059
01:02:17,150 --> 01:02:20,862
I was getting up in the morning,
I sat down to go to the bathroom,
1060
01:02:20,946 --> 01:02:22,906
I felt all this pressure.
1061
01:02:23,240 --> 01:02:24,532
I looked down
1062
01:02:24,616 --> 01:02:26,243
and this huge...
1063
01:02:27,160 --> 01:02:31,414
pomegranate-looking thing
was protruding from my legs.
1064
01:02:31,498 --> 01:02:35,335
I think I was actually at my clothesline,
putting something...
1065
01:02:35,418 --> 01:02:38,838
I think I'd washed a load of sheets,
and I heard a pop.
1066
01:02:38,922 --> 01:02:42,550
I go to the restroom
and I feel something emerge
1067
01:02:42,634 --> 01:02:44,469
from my vagina.
1068
01:02:44,552 --> 01:02:46,596
A whoosh of liquid came out.
1069
01:02:47,472 --> 01:02:52,602
And now there was about three inches
of my insides coming out of me.
1070
01:02:52,686 --> 01:02:54,479
I thought I was gonna throw up.
1071
01:02:55,313 --> 01:02:57,148
And when I did, I heaved...
1072
01:02:57,941 --> 01:03:01,528
and my intestines came down
like halfway to my knees.
1073
01:03:01,611 --> 01:03:03,697
I had three feet of my colon fall out.
1074
01:03:04,531 --> 01:03:07,158
It's in the documentation. So...
1075
01:03:07,242 --> 01:03:08,285
I get a towel...
1076
01:03:09,619 --> 01:03:10,620
and hold it in.
1077
01:03:10,704 --> 01:03:14,291
I run in there, fall out on the floor,
and my husband's like, "What's wrong?"
1078
01:03:14,374 --> 01:03:17,085
I said, "My colon's fallen out."
He said, "Let me see."
1079
01:03:17,168 --> 01:03:21,214
He saw and then he totally
had a nervous breakdown.
1080
01:03:31,016 --> 01:03:34,602
Then, when I got to the hospital,
they didn't know what to do.
1081
01:03:34,686 --> 01:03:36,646
They were freaking out.
They'd never seen it.
1082
01:03:36,730 --> 01:03:39,733
I get to the emergency room,
1083
01:03:39,816 --> 01:03:44,279
and I remember thinking so clearly
that I was dead, like this was it.
1084
01:03:44,362 --> 01:03:47,699
They had to call the specialist,
1085
01:03:47,782 --> 01:03:50,577
and he said,
"I don't even know if the surgery...
1086
01:03:50,660 --> 01:03:51,870
I can't say if it'll...
1087
01:03:52,746 --> 01:03:54,581
save her now. I'll do my best."
1088
01:03:55,832 --> 01:03:57,834
I have nightmares about it all the time
1089
01:03:57,917 --> 01:04:01,713
where I think I'm on that table,
going into the operating room.
1090
01:04:02,297 --> 01:04:04,716
You know, just terrible,
terrible memories of it,
1091
01:04:04,799 --> 01:04:07,218
and it just never seems to leave me.
1092
01:04:07,302 --> 01:04:08,136
It's been...
1093
01:04:09,554 --> 01:04:11,181
what, three years?
1094
01:04:13,516 --> 01:04:15,685
And I still have... problems.
1095
01:04:16,227 --> 01:04:20,982
I have had to give up a dream
of ever having a partner,
1096
01:04:21,066 --> 01:04:23,276
of ever being intimate again,
1097
01:04:23,360 --> 01:04:25,362
because, to me, um...
1098
01:04:26,071 --> 01:04:28,156
penetration means death.
1099
01:04:28,948 --> 01:04:30,575
It changed the full direction...
1100
01:04:31,743 --> 01:04:32,619
of my life.
1101
01:04:33,244 --> 01:04:35,080
It's taken my life away.
1102
01:04:35,163 --> 01:04:37,707
I'm sorry I ever heard
the word Da Vinci.
1103
01:04:37,791 --> 01:04:40,085
And then, like I said,
every time that I...
1104
01:04:41,252 --> 01:04:46,091
hear of more injuries,
it just rubs salt in the wound.
1105
01:05:08,863 --> 01:05:10,031
Car wash!
1106
01:05:13,535 --> 01:05:16,287
After three years of bleeding,
1107
01:05:16,371 --> 01:05:18,123
I ended up having a hysterectomy.
1108
01:05:18,748 --> 01:05:21,668
And no more bleeding,
but the pain is still severe.
1109
01:05:22,544 --> 01:05:25,922
The pain that I had sometimes prevented me
from going to work.
1110
01:05:27,132 --> 01:05:29,801
And eventually, I lost my job.
1111
01:05:31,302 --> 01:05:35,056
I had to do this car wash
because I haven't worked for a month.
1112
01:05:35,932 --> 01:05:37,851
My doctor just put me on disability...
1113
01:05:38,518 --> 01:05:39,894
which could take months.
1114
01:05:40,645 --> 01:05:42,689
So I'm out of income right now.
1115
01:05:43,314 --> 01:05:45,191
- Oh, thank you so much.
- That'll help you out.
1116
01:05:45,275 --> 01:05:47,444
- Thank you. May God bless you.
- Okay.
1117
01:05:48,069 --> 01:05:49,821
I can't afford my rent right now.
1118
01:05:50,530 --> 01:05:51,906
So I have to move out,
1119
01:05:51,990 --> 01:05:55,785
and if I don't find a place,
and without income and proof of income,
1120
01:05:55,869 --> 01:05:57,829
I can't get an apartment or anything,
1121
01:05:57,912 --> 01:06:00,290
so I'm scared I'm gonna have to be split
with my kids.
1122
01:06:06,212 --> 01:06:07,964
Ever since 2011...
1123
01:06:08,631 --> 01:06:10,216
we've moved around a lot.
1124
01:06:12,427 --> 01:06:15,472
I don't think we've had one place
that was stable.
1125
01:06:16,306 --> 01:06:17,223
Ever.
1126
01:06:17,724 --> 01:06:20,101
We don't know
where we're going to be at school.
1127
01:06:21,603 --> 01:06:24,189
Because we're gonna get another house,
1128
01:06:24,272 --> 01:06:26,649
and I don't know
where that house is gonna be.
1129
01:06:27,942 --> 01:06:31,488
My mom can't keep a job
because she has to go to the doctors a lot
1130
01:06:31,571 --> 01:06:34,449
'cause she gets sick a lot,
and it's just...
1131
01:06:35,116 --> 01:06:37,994
It ruins her opportunity of having a job.
1132
01:06:39,537 --> 01:06:42,332
It makes me feel sad
that my mom is at the hospital.
1133
01:07:16,824 --> 01:07:19,702
It's tough,
watching her not be able to do stuff.
1134
01:07:20,828 --> 01:07:22,705
That much more I have to do.
1135
01:07:23,039 --> 01:07:24,374
We used to do it together.
1136
01:07:26,251 --> 01:07:30,713
I suck now. I'm just cranky and miserable,
in pain all the time.
1137
01:07:30,797 --> 01:07:32,715
I'm not fun.
1138
01:07:32,799 --> 01:07:36,803
I can't drink, I can't dance,
I can't do anything.
1139
01:07:40,181 --> 01:07:41,224
Well...
1140
01:07:41,307 --> 01:07:43,393
But at the same time...
1141
01:07:44,435 --> 01:07:47,522
You know,
I'm so grateful for what we have.
1142
01:07:47,605 --> 01:07:49,065
We have great kids
1143
01:07:49,482 --> 01:07:52,569
and a great house
and we have each other and...
1144
01:07:53,319 --> 01:07:55,029
we're alive.
1145
01:07:56,072 --> 01:07:57,907
How does it affect your love life?
1146
01:07:58,575 --> 01:08:00,743
Oh... Oh, God.
1147
01:08:00,827 --> 01:08:03,037
- It was terrible for a while.
- Yeah.
1148
01:08:03,746 --> 01:08:05,623
- There was no love life.
- No.
1149
01:08:06,207 --> 01:08:07,875
- When I...
- With all the surgeries and stuff.
1150
01:08:07,959 --> 01:08:10,378
But even when I first had it in,
it was painful.
1151
01:08:10,461 --> 01:08:11,296
Yeah.
1152
01:08:11,921 --> 01:08:14,716
That part of our life
has been ruined permanently.
1153
01:08:16,175 --> 01:08:17,010
It's hard.
1154
01:08:17,093 --> 01:08:19,637
Yeah, you don't...
I don't think it ever goes away.
1155
01:08:19,721 --> 01:08:21,222
I don't think it ever will.
1156
01:08:21,848 --> 01:08:26,352
It's sad because I have seen other
people's relationships die in the group.
1157
01:08:26,436 --> 01:08:29,230
I've seen a lot of women
whose husbands have walked out
1158
01:08:29,314 --> 01:08:31,065
- over the intimacy...
- Lots.
1159
01:08:31,149 --> 01:08:32,567
...the lack of intimacy.
1160
01:08:33,192 --> 01:08:38,364
I've seen women suicidal,
women losing their families and...
1161
01:08:39,782 --> 01:08:42,452
thinking that there's no reason
to stay alive.
1162
01:08:48,916 --> 01:08:51,044
I think it's amazing what she's done...
1163
01:08:51,586 --> 01:08:52,754
to help these women.
1164
01:08:54,672 --> 01:08:57,550
Facebook is a full-time job for her now,
basically.
1165
01:08:57,634 --> 01:08:59,135
She wakes up in the morning...
1166
01:08:59,218 --> 01:09:00,803
She's a very determined person.
1167
01:09:00,887 --> 01:09:03,514
She gets something in her head,
and that's it.
1168
01:09:17,236 --> 01:09:21,240
I started getting random messages
in my Facebook...
1169
01:09:22,450 --> 01:09:27,497
from women who started connecting me
with the Gabriella Avina
1170
01:09:27,580 --> 01:09:30,375
that was the spokesperson,
the Ask Gaby.
1171
01:09:30,750 --> 01:09:31,709
They found me...
1172
01:09:32,543 --> 01:09:36,089
and said, "Are you the Gaby
that was speaking for Essure?
1173
01:09:36,172 --> 01:09:37,298
Will you talk to us?"
1174
01:09:38,299 --> 01:09:39,300
And finally...
1175
01:09:39,801 --> 01:09:42,470
uh,
probably about a year of them trying...
1176
01:09:43,137 --> 01:09:46,849
one of them said,
"Can you just tell me how your health is?"
1177
01:09:48,142 --> 01:09:49,394
And then I listened.
1178
01:09:51,145 --> 01:09:52,897
I was fatigued.
1179
01:09:52,980 --> 01:09:54,315
I was tired all the time.
1180
01:09:55,149 --> 01:09:56,484
Then I started falling.
1181
01:09:57,026 --> 01:09:58,986
Just... My legs would give out.
1182
01:09:59,237 --> 01:10:03,241
The doctor said
it was an immune response to something.
1183
01:10:04,450 --> 01:10:07,870
My story was similar to so many others.
1184
01:10:09,247 --> 01:10:10,790
All of a sudden,
1185
01:10:10,873 --> 01:10:12,083
it all made sense.
1186
01:10:14,127 --> 01:10:17,880
If only they'd been honest with me
from the very, very beginning.
1187
01:10:17,964 --> 01:10:21,092
The Essure procedure
can be performed in your doctor's office
1188
01:10:21,175 --> 01:10:23,094
and is over 99% effective.
1189
01:10:23,177 --> 01:10:25,763
It's 99.74% effective.
1190
01:10:25,847 --> 01:10:28,474
It's 99.8% effective.
1191
01:10:28,558 --> 01:10:31,686
It's over 99.95% effective.
1192
01:10:32,520 --> 01:10:35,481
It really wasn't tested
for a sufficient amount of time.
1193
01:10:35,565 --> 01:10:40,903
Most patients that had the Essure device
were followed for about 12-18 months,
1194
01:10:40,987 --> 01:10:46,659
and the manufacturer reported
very satisfactory results from it.
1195
01:10:46,743 --> 01:10:50,663
But for a product that's supposed to be
a lifetime implant,
1196
01:10:50,747 --> 01:10:54,625
to cut off the study window
at about a year and a half
1197
01:10:54,709 --> 01:10:56,836
left a lot of questions unanswered.
1198
01:10:58,004 --> 01:10:59,964
I was part of the clinical trial
1199
01:11:00,339 --> 01:11:03,259
and no one asked me,
"Are you feeling sick?
1200
01:11:03,342 --> 01:11:04,802
What is your health like?"
1201
01:11:04,886 --> 01:11:08,139
Almost all women
who participated in the clinical studies
1202
01:11:08,222 --> 01:11:13,895
rated their satisfaction with Essure
as good, very good or excellent.
1203
01:11:14,812 --> 01:11:19,150
The first time I saw the question,
"Rate your comfort of wearing the device,"
1204
01:11:19,233 --> 01:11:21,360
I said, "What does this mean?
1205
01:11:21,444 --> 01:11:22,779
I'm not wearing anything.
1206
01:11:22,862 --> 01:11:25,364
This is something
that's implanted inside of my body."
1207
01:11:25,740 --> 01:11:27,950
The nurse said, "Can you feel it?"
1208
01:11:28,618 --> 01:11:31,913
I said, "I can feel pain in my abdomen.
1209
01:11:31,996 --> 01:11:35,333
Where that pain is coming from,
I don't know."
1210
01:11:35,708 --> 01:11:38,002
And she said,
"Then rate it as excellent."
1211
01:11:38,628 --> 01:11:40,588
They would say,
"Are you happy with the product?"
1212
01:11:41,214 --> 01:11:45,551
I would say, "No," and they would say,
"But you're not pregnant?"
1213
01:11:46,135 --> 01:11:47,345
I would say, "Correct."
1214
01:11:47,929 --> 01:11:51,015
"Then it's doing its job,
so you have to be happy with that."
1215
01:11:52,642 --> 01:11:56,562
The most striking thing is they'd
crossed out answers and changed them
1216
01:11:56,646 --> 01:11:58,689
Where it said I was having pain,
1217
01:11:58,815 --> 01:12:02,068
they'd crossed it off
and said, "No pain reported."
1218
01:12:02,819 --> 01:12:05,071
When I questioned Bayer about it,
1219
01:12:05,154 --> 01:12:08,449
they said this is absolutely customary
in a clinical trial.
1220
01:12:19,919 --> 01:12:21,003
It turns out
1221
01:12:21,087 --> 01:12:24,757
that the vast majority of research
is not coming from an objective source.
1222
01:12:25,424 --> 01:12:29,887
It used to be
that about 70% of biomedical research
1223
01:12:29,971 --> 01:12:31,472
was funded by the government.
1224
01:12:31,556 --> 01:12:33,808
In the last 20, 25 years, that's changed.
1225
01:12:33,891 --> 01:12:39,063
Now about 70% of biomedical research
is funded by industry.
1226
01:12:39,647 --> 01:12:41,315
They're paying for the research,
1227
01:12:41,399 --> 01:12:45,570
so naturally we're going to get
the results that they want to share.
1228
01:12:45,653 --> 01:12:50,575
So devices can be on the market for years
and cause many deaths, many injuries
1229
01:12:50,658 --> 01:12:52,493
before it becomes public.
1230
01:12:52,577 --> 01:12:55,204
A medical device
implanted in thousands of people
1231
01:12:55,288 --> 01:12:57,665
that is linked
to more than two dozen deaths...
1232
01:12:57,748 --> 01:12:59,834
During emergency open-heart surgery,
1233
01:12:59,917 --> 01:13:02,670
doctors removed
this one-inch piece of metal.
1234
01:13:02,753 --> 01:13:04,422
It floated in front of our eyes,
1235
01:13:04,505 --> 01:13:08,718
literally, first into the right atrium
and then into the right ventricle.
1236
01:13:08,801 --> 01:13:11,679
Major health concern over breast implants.
1237
01:13:11,762 --> 01:13:15,057
They could cause a rare form of cancer.
1238
01:13:15,141 --> 01:13:16,851
It may cause other illnesses too.
1239
01:13:16,934 --> 01:13:19,937
When she had hers taken out,
they found mold inside,
1240
01:13:20,021 --> 01:13:21,272
and she's not alone.
1241
01:13:21,355 --> 01:13:25,943
Two dead, 179 exposed
to a dangerous superbug.
1242
01:13:26,027 --> 01:13:28,362
A piece of medical equipment
may be to blame.
1243
01:13:28,446 --> 01:13:32,366
A device called a morcellator
as used to shred fibroid tumors.
1244
01:13:32,450 --> 01:13:34,076
so they could be easily removed.
1245
01:13:34,160 --> 01:13:37,788
The shredding ended up
inadvertently spreading the cancer.
1246
01:13:37,872 --> 01:13:40,082
A defibrillator was withdrawn
from the market
1247
01:13:40,166 --> 01:13:43,210
after 13 deaths
were linked to wiring problems.
1248
01:13:43,294 --> 01:13:47,214
The FDA approved this device,
but did not require testing in humans.
1249
01:13:47,298 --> 01:13:50,051
We can no longer rely
on the medical device companies
1250
01:13:50,134 --> 01:13:52,887
to do what's in the best interest
of the patient.
1251
01:13:53,596 --> 01:13:56,515
And we can no longer rely on the FDA
1252
01:13:56,599 --> 01:13:59,143
to properly regulate these devices.
1253
01:14:00,227 --> 01:14:05,358
I was at the Food and Drug
Administration from 2006 to 2009.
1254
01:14:05,900 --> 01:14:09,070
I was the lead gastroenterologist
of devices.
1255
01:14:10,863 --> 01:14:14,200
I think I cleared,
or was involved in the clearance,
1256
01:14:14,283 --> 01:14:17,119
of over 250-odd devices
1257
01:14:17,870 --> 01:14:20,581
I think the vast majority of doctors
1258
01:14:20,665 --> 01:14:22,667
and scientists at the FDA...
1259
01:14:23,334 --> 01:14:26,420
do their best.
They do it with integrity, honesty.
1260
01:14:27,254 --> 01:14:32,593
In mid-2009, a file came on my desk
to look at this CT scanner,
1261
01:14:32,677 --> 01:14:37,098
this device that affects
many millions of people in our country.
1262
01:14:37,723 --> 01:14:42,061
A CT scan takes the equivalent
of hundreds and hundreds of X-rays.
1263
01:14:42,144 --> 01:14:44,480
while a machine rotates around your body.
1264
01:14:44,563 --> 01:14:49,276
They're an incredibly good test
for diagnosing a range of diseases
1265
01:14:49,360 --> 01:14:52,863
that gives you
very sophisticated 3-D images.
1266
01:14:53,364 --> 01:14:57,535
But the doses of radiation
that we use day in and day out for CT
1267
01:14:57,618 --> 01:15:00,955
are in the range that we know
it will cause cancer in some people.
1268
01:15:01,414 --> 01:15:05,292
And yet, the use of CT scanning
has quadrupled in the last 15 years.
1269
01:15:12,258 --> 01:15:13,843
The elephant in the room
1270
01:15:13,926 --> 01:15:16,846
is it's a very profitable
part of the health care system.
1271
01:15:16,929 --> 01:15:20,683
It's a way a lot of radiologists,
emergency departments, hospitals
1272
01:15:20,766 --> 01:15:21,600
make money
1273
01:15:22,143 --> 01:15:24,645
There's a lot of excess use
of this device,
1274
01:15:24,729 --> 01:15:30,192
and so I simply said,
"We should have a warning on the FDA label
1275
01:15:30,276 --> 01:15:31,652
just to warn the doctor...
1276
01:15:32,319 --> 01:15:36,282
and therefore the patient,
that actually if you use this device...
1277
01:15:37,366 --> 01:15:39,535
and certainly if you use it repeatedly...
1278
01:15:40,244 --> 01:15:41,996
your risk of cancer
1279
01:15:42,079 --> 01:15:45,249
or developing
abdominal cancer will increase.
1280
01:15:45,708 --> 01:15:48,377
I couldn't believe the pushback I'd got
1281
01:15:48,753 --> 01:15:51,464
from managers with no medical experience.
1282
01:15:52,048 --> 01:15:55,092
There was a group of FDA physicians
1283
01:15:55,176 --> 01:15:59,513
who were very concerned about the way
products were being cleared and approved.
1284
01:16:00,097 --> 01:16:02,183
We took these concerns
1285
01:16:02,266 --> 01:16:05,269
up the chain of command to Jeffrey Shuren,
1286
01:16:05,352 --> 01:16:09,023
the director
of the Center for Medical Devices at FDA.
1287
01:16:09,732 --> 01:16:11,400
And what did he do?
1288
01:16:11,484 --> 01:16:14,487
He not only did nothing,
he took it one step further.
1289
01:16:15,112 --> 01:16:17,073
He retaliated against people.
1290
01:16:18,074 --> 01:16:20,201
Once we started complaining...
1291
01:16:20,910 --> 01:16:25,915
FDA put their spy software
in our computers.
1292
01:16:27,124 --> 01:16:31,378
And they were monitoring
all our activities.
1293
01:16:31,796 --> 01:16:35,925
The FDA installed
what's called Spector software
1294
01:16:36,008 --> 01:16:40,096
onto a number of physicians'
and scientists' computers,
1295
01:16:40,513 --> 01:16:44,850
and it allowed them to capture screenshots
every two seconds...
1296
01:16:45,267 --> 01:16:46,560
and keystrokes.
1297
01:16:47,103 --> 01:16:53,484
It's as if to say their own doctors
are somehow criminals for exposing...
1298
01:16:54,944 --> 01:16:57,071
a public health issue.
1299
01:16:58,030 --> 01:17:02,368
It left a tremendous chill
amongst the FDA scientists.
1300
01:17:16,132 --> 01:17:19,385
Listen, safety's as important to us
as it is to anybody else.
1301
01:17:19,468 --> 01:17:23,389
None of us want a product on the market
that's not safe, right?
1302
01:17:23,472 --> 01:17:26,267
That's why we rely on regulators
to help us get there.
1303
01:17:26,350 --> 01:17:28,853
I think the US regulatory system
works well.
1304
01:17:28,936 --> 01:17:31,772
It's robust, it's thorough,
and it's been very effective.
1305
01:17:33,232 --> 01:17:34,358
Ladies and gentlemen,
1306
01:17:34,441 --> 01:17:38,779
please welcome president and CEO
of AdvaMed, Scott Whitaker.
1307
01:17:41,740 --> 01:17:44,451
The device industry
is very well represented
1308
01:17:44,535 --> 01:17:46,662
by their main lobbying group, AdvaMed.
1309
01:17:46,745 --> 01:17:48,372
Good afternoon, everyone,
1310
01:17:48,455 --> 01:17:51,458
and welcome to the Global Summit
for Medical Technology.
1311
01:17:52,334 --> 01:17:54,378
This is a room full of disruptors.
1312
01:17:55,254 --> 01:17:57,673
We are risk-takers of the highest order.
1313
01:17:58,674 --> 01:18:02,678
Not enough Americans understand
the important role we play,
1314
01:18:02,761 --> 01:18:06,432
or frankly give us enough credit
for the innovation we bring.
1315
01:18:07,141 --> 01:18:09,602
Sure, we'll pay attention to Washington.
1316
01:18:09,894 --> 01:18:11,770
That's my job. That's what I do.
1317
01:18:12,438 --> 01:18:16,734
But we have more power in this room
than most governments around the world.
1318
01:18:17,234 --> 01:18:20,112
We have the ability
to create jobs and prosperity...
1319
01:18:20,946 --> 01:18:24,742
to open and expand markets
and unleash innovation.
1320
01:18:25,326 --> 01:18:28,871
Let's show the world that we are
what's next.
1321
01:18:38,339 --> 01:18:39,882
They have lobbied hard
1322
01:18:39,965 --> 01:18:44,678
to see the standards for approval
of devices watered down over the years.
1323
01:18:45,554 --> 01:18:48,766
Device companies
unleash armies of lobbyists
1324
01:18:48,849 --> 01:18:50,893
in order to influence politicians.
1325
01:18:50,976 --> 01:18:54,104
And these politicians are vulnerable.
They don't know science.
1326
01:18:54,188 --> 01:18:57,107
It's often very flowery
and impressive language
1327
01:18:57,191 --> 01:18:59,151
about how they put patients first
1328
01:18:59,235 --> 01:19:01,570
and they want only the best.
1329
01:19:01,654 --> 01:19:05,866
We want to make sure that new
medical innovations get to patients
1330
01:19:05,950 --> 01:19:09,411
and help save lives,
improve the human condition,
1331
01:19:09,495 --> 01:19:12,456
eliminate suffering,
and make this world a better place,
1332
01:19:12,539 --> 01:19:13,999
That's what we all agree on, right?
1333
01:19:14,708 --> 01:19:16,168
The medical device industry
1334
01:19:16,252 --> 01:19:18,712
has incredible levels of influence
in Washington, D.C.
1335
01:19:18,796 --> 01:19:21,048
They have provided dark money
contributions
1336
01:19:21,131 --> 01:19:24,301
that are used to secretly fund
political campaigns.
1337
01:19:24,385 --> 01:19:28,555
Medical device companies also fund
think tanks and patient advocacy groups
1338
01:19:28,639 --> 01:19:30,808
that can go to Congress
and make the case for them.
1339
01:19:32,017 --> 01:19:34,770
Perhaps an even worse problem
is the revolving door.
1340
01:19:34,853 --> 01:19:39,358
A number of FDA officials
have both come from industry
1341
01:19:39,441 --> 01:19:42,194
and then go back to industry
after they're at FDA.
1342
01:19:42,987 --> 01:19:44,947
When they go to work for the companies,
1343
01:19:45,030 --> 01:19:47,199
they can tell the companies all the tricks
1344
01:19:47,283 --> 01:19:51,245
of how to get around FDA regulations,
how to get what you want.
1345
01:19:51,954 --> 01:19:55,374
Almost all the heads at the FDA
went on to work for industry.
1346
01:20:36,957 --> 01:20:39,418
President Donald Trump
says he's picked a nominee
1347
01:20:39,501 --> 01:20:41,503
to run the Food and Drug Administration.
1348
01:20:41,587 --> 01:20:45,591
Dr. Scott Gottlieb is a popular choice
in the pharmaceutical industry.
1349
01:20:45,674 --> 01:20:48,802
"Thank God it's Gottlieb," said
an investment analyst at Robert Baird.
1350
01:20:48,886 --> 01:20:50,596
Why would they have that reaction?
1351
01:20:50,679 --> 01:20:54,933
They were breathing a sigh of relief.
He's a known entity in the industry.
1352
01:20:55,017 --> 01:20:56,894
I've known Scott
for a long time.
1353
01:20:56,977 --> 01:20:57,811
He took that job
1354
01:20:57,895 --> 01:21:01,565
because he wants to do what's in the best
interest of the American people
1355
01:21:02,024 --> 01:21:05,027
and the agency, and not what's
in the best interest of anyone else.
1356
01:21:06,528 --> 01:21:10,783
Gottlieb has been a consultant
to a range of medical industries.
1357
01:21:10,866 --> 01:21:13,077
He's also worked
at a venture capital firm
1358
01:21:13,160 --> 01:21:17,623
that actually specializes in investing
in start-up medical device companies.
1359
01:21:18,248 --> 01:21:20,876
I'm proud of my relationship
with New Enterprise Associates.
1360
01:21:20,959 --> 01:21:23,462
It's been one of the premier
venture capital firms in the country,
1361
01:21:23,545 --> 01:21:25,255
starting a lot of innovative ventures.
1362
01:21:25,339 --> 01:21:28,842
Over the time that I was there,
they invested about $14 billion
1363
01:21:28,926 --> 01:21:30,469
in 500 different companies.
1364
01:21:36,392 --> 01:21:39,144
You have spent
your life entrenched in the companies
1365
01:21:39,228 --> 01:21:42,356
that would benefit
from looser regulations.
1366
01:21:42,439 --> 01:21:44,858
But I think it raises
the very real question
1367
01:21:44,942 --> 01:21:50,572
of whether someone who seems to oppose
the FDA's basic safety mission
1368
01:21:50,656 --> 01:21:52,533
should be running the agency.
1369
01:22:03,919 --> 01:22:07,131
I can tell you he doesn't have any bias
as a result of that.
1370
01:22:07,214 --> 01:22:09,842
I've never seen it
and don't expect to see it,
1371
01:22:09,925 --> 01:22:11,802
knowing him the way I do.
1372
01:22:25,566 --> 01:22:28,444
The FDA is supposed to protect
the public interest.
1373
01:22:28,527 --> 01:22:33,115
Unfortunately, their behavior shows
that they have been captured by industry.
1374
01:22:33,198 --> 01:22:35,534
Scott, thank you for coming
across the country
1375
01:22:35,617 --> 01:22:37,661
to participate with us at this conference.
1376
01:22:38,245 --> 01:22:40,080
I speak, I think, for the entire industry.
1377
01:22:40,164 --> 01:22:42,249
Where we were five years ago at the FDA
1378
01:22:42,332 --> 01:22:44,751
compared to where we are today
is night and day.
1379
01:22:44,835 --> 01:22:47,880
And I think your leadership
has made a huge difference
1380
01:22:47,963 --> 01:22:49,882
and we are really grateful for that.
1381
01:22:53,010 --> 01:22:57,014
In 25 years,
we will, I think, be worse off.
1382
01:22:57,097 --> 01:23:00,517
All the legislation we're seeing,
again, driven by lobbying from industry,
1383
01:23:00,601 --> 01:23:01,727
is moving in the wrong direction
1384
01:23:01,977 --> 01:23:04,938
and there's no evidence
that's gonna shift.
1385
01:23:06,023 --> 01:23:09,610
I just came out of a briefing
with senior officials at the White House
1386
01:23:09,693 --> 01:23:13,614
about the executive order that
President Trump will sign this morning.
1387
01:23:13,697 --> 01:23:15,741
We issued an order which says,
1388
01:23:15,824 --> 01:23:20,954
for every one new regulation,
two old regulations must be eliminated.
1389
01:23:22,331 --> 01:23:25,417
"Regulation is bad. Let's cut regulations.
1390
01:23:25,501 --> 01:23:29,004
For every regulation,
we're going to cut umpteen regulations."
1391
01:23:29,087 --> 01:23:30,297
That bravado...
1392
01:23:31,048 --> 01:23:33,050
may apply to certain fields,
1393
01:23:33,133 --> 01:23:36,553
but it can't and shouldn't apply
1394
01:23:36,637 --> 01:23:40,516
when you're talking about
putting a device in someone's body.
1395
01:23:45,437 --> 01:23:47,022
We're very proud of this one.
1396
01:23:48,357 --> 01:23:50,442
I'm gonna leave.
I need to go find a place.
1397
01:23:51,568 --> 01:23:52,486
Mom!
1398
01:24:00,911 --> 01:24:01,828
You ready?
1399
01:24:08,126 --> 01:24:10,837
We are going to go try to find a hotel
1400
01:24:10,921 --> 01:24:13,674
that will take us all in
with a reasonable price.
1401
01:24:15,008 --> 01:24:16,927
And call it a day, I guess.
1402
01:24:22,641 --> 01:24:24,226
Mom, there's a homeless over there.
1403
01:24:24,309 --> 01:24:25,394
I know, baby.
1404
01:24:26,311 --> 01:24:28,438
You see, girls? It could always be worse.
1405
01:24:28,522 --> 01:24:32,067
He probably doesn't have a car or anything
and we do have a car.
1406
01:24:40,033 --> 01:24:41,034
Does he know us?
1407
01:24:41,952 --> 01:24:44,246
- Does he know us?
- No. Okay.
1408
01:24:45,289 --> 01:24:47,708
Hi. How much is it for a two-bed?
1409
01:24:47,791 --> 01:24:49,751
- 110 for one night?
- Yeah.
1410
01:24:49,835 --> 01:24:52,963
Do you have weekly discounts
or anything like that?
1411
01:24:54,256 --> 01:24:55,549
Nothing right now.
1412
01:24:58,510 --> 01:25:00,387
Give me a second, okay?
1413
01:25:07,436 --> 01:25:09,980
- So it's 110.
- 110 and a private room.
1414
01:25:20,574 --> 01:25:22,284
- Are you guys happy?
- Yeah.
1415
01:25:22,367 --> 01:25:23,285
Yeah.
1416
01:25:28,540 --> 01:25:29,458
Go.
1417
01:25:31,126 --> 01:25:33,128
It's really tiny.
1418
01:25:40,260 --> 01:25:42,220
So I guess we're home.
1419
01:25:43,388 --> 01:25:44,556
For a night.
1420
01:26:01,448 --> 01:26:02,866
Familiar faces.
1421
01:26:05,327 --> 01:26:07,204
Nice to meet you in person.
1422
01:26:07,287 --> 01:26:08,121
Claudia.
1423
01:26:08,914 --> 01:26:09,748
Janet.
1424
01:26:09,831 --> 01:26:11,124
Yes, Janet, how are you?
1425
01:26:11,208 --> 01:26:12,167
Good, how are you?
1426
01:26:12,250 --> 01:26:14,044
You're Marilyn, right?
1427
01:26:14,711 --> 01:26:16,380
- And you are...?
- April.
1428
01:26:16,463 --> 01:26:19,966
Oh, my God!
1429
01:26:20,050 --> 01:26:21,927
- Surreal.
- My God, you guys.
1430
01:26:22,010 --> 01:26:24,304
I want to thank everybody for coming.
1431
01:26:24,388 --> 01:26:28,809
It's just amazing
to finally see all of you.
1432
01:26:28,892 --> 01:26:31,812
So let's start off
by maybe just going around,
1433
01:26:31,895 --> 01:26:34,147
just say who you are
and where you're from.
1434
01:26:34,231 --> 01:26:37,776
My name is Alicia Perry.
I am from Stockton.
1435
01:26:38,443 --> 01:26:43,657
I am an implantee,
I'm just going to say it, for ten years.
1436
01:26:43,740 --> 01:26:47,619
No longer. And I'm so glad
to see everyone here. Thank you.
1437
01:26:47,703 --> 01:26:50,997
I'm Juanita Nunez-Archuleta.
I know it's long.
1438
01:26:51,915 --> 01:26:53,917
I'm an admin on the Spanish page
1439
01:26:54,000 --> 01:26:56,086
and I am E-free, seven months.
1440
01:26:56,586 --> 01:27:00,632
I'm Gaby Avina
and I'm from Martinez, California.
1441
01:27:00,716 --> 01:27:03,802
I was one
of the clinical trial participants,
1442
01:27:03,885 --> 01:27:09,683
so I had mine implanted in 2000,
and I had mine taken out in 2014.
1443
01:27:10,726 --> 01:27:16,273
I don't know if any of you were familiar
with the Ask Gaby website...
1444
01:27:16,940 --> 01:27:19,943
that was on Conceptus
and Essure's website.
1445
01:27:20,026 --> 01:27:21,111
That was me.
1446
01:27:21,194 --> 01:27:22,571
I was a spokesperson.
1447
01:27:23,780 --> 01:27:27,367
I failed thousands of women
for seven years.
1448
01:27:27,451 --> 01:27:30,245
It's a long time to tell women
that a product is great.
1449
01:27:31,037 --> 01:27:32,998
So the guilt that you live with...
1450
01:27:34,958 --> 01:27:36,376
and the pain...
1451
01:27:38,378 --> 01:27:42,758
and just crazy feelings of responsibility
1452
01:27:42,841 --> 01:27:43,967
because of that.
1453
01:27:48,221 --> 01:27:50,515
Thank you for being
on this side now
1454
01:27:50,599 --> 01:27:54,770
because it's important
that people now see the damage
1455
01:27:54,853 --> 01:27:57,606
and more and more doctors
are starting to see it.
1456
01:27:57,689 --> 01:27:58,690
Very validating.
1457
01:28:03,820 --> 01:28:06,782
We just want to have a discussion
and brainstorm.
1458
01:28:06,865 --> 01:28:09,409
What should our new media push be
right now?
1459
01:28:09,910 --> 01:28:13,663
I felt good about it
'cause I saw women that came together
1460
01:28:13,747 --> 01:28:15,707
to fight for what they believe in.
1461
01:28:16,374 --> 01:28:18,210
They're strong, they're smart women,
1462
01:28:18,293 --> 01:28:20,420
and they're getting the media to listen.
1463
01:28:21,546 --> 01:28:24,466
It was supposed to be safer
and less invasive.
1464
01:28:24,549 --> 01:28:27,886
Why are so many people complaining
about a popular birth control device?
1465
01:28:27,969 --> 01:28:29,304
Pain, back pain.
1466
01:28:29,387 --> 01:28:31,515
It was debilitating. I could barely walk.
1467
01:28:31,598 --> 01:28:34,351
I never thought
I would be looking at a hysterectomy...
1468
01:28:35,101 --> 01:28:35,936
at 29.
1469
01:28:36,019 --> 01:28:37,521
My body is just devastated.
1470
01:28:37,604 --> 01:28:41,441
Damaged, they say,
by a birth control device called Essure.
1471
01:28:41,525 --> 01:28:45,028
The stories started getting out
in the news and then other news stations
1472
01:28:45,111 --> 01:28:49,074
started seeing the other stories and were
like, "Okay, let's do this in our area."
1473
01:28:49,157 --> 01:28:51,743
Five heart-wrenching stories
of extreme physical pain.
1474
01:28:52,327 --> 01:28:54,746
Six women with severe medical problems.
1475
01:28:54,830 --> 01:28:58,875
Thousands of women like Becky
are sharing their experiences on Facebook.
1476
01:28:59,543 --> 01:29:02,254
There are now
35,000 members in the group.
1477
01:29:02,754 --> 01:29:04,881
We've set up groups in other countries.
1478
01:29:04,965 --> 01:29:08,051
We found women in Italy,
willing to take over the page.
1479
01:29:08,134 --> 01:29:09,886
We started the Netherlands group.
1480
01:29:12,848 --> 01:29:14,724
We had women from France.
1481
01:29:16,560 --> 01:29:17,894
They're all branches of us.
1482
01:29:18,937 --> 01:29:22,816
So we've got 11 subgroups
that are other countries.
1483
01:29:23,942 --> 01:29:25,944
A controversial birth control device
1484
01:29:26,027 --> 01:29:28,530
in the US is going off the market
in Europe.
1485
01:29:28,613 --> 01:29:31,575
Bayer announced
it is pulling out of the European market
1486
01:29:31,658 --> 01:29:33,326
due to a lack of interest.
1487
01:29:33,410 --> 01:29:36,580
But a spokesperson says,
"Bayer's decision
1488
01:29:36,663 --> 01:29:41,126
does not impact the sale or marketing
of the product in the United States
1489
01:29:41,209 --> 01:29:43,461
where there continues to be demand,
1490
01:29:43,545 --> 01:29:46,548
despite the recent inaccurate
and biased reporting."
1491
01:29:47,716 --> 01:29:49,009
That's bullshit.
1492
01:29:55,015 --> 01:29:59,269
The equivalent of the FDA in Europe
asked Bayer to provide more safety data.
1493
01:30:00,020 --> 01:30:03,231
And Bayer, at that point, decided
to withdraw it from the market.
1494
01:30:04,316 --> 01:30:05,609
It's very frustrating.
1495
01:30:08,194 --> 01:30:11,156
Our group has been fighting
in our country for the longest.
1496
01:30:12,240 --> 01:30:14,659
Yet we're the ones
with it still on the market.
1497
01:30:17,746 --> 01:30:20,457
Bayer has no incentive
to take it off the market here.
1498
01:30:23,627 --> 01:30:26,046
Nobody's holding the manufacturer
accountable.
1499
01:30:26,671 --> 01:30:29,132
- Bye, honey.
- Bye, honey. Knock 'em dead.
1500
01:30:31,927 --> 01:30:34,387
We're not gonna stop
until it's off the market.
1501
01:30:43,605 --> 01:30:46,983
The FDA isn't doing anything,
the manufacturer's not doing anything.
1502
01:30:47,067 --> 01:30:50,278
We need to push Congress
to force the hand of the FDA.
1503
01:30:51,613 --> 01:30:55,700
So this device
is still being inserted in women?
1504
01:30:55,784 --> 01:30:57,953
- In the United States...
- In the US?
1505
01:30:58,036 --> 01:31:01,498
September 18th, it came
off the market everywhere else.
1506
01:31:01,581 --> 01:31:04,709
Look at how far up
the injury and death reports go now.
1507
01:31:04,793 --> 01:31:06,836
Because they're not being held liable,
1508
01:31:06,920 --> 01:31:10,298
they don't have any incentive
to take these devices off the market.
1509
01:31:10,382 --> 01:31:14,344
People are getting harmed and injured,
and nobody's doing anything about it.
1510
01:31:15,512 --> 01:31:18,723
We have many, many women
who are ending up with fragments
1511
01:31:18,807 --> 01:31:21,434
and massive issues and re-surgeries.
1512
01:31:21,518 --> 01:31:24,145
- Women just seem to be expendable.
- Yes.
1513
01:31:24,229 --> 01:31:27,440
That's how we're starting to feel.
We're disposable.
1514
01:31:27,524 --> 01:31:30,986
The FDA has been very clear that they're
not going to take this off the market.
1515
01:31:31,069 --> 01:31:33,905
That this is the manufacturer's
responsibility
1516
01:31:33,989 --> 01:31:35,865
I know of no possible reason,
1517
01:31:35,949 --> 01:31:40,829
when they are chosen to protect
the health of the people of this country,
1518
01:31:40,912 --> 01:31:43,123
that they would choose to go
in the other direction
1519
01:31:43,206 --> 01:31:45,041
and protect the manufacturers.
1520
01:31:45,125 --> 01:31:46,668
That's gotta be changed.
1521
01:31:48,211 --> 01:31:53,925
I wanted to get as much information as
I can with the various personal stories.
1522
01:31:54,426 --> 01:31:57,429
I don't know
how many of those that you have.
1523
01:31:58,054 --> 01:31:58,888
A lot.
1524
01:31:58,972 --> 01:32:00,640
- Thousands.
- Tens of thousands.
1525
01:32:00,724 --> 01:32:01,975
Tens of thousands, okay.
1526
01:32:02,058 --> 01:32:05,520
This place works
with good people on the inside
1527
01:32:05,603 --> 01:32:08,398
trying to maneuver
and push legislation forward.
1528
01:32:09,024 --> 01:32:12,318
The way it really works
is the external pressure.
1529
01:32:13,028 --> 01:32:16,990
And that's all of you
and you are in great numbers out there.
1530
01:32:17,991 --> 01:32:19,075
Welcome to the NFL.
1531
01:32:20,618 --> 01:32:22,662
You just cannot get tired.
1532
01:32:23,121 --> 01:32:25,999
It is a continuous effort.
1533
01:32:27,333 --> 01:32:28,585
We won't stop.
1534
01:32:29,127 --> 01:32:31,087
They've already taken away my health.
1535
01:32:31,629 --> 01:32:33,256
What else can they take from me?
1536
01:32:33,339 --> 01:32:35,050
I have nothing to fear from them.
1537
01:32:36,051 --> 01:32:37,427
This has to come to an end.
1538
01:32:38,011 --> 01:32:40,472
I don't know how anyone with a conscience
1539
01:32:40,555 --> 01:32:43,808
and any sort of compassion
could let this continue to happen.
1540
01:33:14,130 --> 01:33:15,340
I go to work...
1541
01:33:16,216 --> 01:33:17,133
and I'm at work...
1542
01:33:17,217 --> 01:33:18,426
Right.
1543
01:33:18,510 --> 01:33:21,179
...and those issues aren't with me...
1544
01:33:21,513 --> 01:33:25,141
until you think about it
and think about it for an extended time.
1545
01:33:25,975 --> 01:33:27,560
We're insulated from...
1546
01:33:28,645 --> 01:33:29,521
the horror.
1547
01:33:32,315 --> 01:33:34,734
It's the first time
I've really heard him say
1548
01:33:35,485 --> 01:33:38,780
that much detail about how he feels
about what we're feeling.
1549
01:33:39,531 --> 01:33:42,200
- It's hard for the men to talk about.
- Right.
1550
01:33:43,201 --> 01:33:44,994
This is a safe place for us.
1551
01:33:45,537 --> 01:33:46,412
That's right.
1552
01:33:46,496 --> 01:33:48,665
I've probably talked to close to...
1553
01:33:48,748 --> 01:33:53,169
I can't even begin to think of the number
of women that have called me.
1554
01:33:54,337 --> 01:33:57,507
And the only good thing
is knowing that I'm not alone.
1555
01:34:10,145 --> 01:34:12,272
Please help me welcome Dr. Steve Tower.
1556
01:34:16,526 --> 01:34:19,112
The take-home message today
1557
01:34:19,195 --> 01:34:24,784
is that systemic cobalt poisoning
from a hip replacement...
1558
01:34:25,577 --> 01:34:26,786
is a common problem.
1559
01:34:27,370 --> 01:34:31,124
You could make a strong argument
that everyone would be better off
1560
01:34:31,207 --> 01:34:34,836
if we stopped innovating
in total hip replacement
1561
01:34:34,919 --> 01:34:38,590
and stuck with what's been around
for 30 years,
1562
01:34:38,673 --> 01:34:40,633
and we know there's designs...
1563
01:34:54,105 --> 01:34:54,981
Bye.
1564
01:34:55,899 --> 01:34:57,734
I love you.
1565
01:34:57,817 --> 01:34:58,776
Behave, okay?
1566
01:34:58,860 --> 01:35:00,528
- Bye, Liz.
- Bye.
1567
01:35:00,904 --> 01:35:03,156
- Love you, behave, okay?
- Okay.
1568
01:35:03,239 --> 01:35:04,073
Bye.
1569
01:35:07,744 --> 01:35:08,578
Bye.
1570
01:35:08,661 --> 01:35:09,913
Okay.
1571
01:35:09,996 --> 01:35:10,997
Behave, okay?
1572
01:35:11,497 --> 01:35:13,541
- Okay, well.
- All right.
1573
01:35:13,625 --> 01:35:15,376
- Thank you, Ms. Kelly.
- Yeah, okay.
1574
01:35:15,460 --> 01:35:17,086
- Okay, bye.
- Bye.
1575
01:36:51,597 --> 01:36:52,473
Relax.
1576
01:36:53,305 --> 01:36:59,553
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