Good afternoon, everyone,
and welcome to the Global Summit
for Medical Technology.
Here in this room,
many of you
have inspired generational leaps
in medical technologies.
You've created whole new fields
of medical advances.
You've explored new horizons
and broken barriers.
And everything we do is a means to the end
of unleashing innovation
to improve and save lives.
Watches and cell phones
that monitor blood sugar.
3-D printers to create prosthetic limbs.
Artificial intelligence
that today diagnoses melanoma.
All of these things exist today.
So let's pause for a minute
and take a look at the future.
What if, by 2050,
we have micro laboratories
implanted in our bodies
that predict illnesses
before we ever get sick?
What if, by 2050, we have 3-D printers
creating custom biomechanical organs?
Or what if artificial intelligence
can be used to predict heart att*cks
before they even happen?
If we succeed...
imagine the impact we will have
on medical care.
Let's continue to improve lives
by unleashing innovation.
Before you're born,
they use medical devices to find out
when you're gonna be born.
When you're born,
they use medical devices
to find out how healthy you are.
When you're growing up,
they oftentimes use medical devices
to enhance what's going on with you.
Medical devices are a way of life
in America.
They are a way of life
in postindustrial society.
They are a reason,
in some ways, for postindustrial society.
They help us live longer.
They give us better quality of life.
And they're just about everywhere.
There are devices
that are truly lifesaving.
My husband has a pacemaker in.
I'm glad for it.
It saved his life.
I have a cataract lens in
that makes me see beautifully.
It's everything from the very simple
little thing like a tongue depressor
to breast implants,
drug-eluting stents.
There's such an array of devices.
It's pretty amazing.
The medical device industry
is a 300 billion-a-year industry.
This is big business.
It's kind of a parallel
to the drug industry,
and it isn't nearly as well understood.
People think pharma's got power.
No, no, no, no.
The device industry
has much more power than pharma.
The medical device industry has been
expanding faster
than just about any other industry.
And that's because technology
is just running away right now.
And it's running away faster than we're
keeping up with the actual science.
We're living
in a very highly technological society,
and medical technology
is a... a wonder and a miracle.
But because it's everywhere,
we have to be careful.
I grew up in Western New York,
right between Rochester and Buffalo.
I'm a mail carrier.
And I work in the morning,
delivering mail to 70 mailboxes.
I'm married.
Hey, Bud. Do me a favor?
I was engaged
to somebody else,
and we broke up, and my friends threw me
a party to try to make me feel better.
And, um, he was driving by,
and one of my friends yelled out to him,
"Porch party!"
A friend of mine invited me in,
and that's kind of where we met.
What did you like about her?
Everything.
My daughter didn't have a father
in her life,
and Pete's children lost their mother
when she passed away.
So to come together
and all of us to just have each other,
it was just a blessing.
My last child was born in 2009.
I was 37 when we became pregnant.
We had decided,
you know, we wanted to have one together,
but that was enough.
So I went and spoke to my ob-gyn.
And he talked to me
about a new permanent birth control device
called Essure,
which could be done right in the office,
and I could go back to work the next day.
Put them in there. Yeah.
Wow!
You protect...
...and prevent...
...and even plan ahead.
But what about your birth control?
Maybe it's time to consider the proven,
permanent birth control of Essure.
Essure is
a permanent sterilization device.
It is made out of
little four-centimeter coils.
It's inserted through the uterus
and placed inside of the fallopian tubes.
It's intentionally designed
to cause an inflammatory response,
which generates scar tissue.
The scar tissue closes off
the fallopian tubes permanently,
blocking the sperm
and the egg from meeting,
therefore preventing pregnancy.
The early studies that were done
to get this device approved
suggested it's 99% effective
in closing the fallopian tube
and causing sterilization.
It originally was designed by Conceptus
and then bought by Bayer.
It was marketed as a better choice
than the traditional tubal ligation
The Essure procedure does not require
any incisions.
And because there are no incisions,
the procedure does not leave any scars.
And when it comes to recovery
after the Essure procedure,
women were typically discharged
from the medical facility
within 45 minutes.
It took no time out of my life.
And there was no chance
of having to go under anesthesia.
I was a nurse assisting
in the placement of Essure
during the clinical trials.
So I watched the procedure.
I thought it was simple.
It was non-surgical, it was permanent,
and it was everything I was looking for.
Seeing how easy it was to put it in,
I thought I should do it too.
For us, we were now allowed
to have a type of intimacy...
The company liked my story
because I was a nurse,
I'd participated
on both ends of the product.
So I was invited to be a spokesperson.
I even went so far as I had my own website
called Ask Gaby.
Patients would to me,
doctors would write to me.
I told them all the benefits.
I used to tell them that it took longer
to get your nails done
than it did to get sterilized.
Where's your headband?
Oh, hi!
How was school?
- We had to do dance inside, but...
- Yeah?
We were inside the whole time.
I have a full-time job in a business firm.
I am an account executive.
I love my job.
I have four daughters.
And I enjoy every moment
with my kids.
I want to go on Area 51.
You've got to try that!
My husband and I had decided
that four kids was enough.
So when I went to my doctor,
my doctor recommended Essure.
Wait, let me take a picture
of all you winners.
Smile!
Okay.
He said that it was easy.
You come in the office,
you leave and you're good.
You go back to your normal life.
Thread the Essure device
through the introducer
while you hold the hysteroscope.
Slowly and steadily advance
the Essure delivery system
into the fallopian tube.
He said I shouldn't feel anything.
Just two little devices
that I wouldn't even notice.
But the moment
I stepped out of the doctor's office,
I started feeling cramping.
Then, in the first week,
I started bleeding
more than I have ever bled
in my whole life during a period.
I called the doctor.
He's like, "Those two little things
doesn't do anything,
doesn't do all those changes
that you're telling me."
So I just kept continuing to believe
that it was in my head.
I went in for the procedure.
I could feel the whole thing.
I felt it go into my tube.
I remember hearing the clicking noises.
I felt it expand.
Um, it was pretty intense.
After the procedure,
I was running fevers a lot.
The bleeding was almost continual.
There may be a day or two
during the month when I wasn't bleeding.
The sharp, stabbing pain on my left side
was getting more and more intense.
So I made an appointment to go in
and have an exam.
The doctor ordered an ultrasound.
He came in and he looked at the screen
and just said, "Oh, it looks likeone
of her Essure devices is in her uterus."
And I was kind of in shock.
So he says,
"You know, we need to get these out."
And I agreed.
Woke up and the doctor said,
"Everything went good."
You know. "Go home and heal and rest
and you should feel better."
But after the procedure,
I started having problems again.
The bleeding started picking up.
My husband had gone with me
to the hospital
and we're in a room,
and I've got the IV in...
and just blood exploded out of me.
Like, it looked like a horror scene.
And there were large clots
all over the floor.
And he went out in the hallway
and just screamed for someone to come,
and they all just came in.
They threw me on a gurney, and off I went,
stretcher down the hallway.
I was scared.
I was really thinking about...
"What's gonna happen to my kids
if I don't wake up?"
The old-time medicine man
would sell his snake oil
by positively guaranteeing
it would cure any and every disease
known to man and beast.
Fortunately,
this form of quackery in medicine
is gradually being eliminated
by our food and drug laws,
but there's still another form,
equally dangerous
and far more difficult to control.
Phony machines and devices,
which are supposed to diagnose
and treat disease.
Unlike new dr*gs,
therapeutic devices do not have to be
proved either safe or effective
before they are sold or used.
The history
of medical devices is odd.
There was an expl*si*n in the 1920s
and '30s and '40s of fraudulent devices
that pretended to put sound waves
into the body to cure cancer
or any number of these weird devices.
Some were dangerous, such as ones
that had radioactive qualities.
There are some as phony
as a three dollar bill.
Like this Zerret Applicator, for example,
which has claimed to cure arthritis
with Z-rays.
There are no Z-rays.
Investigate before you invest
in health services or products.
Help stamp out quackery.
This has been
a public service announcement
from the Food and Drug Administration.
For many years,
devices just came onto the market
with the anecdotes
of doctors who used them,
who would say, "Well, I think it works."
It was only with
the Medical Device Amendments of 1976
that devices came under control of FDA.
At that point, industry argued,
"We don't want to have to test everything
we're already using,
pacemakers and other devices."
And the FDA said,
"Okay, you can grandfather in
anything that was on the market
prior to 1976.
The regulation of medical devices
has always been less than ideal.
Since 1976, the complexity of devices,
the number of devices,
the types of devices,
just rapidly expanded.
So we have the same framework
that was imposed, you know, 40 years ago
for a device world that is much more
complicated today.
Dr. Kessler,
please proceed when ready, sir.
Mr. Chairman, Americans rightfully expect
public health decisions...
to be made in their interest
and to be based on the best science
and medicine.
I was appointed as FDA commissioner
by the first President Bush
and asked to stay on by President Clinton.
FDA is the most important
consumer protection agency in the world.
It regulates virtually everything
that comes in contact with the body.
FDA is organized by centers.
So there's a center for foods.
There's a center for dr*gs,
there's a center for biologics
and there's a center for medical devices.
And FDA does a credible job
with the vast majority of products.
The problem we have...
is that, when it comes to medical devices,
we built a system that doesn't work.
Before I went into medicine,
I worked as a bike mechanic.
I always have loved taking things apart
and putting them back together again.
I grew up in Alaska.
Both my parents were physicians.
So I had a lot of knowledge
about medicine in general.
He's probably the most genuine person
you'll ever meet.
He's very caring, giving,
honest, and his patients love him.
That head now is ceramic.
The stem is titanium alloy, same as...
The first operation I ever saw
as a third-year medical student
was a hip replacement.
And I loved it. Very mechanical.
Something's broken and you fix it.
And it's... it's the simplicity of it.
He was having
a lot of degenerative hip issues himself.
And, on the one side,
the pain was more prevalent
and persistent.
It was starting to limit his bike riding.
The hip was getting
progressively more painful.
I realized,
doing the 100-Mile Winter Race,
that I could never do that again
unless I got the hip replaced.
The most critical fundamental
about hip replacement
is what are the materials of the parts
and pieces that rub together?
The most commonly used combinations
are ceramic-on-ceramic,
ceramic-on-plastic, metal-on-plastic,
and metal-on-metal.
The metal is almost exclusively
chrome cobalt.
Cobalt is used in a lot of machine alloys,
because it's made very, very hard.
It's one reason
that we use it in joint replacement.
I was swayed
to the metal-on-metal ASR hip
because that particular device
had been marketed
specifically
to exceptionally active individuals.
Within six weeks after my operation,
I did a 200-mile road race
without a lot of difficulty.
I... I thought it was great.
Most people probably believe,
when they get a medical device implanted,
be it a pacemaker or a joint,
that those medical devices
have undergone appropriate testing
to demonstrate that they are safe
and effective
before they came on the market
and doctors started using them.
But for most moderate
and high-risk devices,
that is not the case.
Originally, Congress intended
that almost all new devices
go through pre-market approval.
A PMA is similar
to a new drug application,
in that a manufacturer
must test it first in humans,
compile all this data,
and then present that to FDA scientists,
who will approve the device
if in fact it is safe and effective.
Industry argues, "We're innovating,
we're changing products every year
and that costs a lot of money, to test
each of those iterations in humans.
So Congress established
the 510 process.
For the 510 pathway,
all the manufacturer needs to demonstrate
is that their device is substantially
equivalent, is the regulatory term,
to another device
that's already on the market.
That provision,
which was meant as an exception,
in essence, a little loophole...
That exception became the rule.
So the vast majority of devices today,
regrettably, are regulated
under this framework.
This really can cause problems
when one medical device is approved
on the basis of being
substantially equivalent
to a previous medical device
that was approved
because it was substantially equivalent
to an earlier medical device than that.
You end up
with what we call a daisy chain.
And then, quite often what you found
is that some of these predicate devices,
as they call them...
have been recalled from the market
because they've been failing.
I called the FDA and asked them,
"How can you clear something
based on a predicate device
that's already been shown to be dangerous?
And they said,
"We don't judge what the prior device is."
So even if the device was recalled
because it was dangerous,
you can still use it as a predicate
and get your device cleared
'cause it's substantially equivalent.
So there's a lot of problems
with that 510 system.
And that's how metal-on-metal hips
got on the market.
A year and a half
after my operation,
I started having a slew
of health issues that I hadn't had before.
I developed a tremor
in my non-dominant hand.
His ears were ringing.
He was starting to repeat himself a lot
and explain things...
over and over.
As time went on,
those issues accelerated, and then,
I... I had a psychological decompensation.
He was attending a conference,
and I got a call.
He had trashed a hotel room.
He wrote all over the walls.
He took pens, Sharpies,
he wrote on the ceiling,
he wrote all over.
And when that was done, he took soap...
and he wrote on the mirrors.
It was a full-on breakdown.
You could see it in his eyes.
And just...
in turmoil...
knowing full well...
that he'd lost it.
All the while, he's still thinking.
He's still connecting the dots.
Eventually,
I started checking my blood and urine.
And my levels of cobalt
were 100 times what I should have.
I started calling up engineers at DePuy
and salespeople, saying,
"Is anyone else talking about this?"
The answer back was,
"No, we've never heard
of that being a problem."
But it was clear to me
that the hip would need to be redone.
So I chose a different model
with a plastic socket and a ceramic head.
When my doctor went in there
to revise my hip,
he found a virtual crankcase
of metal sludge.
And the critical ligaments, what we call
the hip capsule that holds a hip in place,
that had just kind of liquefied.
Within a month,
I had an incredible recovery
in terms of my psychologic symptoms
and my ability to think.
All the other symptoms
magically disappeared.
I got my husband back.
Come in.
Hey, Rodney.
Hello, Dr. Tower.
A long time, no see.
It's been a while.
How was your drive?
It was... The last 100 miles was snowy,
but it was a good drive before that.
Unless I'd personally
experienced this myself...
I wouldn't believe an orthopedic implant
could cause neurologic problems.
But with my experience,
I started to notice problems
in my own patients,
and it's not just metal-on-metal,
but metal-on-plastics, too.
I was going blind.
I was seeing stars,
constant stars in my eyes.
I couldn't remember words.
I'd start a sentence, then couldn't think
of the word that was supposed to go next
Problems with memory.
I was writing it off to, um, aging.
I thought I had Alzheimer's ordementia.
And that was really scary.
Just diagnosed me with Parkinson's.
My mind was... slowly slipping away.
I've seen so much of this
that now,
when a patient comes into the office,
if they have an artificial hip
and I know it has a chrome cobalt piece,
I routinely check
the level of cobalt in their urine.
I've just been progressively
getting better and better
since I had the hips both replaced.
It's very hard
to convince people this problem exists,
unless you show reversibility.
Get rid of the cobalt,
the problem goes away.
It's hard for people to argue with that.
The real breakthrough
in the last 18 months
has been the ability to actually image
the neurologic problem.
Dr. Tower came down
to the Imaging Center
to look at an MRI of the hip
and we got into a discussion
about the symptoms
of cobalt poisoning toxicity,
and he mentioned cognitive issues.
Dr. Bridges said, "Gee, yeah,
we ought to get an FDG PET brain scan
on a patient that you think
is having the neurologic problems,
because I bet we can see it.
We have a tool that can
actually detect dementias like Alzheimer's
years before they become clinically
evident on physical examination.
Basically, what I'm looking at
is the slice through the basal ganglia.
Blue is bad.
Blue is bad.Those are the areas
of the brain that are most affected.
By this scale, we're looking
at 2 to 3 standard deviation.
At least greater
than two standard deviations below normal.
The first patient came up very abnormal.
So then he suggested we do another patient
and then another patient,
and they all began to look the same.
You've got the typical findings
on the brain scan
that we're seeing
with the other 23 patients.
So you're number 24.
Doing a study on this
is something that I feel
I'm morally obligated to do.
But I don't think I should be the guy
who has to do that.
This work really needs to be reproduced
with hundreds,
if not thousands, of patients
to fully understand it.
I think the CDC should be doing it.
I think the FDA should be doing it.
And I've approached all those people,
and just not getting
a lot of support there.
I'm horrified because,
the more I'm looking at it,
I'm beginning to wonder,
is cobalt the new mercury poisoning?
Are these people being relegated
to the dustbin
because they have what somebody
misperceives as dementia?
How many people have been
misdiagnosed
with a permanent disease process
that actually have a reversible
disease process?
That's the horror right there.
Innovation lives here.
It's the foundation of our legacy
and the backbone of our DNA.
Our motto is never stop moving.
And some of the words that are behind that
are just this relentless pursuit...
of innovation that improves patient care.
Industry likes to use the term
innovation, innovation, innovation.
Innovation, to me,
means we've got something new,
but we've got good evidence to support it.
We've got good evidence about the benefits
and the harms.
You're developing medicine,
you're bringing it forward.
Without evidence, we don't know
whether it's really a development. It...
You know? Who knows? You don't know.
Surgeons and patients like the idea
that they're getting something new.
I tell my patients
new equates to unproven.
Companies can develop new products
that may not be safer and more effective
than other products already on the market,
but they will certainly
heavily promote them
to doctors, to hospitals,
to drive up their profits.
They wheel out patients and say,
"This person wouldn't be alive today
if they didn't have
this innovative product."
It's all very glossy.
It's a slick machine.
We've doubled life expectancy
in 150 years.
And that's happened because of innovation.
Just because you have a new technology
doesn't mean it's innovation.
And, I think, too often I hear people say,
"Oh, you're gonna stifle innovation."
They're not talking
about stifling innovation.
They're talking about stifling, um,
putting untested devices on the market.
That's not innovative.
Before Essure,
the only times I was in the hospital
was because I was pregnant.
For the past three years
that I had the Essure,
I've visited the hospital a lot
because of pain.
I was working
and passed out 'cause of the pain,
and I woke up
and I drove myself to the hospital.
I'm more scared because,
if they have to admit me,
I have to find someone
to take care of my kids.
Especially because it's a school night.
So I don't want them to miss school.
Are you Ana Fuentes?
After Essure,
my bleeding wouldn't stop.
It came to the point that I had to start
wearing baby diapers.
I couldn't even function
as a wife to my husband,
and eventually, he ran away.
One of the doctors that I had,
he mentioned that most Latinas
have menstrual problems.
So they thought it was...
because I was Latina
that I would bleed a lot.
But I'm like,
"I've been Latina since I was born
and I became a...
And my mom saw me grow up
and I never bleeded this much.
So this doesn't have to do
with me being Latina."
I've had a headache since 2011.
Normally, the headache's about a four.
And then at night, it starts spiking up.
Seven, eight, nine.
Sometimes ten.
So this is my traction unit.
It stretches my cervical spine,
'cause the inflammation
gives me insane headaches.
Before I had Essure put in,
I was really strong and really healthy.
We went hiking, we went camping.
I could do all the normal things
that moms do.
It's hard for me
not to be doing those things.
I did a little research.
I didn't see too many people online
talking about Essure.
And I said, "I have to warn my friends
and my family members,
and I need to tell them
to stay away from this."
So I started this little Facebook group
called Essure Problems,
and I added all my girlfriends.
I didn't really know
much about Facebook groups,
but then slowly people that I didn't know
started commenting and saying,
"Oh, my God,
this is what I'm going through."
Just stories just started coming in.
People just found me.
It just started snowballing.
I remember hitting 65 people
and going, "Wow, there's 65 people
that are having this problem."
Every day, we had new people
joining the group.
Women were telling their stories.
The day that I was implanted,
I left the hospital
and I was in pain.
They told me to take some Ibuprofen
and it'll get better.
Now I'm going to the OB this week to have
a full hysterectomy at 31 years old.
Slowly, the progression of women
joining and having similar stories,
um, we became a support group
for each other.
And then we started finding information
about how the device was approved.
We found out that Essure
went through something
called the pre-market approval process,
or PMA.
Pre-market approval
is the most stringent pathway
to get a device approved.
But even that process is not that strict.
It's less rigorous
than the process for dr*gs.
Most dr*gs had to have
two clinical trials,
and they have to have large
numbers of patients.
With devices, it's only one study.
Those studies are often small.
Sometimes it's 100 people.
I've seen studies with 50 people.
So the approval process
for the riskiest devices is not good.
One of the members of the group
found the transcript
for the 2002 approval meeting
where the FDA approved Essure.
I noticed at the bottom of the transcript
that the entire meeting
had been videotaped
by this video company,
and their phone number was there
so I thought, "I should call them
and see if I can get a copy of that."
And so I did, and they found it,
and they said it was going to be
several hundred dollars.
I put a post on the page.
I'm like, "I think we need this."
And within 15 minutes,we raised $900
on the page, and I ordered those DVDs.
All right.
Let's go ahead and get started.
They approved this device
on such a small number of women
that were followed
for such a short amount of time.
The lead investigator
for the clinical trials
who presented the evidence
to the FDA
on the safety and efficacy of this device,
he owned stock in this company.
I have received compensation
which now represents
a financial interest in the company.
There was a paid spokesperson
that had Essure implanted herself.
Gabriella Avina.
They hired her to come and speak.
It brought about a peace
to my life and to my relationship
that I cannot express to you.
And it was just mind-blowing
because they didn't have a lot of data
for the questions
the panel members were asking.
What would happen if you touched
the electrode to the coils?
How much
uterine cavity will be compromised?
The panel was not supplied with
a summary about compatibility testing.
What about the tubal perforation issue?
I don't know what happens to people
with metal sensitivity
when you implant metals in them.
They still approved it,
even with these open-ended questions.
The device clearly met the criteria
of safety and effectiveness
that are required for approval.
At the end of the meeting,
one of the panel members asked,
"What are we gonna do
if we're seeing problems in ten years?"
Private investigators would find
each of us, bring us back here,
and ask us why we approved this.
How could they joke about this?
Like, they're joking about... us.
You know, here we are, ten years later,
and all these problems...
And... and, you know,
they approved it on... on a joke.
If this is our FDA process
of medical device approval,
then we have a big problem
in this country,
because this is just one device.
I'm from Nicholasville, Kentucky.
Kind of a... Anywhere, USA.
It's a small town.
Great schools.
Great people, wonderful church.
I was in nursing.
I did pediatrics, uh, children.
And I just loved working with the people.
My husband is a machinist
at General Electric.
He works on the machines.
They're bigger than a house.
He's my rock.
Well, we met... Um...
I was young and we were out partying.
So, um, she was with a group of friends
and I was kind of out on my own...
um, looking for trouble, I should say.
Ah... I found it!
We've got a daughter
that's got a beautiful spirit.
Very loving, very compassionate.
Uh, make a great doctor one day,
if she chose to.
I delivered my daughter at 41
and I was working at the hospital,
and when I would go to assist my patients
by transporting them from the bed,
I would leak some.
She started having some problem
with holding her urine.
She went to the doctor to see about it.
And, um, of course...
they suggested some procedures.
My doctor said, "We can take care
of that in a simple 45-minute procedure
with this new thing called mesh.
It's a simple, golden standard
outpatient surgery.
It's better than sliced bread.
It's the new thing."
Mesh is a polypropylene resin
that gets extruded into fibers
and then woven and knit into a mesh.
Johnson & Johnson saw that doctors
were starting to take hernia mesh
and cut very little tiny pieces of it
to help support repairs
where they felt they needed a little bit
extra because the woman's tissue was weak.
So they said, "That's a great idea.
Let's sell the hernia mesh
for pelvic floor treatments."
As women get older,
and if they have several children,
things start to bulge or drop.
Patients come to us
and want things to be fixed.
One approach is what's called
a native tissue repair,
which is basically where we suture
things in place using stitches,
suture material.
Or, theoretically, one could use mesh
to augment the repair.
The surgeon makes a cut in the vag*na
and then implants the mesh
to hold organs up in place.
It costs about $25 to bring to market
and they sell for about $2,000 a pop.
I was told that it is superior to
the traditional surgery that's required.
Very easy to place.
Very, very few complications.
I wish I could say that doctors
really understood
the regulation of medical devices.
But the fact is that's not what they do.
That's not their area of expertise.
We were surprised to see how little
surgeons knew, in our study,
about the approval process for devices.
Some of the surgeons seemed to think,
"Well, the FDA are taking care of this."
That of course these devices
had been tested in humans.
I came home from my surgery.
I started having a lot of pain,
discomfort.
I couldn't sit, I'd climb steps,
I felt like a 90-year-old woman.
She had a bad fever.
She was throwing up.
We ended up going
to a few emergency rooms.
We'd seen so many doctors.
They didn't know what was going on
with her. They had no clue.
Once you put mesh in,
it is scarred into place,
permanently affixing it to the tissue.
The scar tissue
causes the mesh to shrink up
and as it shrinks, it starts to contract
and pull against the adjacent tissues
that are in contact with the mesh.
The scar tissue creates
a hard and flexible object in the pelvis.
Around the vag*na, around the bladder,
around the urethra.
Structures that need to be able tomove
in very subtle ways in order to function.
Now you have this hard object in there,
and there's a cascade of problems.
So eventually, I find this doctor
in Louisville.
And he says,
"You've got a problem with your mesh
and it needs to be removed...
but I can't do it."
I was never trained to take it out.
I've never took it out.
We were just trained on how to put it in.
Once it's scarred in place...
that's it.
Ain't coming out. Not in its entirety.
I've been told
it's like removing rebarout of concrete,
bubblegum out of your hair.
Because of the position
that they're placed,
they're in very delicate areas
where it's almost impossible
to remove the mesh completely
Once the scarring is complete,
the body doesn't want it to be there.
So it keeps scarring and scarring,
keeps pushing and pushing,
and sometimes it tries to push it
out of the body.
So we do a partial mesh removal.
Six to eight weeks of healing.
My husband and I are trying to get back
to our sexual relations.
I've set the stage, actually.
I've got candles going,
I've got my daughter in bed.
You know, I'm gonna feel
like a woman again.
This mesh problem's gone.
Very shortly into our intercourse,
my husband jumps up.
When I penetrated her...
I ended up getting a...
cut.
He grabs himself.
He turns the light on.
And I have cut...
the top of his penis.
I mean, like, what the hell?
You know? What's going on?
And he's like, "Tammy,
you... you've cut me."
She was confused about it.
Just as well as I was.
So I'm thinking in my head,
"Well, the rest of the mesh."
As a woman, you're thinking,
"Am I ever gonna be able to have relations
with my husband again?"
Was he ever
gonna want to stay with me?
At first, as she's going through
her illnesses and everything,
you're not thinking about that.
But then, you know,
we're talking an eight-year period...
of not having relationships
with your mate.
It can be really stressful.
That was taken from us.
I've had a major surgery...
bladder repair...
cervix removal...
reconstruction.
Your surgeries,
that's a grand total of how many?
Oh, Lord.
Eighteen?
Nineteen?
- Byonia?
- Yeah?
What's today's surgery?
I don't know. I've lost count.
Byonia knows more about mesh
than a lot of doctors.
She's been through every surgery.
I want to be a good wife
and I want to be a good mother,
and I still cannot do the things
I want to do with my daughter.
- Slow up.
- Byonia, slow up.
Yeah.
Mommy can't keep up with you.
I have a daughter that says, "I wish."
"Momma, I wish we could ride my bike.
I wish that I could take your pain."
The hardest one to hear is, uh...
"Mommy, is it my fault you had mesh?"
She's smart enough to know...
She's heard women talk.
That she knows it is a lot of it
from childbirth.
That should never be in her heart
or her mind.
That's my guilt.
We take our responsibilities
as a leader in health care very seriously.
We're fortunate to be in an industry
where human health care
is the basis of our business.
And we measure successby improving
the quality of people's lives.
The CEO of Johnson & Johnson
is Alex Gorsky.
Before he was the CEO,
he actually was the head of Ethicon,
the unit in the company
that these products were sold through.
And on his watch, there was a flood
of information coming into the company...
of women suffering
very severe complications.
When did anybody first
make you aware that anybody in the world
had a concern
about the safety of the Prolift?
I don't recall.
Before the pelvic mesh devices
even came to market,
the surgeons who were developing
the prototypes...
were telling Johnson & Johnson,
"This mesh is not safe."
And the director of medical affairs
acknowledged it on the record
when I took his deposition.
You knew significant retraction
could occur?
Yes.
You knew
that a significant retraction
could lead to pain for the patient,
correct?
Yes.
You knew it could lead
to the need
to have subsequent invasive operations
to try to either...
re... remove or revise
that contracted mesh, correct?
Yes, sir.
As you sit here now,
are there any risks or adverse reactions,
adverse events connected to the Prolift
that medical affairs at Ethicon know of
that were not known at the time of launch?
No. There are no new adverse events that
we were unaware of at the time of launch.
What they did
was willfully ignore the risks
they were putting these women to
without telling them.
And actually, not just not telling them,
but telling them
how safe this was going to be
and how wonderful
this was going to be,
knowing they didn't have
a basis to say that.
People who go to work
in medical device companies,
they're scientists
who actually want to do the right thing.
But if the science or the medicine
isn't jiving with the marketing,
the marketing is always gonna win out,
always.
So it is December 10th, Sunday.
Um, two days before my lumbar puncture
spinal tap.
My daughter, Rayne, is going to drive me
and stay with me there the whole day.
I think they said they do the procedure
around 7:00 a.m.
So, yeah.
Yay, spinal tap.
Coming up soon.Oneida.
Have you ever had
any surgeries done?
- Lots.
- What have you had?
I had a medical device called Essure,
- the new female sterilization.
- Oh, yeah.
Those expelled and got migrated
in my uterus.
I had surgery to remove those,
then I had to have a tubal ligation.
- Um...
- So I guess you're not pregnant.
No, because then, later,
I had to have a hysterectomy
because of the fragments
from the devices that broke.
Get out of town!
Then I had two more surgeries
as I wasn't healing from the hysterectomy.
So they had to repair the vaginal cuff
twice.
- Holy crap!
- Yeah.
Sorry, that's like...
I've had three joint surgeries because...
Essure removal
is the bane of my existence.
We've seen the manufacturer
change the removal protocol,
contradicting themselves
and going back and forth on what's okay
and what's not okay.
Because of that,
a lot of doctors are winging it.
And, unfortunately, breaking them,
pulling them,
cutting them, stretching them.
'Cause If you pull them
or stretch them at all,
it'll fragment and leave pieces behind.
This is what happened to me.
The device ended up breaking
and leaving me with fragments everywhere,
which then set off
my immune system.
Which then set off
a connective tissue disorder
that started deteriorating my joints.
Bayer has admitted that it causes
an autoimmune response
in a small percentage of women.
Um, however,
we don't think it's a small percentage.
Women have all these problems
that seem to have nothing to do
with their pelvic area.
So we started
the Autoimmune After Essure group.
What's just as crazy as that,
we see a really high rate of women
that are becoming pregnant
after being implanted with Essure.
So we've started
a Parents of E-babies group.
We're seeing patterns of health problems
with these babies.
We have seen the device puncture
the amniotic sac and cause preterm labor.
We've seen a lot of loss.
I've seen women have to bury
premature babies.
This is devastation.
Life devastation.
There's nobody paying attention.
We are keeping those records
because nobody else is.
We assume the FDA
has the data that they need
to cr*ck down on manufacturers
that have bad devices
or to recall a product,
and they don't have that.
- They don't?
- They don't have that.
There is a system
for reporting complications...
but there's tremendous underreporting,
because it's a voluntary system.
The FDA has said, "If there's a problem,
just come back to us and let us know."
Well, that reporting system
relies on self-reporting.
There are huge problems
with self-reporting complications.
If a physician observes an adverse event,
they do not have to report it.
The only...
bodies that are required to report
adverse events are the companies.
And the industry is not interested
in having problems with devices
become apparent.
It's estimated
that only three to four percent
of all adverse events...
get reported to the FDA.
A study found
that the worse the outcome was,
the less likely it was
that they would report it to FDA.
So we don't know
about the adverse effects of a new implant
until months or years
after it's on the market.
By then, that may have been put into
hundreds or thousands of people.
Yes. That one.
Here's some examples
of doctors putting in multiple coils.
There's three coils here on this side
and one on this side.
This one is way, way out
of the fallopian tube.
Here's one with six devices.
The doctors are told by the Bayer reps
that come in, who aren't doctors...
Reps come into these rooms
to sell these devices,
and they stand there
and watch you get implanted,
and, if it misfires
and it just gets sh*t off into the uterus,
they just tell the doctor
to load up another one and try again.
So we're seeing women with five, six,
sometimes eight devices, inside of them,
when you're only supposed
to have one per tube.
Every year,
there's an annual ACOG convention.
And ACOG is
the largest gynecological organization
in the United States,
so there will be thousands
of ob-gyn doctors
at this ACOG convention.
There are so many doctors
that still believe
there are no problems with this device.
Looking at the photos
I think changes their minds.
- There's Holly.
- Hi! How's it going?
I'm Janet, one of the main admins.
Nice to meet you.
- I'm Eva.
- Nice to meet you, Eva.
Oh, there's Angie.
Hi!
Oh, what's up?
Nice shirt.
Yeah, you like it?
I love it. Love it.
Bayer has no data!
Do you have malpractice?
Bayer has no data!
Do you have malpractice?
Bayer has no data!
Do you have malpractice?
Bayer has no data!
Do you have malpractice?
Make sure you tell Bayer
we're out here.
- We're not going.
- Are you giving warning?
What was the biggest problem with them?
- Where do we begin? Chronic inflammation.
- Which part?
Uteruses that are swollen,
two and three times the size.
It's been in the market for...
It's been
in the market 15 years.
Oh, really?
Like I said, I'm putting them in
less than I used to.
- But for some...
- You should never put them in.
You have two doctors here
who've been around long enough to know
that there are complications that occur
all the time,
- in all of medicine and surgery.
- Absolutely.
And it's unfortunate.
I'm sorry you had to go through that.
Are you aware
of all the side effects of Essure?
No, if you do a good job,
you don't have any problem.
- Even if they do a good job...
- No, no.
All those women...
See that sign?
All those names are all hysterectomies
and surgeries and salpingectomies.
It doesn't matter where they're implanted.
They move.
- No, no, they don't.
- They... We have proof.
What happens if there is a complication?
Well, then it goes in the category
of people who have complications.
You remove it, and that's it.
How do you remove it?
You remove it by hysteroscopy.
You put it...
You... you pull it out?
You put an instrument inside,
and you pull it out. You pull.
You cannot do that.
It breaks.
You... you...
You are not a doctor.
You are working...
You are talking like nonsense.
I have 33,000 women
in this group...
No, no, no.
...with over 9,000 surgeries.
I can tell you that we've had fragments
that are unretrieveable.
They cannot get them.
Ah.
Okay, guys, nice to talk to you. Okay?
Good luck.
There's a lot of uncertainty
in medicine.
I think, as physicians, we're not very
good at saying, "We don't know," at times.
It's fine for you
to shout about the benefits
or overstate the benefits of a treatment.
The minute you raise concerns
that something might not be working
as well as it should,
you are often criticized.
You're told
you're unnecessarily scaring patients.
It doesn't seem like doctors
are requiring a high level of evidence
in order to implant a new device.
Yet in order to abandon that device,
they're requiring
a greater level of evidence.
than it took them
to decide to implant the device.
That's turning everything on its head.
We attract good people
in health care,
but there's this tremendous hunger
to have the latest gadgets,
the newest technology,
without the proper evaluation
of that technology.
We shouldn't be surprised
when some of the health care goes wrong.
If I knew this business...
when I got into it X amount of years ago,
I would have done something else.
I worked for one of the largest
medical device companies in the world.
My ultimate job was to make surethat
the surgeons used my implants in surgery.
It's all about usage.
So the more implants you use,
the more money they're going to make.
It's gotten worse over time
because of greed.
Most doctors do the right thing and
always will tothe best of their ability.
But some fraction of doctors
respond to the perverse incentives
of getting paid more for the more you do,
regardless of the appropriateness
of that medical care.
There are kickbacks in the United States
today that are entirely legal.
It doesn't have to necessarily be,
"Dr. Jones, I'm giving you money."
It could be consulting,
it could be teaching.
It could be providing money
for a fellowship program.
There's some doctors that are good,
some doctors that aren't.
I had one surgeon recently who said,
"You make the best products,
but you don't do enough for me,
so I'm using somebody else
because they do more for me."
Welcome to the business.
In days gone by,
surgery was all about blood and guts.
In the future,
surgery will be about bits and bytes.
Is the future already here?
It's a blend of science fiction
and medical reality.
The robot will see you now.
Tonight, a story
from the cutting edge.
The million-dollar Da Vinci system,
a revolutionary tool
for surgeries of all kinds.
The Da Vinci is a large,
fairly complicated robot
able to bring a camera and instruments
in together through one small tube.
The Da Vinci is able to reach anywhere
Very exciting to think
where we get to go with this.
Da Vinci allows us
to do remote surgery
from about seven feetaway
from the patient.
We work in a remote control console,
sort of like a video game machine.
We look on the screen,
at the image from inside the abdomen.
And we can perform the operation
with remote control hands.
Da Vinci, by Intuitive Surgical.
They're now in 64 countries.
Intuitive is absolutely
the dominant market leader in this field
with a turnover last year
of over $2 billion.
We're an innovative company.
We will continue to innovate,
put new products out.
Intuitive is motivated by the opportunity
to invent new things, create the future.
That is my vision for your future.
Thank you.
The story of how the robot
came into health care
is the story of what's wrong with medicine
in America today.
Massive adoption of a new technology
with little evaluation of the outcomes.
The Da Vinci robot
was marketed with a strategy
of approaching doctors and communities
and telling those doctors,
"We can help drive business to you.
We can market you as the robot doctor."
The robot is better
for certain operations.
But in many situations,
it provides no benefit to the patient,
and it may add operation time
and it may add some risks.
"You need surgery."
Three words no one wants to hear.
This video will explain your surgical
options for a hysterectomy...
Hysterectomies are a very high-volume,
common procedure in the US.
About 500,000 women
have their uterus removed every year.
During a hysterectomy,
doctors remove part or all of the uterus,
the cervix, both fallopian tubes,
and both ovaries.
The surgeon then stitches
the internal opening closed.
If you're told you need a hysterectomy...
ask your doctor about Da Vinci surgery.
I had a biopsy,
and it came back positive
for, um, endometrial cancer.
I was having a lot of female trouble,
a lot of ovarian cysts.
They sent me for a vaginal ultrasound
because we couldn't figure out
why my blood counts were so low,
and I had a tumor.
I was diagnosed with uterine cancer.
I actually was kind of happy,
because I said,
if I have to have cancer anywhere,
that's the place to have it,
because I can have it taken out.
The doctor recommended a hysterectomy.
And the only type that he said he did
was the Da Vinci.
He said, "Well the best way to do this,
the fastest way and the quickest recovery
would be to use the Da Vinci robot."
It just sounded like the newest,
greatest thing,
and I had no reason to believe otherwise.
Originally,
Intuitive Surgical told the FDA
that a huge amount of training
would be provided
as part of the sale of the machine
to the hospitals,
but shortly after
the FDA gave permission to market,
Intuitive scaled back
all of the training requirements.
And the reason is,
if they said, "Your surgeons can use it,
but they need nine weeks of training,"
no one's gonna buy the machine.
So you have surgeons who
operate for half a day on pigs,
take a ten-question multiple-choice test,
and have a proctor, another surgeon,
watch them do two surgeries,
then they're turned loose
with the machine.
I was told that it takes ten cases
to get good at robotics.
But I know now, in retrospect,
that I didn't really start
to feel comfortable
until I was about 200 or 300 cases.
In other words, that area
where you'd call yourself proficient.
The surgical robot in inexperienced hands
adds complication or injury rates
to the patient.
A lot of surgeons
that shouldn't be using it are using it.
That's the problem.
So I had the hysterectomy, go home.
I'm thinking, "Wow, This is smooth, easy."
Within a day or two,
I was running up and down the stairs.
And then a couple of weeks later,
I started to not feel so great.
I was getting up in the morning,
I sat down to go to the bathroom,
I felt all this pressure.
I looked down
and this huge...
pomegranate-looking thing
was protruding from my legs.
I think I was actually at my clothesline,
putting something...
I think I'd washed a load of sheets,
and I heard a pop.
I go to the restroom
and I feel something emerge
from my vag*na.
A whoosh of liquid came out.
And now there was about three inches
of my insides coming out of me.
I thought I was gonna throw up.
And when I did, I heaved...
and my intestines came down
like halfway to my knees.
I had three feet of my colon fall out.
It's in the documentation. So...
I get a towel...
and hold it in.
I run in there, fall out on the floor,
and my husband's like, "What's wrong?"
I said, "My colon's fallen out."
He said, "Let me see."
He sawand then he totally
had a nervous breakdown.
Then, when I got to the hospital,
they didn't know what to do.
They were freaking out.
They'd never seen it.
I get to the emergency room,
and I remember thinking so clearly
that I was dead, like this was it.
They had to call the specialist,
and he said,
"I don't even know if the surgery...
I can't say if it'll...
save her now. I'll do my best."
I have nightmares about it all the time
where I think I'm on that table,
going into the operating room.
You know, just terrible,
terrible memories of it,
and it just never seems to leave me.
It's been...
what, three years?
And I still have... problems.
I have had to give up a dream
of ever having a partner,
of ever being intimate again,
because, to me, um...
penetration means death.
It changed the full direction...
of my life.
It's taken my life away.
I'm sorry I ever heard
the word Da Vinci.
And then, like I said,
every time that I...
hear of more injuries,
it just rubs salt in the wound.
Car wash!
After three years of bleeding,
I ended up having a hysterectomy.
And no more bleeding,
but the pain is still severe.
The pain that I had sometimes prevented me
from going to work.
And eventually, I lost my job.
I had to do this car wash
because I haven't worked for a month.
My doctor just put me on disability...
which could take months.
So I'm out of income right now.
- Oh, thank you so much.
- That'll help you out.
- Thank you. May God bless you.
- Okay.
I can't afford my rent right now.
So I have to move out,
and if I don't find a place,
and without income and proof of income,
I can't get an apartment or anything,
so I'm scared I'm gonna have to be split
with my kids.
Ever since 2011...
we've moved around a lot.
I don't think we've had one place
that was stable.
Ever.
We don't know
where we're going to be at school.
Because we're gonna get another house,
and I don't know
where that house is gonna be.
My mom can't keep a job
because she has to go to the doctors a lot
'cause she gets sick a lot,
and it's just...
It ruins her opportunity of having a job.
It makes me feel sad
that my mom is at the hospital.
It's tough,
watching her not be able to do stuff.
That much more I have to do.
We used to do it together.
I suck now. I'm just cranky and miserable,
in pain all the time.
I'm not fun.
I can't drink, I can't dance,
I can't do anything.
Well...
But at the same time...
You know,
I'm so grateful for what we have.
We have great kids
and a great house
and we have each other and...
we're alive.
How does it affect your love life?
Oh... Oh, God.
- It was terrible for a while.
- Yeah.
- There was no love life.
- No.
- When I...
- With all the surgeries and stuff.
But even when I first had it in,
it was painful.
Yeah.
That part of our life
has been ruined permanently.
It's hard.
Yeah, you don't...
I don't think it ever goes away.
I don't think it ever will.
It's sad because I have seen other
people's relationships die in the group.
I've seen a lot of women
whose husbands have walked out
- over the intimacy...
- Lots.
...the lack of intimacy.
I've seen women suicidal,
women losing their families and...
thinking that there's no reason
to stay alive.
I think it's amazing what she's done...
to help these women.
Facebook is a full-time job for her now,
basically.
She wakes up in the morning...
She's a very determined person.
She gets something in her head,
and that's it.
I started getting random messages
in my Facebook...
from women who started connecting me
with the Gabriella Avina
that was the spokesperson,
the Ask Gaby.
They found me...
and said, "Are you the Gaby
that was speaking for Essure?
Will you talk to us?"
And finally...
uh,
probably about a year of them trying...
one of them said,
"Can you just tell me how your health is?"
And then I listened.
I was fatigued.
I was tired all the time.
Then I started falling.
Just... My legs would give out.
The doctor said
it was an immune response to something.
My story was similar to so many others.
All of a sudden,
it all made sense.
If only they'd been honest with me
from the very, very beginning.
The Essure procedure
can be performed in your doctor's office
and is over 99% effective.
It's 99.74% effective.
It's 99.8% effective.
It's over 99.95% effective.
It really wasn't tested
for a sufficient amount of time.
Most patients that had the Essure device
were followed for about 12-18 months,
and the manufacturer reported
very satisfactory results from it.
But for a product that's supposed to be
a lifetime implant,
to cut off the study window
at about a year and a half
left a lot of questions unanswered.
I was part of the clinical trial
and no one asked me,
"Are you feeling sick?
What is your health like?"
Almost all women
who participated in the clinical studies
rated their satisfaction with Essure
as good, very good or excellent.
The first time I saw the question,
"Rate your comfort of wearing the device,"
I said, "What does this mean?
I'm not wearing anything.
This is something
that's implanted inside of my body."
The nurse said, "Can you feel it?"
I said, "I can feel pain in my abdomen.
Where that pain is coming from,
I don't know."
And she said,
"Then rate it as excellent."
They would say,
"Are you happy with the product?"
I would say, "No," and they would say,
"But you're not pregnant?"
I would say, "Correct."
"Then it's doing its job,
so you have to be happy with that."
The most striking thing is they'd
crossed out answers and changed them
Where it said I was having pain,
they'd crossed it off
and said, "No pain reported."
When I questioned Bayer about it,
they said this is absolutely customary
in a clinical trial.
It turns out
that the vast majority of research
is not coming from an objective source.
It used to be
that about 70% of biomedical research
was funded by the government.
In the last 20, 25 years, that's changed.
Now about 70% of biomedical research
is funded by industry.
They're paying for the research,
so naturally we're going to get
the results that they want to share.
So devices can be on the market for years
and cause many deaths, many injuries
before it becomes public.
A medical device
implanted in thousands of people
that is linked
to more than two dozen deaths...
During emergency open-heart surgery,
doctors removed
this one-inch piece of metal.
It floated in front of our eyes,
literally, first into the right atrium
and then into the right ventricle.
Major health concern over breast implants.
They could cause a rare form of cancer.
It may cause other illnesses too.
When she had hers taken out,
they found mold inside,
and she's not alone.
Two dead, 179 exposed
to a dangerous superbug.
A piece of medical equipment
may be to blame.
A device called a morcellator
as used to shred fibroid tumors.
so they could be easily removed.
The shredding ended up
inadvertently spreading the cancer.
A defibrillator was withdrawn
from the market
after 13 deaths
were linked to wiring problems.
The FDA approved this device,
but did not require testing in humans.
We can no longer rely
on the medical device companies
to do what's in the best interest
of the patient.
And we can no longer rely on the FDA
to properly regulate these devices.
I was at the Food and Drug
Administration from 2006 to 2009.
I was the lead gastroenterologist
of devices.
I think I cleared,
or was involved in the clearance,
of over 250-odd devices
I think the vast majority of doctors
and scientists at the FDA...
do their best.
They do it with integrity, honesty.
In mid-2009, a file came on my desk
to look at this CT scanner,
this device that affects
many millions of people in our country.
A CT scan takes the equivalent
of hundreds and hundreds of X-rays.
while a machine rotates around your body.
They're an incredibly good test
for diagnosing a range of diseases
that gives you
very sophisticated 3-D images.
But the doses of radiation
that we use day in and day out for C are in the range that we know
it will cause cancer in some people.
And yet, the use of CT scanning
has quadrupled in the last 15 years.
The elephant in the room
is it's a very profitable
part of the health care system.
It's a way a lot of radiologists,
emergency departments, hospitals
make money
There's a lot of excess use
of this device,
and so I simply said,
"We should have a warning on the FDA label
just to warn the doctor...
and therefore the patient,
that actually if you use this device...
and certainly if you use it repeatedly...
your risk of cancer
or developing
abdominal cancer will increase.
I couldn't believe the pushback I'd got
from managers with no medical experience.
There was a group of FDA physicians
who were very concerned about the way
products were being cleared and approved.
We took these concerns
up the chain of command to Jeffrey Shuren,
the director
of the Center for Medical Devices at FDA.
And what did he do?
He not only did nothing,
he took it one step further.
He retaliated against people.
Once we started complaining...
FDA put their spy software
in our computers.
And they were monitoring
all our activities.
The FDA installed
what's called Spector software
onto a number of physicians'
and scientists' computers,
and it allowed them to capture screenshots
every two seconds...
and keystrokes.
It's as if to say their own doctors
are somehow criminals for exposing...
a public health issue.
It left a tremendous chill
amongst the FDA scientists.
Listen, safety's as important to us
as it is to anybody else.
None of us want a product on the market
that's not safe, right?
That's why we rely on regulators
to help us get there.
I think the US regulatory system
works well.
It's robust, it's thorough,
and it's been very effective.
Ladies and gentlemen,
please welcome president and CEO
of AdvaMed, Scott Whitaker.
The device industry
is very well represented
by their main lobbying group, AdvaMed.
Good afternoon, everyone,
and welcome to the Global Summit
for Medical Technology.
This is a room full of disruptors.
We are risk-takers of the highest order.
Not enough Americans understand
the important role we play,
or frankly give us enough credit
for the innovation we bring.
Sure, we'll pay attention to Washington.
That's my job. That's what I do.
But we have more power in this room
than most governments around the world.
We have the ability
to create jobs and prosperity...
to open and expand markets
and unleash innovation.
Let's show the world that we are
what's next.
They have lobbied hard
to see the standards for approval
of devices watered down over the years.
Device companies
unleash armies of lobbyists
in order to influence politicians.
And these politicians are vulnerable.
They don't know science.
It's often very flowery
and impressive language
about how they put patients first
and they want only the best.
We want to make surethat new
medical innovations get to patients
and help save lives,
improve the human condition,
eliminate suffering,
and make this world a better place,
That's what we all agree on, right?
The medical device industry
has incredible levels of influence
in Washington, D.C.
They have provided dark money
contributions
that are used to secretly fund
political campaigns.
Medical device companies also fund
think tanks and patient advocacy groups
that can go to Congress
and make the case for them.
Perhaps an even worse problem
is the revolving door.
A number of FDA officials
have both come from industry
and then go back to industry
after they're at FDA.
When they go to work for the companies,
they can tell the companies all the tricks
of how to get around FDA regulations,
how to get what you want.
Almost all the heads at the FDA
went on to work for industry.
President Donald Tr*mp
says he's picked a nominee
to run the Food and Drug Administration.
Dr. Scott Gottlieb is a popular choice
in the pharmaceutical industry.
"Thank God it's Gottlieb," said
an investment analyst at Robert Baird.
Why would they have that reaction?
They were breathing a sigh of relief.
He's a known entity in the industry.
I've known Scott
for a long time.
He took that job
because he wants to do what'sin the best
interest of the American people
and the agency, and notwhat's
in the best interest of anyone else.
Gottlieb has been a consultant
to a range of medical industries.
He's also worked
at a venture capital firm
that actually specializes in investing
in start-up medical device companies.
I'm proud of my relationship
with New Enterprise Associates.
It's been one of thepremier
venture capital firms in the country,
starting a lot of innovative ventures.
Over the time that I was there,
they invested about $14 billion
in 500 different companies.
You have spent
your life entrenched in the companies
that would benefit
from looser regulations.
But I think it raises
the very real question
of whether someone who seems to oppose
the FDA's basic safety mission
should be running the agency.
I can tell you he doesn't have any bias
as a result of that.
I've never seen it
and don't expect to see it,
knowing him the way I do.
The FDA is supposed to protect
the public interest.
Unfortunately, their behavior shows
that they have been captured by industry.
Scott, thank you for coming
across the country
to participate with us at this conference.
I speak,I think, for the entire industry.
Where we were five years ago at the FDA
compared to where we are today
is night and day.
And I think your leadership
has made a huge difference
and we are really grateful for that.
In 25 years,
we will, I think, be worse off.
All the legislation we're seeing,
again, driven by lobbying from industry,
is moving in the wrong direction
and there's no evidence
that's gonna shift.
I just came out of a briefing
with senior officials at the White House
about the executive order that
President Tr*mp will sign this morning.
We issued an order which says,
for every one new regulation,
two old regulations must be eliminated.
"Regulation is bad. Let's cut regulations.
For every regulation,
we're going to cut umpteen regulations."
That bravado...
may apply to certain fields,
but it can't and shouldn't apply
when you're talking about
putting a device in someone's body.
We're very proud of this one.
I'm gonna leave.
I need to go find a place.
Mom!
You ready?
We are going to go try to find a hotel
that will take us all in
with a reasonable price.
And call it a day, I guess.
Mom, there's a homeless over there.
I know, baby.
You see, girls? It could always be worse.
He probably doesn't have a car or anything
and we do have a car.
Does he know us?
- Does he know us?
- No. Okay.
Hi. How much is it for a two-bed?
- 110 for one night?
- Yeah.
Do you have weekly discounts
or anything like that?
Nothing right now.
Give me a second, okay?
- So it's 110.
- 110 and a private room.
- Are you guys happy?
- Yeah.
Yeah.
Go.
It's really tiny.
So I guess we're home.
For a night.
Familiar faces.
Nice to meet you in person.
Claudia.
Janet.
Yes, Janet, how are you?
Good, how are you?
You're Marilyn, right?
- And you are...?
- April.
Oh, my God!
- Surreal.
- My God, you guys.
I want to thank everybody for coming.
It's just amazing
to finally see all of you.
So let's start off
by maybe just going around,
just say who you are
and where you're from.
My name is Alicia Perry.
I am from Stockton.
I am an implantee,
I'm just going to say it, for ten years.
No longer. And I'm so glad
to see everyone here. Thank you.
I'm Juanita Nunez-Archuleta.
I know it's long.
I'm an admin on the Spanish page
and I am E-free, seven months.
I'm Gaby Avina
and I'm from Martinez, California.
I was one
of the clinical trial participants,
so I had mine implanted in 2000,
and I had mine taken out in 2014.
I don't know if any of you were familiar
with the Ask Gaby website...
that was on Conceptus
and Essure's website.
That was me.
I was a spokesperson.
I failed thousands of women
for seven years.
It's a long time to tell women
that a product is great.
So the guilt that you live with...
and the pain...
and just crazy feelings of responsibility
because of that.
Thank you for being
on this side now
because it's important
that people now see the damage
and more and more doctors
are starting to see it.
Very validating.
We just want to have a discussion
and brainstorm.
What should our new media push be
right now?
I felt good about it
'cause I saw women that came together
to fight for what they believe in.
They're strong, they're smart women,
and they're getting the media to listen.
It was supposed to be safer
and less invasive.
Why are so many people complaining
about a popular birth control device?
Pain, back pain.
It was debilitating. I could barely walk.
I never thought
I would be looking at a hysterectomy...
at 29.
My body is just devastated.
Damaged, they say,
by a birth control device called Essure.
The stories started getting out
in the news and then other news stations
started seeing the other stories and were
like, "Okay, let's do this in our area."
Five heart-wrenching stories
of extreme physical pain.
Six women with severe medical problems.
Thousands of women like Becky
are sharing their experiences on Facebook.
There are now
35,000 members in the group.
We've set up groups in other countries.
We found women in Italy,
willing to take over the page.
We started the Netherlands group.
We had women from France.
They're all branches of us.
So we've got 11 subgroups
that are other countries.
A controversial birth control device
in the US is going off the market
in Europe.
Bayer announced
it is pulling out of the European market
due to a lack of interest.
But a spokesperson says,
"Bayer's decision
does not impact the sale or marketing
of the product in the United States
where there continues to be demand,
despite the recent inaccurate
and biased reporting."
That's bullshit.
The equivalent of the FDA in Europe
asked Bayer to provide more safety data.
And Bayer, at that point, decided
to withdraw it from the market.
It's very frustrating.
Our group has been fighting
in our country for the longest.
Yet we're the ones
with it still on the market.
Bayer has no incentive
to take it off the market here.
Nobody's holding the manufacturer
accountable.
- Bye, honey.
- Bye, honey. Knock 'em dead.
We're not gonna stop
until it's off the market.
The FDA isn't doing anything,
the manufacturer's not doing anything.
We need to push Congress
to force the hand of the FDA.
So this device
is still being inserted in women?
- In the United States...
- In the US?
September 18th, it came
off the market everywhere else.
Look at how far up
the injury and death reports go now.
Because they're not being held liable,
they don't have any incentive
to take these devices off the market.
People are getting harmed and injured,
and nobody's doing anything about it.
We have many, many women
who are ending up with fragments
and massive issues and re-surgeries.
- Women just seem to be expendable.
- Yes.
That's how we're starting to feel.
We're disposable.
The FDA has been very clear that they're
not going to take this off the market.
That this is the manufacturer's
responsibility
I know of no possible reason,
when they are chosen to protect
the health of the people of this country,
that they would choose to go
in the other direction
and protect the manufacturers.
That's gotta be changed.
I wanted to get as much information as
I can with the various personal stories.
I don't know
how many of those that you have.
A lot.
- Thousands.
- Tens of thousands.
Tens of thousands, okay.
This place works
with good people on the inside
trying to maneuver
and push legislation forward.
The way it really works
is the external pressure.
And that's all of you
and you are in great numbers out there.
Welcome to the NFL.
You just cannot get tired.
It is a continuous effort.
We won't stop.
They've already taken away my health.
What else can they take from me?
I have nothing to fear from them.
This has to come to an end.
I don't know how anyone with a conscience
and any sort of compassion
could let this continue to happen.
I go to work...
and I'm at work...
Right.
...and those issues aren't with me...
until you think about it
and think about it for an extended time.
We're insulated from...
the horror.
It's the first time
I've really heard him say
that much detail about how he feels
about what we're feeling.
- It's hard for the men to talk about.
- Right.
This is a safe place for us.
That's right.
I've probably talked to close to...
I can't even begin to think of the number
of women that have called me.
And the only good thing
is knowing that I'm not alone.
Please help me welcome Dr. Steve Tower.
The take-home message today
is that systemic cobalt poisoning
from a hip replacement...
is a common problem.
You could make a strong argument
that everyone would be better off
if we stopped innovating
in total hip replacement
and stuck with what's been around
for 30 years,
and we know there's designs...
Bye.
I love you.
Behave, okay?
- Bye, Liz.
- Bye.
- Love you, behave, okay?
- Okay.
Bye.
Bye.
Okay.
Behave, okay?
- Okay, well.
- All right.
- Thank you, Ms. Kelly.
- Yeah, okay.
- Okay, bye.
- Bye.
Relax.
Bleeding Edge, The (2018)
Moderator: Maskath3