Download the essure® office guide

THE ESSURE® OFFICE GUIDE
THE ESSURE®
OFFICE GUIDE
A resource for providing Essure in the office setting
To access and customize the most up-to-date forms, please go to EssureMDResources.com.
References: 1. Cooper JM, Carignan CS, Cher D, Kerin JF; Selective Tubal Occlusion Procedure 2000
Investigators Group. Microinsert nonincisional hysteroscopic sterilization. Obstet Gynecol. 2003;102(1):59-67.
2. Arjona JE, Miño M, Cordón J, Povedano B, Pelegrin B, Castelo-Branco C. Satisfaction and tolerance with
office hysteroscopic tubal sterilization. Fertil Steril. 2008;90(4):1182-1186. 3. Chudnoff S, Einstein M, Levie M.
Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial. Obstet Gynecol.
2010;115(1):26-34. 4. Isley MM, Jensen JT, Nichols MD, Lehman A, Bednarek P, Edelman A. Intrauterine
lidocaine infusion for pain management during outpatient transcervical tubal sterilization: a randomized
controlled trial. Contraception. 2012;85(3):275-281. 5. Miño M, Arjona JE, Cordón J, Pelegrin B, Povedano B,
Chacon E. Success rate and patient satisfaction with the Essure sterilisation in an outpatient setting:
a prospective study of 857 women. BJOG. 2007;114(6):763-766. 6. The American College of Obstetricians
and Gynecologists. Frequently asked questions: FAQ 143, special procedures. https://www.acog.org/~/
media/For%20Patients/faq143.pdf. Accessed December 9, 2013. 7. Guiahi M, Goldman KN, McElhinney MM,
Olson CG. Improving hysterosalpingogram confirmatory test follow-up after Essure hysteroscopic
sterilization. Contraception. 2010;81(6):520-524.
BAYER, the Bayer Cross, and Essure are registered trademarks of Bayer.
© 2013 Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981
All rights reserved. 250-87-0003-13a Printed in USA December 2013
Indication
Essure is indicated for women who desire permanent birth
control (female sterilization) by bilateral occlusion of the
fallopian tubes.
Important Safety Information
Prescription Only
Caution: Federal law restricts this device to sale by or on the
order of a physician. Device to be used only by physicians
who are knowledgeable hysteroscopists; have read and
understood the Instructions for Use and Physician Training
manual; and have successfully completed the Essure
training program, including preceptoring in placement until
competency is established, typically 5 cases.
Who should not use Essure
• Essure is contraindicated in patients who are uncertain
about ending fertility, can have only one insert placed
(including contralateral proximal tubal occlusion
or suspected unicornuate uterus), have previously
undergone a tubal ligation, are pregnant or suspect
pregnancy, delivered or terminated a pregnancy less than
6 weeks prior to the Essure procedure, have an active or
recent upper or lower pelvic infection, or have a known
allergy to contrast media.
• Patients undergoing immunosuppressive therapy
(e.g. systemic corticosteroids or chemotherapy) are
discouraged from undergoing the Essure procedure.
• Uterine or fallopian tube anomalies may make it difficult
to place Essure inserts.
PLEASE SEE ADDITIONAL IMPORTANT SAFETY
INFORMATION ON PAGE 3.
IMPORTANT: Bayer is providing the information in this guide to you for
informational and educational purposes only. This document is not intended
as training materials, an all-inclusive list, nor to establish a standard of care.
You are solely responsible for ensuring that you and your staff have been
properly trained in all aspects of providing the Essure procedure to your
patients in the office setting. For complete instructions, please refer to the
Instructions for Use and Physician Training Manual.
If you have any questions, please do not hesitate to contact your Clinical Sales Specialist using
the business card provided.
To make this process as streamlined as possible, we have created a website where you can
access examples of Essure forms and customize them based on your professional judgment:
EssureMDResources.com.
• Example forms and letters
• Reimbursement codes
• Account setup and ordering
The Essure Office Guide offers information and resources to help you achieve a successful
practice implementation, including:
You have joined a growing number of practices that have chosen to provide their patients
with the Essure in-office procedure for permanent birth control.
Welcome to the Essure Office Guide!
Dear Doctor and Staff:
Introducing the Essure®
Office Guide
131806_L01_CVR.indd 1
12/18/13 9:25 PM
THE ESSURE® OFFICE GUIDE
THE ESSURE®
OFFICE GUIDE
A resource for providing Essure in the office setting
To access and customize the most up-to-date forms, please go to EssureMDResources.com.
Indication
Essure is indicated for women who desire permanent birth
control (female sterilization) by bilateral occlusion of the
fallopian tubes.
Important Safety Information
Prescription Only
Caution: Federal law restricts this device to sale by or on the
order of a physician. Device to be used only by physicians
who are knowledgeable hysteroscopists; have read and
understood the Instructions for Use and Physician Training
manual; and have successfully completed the Essure
training program, including preceptoring in placement until
competency is established, typically 5 cases.
References: 1. Cooper JM, Carignan CS, Cher D, Kerin JF; Selective Tubal Occlusion Procedure 2000
Investigators Group. Microinsert nonincisional hysteroscopic sterilization. Obstet Gynecol. 2003;102(1):59-67.
2. Arjona JE, Miño M, Cordón J, Povedano B, Pelegrin B, Castelo-Branco C. Satisfaction and tolerance with
office hysteroscopic tubal sterilization. Fertil Steril. 2008;90(4):1182-1186. 3. Chudnoff S, Einstein M, Levie M.
Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial. Obstet Gynecol.
2010;115(1):26-34. 4. Isley MM, Jensen JT, Nichols MD, Lehman A, Bednarek P, Edelman A. Intrauterine
lidocaine infusion for pain management during outpatient transcervical tubal sterilization: a randomized
controlled trial. Contraception. 2012;85(3):275-281. 5. Miño M, Arjona JE, Cordón J, Pelegrin B, Povedano B,
Chacon E. Success rate and patient satisfaction with the Essure sterilisation in an outpatient setting:
a prospective study of 857 women. BJOG. 2007;114(6):763-766. 6. The American College of Obstetricians
and Gynecologists. Frequently asked questions: FAQ 143, special procedures. https://www.acog.org/~/
media/For%20Patients/faq143.pdf. Accessed December 9, 2013. 7. Guiahi M, Goldman KN, McElhinney MM,
Olson CG. Improving hysterosalpingogram confirmatory test follow-up after Essure hysteroscopic
sterilization. Contraception. 2010;81(6):520-524.
Who should not use Essure
• Essure is contraindicated in patients who are uncertain
about ending fertility, can have only one insert placed
(including contralateral proximal tubal occlusion
or suspected unicornuate uterus), have previously
undergone a tubal ligation, are pregnant or suspect
pregnancy, delivered or terminated a pregnancy less than
6 weeks prior to the Essure procedure, have an active or
recent upper or lower pelvic infection, or have a known
allergy to contrast media.
• Patients undergoing immunosuppressive therapy
(e.g. systemic corticosteroids or chemotherapy) are
discouraged from undergoing the Essure procedure.
• Uterine or fallopian tube anomalies may make it difficult
to place Essure inserts.
PLEASE SEE ADDITIONAL IMPORTANT SAFETY
INFORMATION ON PAGE 3.
BAYER, the Bayer Cross, and Essure are registered trademarks of Bayer.
© 2013 Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981
All rights reserved. 250-87-0003-13a Printed in USA December 2013
IMPORTANT: Bayer is providing the information in this guide to you for
informational and educational purposes only. This document is not intended
as training materials, an all-inclusive list, nor to establish a standard of care.
You are solely responsible for ensuring that you and your staff have been
properly trained in all aspects of providing the Essure procedure to your
patients in the office setting. For complete instructions, please refer to the
Instructions for Use and Physician Training Manual.
If you have any questions, please do not hesitate to contact your Clinical Sales Specialist using
the business card provided.
To make this process as streamlined as possible, we have created a website where you can
access examples of Essure forms and customize them based on your professional judgment:
EssureMDResources.com.
• Example forms and letters
• Reimbursement codes
• Account setup and ordering
The Essure Office Guide offers information and resources to help you achieve a successful
practice implementation, including:
You have joined a growing number of practices that have chosen to provide their patients
with the Essure in-office procedure for permanent birth control.
Welcome to the Essure Office Guide!
Dear Doctor and Staff:
Introducing the Essure®
Office Guide
131806_L01_CVR.indd 1
12/18/13 9:25 PM
Components
GETTING STARTED
4
Account setup and ordering 5
Physician coding guide
9
Suggested equipment and supplies checklist 11
Vendor listing 14
Reprocessing hysteroscopic equipment
PRE-PROCEDURE
15
Patient selection and scheduling
16
Patient scheduling form (example)
17
Patient pre-procedure letter (example)
PROCEDURE
18
Consent form (example)
19
Patient comfort
21
Pre-procedure nursing form (example)
22
Placement steps
POST-PROCEDURE
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24
Post-procedure nursing form (example)
25
Procedure note (example)
26
Post-procedure instructions (example)
27
Essure Confirmation Test overview
28
Essure Confirmation Test checklist (example)
29
Essure Confirmation Test reminder letter (example)
30
Essure Confirmation Test missed appointment letter (example)
12/18/13 9:47 PM
Important Safety Information (continued)
Pregnancy Considerations
• The Essure® procedure should be considered irreversible. Patients should not rely on Essure
inserts for contraception until an Essure Confirmation Test [modified hysterosalpingogram
(HSG)] demonstrates bilateral tubal occlusion and satisfactory location of inserts.
• Effectiveness rates for the Essure procedure are based on patients who had bilateral
placement. If Essure inserts cannot be placed bilaterally, then the patient should not rely on
Essure inserts for contraception.
• Effects, including risks, of Essure inserts on in vitro fertilization (IVF) have not been evaluated.
• Pregnancies (including ectopic pregnancies) have been reported among women with Essure inserts
in place. Some of these pregnancies were due to patient non-compliance or incorrect clinician
interpretation of the Essure Confirmation Test (modified HSG).
Procedural Considerations
• Perform the Essure procedure during early proliferative phase of the menstrual cycle. Terminate
procedure if distension fluid deficit exceeds 1500cc or hysteroscopic time exceeds 20 minutes
as it may signal uterine or tubal perforation. Never attempt to advance Essure insert(s) against
excessive resistance. If tubal or uterine perforation occurs or is suspected, discontinue procedure
and work-up patient for possible complications related to perforation, including hypervolemia. Do
not attempt hysteroscopic Essure insert removal once placed unless 18 or more trailing coils are
seen inside the uterine cavity due to risk of fractured insert, fallopian tube perforation or
other injury.
• DO NOT perform the Essure procedure concomitantly with endometrial ablation. Avoid
electrosurgery on uterine cornua and proximal fallopian tubes without visualizing inserts.
Nickel Allergy
Patients who are allergic to nickel may have an allergic reaction to this device, especially those
with a history of metal allergies. In addition, some patients may develop an allergy to nickel if
this device is implanted. Typical allergy symptoms reported for this device include rash, pruritus,
and hives.
MRI Information
The Essure insert was determined to be MR-conditional according to the terminology specified in
the American Society for Testing and Materials (ASTM) International, Designation: F2503-05.
Clinical Trial Experience
• Safety and effectiveness of Essure is not established in patients under 21 or over 45 years old,
nor in patients who delivered or terminated a pregnancy less than 8-12 weeks before procedure.
Women undergoing sterilization at a younger age are at greater risk of regretting their decision.
• The most common (≥10%) adverse events resulting from the placement procedure were
cramping, pain, and nausea/vomiting. The most common adverse events (≥3%) in the first
year of reliance were back pain, abdominal pain, and dyspareunia.
This product does not protect against HIV infection or other sexually transmitted diseases.
3
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Account Setup and Ordering
PHONE:
855-406-2861
EMAIL:
[email protected]
FAX:
888-281-8199
FOR OUR NEW CUSTOMERS
• Shipping/billing address (including facility name)
• Name of certified/trained Essure® provider and date of certification or scheduled training
• Facility license, in-house pharmacy license, or provider license*
• Letter of Affiliation form†
• Copy of resale certificate or Department of Revenue letter proving tax exemption
(if applicable)
FOR OUR EXISTING CUSTOMERS
• Facility license, in-house pharmacy license, or provider license*
• Letter of Affiliation form†
• Copy of resale certificate or Department of Revenue letter proving tax exemption
(if applicable)
• Shipping is FREE
• Orders received prior to 3:30 PM ET will ship the SAME DAY, unless otherwise requested
• Standard delivery is 2 business days; expedited delivery may be available upon request
A FACILITY LICENSE, IN-HOUSE PHARMACY LICENSE, OR PROVIDER LICENSE IS REQUIRED
FOR SHIPPING
*Once the license is on file, it is not necessary to provide another copy until the license has expired.
†For all states except Florida, a Letter of Affiliation form is needed if there is not an address on the license or if the address on the license
does not match the shipping location. Please note that some offices are slow to return this document. Due to the E-Pedigree law in the
state of Florida, Florida customers must submit their HCCE permit or the Declaration of Intent Letter before orders can be released.
GETTING STARTED
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Physician Coding Guide
Accurate diagnosis, procedure, and product coding are essential to help ensure prompt
claims processing and reimbursement.
Using the correct and specific codes is critical. Most payers, public and private, utilize
coding systems developed by the Centers for Medicare & Medicaid Services (CMS).
Healthcare providers are responsible for selecting the appropriate codes used in filing
a claim. Codes should be based on the patient’s diagnosis and the items and services
furnished by the provider.
GLOBAL FEE
There are multiple necessary services done by a healthcare provider when performing a
procedure. These services are said to be billed/paid “globally”—sometimes referred to as
the global/surgical package.
The global/surgical package also includes a global period: a set number of days during
the post-operative period. The global period is usually 90 days for major procedures and
0-10 days for minor procedures. Therefore, all follow-up care, including the treatment of
complications, is included in the global period and cannot be billed separately.
Because the Instructions for Use states that a hysterosalpingogram is a required part of the
Essure® procedure, it is considered typical and usual, and will not be paid separately if it is
performed within the 90-day global period of the Essure procedure.
IMPORTANT: The information in this guide is for informational purposes and does
not guarantee payment or coverage. Offices should research coding, coverage,
and payment for individual patients prior to initiating treatment since policies and
guidelines vary by payer and health plan. Offices are responsible for submitting
accurate, complete, and appropriate claims to payers and for compliance with any
obligations required by law, contract, or otherwise.
GETTING STARTED
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Physician Coding Guide (cont'd)
ESSURE PROCEDURE CODING
Current Procedural Terminology (CPT®) Fourth Edition* codes
CPT-4 is a listing of descriptive terms and codes for reporting services and procedures
performed by healthcare providers.
The following code may be used to report procedures associated with Essure:
Product/Service
CPT Code
Code Description
Essure procedure
58565
Hysteroscopy, surgical; with bilateral fallopian
tube cannulation to induce occlusion by
placement of permanent implants
Healthcare Common Procedure Coding System (HCPCS) codes
Level II HCPCS codes are published and updated annually by CMS. These alphanumeric
codes are used to report drugs, supplies, and services.
Please note that Medicare does not allow for separate reporting and billing of the
permanent implantable contraception. Private payers and Medicaid will make their own
determination on whether or not to use the HCPCS code. Please confirm with your payer
that A4264 is allowed for billing and will be paid.
The HCPCS code used by facilities and some Medicaid plans to report Essure is:
Product/Service
HCPCS Code
Code Description
Essure
A4264
Permanent implantable contraceptive intratubal
occlusion device(s) and delivery system
ICD-9 diagnosis codes
The International Classification of Diseases, 9th Revision, Clinical Modification
(ICD-9-CM) codes are used to classify diagnoses and conditions, and support
medical necessity for specific procedures and services. They are used to indicate
the reason for performing a given procedure and may be used by payers to
determine coverage.
The following ICD-9-CM codes may be applicable to women who receive Essure:
ICD-9-CM Code
Code Description
V25.2
Encounter for contraceptive management; sterilization
*CPT codes, descriptions, and other data only are copyright 2010 American Medical Association. All rights reserved.
CPT is a registered trademark of the American Medical Association (AMA).
(continued on next page)
GETTING STARTED
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Physician Coding Guide (cont'd)
ESSURE® CONFIRMATION TEST CODING
Current Procedural Terminology (CPT®) Fourth Edition* codes
Product/Service
CPT Code
Code Description
Modified HSG
58340
Catheterization and introduction of
saline or contrast material for saline
infusion sonohysterography (SIS) or
hysterosalpingography (HSG)
Modified HSG, interpretation
and supervision
74740
HSG, radiologic supervision and
interpretation
Modified HSG, interpretation
74740-26
Professional component only
Modified HSG, supervision
74740-TC
Technical component only
ICD-9 diagnosis codes
These codes must be used together and in this order:
ICD-9-CM Code
Code Description
V67.09
Follow-up examination following other surgery
V26.51
Tubal ligation status
The following code may be used to identify the Essure Confirmation Test as a
preventive service:
ICD-9-CM Code
Code Description
V25.8
Other specified contraceptive management
*CPT codes, descriptions, and other data only are copyright 2010 American Medical Association. All rights reserved.
CPT is a registered trademark of the AMA.
IMPORTANT: The information in this guide is for informational purposes and does
not guarantee payment or coverage. Offices should research coding, coverage,
and payment for individual patients prior to initiating treatment since policies and
guidelines vary by payer and health plan. Offices are responsible for submitting
accurate, complete, and appropriate claims to payers and for compliance with
any obligations required by law, contract, or otherwise.
GETTING STARTED
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Physician Coding Guide (cont'd)
MODIFIERS
Preventive services
CPT Modifier 33 is applicable for the identification of preventive services without
cost sharing and may be added to the following codes as shown below.
Product/Service
CPT Code
Code Description
Essure procedure
58565-33
Hysteroscopy, surgical; with bilateral fallopian
tube cannulation to induce occlusion by
placement of permanent implants
Modified HSG
58340-33
Catheterization and introduction of saline
or contrast material for SIS or HSG
Note: Not all commercial payers will require the use of Modifier 33. Some will
automatically process Essure and the Essure Confirmation Test without patient
cost sharing.
Incomplete procedure
In some cases, the Essure procedure is initiated but cannot be completed. In these
cases, it may be appropriate to bill within Modifier 52 or 53 as described below.
Product/Service
CPT Code
Code Description
Essure procedure,
reduced services
58565-52
This modifier is used to report a service or
procedure that is partially reduced or eliminated
at the physician’s election. An example of the
correct use of Modifier 52 would be a failure of
placement on one side, resulting in unilateral
placement of Essure.
Essure procedure,
discontinued
58565-53
This modifier is used to report a procedure
that is discontinued by the physician because
of extenuating circumstances. Modifier 53
can only be used after anesthesia has been
administered. An example of the correct use
of Modifier 53 would be an Essure procedure
being discontinued because the ostium of the
fallopian tube is not visible.
LOCAL CODING
Some state Medicaid programs may require the use of state-specific coding.
Providers should research Medicaid coding guidelines on a state-specific basis.
To access state Medicaid reimbursement
information, please go to EssureMDResources.com.
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8
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Suggested Equipment and Supplies
Checklist
ESSURE® PROCEDURE SETUP
Review the following checklist to help make sure you have what you need to begin
the Essure procedure.
EQUIPMENT AND SUPPLIES CHECKLIST
General
£ Urine pregnancy test
£ Under-buttocks pouch drape
£ Leg drapes
£ Drape sheet (optional)
£ Essure kit
—Do not open until ostia have been visualized
—Have a back-up kit available
Essure procedure tray/Mayo stand
£ 2 sterile field drapes (one to cover tray until needed)
£ Sterile single-hinged (open-sided) speculum
£ Sterile gloves
£ Sterile tenaculum
£ Sterile ring forceps
£ Sterile 4" ⫻ 4"
£ Sterile cervical dilators (small sizes)
Paracervical block supply items (optional)
£ Sterile speculum—warmed if possible
£ Sterile tenaculum
£ Supplies to clean off cervix (ie, antibacterial swabs or antibacterial
solution in a specimen cup with 4" ⫻ 4")
£ 18G needle for drawing up local anesthetic agent—1 or 1.5 inch
£ 22G 1.5-inch needle
£ 6-inch-long needle extender
£ Sterile control syringe
£ Local anesthetic, per physician
GETTING STARTED
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Suggested Equipment and Supplies
Checklist (cont'd)
Hysteroscopy equipment
£ Sterile 12- or 30-degree hysteroscope with a ≥5 French operating channel
£ Sterile sealing cap for instrument port
£ Camera (white balance; use sterile drape if camera is not sterile)
£ Sterile light cord
£ Sterile inflow tubing
£ Sterile outflow tubing
£ Warm, normal saline bag (preferably 3 liters)
£ Pressure bag or cuff for saline infusion
Have available
£ Hysteroscopic grasper
IMPORTANT: Bayer is providing the information in this guide to you for informational
and educational purposes only. This document is not intended as training materials,
an all-inclusive list, nor to establish a standard of care. You are solely responsible for
ensuring that you and your staff have been properly trained in all aspects of providing
the Essure procedure to your patients in the office setting. For complete instructions,
please refer to the Instructions for Use and Physician Training Manual.
GETTING STARTED
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Vendor Listing
Although the majority of supplies for the Essure® procedure may already be available in
your practice, there are several items you may need to order. Please contact the vendor
for the most up-to-date pricing, order numbers, and availability.
MEDICAL OFFICE RESOURCES (MOR) HYSTEROSCOPIC
STERILIZATION PACKS
Pre-assembled, sterile trays designed specifically for Essure office procedures.
Tel: 419-367-8249
Website: http://www.medofficeresources.com/essu001.htm
Product #ESSU001
Product #ESSU006
Prep tray components:
1 tray, 2 compartments
1 gloves, exam LG
12 oz Betadine solution
20 gauze, 4 x 4 12 ply
4 swab 8"
1 wrap 30 x 30
Prep tray components:
1 tray, 2 compartments
1 gloves, exam LG
12 oz Betadine solution
15 gauze, 4 x 4 12 ply
4 swab 8"
1 wrap 30 x 30
Pack components:
1 back table cover
2 10-cc control syringes L/L
1 needle, spinal 22G x 3.5
1 pad, prep alcohol
1 large-bore cystoscopy tubing set
1 tubing suction
1 gown, XLG
1 drape, camera
1 needle, 18G x 1.5 short
1 drape, under-buttocks 40 x 44 w/pouch
1 Lidocaine® 1% HCl 20 mL
1 17" x 11" x 2.5" platform tray
3 towels OR blue 17" x 26"
1 label, 3 3/8" x 2 1/3"
1 label, custom kit
1 bag, header 19 x 24
Pack components:
1 back table cover
2 10 cc control syringes L/L
1 needle, spinal 22G x 3.5
1 pad, prep alcohol
1 large-bore cystoscopy tubing set
1 tubing suction
1 drape, camera
1 drape, under-buttocks 40 x 44 w/pouch
3 towels OR blue 17" x 26"
1 label, 3 3/8" x 2 1/3"
1 label, custom kit
1 bag, header 19 x 24
1 17" x 11" x 2.5" platform tray
GETTING STARTED
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Vendor Listing (cont'd)
OBP MEDICAL OFFICEPACK HYSTEROSCOPY KIT
Pre-assembled sterile kits for use in office hysteroscopy.
Tel: 1-888-300-2946
Website: www.obpmedical.com
Product #C040101
OfficePACK Hysteroscopy Kit includes:
1 disposable Mayo tray
1 Mayo tray drape
2 plastic cotton tips
15 gauze 100 x 100 mm
1 surgical lubricant, 3 g
1 povidone iodine solution w/ plastic cotton tips
1 alcohol prep pad
2 control syringes, 10 mL
1 hypodermic needle 18G
1 spinal needle 22G
1 sanitary paper
1 OR towel
1 cysto irrigation set in-flow w/ Luer lock
1 OutflowBAG drainage collection bag w/ tubing & Luer lock
2 pair gloves
1 OfficeSPEC disposable side-opening speculum w/ light
1 endoscopic seal GYN 1-size-fits-all w/ Luer lock
1 item tray
1 under-buttocks drape w/ graded collection bag
LARGE-BORE INFLOW/OUTFLOW TUBING
Baxter Healthcare Corporation
Tel: 1-800-933-0303
Saline 3000cc bags; cat #2B7126
Cysto/Bladder Irrigation set; cat #2C4040
Hospira Inc.
Address: Lake Forest, IL 60045
TUR Y-Set; cat #6543-01
McKesson
Irrigation set/cysto; cat #208806
(continued on next page)
GETTING STARTED
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Vendor Listing (cont'd)
SUCTION TUBING
Cardinal Health
Tel: 1-800-964-5227
Suction tubing for outflow; cat #N56A 3/16"
CONMED
Tel: 1-315-797-8375
Website: www.conmed.com
Suction tubing, 10 feet, 3/16''; ref #0036770
Kendall Tyco/Healthcare
Tel: 1-800-962-9888
Argyle non-conductive connecting tubing, 3/16" x 6'; cat #284513
UNDER-BUTTOCKS DRAPES
3M
Tel: 1-800-228-3957
Fluid pouch 3M Steri-Drape; cat #1016
Mölnlycke Healthcare
Website: www.molnlycke.com/us/
Under-buttocks drape with pouch, latex free; ref #229
Allegiance
Address: McGaw Park, IL 60085
Under-buttocks drape with fluid control; pouch II; cat #8482
Medline
Tel: 1-800-MEDLINE (633-5463)
Proxima under-buttocks drape with pouch and drainage port; re-order #DYNJP6002
Gyrus ACMI
Tel: 1-888-524-7266
DISTEN-U-FLO fluid management system
(set includes under-buttocks drape and outflow tubing); ref #GY5-TUB
McKesson
Under-buttocks drape; #314027
CAMERA DRAPES
McKesson
Camera drape; arthroscopy covers; part #577706
GETTING STARTED
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Reprocessing Hysteroscopic Equipment
It is important to establish a protocol for reprocessing your hysteroscopy equipment.
Refer to the manufacturer’s Instructions for Use for recommended guidelines for your
particular hysteroscope and/or accessory.
The following contacts are provided for your convenience:
Richard Wolf Medical Instruments
Tel: 1-800-323-9653
Website: www.richardwolfusa.com
Karl Storz Endoscopy
Tel: 1-800-421-0837
Website: www.karlstorz.com
Olympus
Tel: 1-800-848-9024
Website: www.olympusamerica.com/msg_section/msg_ask.asp
Gyrus ACMI, an Olympus Company
Tel: 1-888-524-7266
Website: www.olympusamerica.com/msg_section/msg_ask.asp
GETTING STARTED
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Patient Selection and Scheduling
PATIENT SELECTION
Indications for use
The Essure® system is indicated for women who desire permanent birth control
(female sterilization) by bilateral occlusion of the fallopian tubes.
Contraindications for use
The Essure Permanent Birth Control System should not be used in those patients:
• Unsure about desire to end fertility
• In whom only one insert can be placed (including proximal tubal occlusion [PTO]
and unicornuate uterus)
• Who have previously undergone a tubal ligation
Or any patient with any of the following conditions:
• Pregnancy or suspected pregnancy
• Delivery or termination of a pregnancy (<6 weeks before placement)
• Active or recent upper or lower pelvic infection
• Known allergy to contrast media
PATIENT SCHEDULING
Insert placement should be performed during the early proliferative phase of the
menstrual cycle to:
• Decrease potential for insert placement in a patient with an undiagnosed
(luteal phase) pregnancy
• Enhance visualization of the fallopian tube ostia
In women with menstrual cycles shorter than 28 days, the day of ovulation must
be carefully calculated to reduce the potential of a luteal phase pregnancy. Insert
placement should NOT be performed during menstruation.
PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION ON PAGE 3.
IMPORTANT: Bayer is providing the information in this guide to you for informational
and educational purposes only. This document is not intended as training materials, an
all-inclusive list, nor to establish a standard of care. You are solely responsible for ensuring
that you and your staff have been properly trained in all aspects of providing the Essure
procedure to your patients in the office setting. For complete instructions, please refer to
the Instructions for Use and Physician Training Manual.
PRE-PROCEDURE
131806_L01_TXT.indd 15
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Patient Scheduling Form (Example)
To access and customize this form, please go to EssureMDResources.com.
This form is an example. You should review and modify this form as you deem appropriate based on your professional judgment.
ESSURE® PROCEDURE SCHEDULING (EXAMPLE)
Patient name:
Allergies:
NSAID allergy:
Contrast media (dye) allergy:
Current form of birth control (to be continued until insert location and tubal occlusion verification by the Essure
Confirmation Test):
Last menstrual period:
The Essure procedure should be performed during the early proliferative phase for most women. If less than a 28-day cycle is
occurring, consideration should be given for timing of the procedure.
Date scheduled:
Insurance:
E
L
P
M
A
X
E
Insurance reimbursement amount for procedure:
Insurance reimbursement amount for the Essure Confirmation Test:
Total patient financial responsibility (includes co-pay, deductible, non-covered services):
rvices
Did you remember to:
Give the Patient Information Booklet, patient pre-procedure letter,
ter, and any prescriptions to the patient?
pa
‫ ܆‬Yes ‫ ܆‬No
Prescriptions (please list):
Prescriptions provided to (please checkk one):
one ‫ ܆‬Patient ‫ ܆‬Pharmacy
Pharma
If pharmacy, please provide pharmacy
armacy name:
Order a urine pregnancy test to be completed within 24 hours before the procedure? ‫ ܆‬Yes ‫ ܆‬No
Inform the patient of the
e need for alternative contraception
contraceptio until insert location and tubal occlusion verification by the
Essure Confirmation
tion Test? ‫ ܆‬Yes ‫ ܆‬No
o
Provide the
location (office, surgery center, or hospital)? ‫ ܆‬Yes ‫ ܆‬No
e patient with the procedure locati
Inform the patient
atient of the potential need for transportation to/from procedure? ‫ ܆‬Yes ‫ ܆‬No
Inform the patient
responsibility? ‫ ܆‬Yes ‫ ܆‬No
ent of her financial
finan
Indication
Essure is indicated for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes.
Important Safety Information
Prescription Only
Caution: Federal law restricts this device to sale by or on the order of a physician. Device to be used only by physicians who are
knowledgeable hysteroscopists; have read and understood the Instructions for Use and Physician Training manual; and have
successfully completed the Essure training program, including preceptoring in placement until competency is established, typically 5
cases.
Who should not use Essure
x Essure is contraindicated in patients who are uncertain about ending fertility, can have only one insert placed (including contralateral
proximal tubal occlusion or suspected unicornuate uterus), have previously undergone a tubal ligation, are pregnant or suspect
pregnancy, delivered or terminated a pregnancy less than 6 weeks prior to the Essure procedure, have an active or recent upper or
lower pelvic infection, or have a known allergy to contrast media.
x
Patients undergoing immunosuppressive therapy (e.g. systemic corticosteroids or chemotherapy) are discouraged from undergoing
the Essure procedure.
x
Uterine or fallopian tube anomalies may make it difficult to place Essure inserts.
PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION ABOUT ESSURE ON NEXT PAGE.
PRE-PROCEDURE
131806_L01_TXT.indd 16
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Patient Pre-Procedure Letter (Example)
To access and customize this form, please go to EssureMDResources.com.
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RQWKHLUFXUUHQWELUWKFRQWURO2WKHUZRPHQVXFKDVWKRVHXVLQJDQLQWUDXWHULQHGHYLFHRUFRQWUDFHSWLYH,8'RU,8&ZLOOQHHGWR
VZLWFKWRDQRWKHUPHWKRG
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PRE-PROCEDURE
131806_L01_TXT.indd 17
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Consent Form (Example)
To access and customize this form, please go to EssureMDResources.com.
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WKHUHE\SUHYHQWLQJSUHJQDQF\
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DUHFHQWSHOYLFLQIHFWLRQ
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x ,XQGHUVWDQGWKDWVRPHZRPHQPD\QRWKDYHVXFFHVVIXOSODFHPHQWRIERWK(VVXUHLQVHUWVDQGVKRXOGWKLVRFFXU,ZLOOQHHGDQRWKHU
IRUPRIELUWKFRQWURO
x ,XQGHUVWDQGWKDWQRELUWKFRQWUROPHWKRGLVHIIHFWLYHDQGWKDWWKH(VVXUHSHUPDQHQWELUWKFRQWUROSURFHGXUHLVHIIHFWLYH
LQSUHYHQWLQJSUHJQDQF\LQZRPHQZKRKDGVXFFHVVIXOSODFHPHQWLQHDFKIDOORSLDQWXEHDVFRQILUPHGE\WKH(VVXUH&RQILUPDWLRQ
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PROCEDURE
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Patient Comfort
Patient comfort is an important part of a successful Essure® placement. Recommended
anesthesia options for the Essure procedure include:
£ NSAIDs 1-2 hours pre-procedure
£ Anxiolytic 30 minutes pre-procedure
£ Paracervical block with or without IV sedation
An NSAID given prior to the procedure has been shown to increase the likelihood of
bilateral placement success in clinical trials.
IN THE ESSURE PIVOTAL TRIAL
NSAIDs were administered prior to the procedure1
£ In 84% of 544 procedures, patients received pre-operative NSAIDs1
PREDOMINANT ANESTHESIA USED1
n
Percent
Local anesthesia
283
52.0%
IV sedation and/or analgesia
222
40.8%
None*
38
7.0%
1
0.2%
544
100%
General anesthesia
Total
*Other than pre-operative oral nonsteroidal anti-inflammatory drug (NSAID).
RECOVERY ROOM MEDICATION1
75% of patients required no pain medication in the recovery room
Ensure that office staff members are properly trained and that emergency
equipment is on hand in accordance with the level of anesthesia selected
and pursuant to any state requirements.
PROCEDURE
131806_L01_TXT.indd 19
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Patient Comfort (cont'd)
SUMMARY OF LITERATURE FOR PAIN MANAGEMENT DURING
HYSTEROSCOPIC STERILIZATION PROCEDURES
Publication
Arjona J. Satisfaction
and tolerance with
office hysteroscopic
tubal sterilization.
Fertility and Sterility.
2008.2
Chudnoff S.
Paracervical block
efficacy in office
hysteroscopic
sterilization.
Obstetrics and
Gynecology. 2010.3
Isley MM. Intrauterine
lidocaine infusion for
pain management
during outpatient
transcervical
tubal sterilization:
a randomized
controlled trial.
Contraception. 2012.4
Miño M. Success
rate and patient
satisfaction with the
Essure sterilisation
in an outpatient
setting: a prospective
study of 857 women.
BJOG. 2007.5
Trial design
Prospective
analysis of case
series
N=1630
Double-blind,
randomized,
placebocontrolled trial
N=80
NSAID
Local
anesthesia
Sedation
Anxiolytic
Ibuprofen
600 mg
Benzodiazepine
10 mg
1 hour
pre-procedure
1 hour
pre-procedure
Ketorolac
60 mg IM
immediately
before
procedure
Randomized,
double-blind,
placebocontrolled trial
Ibuprofen
800 mg PO
N=58
30-45 min
pre-procedure
Paracervical
block with 1%
lidocaine at
12:00, 4:00, and
8:00
Paracervical
block with
buffered 1%
lidocaine, at the
tenaculum site,
at 4:00, and
8:00
Lorazepam
2 mg PO
30-45 minutes
pre-procedure
5 mL 4%
intrauterine
lidocaine†
Prospective,
single-center
cohort
N=857
Ibuprofen
600 mg
1 hour
pre-procedure
50.5% of
patients
received
paracervical
block with
mepivacaine
cloridrate 3%
Diazepam
10 mg
1 hour
pre-procedure
†Did not significantly reduce pain.
Note: This selection of literature is not intended to be a comprehensive
list, nor provide a conclusive approach to pain management, but rather,
a range of examples.
PROCEDURE
131806_L01_TXT.indd 20
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Pre-Procedure Nursing Form (Example)
To access and customize this form, please go to EssureMDResources.com.
This form is an example. You should review and modify this form as you deem appropriate based on your professional judgment.
ESSURE® PRE-PROCEDURE NURSING FORM (EXAMPLE)
Date of procedure:
Patient name:
Last menstrual period:
Current birth control:
Birth control to be used between Essure procedure and Essure Confirmation Test:
Birth control prescription given?
‫ ܆‬Yes ‫ ܆‬No
Results of urine pregnancy test (within 24 hours):
BP:
E
L
P
M
A
X
E
Pulse:
Temp:
Medications taken today:
NSAID given?
Other?
Time:
Time:
Time:
When did patient last eat or drink?
What did she eat or drink?
Consent signed and witnessed?
nessed?
‫ ܆‬Yes ‫ ܆‬No
Physician reviewed
viewed and answered patient questions?
‫ ܆‬Yes ‫ ܆‬No
Indication
Essure is indicated for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes.
Important Safety Information
Prescription Only
Caution: Federal law restricts this device to sale by or on the order of a physician. Device to be used only by physicians who are
knowledgeable hysteroscopists; have read and understood the Instructions for Use and Physician Training manual; and have
successfully completed the Essure training program, including preceptoring in placement until competency is established, typically
5 cases.
Who should not use Essure
x Essure is contraindicated in patients who are uncertain about ending fertility, can have only one insert placed (including contralateral
proximal tubal occlusion or suspected unicornuate uterus), have previously undergone a tubal ligation, are pregnant or suspect
pregnancy, delivered or terminated a pregnancy less than 6 weeks prior to the Essure procedure, have an active or recent upper or
lower pelvic infection, or have a known allergy to contrast media.
x
Patients undergoing immunosuppressive therapy (e.g. systemic corticosteroids or chemotherapy) are discouraged from undergoing
the Essure procedure.
x
Uterine or fallopian tube anomalies may make it difficult to place Essure inserts.
PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION ABOUT ESSURE ON NEXT PAGE.
PROCEDURE
131806_L01_TXT.indd 21
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Placement Steps
INTRODUCE
Place introducer through working channel.
Hysteroscopically
visualize and assess
both fallopian
tube ostia.
Carefully insert Essure catheter.
Advance the catheter until the black
positioning marker is at the tubal
ostium. If excessive force is encountered,
terminate procedure to avoid uterine
perforation or placement into a
false passage.
PLACE
Stabilize the Essure handle to the
hysteroscope to prevent inadvertent
forward movement. Roll thumbwheel
back so black positioning marker moves
towards you until reaching a hard stop.
Gold band
Stop and check placement of insert. The
entire gold band must be just outside the
ostium with the green release catheter
in view. If the gold band is not in view,
reposition catheter prior to deployment.
Press button to release thumbwheel.
Insert will not yet expand.
Roll thumbwheel back to a hard stop that
expands and detaches insert.
DOCUMENT
Document placement
and visible coils.
(continued on next page)
Ideally, 3 to 8 coils should be trailing into
the uterus. Inserts showing 0-17 trailing
coils should be left in place. 18 or more
visible coils requires insert removal.
Withdraw Essure catheter.
Repeat steps with second catheter for
contralateral ostium.
IMPORTANT: Bayer is providing this information to you for
informational and educational purposes only. This document is
not intended to be a training document. You and your staff
must be properly trained in all aspects of providing the Essure
procedure. For complete placement procedure, please refer to
Instructions for Use and Physician Training Manual.
131806_L01_TXT.indd 22
PROCEDURE
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Placement Steps (cont'd)
TIPS AND TECHNIQUES
• Insert placement should be performed during the early proliferative phase of the menstrual
cycle to decrease the potential of an undiagnosed (luteal phase) pregnancy and enhance
visualization of the fallopian tubes. DO NOT perform during menstruation
• Administer an NSAID 1-2 hours prior to procedure. Data suggests this will increase the
likelihood of placement success
• A bivalve, open-sided speculum is recommended so that it can be readily removed once the
hysteroscope is in place
• Do not dilate cervix unless necessary. If necessary, dilate only enough for
hysteroscope insertion
• Use warm saline for uterine distension medium—preferably a 3-liter bag
• If having difficulty advancing insert into tube, advance the hysteroscope closer to provide
column strength, then apply gentle, constant forward movement of the
Essure® catheter
• Operative notes should include the number of visible coils, and the need for a 3-month Essure
Confirmation Test
• Counsel patient on the need for alternative contraception until insert location and tubal
occlusion are verified by the Essure Confirmation Test
Delivery system after deployment of insert
If no trailing coils are visible after deployment,
examine delivery system upon removal from
the hysteroscope to verify device deployment
(see picture).
Do not place more than one device in each
fallopian tube unless an Essure Confirmation
Test has been performed.
Delivery system with insert
PROCEDURE
131806_L01_TXT.indd 23
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Post-Procedure Nursing Form (Example)
To access and customize this form, please go to EssureMDResources.com.
This form is an example. You should review and modify this form as you deem appropriate based on your professional judgment.
ESSURE® POST-PROCEDURE NURSING FORM (EXAMPLE)
Date of Procedure:
BP:
Patient Name:
Pulse:
Temp:
Procedure documentation:
Number of coils visible in uterine cavity: Left:
Right:
Scope time: Start:
Total:
Stop:
Lot #:
(Use sticker from Essure kit)
Nursing responsibility after procedure:
‫ ܆‬Provide patient with Essure ID card
E
L
‫ ܆‬Give post-procedure instructions to patient
‫ ܆‬Clean room and equipment per protocol
P
M
A
X
E
‫ ܆‬Place this sheet in patient’s chart
Patient instructions:
x May resume normal activities on:
x May resume intercourse on:
x Call when:
he office, make an appointm
appointment for your 3-month Essure Confirmation Test
x Before leaving the
n:
x Return on:
irth control until your physician verifies that the inserts are in the correct location and your fallopian tubes
x Continue birth
are blocked
x Take
as prescribed by your physician
Indication
Essure is indicated for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes.
Important Safety Information
Prescription Only
Caution: Federal law restricts this device to sale by or on the order of a physician. Device to be used only by physicians who are
knowledgeable hysteroscopists; have read and understood the Instructions for Use and Physician Training manual; and have
successfully completed the Essure training program, including preceptoring in placement until competency is established, typically
5 cases.
Who should not use Essure
x
Essure is contraindicated in patients who are uncertain about ending fertility, can have only one insert placed (including contralateral
proximal tubal occlusion or suspected unicornuate uterus), have previously undergone a tubal ligation, are pregnant or suspect
pregnancy, delivered or terminated a pregnancy less than 6 weeks prior to the Essure procedure, have an active or recent upper or
lower pelvic infection, or have a known allergy to contrast media.
x
Patients undergoing immunosuppressive therapy (e.g. systemic corticosteroids or chemotherapy) are discouraged from undergoing
the Essure procedure.
x
Uterine or fallopian tube anomalies may make it difficult to place Essure inserts.
PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION ABOUT ESSURE ON NEXT PAGE.
POST-PROCEDURE
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Procedure Note (Example)
To access and customize this form, please go to EssureMDResources.com.
This form is an example. You should review and modify this form as you deem appropriate based on your professional judgment.
ESSURE® PROCEDURE NOTE (EXAMPLE)
Patient name:
Date:
Risks, alternatives, and benefits of the procedure were discussed with the patient. All questions were answered, and
informed consent was signed.
The patient received the following medication prior to the procedure:
A paracervical block was performed using a
gauge spinal needle and
cc of
.
The Essure procedure was performed per protocol.
Trailing coils: Left:
Right:
E
L
P
M
A
X
E
Other findings during the hysteroscopy are noted here:
The Essure patient card was given.
for pain relief, and will call if she has unusual
ven. She will use
symptoms such as pain/cramping,
or fever. She will use alternative contraception
ramping, heavy bleeding, vaginal discharge,
d
(except IUD or IUS) until
occlusion are verified by the Essure Confirmation Test, done at
til insert location and tubal occlus
3 months post-procedure.
rocedure.
Essure Lot #
<Physician name>, MD
Indication
Essure is indicated for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes.
Important Safety Information
Prescription Only
Caution: Federal law restricts this device to sale by or on the order of a physician. Device to be used only by physicians who are
knowledgeable hysteroscopists; have read and understood the Instructions for Use and Physician Training manual; and have
successfully completed the Essure training program, including preceptoring in placement until competency is established, typically 5
cases.
Who should not use Essure
x Essure is contraindicated in patients who are uncertain about ending fertility, can have only one insert placed (including contralateral
proximal tubal occlusion or suspected unicornuate uterus), have previously undergone a tubal ligation, are pregnant or suspect
pregnancy, delivered or terminated a pregnancy less than 6 weeks prior to the Essure procedure, have an active or recent upper or
lower pelvic infection, or have a known allergy to contrast media.
x
Patients undergoing immunosuppressive therapy (e.g. systemic corticosteroids or chemotherapy) are discouraged from undergoing
the Essure procedure.
x
Uterine or fallopian tube anomalies may make it difficult to place Essure inserts.
PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION ABOUT ESSURE ON NEXT PAGE.
POST-PROCEDURE
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Post-Procedure Instructions (Example)
To access and customize this form, please go to EssureMDResources.com.
This form is an example. You should review and modify this form as you deem appropriate based on your professional judgment.
ESSURE® POST-PROCEDURE INSTRUCTIONS (EXAMPLE)
Going Home
x Obtain a completed ID card before you leave. Keep your ID card with you at all times and present it to other doctors involved in your
present or future care.
x
Schedule your Essure Confirmation Test (see below) for 3 months from now.
When You are Home
x If you are experiencing cramping, follow your doctor’s instructions regarding pain medication.
— Medication instructions:
x
E
L
P
M
A
X
E
You may feel faint or nauseous. Follow your doctor’s recommendations regarding activity during the first 24 hours ffollowing your
procedure.
Spotting or light bleeding is normal. If bleeding becomes heavy, you suspect you may be
e pregnant, or you become conc
concerned, please
contact your doctor.
x
You must use alternative contraception until your physician verifies that
hat the inserts are in the correct loca
location and your
.
fallopian tubes are blocked. You may resume intercourse on
x
Please call your doctor if your period is more than 5 days late or you
u suspect you may be pregnant.
3-month Essure Confirmation Test
x
You will need to schedule the Essure Confirmation
n Test for 3 months post-procedure. The test is performed to make sure that both of your
Essure inserts are in the correct location and that
hat your fallopian
n tubes are blocked sso you can rely on Essure as permanent birth control.
x
Return on
for the Essure
ssure Confirmation Test.
Tes
You must use alternative
e contraception until your 3-month Essure Confirmation Test confirms that your Essure inserts are in
the correct location and that your fallopian tubes are blocked. Only at that point can you rely on Essure for birth control.
he Essure device for birth control before
befo completing the Essure Confirmation Test, you may get pregnant or have an
If you rely on the
nancy (pregnancy outside of yourr u
ectopic pregnancy
uterus, but inside the body). Ectopic pregnancies can be life-threatening; so if you think
you might be pregnant, please call yo
your physician.
Indication
nent birt
Essure is a permanent
birth control procedure that works with your body to create a natural barrier against pregnancy.
Important Safety Information
WARNING: You must continue to use another form of birth control until you have your Essure Confirmation Test and your
doctor tells you that you can rely on Essure for birth control.
x
You can rely on Essure for birth control only after your doctor has reviewed your Essure Confirmation Test results. Your doctor will
confirm that the inserts are properly placed and both of your fallopian tubes are blocked. If you rely on Essure for birth control before
having your Essure Confirmation Test, you are at risk of getting pregnant.
x
Talk to your doctor about which method of birth control you should use for the 3 months after the procedure. Some women can remain
on their current birth control. Other women, such as those using an intrauterine device or contraceptive (IUD or IUC), will need to
switch to another method.
x
It can take longer than three months for the Essure procedure to be effective. In rare cases, it has taken up to 6 months. Make sure to
continue using an alternate form of birth control up until your doctor has reviewed your Essure Confirmation Test results and
confirmed that you can rely on Essure for birth control.
WARNING: Be sure you are done having children before you undergo the Essure procedure. Essure is a permanent method of
birth control. The younger a woman is when she chooses to end her fertility, the more likely she is to regret her choice later.
PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION ABOUT ESSURE ON NEXT PAGE.
POST-PROCEDURE
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Essure® Confirmation Test Overview
ESSURE CONFIRMATION TEST
Patients must have the Essure Confirmation Test to verify that the Essure inserts are in
the correct location and that the fallopian tubes are blocked.
Besides being an integral part of the Essure procedure, the Essure Confirmation Test
provides confirmation that the procedure was successful and can be relied upon
for permanent birth control.
KEY POINTS
• To avoid confusion with an infertility HSG and help ensure a positive patient experience,
gynecologists should contact the radiologist and provide a copy of the Essure
Confirmation Test Process and Checklist prior to referring patients. Both can be
downloaded at EssureMDResources.com
• Consider administering an over-the-counter pain reliever 1 hour prior to the procedure6
• Consider establishing a protocol in your office for scheduling confirmation test
appointments, calling with appointment reminders, and tracking confirmation test
compliance. This has been shown to increase patient compliance and rates of confirmed
Essure location and tubal occlusion7
ESSURE CONFIRMATION TEST RESOURCES
For Physicians
Process for performing the Essure Confirmation Test:
Electronic version available at EssureMDResources.com. Can be forwarded to the
radiologist.
Essure Confirmation Test Checklist:
Can be found on the next page and is also available electronically at
EssureMDResources.com. The checklist can be provided to the radiologist to ensure that
the procedure is performed correctly and that the radiology report contains all required
information.
Example Essure Confirmation Test letters:
Remind your patients to schedule their Essure Confirmation Test. See example letters at
EssureMDResources.com.
For Patients
Essure Confirmation Test patient brochure:
Provides an overview of Essure Confirmation Test for your patients.
IMPORTANT: Bayer is providing the information in this guide to you for
informational and educational purposes only. This document is not intended
as training materials, an all-inclusive list, nor to establish a standard of care.
You are solely responsible for ensuring that you and your staff have been
properly trained in all aspects of providing the Essure procedure to your
patients in the office setting. For complete instructions, please refer to the
Instructions for Use and Physician Training Manual.
POST-PROCEDURE
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Essure Confirmation Test Checklist (Example)
To access and customize this form, please go to EssureMDResources.com.
This form is an example. You should review and modify this form as you deem appropriate based on your professional judgment.
ESSURE® CONFIRMATION TEST OVERVIEW (EXAMPLE)
The Essure Confirmation Test is a modified hysterosalpingogram (HSG) performed 3 months after the Essure placement procedure.
This test is used to confirm and document satisfactory location of both inserts and bilateral tubal occlusion.
The Essure Confirmation Test differs from an infertility HSG by using a lower contrast volume and a slow, gentle, constant filling of the
uterine cavity. This is NOT a pressure study.
In order to produce and report satisfactory images to allow for adequate evaluation of location and occlusion, adhere to the
following guidelines:
1.
Do not dilate cervix unless necessary; if dilation occurs, maintain a good cervical seal.
2.
Obtain good cornual filling; uterine cavity silhouette should be clearly visualized. Instill contrast slowly and gently until the uterine
cornua are distended. An increase in intrauterine pressure beyond that should be avoided due to patient discomfort and the
possibility of resultant vasovagal reaction.
3.
Place fluoroscopy beam as close to anterior/posterior (A/P) projection as possible. If patient has a midpositional uterus, downward
traction with tenaculum may be required to achieve adequate images. Remove speculum prior to fluoroscopy
scopy for best visualization
of uterine anatomy.
4.
Take a minimum of 6 radiographs to assess insert location and tubal occlusion.
5.
Report must include reference to satisfactory location and occlusion.
L
P
M
A
X
E
The Radiology Report must include:
ude:
1.
Number and location of inserts
serts
2.
Tubal occlusion assessment
sessment for each side
3.
Description
n of unusual findings
LOCATION
‫ ܆‬Satisfactory Location
Distal end of the inner coil is within the fallopian tube, with <50% of the inner coil
trailing into the uterine cavity, OR the proximal marker of the inner
inn coil is ”30 mm
into the tube from where
contrast
ere co
rast fills the uterine cornua
‫܆‬
LEFT
‫܆‬
RIGHT
‫܆‬
Proximal
al location
location: •50%
50% of the inner coil is tr
trailing into the uterine cavity
‫܆‬
‫܆‬
Expulsion:
n: One or both inserts are
a not present in the radiographic image
‫܆‬
‫܆‬
Distal location:
tion: Insert is in the fa
fallopian tube, but the proximal end of the inner coil is
more than 30
0 mm from the contrast filling the uterine cornua
‫܆‬
‫܆‬
Perforation or perito
peritoneal location of the insert: Insert has punctured the uterine
cavity and may be in the peritoneal cavity
‫܆‬
‫܆‬
‫܆‬
‫܆‬
‫܆‬
‫܆‬
ory Location
Unsatisfactory
OCCLUSION
‫ ܆‬Satisfactory Occlusion
Tube is occluded at the cornua OR contrast is visible within the tube
but not past any portion of distal end of the outer coil of the insert
‫܆‬
Unsatisfactory Occlusion
Contrast is visible past the insert OR in the peritoneal cavity
Assessing patient ability to rely on Essure:
x
Patient can rely on Essure for permanent birth control (satisfactory bilateral insert location and bilateral tubal occlusion)
x
Patient cannot rely on Essure (unsatisfactory bilateral insert location with or without tubal patency)
x
Patient should return for a repeat Essure Confirmation Test in 3 months (satisfactory bilateral insert location with tubal patency)
PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION ABOUT ESSURE ON NEXT PAGE.
POST-PROCEDURE
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Essure® Confirmation Test Reminder
Letter (Example)
To access and customize this form, please go to EssureMDResources.com.
This form is an example. You should review and modify this form as you deem appropriate based on your professional judgment.
ESSURE® CONFIRMATION TEST REMINDER LETTER (EXAMPLE)
Date:
Patient Name:
Address:
Dear
As a follow-up to your recent Essure procedure, I am writing to remind you to schedule an Essure Confirmation Test appointment with
our office as soon as possible.
This simple test verifies that the Essure inserts are in the correct location and that your fallopian tubes are blocked so you can rely on
Essure as your permanent birth control. Besides being an integral part of the Essure procedure, the Essure Confirmation Test provides
you with confirmation that the procedure was successful and can be relied upon for permanent birth control. You can visit the
Essure.com website to learn more about the Essure Confirmation Test.
As a reminder, until the Essure Confirmation Test verifies that the inserts are in the correct location
your fallopian
on and that yo
tubes are blocked, you must use alternative contraception and cannot rely on Essure.
E
L
Please call our office today to schedule your Essure Confirmation Test appointment. We will be happy to answer any questio
questions you
may have.
Sincerely,
Physician Name:
P
M
A
X
E
Indication
Essure is a permanent birth control procedure that works with your body to create a natur
natural barrier against pregnancy.
Important Safety Information
WARNING: You must continue to use another
control until you have your Essure Confirmation Test and your
er form of birth cont
doctor tells you that you can rely on Essure for birth control.
x
You can rely on Essure for birth control only after your doctor has re
reviewed your Essure Confirmation Test results. Your doctor will
re properly placed and both of your fal
confirm that the inserts are
fallopian tubes are blocked. If you rely on Essure for birth control before
e Confirmation Test, you are at ri
having your Essure
risk of getting pregnant.
x
Talk to yourr doctor about which method of birth control
con
you should use for the 3 months after the procedure. Some women can remain
rent birth control. Other women, su
on their current
such as those using an intrauterine device or contraceptive (IUD or IUC), will need to
switch to another
other method.
x
It can take longer
er than three mont
months for the Essure procedure to be effective. In rare cases, it has taken up to 6 months. Make sure to
n alternate fo
continue using an
form of birth control up until your doctor has reviewed your Essure Confirmation Test results and
confirmed that you
rely on Essure for birth control.
u can re
WARNING: Be sure you are done having children before you undergo the Essure procedure. Essure is a permanent method of
birth control. The younger a woman is when she chooses to end her fertility, the more likely she is to regret her choice later.
PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION ABOUT ESSURE ON NEXT PAGE.
POST-PROCEDURE
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Essure Confirmation Test Missed
Appointment Letter (Example)
To access and customize this form, please go to EssureMDResources.com.
This form is an example. You should review and modify this form as you deem appropriate based on your professional judgment.
ESSURE® CONFIRMATION TEST MISSED APPOINTMENT LETTER (EXAMPLE)
Date:
Patient Name:
Address:
Dear
I am writing to let you know that you missed your appointment for the Essure Confirmation Test following your Essure procedure.
This simple test verifies that the Essure inserts are in the correct location and that your fallopian tubes are blocked so you can rely on
Essure as your permanent birth control. Besides being an integral part of the Essure procedure, the Essure Confirmation Test provides
you with confirmation that the procedure was successful and can be relied upon for permanent birth control. You can visit the
Essure.com website to learn more about the Essure Confirmation Test.
As a reminder, until the Essure Confirmation Test verifies that the inserts are in the correct location and that your
fallopian
y
tubes are blocked, you must use alternative contraception and cannot rely on Essure.
Please call our office today to reschedule your Essure Confirmation Test appointment. We will be happy to
questions you
o answer any q
may have.
Sincerely,
Physician Name:
Indication
Essure is a permanent birth control procedure that works with your body to create a natural
natu barrier against pregnancy.
Important Safety Information
WARNING: You must continue to use another
controll until you
ther form of birth co
yo have your Essure Confirmation Test and your
doctor tells you that you can rely
y on Essure for birth control.
x
You can rely on Essure for birth control only after your doctor has
as rreviewed your Essure Confirmation Test results. Your doctor will
ts are properly placed and both of your fa
confirm that the inserts
fallopian tubes are blocked. If you rely on Essure for birth control before
having your Essure
ure Confirmation Test, you are at risk of getting pregnant.
x
Talk to your
our doctor about which method of birth
b rth control
c
you should use for the 3 months after the procedure. Some women can remain
on their current birth control. Other women, ssuch as those using an intrauterine device or contraceptive (IUD or IUC), will need to
switch to another metho
method.
x
It can take longer
onger than three mon
months for the Essure procedure to be effective. In rare cases, it has taken up to 6 months. Make sure to
continue using
ng an alternate form of birth control up until your doctor has reviewed your Essure Confirmation Test results and
confirmed that you can rely on Essure for birth control.
WARNING: Be sure you are done having children before you undergo the Essure procedure. Essure is a permanent method of
birth control. The younger a woman is when she chooses to end her fertility, the more likely she is to regret her choice later.
PLEASE SEE ADDITIONAL IMPORTANT SAFETY INFORMATION ABOUT ESSURE ON NEXT PAGE.
POST-PROCEDURE
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Notes
31
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GETTING STARTED
GETTING STARTED
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PRE-PROCEDURE
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PROCEDURE
PROCEDURE
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POST-PROCEDURE
POST-PROCEDURE
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THE ESSURE® OFFICE GUIDE
THE ESSURE®
OFFICE GUIDE
A resource for providing Essure in the office setting
To access and customize the most up-to-date forms, please go to EssureMDResources.com.
References: 1. Cooper JM, Carignan CS, Cher D, Kerin JF; Selective Tubal Occlusion Procedure 2000
Investigators Group. Microinsert nonincisional hysteroscopic sterilization. Obstet Gynecol. 2003;102(1):59-67.
2. Arjona JE, Miño M, Cordón J, Povedano B, Pelegrin B, Castelo-Branco C. Satisfaction and tolerance with
office hysteroscopic tubal sterilization. Fertil Steril. 2008;90(4):1182-1186. 3. Chudnoff S, Einstein M, Levie M.
Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial. Obstet Gynecol.
2010;115(1):26-34. 4. Isley MM, Jensen JT, Nichols MD, Lehman A, Bednarek P, Edelman A. Intrauterine
lidocaine infusion for pain management during outpatient transcervical tubal sterilization: a randomized
controlled trial. Contraception. 2012;85(3):275-281. 5. Miño M, Arjona JE, Cordón J, Pelegrin B, Povedano B,
Chacon E. Success rate and patient satisfaction with the Essure sterilisation in an outpatient setting:
a prospective study of 857 women. BJOG. 2007;114(6):763-766. 6. The American College of Obstetricians
and Gynecologists. Frequently asked questions: FAQ 143, special procedures. https://www.acog.org/~/
media/For%20Patients/faq143.pdf. Accessed December 9, 2013. 7. Guiahi M, Goldman KN, McElhinney MM,
Olson CG. Improving hysterosalpingogram confirmatory test follow-up after Essure hysteroscopic
sterilization. Contraception. 2010;81(6):520-524.
BAYER, the Bayer Cross, and Essure are registered trademarks of Bayer.
© 2013 Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981
All rights reserved. 250-87-0003-13a Printed in USA December 2013
Indication
Essure is indicated for women who desire permanent birth
control (female sterilization) by bilateral occlusion of the
fallopian tubes.
Important Safety Information
Prescription Only
Caution: Federal law restricts this device to sale by or on the
order of a physician. Device to be used only by physicians
who are knowledgeable hysteroscopists; have read and
understood the Instructions for Use and Physician Training
manual; and have successfully completed the Essure
training program, including preceptoring in placement until
competency is established, typically 5 cases.
Who should not use Essure
• Essure is contraindicated in patients who are uncertain
about ending fertility, can have only one insert placed
(including contralateral proximal tubal occlusion
or suspected unicornuate uterus), have previously
undergone a tubal ligation, are pregnant or suspect
pregnancy, delivered or terminated a pregnancy less than
6 weeks prior to the Essure procedure, have an active or
recent upper or lower pelvic infection, or have a known
allergy to contrast media.
• Patients undergoing immunosuppressive therapy
(e.g. systemic corticosteroids or chemotherapy) are
discouraged from undergoing the Essure procedure.
• Uterine or fallopian tube anomalies may make it difficult
to place Essure inserts.
PLEASE SEE ADDITIONAL IMPORTANT SAFETY
INFORMATION ON PAGE 3.
IMPORTANT: Bayer is providing the information in this guide to you for
informational and educational purposes only. This document is not intended
as training materials, an all-inclusive list, nor to establish a standard of care.
You are solely responsible for ensuring that you and your staff have been
properly trained in all aspects of providing the Essure procedure to your
patients in the office setting. For complete instructions, please refer to the
Instructions for Use and Physician Training Manual.
If you have any questions, please do not hesitate to contact your Clinical Sales Specialist using
the business card provided.
To make this process as streamlined as possible, we have created a website where you can
access examples of Essure forms and customize them based on your professional judgment:
EssureMDResources.com.
• Example forms and letters
• Reimbursement codes
• Account setup and ordering
The Essure Office Guide offers information and resources to help you achieve a successful
practice implementation, including:
You have joined a growing number of practices that have chosen to provide their patients
with the Essure in-office procedure for permanent birth control.
Welcome to the Essure Office Guide!
Dear Doctor and Staff:
Introducing the Essure®
Office Guide
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