Permanent Contraception - HD

Welcome and Introduction

Welcome to the Omnia Education online activity entitled
Permanent Contraception, utilizing transvaginal ultrasound
to confirm appropriate insert placement presented
by Hector Choppa, MD
and Laura Decker, B-S-R-D-M-S-M-H-A.

Prior to beginning the activity, please be sure
to review the faculty and commercial support disclosure
statements as well as the learning objectives.

I welcome everybody to this presentation,
this program, which is really vital
as we move forward in the area of female sterilization.

This program will cover permanent contraception,
but specifically utilizing transvaginal ultrasound
as a confirmation test, as an alternative, as a compliment,
or as a second version of the old standard,
which is a modified HSG.

As part of introduction, my name is Hector Choppa.
I'm part of the clinical faculty at Texas A&M College
of Medicine for the Department of OB GYN.

Objectives

As we move on, let's move on to the second slide
and review the purpose of our meeting.
What are the objectives?

Of course the main objective
is to review how to do this.
This is to review the protocol for the employment
of transvaginal ultrasound.

In order to allow a patient
to rely on the micro inserts placed by the physician,
we have to understand the benefits
and the disadvantages of TVU in the confirmation process
of these micro inserts.

And where does this whole algorithm fit in?
And did modified HSG go away?
How does this algorithm, this new flow look like?
We'll cover that.

And the third is to bring some awareness
to bring some resources
to anybody who's doing transvaginal
ultrasound for this purpose.
In other words, to bring awareness to resources
that can help physicians, technicians
or any provider who is going to be doing this procedure
to allow reliance for a patient.

And that will happen at the end of this presentation
with a couple of references that I think will be helpful.

The Problem: Unintended Pregnancy

Let's get into the basics here.
On slide three, we have the real crux of the problem here
and that's that women remain at risk
for unintended pregnancy.

In the US, 43 million women
who are childbearing age are at risk
of unintended pregnancy.
That's a lot of women.

Of women who currently use contraception,
more than half, actually about 67% use some method
of non-permanent methods.
That includes birth control pills, vaginal ring,
or injectables.

But 25% of women rely on female sterilization.

The oral contraceptive pill
and female sterilization have been the two most commonly
used methods since 1982.

That's why we have to do better.

Overview of Permanent Contraception Methods

How does this permanent contraception arena
or theater look like?

Historically, of course that was all done
by laparoscopy.
Laparoscopy entailed the patient going to day surgery
or outpatient surgical center getting placed under general
anesthesia and entering the abdomen
to occlude the fallopian tubes.

But more recently, as of 2002,
the hysteroscopic method came to be.

The hysteroscopic approach is a non incision method
of going through the natural orifice of the cervix
of the uterine opening
to occlude the tubes from the uterine cavity out
towards the tube lumen.

This happened as we just mentioned,
with FDA approval in 2002.

Currently there's only one FDA approved medical device
for hysteroscopic sterilization.

This device uses a combination of nitinol
and fibers called polyethylene terephthalate because that's too big.
Everybody always calls it PET fibers and that's fine.

This nitinol PET fiber combination
make up the micro inserts which are placed hysteroscopically bilaterally into the tubal lumen.

And after a slow natural process of about 12 weeks,
there's tissue ingrowth
through those micro inserts which result in tubal
lumen occlusion.

Here's the catch though
because this is done hysteroscopically
and unlike a laparoscopic approach that doctors
and patients are told to rely, this is the only method
that actually has a confirmation test.

That can be attractive to some patients rather than
just taking our word for it.
There's a confirmation test that is done at 12 weeks
to not only assure the physician
that is involved from more importantly
to give the patient the peace of mind that she can.

Confirmation of Placement: Historical and Current Methods

That brings us to our next slide, which is slide six.
Let's talk about this confirmation of placement
because historically there was a modified x-ray modified
for a fluoroscopic exam called a modified HSG.

Traditionally an HSG was an infertility test looking
for tubal occlusion,
but using a variant of that with lower volume
and lower pressure, this instilled a little bit
of contrast into the uterus
to see if there's any spillage through the tubes.

In July of 2015,
this transvaginal ultrasound approach was approved
by the FDA as an alternative confirmation test
for hysteroscopic sterilization.

What does that mean? It means patients now if they qualify
and if they want it now have a choice rather than just
having to be mandated to go to the modified HSG,
you have a choice to choose that
or an office ultrasound for confirmation.

Physicians have to advise a patient about the type
of confirmation test that is required.
They can't force one towards the other.
They have to be given the option.

They can have the modified HSG or the TVU,
but they have to pick one of those two
because without the confirmation test,
the patient cannot have reliance
and must use an alternative method of birth control.

Let's jump into this
'cause this is really what we're here
for this confirmation test.
And the next slide kind of
breaks this down a little bit further.

Modified HSG: Pros and Cons

In the past, before July of 2015,
the traditional method used a modified HSG
or hysterosalpingogram, which put the patient under fluoroscopy.

The benefit of that is that
that was considered the gold standard.
That was the definitive.
In other words, if the HSG said you can't rely
the game was over, there was no second opinion to the HSG.

However, the con, the disadvantage is
that it does expose patient to radiation
and it uses an outside facility, not one that's familiar
to the patient like the physician's own office.

And here's the catch though.
Just because you don't see dye leakage
doesn't mean the tube is occluded.
How's that possible? We know from published studies
that HSGs can be falsely positive for occlusion
because sometimes tubal spasm can occur
and it looks like it's occluded and it's not.

There's issues with the HSG.

Transvaginal Ultrasound (TVU): Pros and Cons

Bring us to 2015 and forward.
The transvaginal ultrasound provides this
present alternative.

What's the pro here? What's the advantage?

The advantage is it's less invasive.
There's no radiation.
It's just an ultrasound and it can be performed in an area
that's familiar to the
patient like the physician's own office.

Here's the biggest advantage.
Remember the modified HSG is a photo negative,
it's an x-ray, so you really don't see the uterus.
You're looking at the uterine cavity filled with dye
and the micro inserts,
but only TVU provides a relationship
between those micro inserts
and the soft tissue surrounding it to give you a better idea
of where they actually lie.

What's the con?

The con of course is that we're looking for location,
which is okay, but doesn't tell us anything about occlusion
because the assumption is that they're placed, right?
We know from the data it should work, right?

However, about 15 to 20% of patients based on the data
can get an inconclusive ultrasound report.
Why? Uterine lie uterine position echoing,
there's several reasons that every sonographer knows,
sometimes gives you an inconclusive picture
and these patients need to continue down the path
to the modified HSG.

Unlike the HSG, that was the end all be all referee.
The TVU is not the end all end say in this
reliance algorithm.

If a patient cannot get a definitive allowance based on TVU,
it's not over for her,
but she needs to continue on in the diagnostic path
and proceed with the HSG.

Algorithm for Confirmation Testing

Let's talk about this a little bit more
because I'm kind of a visual person.
And slide eight really
breaks it down a little bit better.

Here's how it looks.

First of all, there is bilateral
placement of the micro insert.
Remember if she has two tubes, which she needs
for this procedure to occur, she has
to have two inserts placed.

Then the option can be given to patients
who meet the procedure criteria.
In other words, just because she has the micro inserts
placed doesn't mean she goes right to TVU as an option.
She has to qualify based on procedure characteristics.

What are those? The physician is charged
with knowing those qualifications, those indications.
And that's on his or her part.

Once the patient qualifies,
then she can be offered either the TVU at three months
or the modified HSG both again at three months.

They shouldn't pick one because they think one's faster.
They're both done at 12 weeks post procedure.

Let's take a look at this a little bit further.
In slide nine, we've kind of said this already,
but it's nice to break this up
because we can't mention this enough.

If the patient meets the procedure requirements at placement
and she wants TVU can offer it
and remember that this is TVU transvaginal ultrasound,
not TAU, not transabdominal ultrasound.

Make sure you have the right transducer,
which is anywhere from a 5.8
to about a 6.5 based on the study.
But of course we know that it vary.

If the TVU results allow reliance, she's fine.
But if the TVU results are not appropriate for reliance,
she must continue down that path.
That's a side box to continue on to the modified HSG
for a final determination.

Training for Confirmation Tests

Let's keep going here.
On slide 10, we have some information about confirmation
test training because there's nothing worse than doing a
great placement, but the whole thing falls apart
because we have inadequate training
and it's not fair to allow a patient
to rely when it wasn't done correctly.

The confirmation test by either TVU
or the modified HSG should be performed only by those
who have the experience and the training.
That's a gynecologist, a sonographer,
a radiologist, whoever's trained to do this.

Make sure that we don't just give this to anybody,
we gotta know what they're doing.

Basic TVU skills are required.
And of course AIUM online has those guidelines
and that's of course the American Institute
of Ultrasound in Medicine.

Anatomy Review for TVU Confirmation

Having covered the basics of training
and why that's important, let's now get into the specific
and some of the anatomy review.

Bear with me.
I know that you know this already,
but we have to do this for quality measures.

Let's take a look at some of the basic anatomy
and terminology that will apply for the TVU confirmation.

What we all know, one of the big advantages
that we already stated is that the micro insert has
spatial relationship to the soft tissue surrounding it.

Let's take a look at that soft tissue
that surround the insert.

Number one, we have to orient ourselves
and we'll get into that step in a minute of the uterine
and sagittal view and of course where the fundus is.

This micro insert crosses the interstitial portion
coming from the tubal ostia at the internal
structure of the cavity through the muscular area
through the UTJ.
Of course, that's the serosal utero tubal junction.

This is visible only on TVU and not on x-ray.

Our next slide kind of reviews the same thing.
We have to remember what we're talking about here.

The cornua
or the cornu is where these micro insert should be placed.

Once we talk about the protocol itself,
any variance in symmetry, if they're not symmetrical,
that patient may have an indication to go
for confirmatory test with HSG, the modified HSG,
this is what we're talking about here.

These marker inserts have to span that interstitial zone
from the endometrial cavity optimally it touches it.
We'll talk about that in a minute through the muscular area
without kink or coil.
And then through the SUTJ.

And again, that's only visible on ultrasound.

We just mentioned the ostium
or the tubal opening that's visible hysteroscopically
not on ultrasound,
but what you can see on ultrasound is the utero tubal
junction where that insert leaves the serosal contour
of the uterine structure.

The external uterine ostium is seen is vital
to in determining the location of this insert for reliance.

And those are images, it's better to kind of talk about it
with an image itself.
And let's take a look at that on slide 14.

Here's what we're talking about, taking those schematic
and put in it in real life practice.

Of course what we see off to the left hand side is the
globular structure of the uterus.

The echogenic line, of course, is a micro insert.

On the left there's a small echogenic dot
or spec that actually is a proximal band, the platinum band,
but that's not necessary for confirmation.

What we see here is that the proximal end of the insert
actually abuts the endometrium.

We see the linear axis of the insert come out
and through or past rather the serosal edge
and cross the SUTJ, the serosal utero tubal junction.

If you can actually see distal, you see
that other little echogenic dot, that's the bi,
the distal ball tip of the micro insert itself.
That may or may not be visible.
This was just seen on this image.

What is vital though is the location of that linear axis,
which must be without vendor kink
and must be through the SUTJ.

Here's what's important
and you can get this again on the AIUM website,
but remember we're talking about three
anatomical planes here.

That's important for ultrasound and any other imaging,
and that's a transverse plane, this sagittal plane
and the oblique plane.

Remember what these are.

The transverse plane is coming right
across in a cross section.
In other words, if it's on your body taking away your top
half from your bottom half,
and that's a transverse view,

the sagittal view is cutting you right down the middle,
separating your right from your left half.
That's important because we're going
to take a look at the sagittal view for orientation
of the uterus in just a minute.

And what about oblique? That's just between those two.
Any image between the transverse
and the sagittal plane is the oblique view.

And that's important because sometimes we need
that oblique transverse view of the fundus in order
to see the full linear access of the micro insert.

I know these words are kind of flying around everywhere,
but it's gonna make some sense whenever we see the images.

Sagittal View for Orientation

Slide 16. Let's take a look at the first view here.
This of course is not new to anybody.
This is just a sagittal view of the uterus.

We actually see the ovary in the right upper hand corner.
But the sagittal view of the uterus is where we start
because it gives us the orientation of the pelvis, not
of the inserts, but of the uterus.

This sagittal view is important
because we should see no inserts in this view.

That has to be said again on sagittal view
with the endocervical canal
and the myometrium in one continuous line,
the endocervical canal
and the endometrium in one continuous line
that the endometrial stripes should be in
one line with the cervix.

If there's a micro insert seen here anywhere in the fundus
or in the myometrium, that's abnormal
and concerning for a perforation.

The sagittal view of the uterus is one
of our first steps in this transvaginal
ultrasound confirmation.

The OIL Acronym

Here's an acronym you'll never forget. OIL, OIL.
That's what you want to remember for this confirmation test.

OIL O is orientation of the uterus done in a sagittal plane.
I in oil is identification of the inserts
that's done in a transverse plane.
And then the L is location
and that's done in an oblique plane.

Isn't that easy? Sagittal, transverse
and oblique stand for orientation of the uterus,
identification of the inserts and then location.

It's a location that gets the patient the
ability to rely or not.

Transverse View for Identification

Here we're in a transverse view
and here's where the eye comes in.

By moving the probe from sagittal to transverse, we get
to identify two inserts
and listen, if the patient has had two inserts placed,
which she should have, but we only
identify one, it's all over.

One's missing and it's a perforation
or expulsion until proven otherwise, the ultrasound is done
and she needs to go get definitive HSG test.

But here in this image we see very nicely the two
symmetrical notched appearance
of the two inserts for identification.

Let's take a look at why it looks notched.
We gotta pause here for a minute because sometimes we're
looking at these images and I realize that if you are
a sonographer or a technician,
or radiologist, you may never have seen this insert.

You're saying what? What is that white line?

Here's what we're talking about.
Slide 18 is the anatomy, so to speak, of the micro insert.

Of course this is not the scale,
but the micro insert itself wound down is 0.8 millimeters,
completely expanded within the tube in about two
millimeters, two millimeters,
and the entire length device is four centimeters long.

It actually is an inner stainless steel coil, part
of an inner stainless steel rod surrounded
by an outer nitinol coil which provide stability.

Performing the Confirmation Test

Let's understand these specifics in the next slide.

How do we perform this confirmation test?
We know the basics. We talked about sagittal, transverse
and oblique, but what does this mean?
What do we do when we get some images?
How do we interpret these results?

Let's jump right into that
because we're short on time.

Let's get into the FDA requirements of
how to do this right?

The TVU confirmation test, just like the modified HSG has
to occur at 12 weeks.
That's three months post placement.
It's not at six weeks or eight weeks.
They are both at the exact same time.

By FDA requirement,
there are three required images.
That's our first kind of clue here.

The whole topic here, the whole theme
of this 30 minute presentation or so is the number three.

There's three images.
There's gonna be three planes of view, sagittal, transverse
and oblique, and then three possible outcomes.
Remember three.

What are those three images captured?

The first is the scout image.
That scout image is looking for
or scouting for both micro inserts.

We've already covered that. That's done in the transverse
view for the identification of them.

And then the other two images are the oblique
views of each insert.
One for the right and one for the left.

Three views, three pictures, three possible outcomes.

The next slide goes over what we've already introduced
here is our three components.

For TVU. We need
to know the uterine orientation determined in SVU.

We need to scout out these inserts.
We need to identify them in transverse views.

And then the L in oil is we need to see their location.

And remember both of 'em have to be correct, either optimal
or satisfactory to allow reliance.

We'll show you what that means in a minute.
But the location is based on a cornual oblique view,
which is between sagittal and transverse.

To find that linear access of each insert in relation
to each specific cornual location is
how we determine reliance.

Location is how we determine reliance.

Step 1: Orientation

Let's get into orientation first, not location,
but orientation.

Remember that orientation of the OIL is the
first step in this algorithm.

Placing the endovaginal probe in its sagittal view,
we see the sagittal plane of the uterus from cervix
to fundus all in one image.

The endocervical canal must be continuous
with the endometrial stripe.

For this view, if you pan from right to left,
each insert can be visible.

However, in the midline sagittal view, which is required
for orientation of uterus, no micro insert should be seen.

Visualization of the proximal end of one
or both inserts in cross section
may indicate trail coils in the uterine cavity.

When you look to the right
or left, I can't stress that enough that the linear axis
of either insert should not be visualized in the
midline sagittal view.

The whole point here, that orientation is only
to know which way the uterus is headed.
Is it mid ante or retro?
So we get our correct labeling in the next step.

Step 2: Identification

Next is identification
or the I in OIL,
which is our scout image going from the sagittal view,
rotating the transducer 90 degrees will give us our
transverse fundal view.

The goal is to visualize the portion
of each insert simultaneously within the cornua.

What does that mean? We need one picture transverse view.
Two insert shadows.
Both have to be seen for the step to work.

Slight probe rotation
and adjustment can be required to get this right image
or gentle endovaginal probe pressure can be applied
to improve the tissue contraction and the visualization.

Those are things by moving the probe 90
degree, they're gonna pop up.
Sometimes it takes a little bit of manipulation.

Continuing on with identification.
The next slide breaks this up a little bit more.

Both inserts must be identified in the fundal transverse
view to reduce risk of a duplicate image.
That's the purpose of the I in OIL.

Make sure we see two
so we don't label the right micro insert,
both right left by accident.

A portion of each insert should yet,
but in the myometrium, in each cornua, the linear axis
of the inserts should appear relatively symmetrical
and then opposite direction.

Listen, if we have a transverse view
and there's two inserts all on the right side,
stop right there, one has
to be on the right and one on the left.

If there's two on one side of midline, she needs to go
to definitive HSG because that suggests an abnormality.

And the location of these inserts on TVU may appear
to be more distal than noted that time of hysteroscopy.
But don't worry about that because remember that
that hysteroscopy at placement,
the uterine have these actually distended.

And the difference in visualization
can look a little bit different.
It's okay, we'll talk about this location coming up next.

Here's what this image looks like, not in sagittal
because we shouldn't see one, but the first time these
inserts come into play is in this transverse fundal
view for identification.

Here we see the transverse fundus
and both inserts visible in the cornua.

Don't get worried about giving some,
but the ability to rely based on this.
This is not the job of this image.

We just wanna make sure that they're symmetrical.
Two are there and they seem
to be grossly in the correct position.

Step 3: Location

Let's get into location
because location is really where it's at.

Location will determine are three possible outcomes here,
either satisfactory placement, optimal placement,
or unsatisfactory.

In order for the patient to have reliance
that micro inserts should be an either optimal
or satisfactory.

But if it's anything either than that, in other words,
unsatisfactory, the patient should go to modified HSG
for definitive confirmation testing.

The goal here is determine the location of each insert
with a targeted oblique view of each cornua.

How is this done? While maintaining a transverse
orientation of the probe moving towards each cornua
and looking at it by the oblique angle
to find the entire linear axis of each insert,

each linear axis of each insert should be seen
as a contiguous echogenic structure without bend
or a kink mild pressure.

Sometimes it can be needed
to put on the abdominal wall in order
to get a better visual image.

If you suspect an unsatisfactory location, meaning
it's got a bend, it's a kink
or just can't get a good linear axis,
a modified HSG is required.

The position of the insert within the cornua
and the relationship with the endometrium
and the SUTJ should be noted here.

In other words, we can't just find each insert
and say, well they're there.
It's relationship to the endometrial cavity
and the UTJ is how we determine the three outcomes.

On the next slide we
go into this a little bit further.

This image of a linear axis of the left
or right is done again in this transverse oblique view,
make sure to label each one left or right accordingly.

We don't wanna duplicate an image calling this the right
when it was really the left and
give you the same image twice.

We have to demonstrate the linear
axis without bend or break.

Repeat the process on the contralateral side in order
to find each micro insert category as either optimal,
satisfactory, or unsatisfactory.

Both inserts don't have to have the same category.
In other words, one micro insert can be satisfactory
and the other optimal and that still allows for reliance.

But if one micro insert is unsatisfactory, she must proceed
to a confirmatory test like a modified HSG.

Let me say that again. Both inserts do not have
to have the same category.
They both don't have to be optimal
or they both don't have to be satisfactory.

It could be optimal and satisfactory
and that's okay for reliance.

Defining Optimal, Satisfactory, and Unsatisfactory

What does this mean optimal and satisfactory
or unsatisfactory?

It's on our screen now.
On slide 29, optimal means
that the micro insert the proximal end of but
or touches the endometrial strip
and the seen in one linear continuous shadow
through the SUTJ without break or bend.

Satisfactory means that the proximal end, while not abiding,
the endometrium is still seen within the myometrium
and not past the UTJ.

In other words, we can't have a
suspicion that it's too distal.

Either optimal
or satisfactory allows reliance on the micro
inserts and they do not require further
alternative contraception.

However, unsatisfactory does not mean
the patient can't rely.
She means she can't rely yet until the modified HSG.
The next step in the algorithm is performed.

I want to clarify this slide
because it looks like the yellow is kind
of cautionary there for satisfactory.
It is not optimal
and satisfactory are both good to go for reliance.

It was just a nice visual as we're all familiar
with the typical stoplight sign.

Let's take a break. Let's break this down a little bit more
in the next slide and take a look at optimal location.

Remember, this is in a transverse oblique view of the fundus
and the image here is gonna qualify
or describe what I'm going to narrate.

Each micro insert here
for optimal should be seen in each cornua,
each perspective cornua with a proximal end
of the insert abut or touching the endometrium.

The linear axis should be seen in a continuous line
or shadow without bend or break transversing through
and past the edge of uterine serosa that is optimal.

Optimal touches, endometrium crosses
through the SUTJ without break.

What about satisfactory?

It is similar to optimal except the micro insert has
moved away from the endometrium just a tad.

In other words, the proximal end of the micro insert.
Now here it is, does not touch the endometrial stripe.

However, it's still within the interstitial zone.
In other words, it's still within the myometrium
and then transverses in the linear continuous shadow
without break or bend through the SUTJ

and I can't say this enough.
Optimal and satisfactory are both okay for reliance.

We all want the endometrium
to abut the micro insert because it looks nice.
It makes us feel fine, but satisfactory is not inferior.
It is okay for reliance.

Slide 32 kind of brings this back home
and this is a nice image of satisfactory
and you can put this in perspective to
what we just saw when it touches the endometrium.

As you can see here, the proximal end
of the micro insert on the sonographic image does not
abut the endometrium.

However, as you can see where the UTJ is,
the serosal utero tubal junction is actually past
that proximal tip.

In other words, it's about halfway towards the micro insert.

This means that micro insert is still within the
interstitial canal transversing through the SUTJ
and can still rely.

The last one's easy guys,
if it is not satisfactory or
optimal, if it's not the either two
that we've discussed, it's the red box.

Any other variant outside of satisfactory
or optimal is unsatisfactory
and the patient must proceed to a modified HSG.

For example, if an insert location is bent or kinked
or we can't get a good linear axis
or of course if one is missing, all of that is problematic
and requires a definitive HSG for determination.

Reliability insert location is unsatisfactory if a portion
of each insert cannot be visualized in the cornua in the
transverse oblique view in one scout image.

Examples of Unsatisfactory Locations

Let's take a look at this again in
this other example.

On the next slide, we see an example
of an unsatisfactory location take a look at.

Image, of course, we see the globular structure
of uterine fundus.

We see the myometrium, but look where the insert is.

That insert does not begin in the endometrial cavity.
It actually is exterior to the uterine serosa.

This is concerning. Concerning for distal placement.
I didn't say it is distal placement.
It's concerning for distal placement
and the only way to make that determination is
modified HSG.

As we move towards the end of our program,
let's take another look at an unsatisfactory location.

This is just the opposite here.
We see a micro insert not too distal where it's suspected
but too proximal here.

The micro insert is totally within the endometrial cavity
and still within the myometrial zone.

We see it is not crossing the SUTJ.
That's evident on the left image,
but on the right image when you see it in sagittal view,
we say we shouldn't see any micro insert in the fundus.

We'll forget that this micro insert is in
the endometrial cavity.

This is a prime example of unsatisfactory
and a need to continue for definitive modified HSG.

Preparation and Additional Unsatisfactory Indicators

What about preparation?
Remember we talked about at the beginning in that sagittal
orientation view,
there should not be a micro insert seen in the midline.

We'll take a look at this image.
Here we see the endometrial stripe continuous
with the endometrial stripe, but look what's continuous.
Further on towards the fundus,
we see the echogenic structure of the micro inserts.

They're all in one plane
unless there's micro inserts in the
fundus, which is incorrect.

This is highly suspicious and the patient cannot rely,
but needs to go on to modified HSG
for definitive determination during the identification step.

Remember, that's a transverse fundal view.
If there's only one micro insert seen
or none at all, that also is unsatisfactory
and she needs to go for further testing.

Talking about no micro
inserts, look at the next slide.

This is a transverse view
and there's no scout image mobilization here.

Where's the location here? Where's the identification?
It isn't.

This is a transverse fundal view with a patient
who had two inserts placed
but no micro inserts seen on ultrasound.

That stops right here
and the patient must go to definitive HSG
because this is unsatisfactory.

Managing Equivocal or Unsatisfactory TVU

Let's now reemphasize the importance of how
to manage an equivocal or an unsatisfactory TVU.

If the TVU is equivocal
or unsatisfactory, there's two things we have to remember.

Number one, she has to proceed directly to that modified HSG
for the definitive word, whether she can rely or not,

and we have to counsel the patient that she has
to remain on alternative contraception.

She needs other backup birth control until
that modified HSG says yes or no.

Summary

This is it. We're at the end. What's our summary?

Remember the rules of three?

There's three images, there's three tissue planes,
and then there's three possible outcomes.

The rule of three. The three images
of course are the scout film in transverse fundal views,
and then the right and left
oblique transverse views for location.

Those are our three images.

The three planes to do this whole procedure are transverse,
sagittal and transverse oblique.

And remember the three possible outcomes for OIL
uterine orientation, identification of the inserts,
and then location of the inserts

for our three possible outcomes of satisfactory optimal.
Both of those are okay or unsatisfactory,

Resources

I told you at the end I would provide you some resources
for further training or education on this.

We can always go to AIUM
and get guidelines for basic ultrasound and interpretation.

Also, the instructions for use
of the micro insert provides these steps for more clarity.

Remember to also go to essuremedicalresources.com
to review this at your own time
and always remember they can contact the representative
of the micro insert for further training
or resources to help us do this correctly.

Thank you for your time and thank you for your attention.

There are a number of resources available to sonographers
and other healthcare professionals regarding the use of TVU
to ensure confirmation
of appropriate permanent contraceptive device placement.

One such resource is the Essure Instructions
for Use Healthcare Professionals Guide.

Please find additional information under related
content for this activity.

The US Food and Drug Administration requested
that the manufacturer of Essure enhance sonographer awareness
of the availability of the training certification program
provided by the manufacturer.

For the confirmation of appropriate TVU insert placement,
please find additional information at
www.essuremedicalresources.com.

Finally, the American Institute of Ultrasound in Medicine
or AIUM is a valuable resource for obtaining information
regarding the utilization of TVU.

Please visit
www.aium.org for more information.

To earn your CME credit, please proceed
to take the post-test and evaluation.