1. Hysteroscopic Sterilization in the Office
Amy Garcia, MD
Director, Center for Women’s Surgery
Assistant Professor, University of New Mexico
Department of Obstetrics and Gynecology
Division of Urogynecology
Albuquerque, New Mexico

2. Disclosure Conceptus, Inc Minerva Surgical
Consultant
Speaker
Minerva Surgical
Ethicon Women’s Health and Urology
Ethicon EndoSurgery

3. Why Hysteroscopic Sterilization in the Office?
Patient Comfort
Patient Financial Burden Lessened
Office co-pay vs. outpatient co-pay
Co-insurance, self-pay
Health System Financial Burden Lessened
Improved reimbursement for physicians
Reduced Risk
No general anesthesia
No incisions
Patient Convenience
Physician Convenience

4. What Women Want for Permanent Birth Control
Safest Available Procedure
Reliable
Quick Recovery
In-Office Availability
Office Co-pay

5. Women Whose Families Are Complete
Women >35 is the largest group of unintended pregnancy
Family Planning Perspectives Volume 30, Number 1, January/February 1998
Unintended Pregnancy in the United States

6. Hysteroscopic Sterilization History

7. Female Sterilization Trend
JMIG 2009;16:22-7

8. Essure in the Office With Local Anesthesia
JMIG 2006;13:447-50

9. In-Office Hysteroscopic vs. LS TL
JMIG 2005;12:318-22

10. Essure in the Office with Local Anesthesia
Ketorolac
60 mg IM
30 min. pre
Paracervical
10 mL
2% Lidocaine
10 Minutes

11. Essure System FDA Approved 2002
Fully deployed micro-insert
delivery catheter
micro-insert
DryFlow® Introducer
Nursing Presentation
The Essure Permanent Birth Control System is comprised of the Essure micro-insert, a disposable delivery system and a disposable split introducer (not shown here).
-The disposable delivery system (shown in this picture) consists of a delivery wire, a release catheter, a delivery catheter and an ergonomic handle. The delivery wire and release catheter are layered beneath the delivery catheter.
-The ergonomically designed handle makes use of a rotatable wheel and gear system which provides for retraction of the outer delivery catheter followed by withdrawal of the inner release catheter causing the micro-insert to be fully deployed.
-The outer delivery catheter is 1mm in diameter allowing it to be placed through a 5fr operating channel of any commercially available hysteroscope.
ergonomic handle 11

12. Stainless Steel Innercoil
Micro-insert Design
PET Fiber
Dynamic Expanding Superlastic Nitinol Outer Coil
Device Length: cm
Wound Down Outer Diameter: 0.8 mm
Expanded Outer Diameter: 1.5 – 2.0 mm
Stainless Steel Innercoil

13. Essure Placement Gold Band 1. Ostia visualized
2. Delivery Catheter Positioned
3. Release Catheter with Gold Band
4. Micro-insert Positioned
Takeaway: Key steps in device placement as viewed through the hysteroscope.
Image 1
Uterus distended with physiologic saline
Tubal ostium in center of visual field
Identify and assess both ostiahysteroscopically before proceeding to micro-insert placement
Image 2
Delivery catheter advanced until black positioning marker is at tubal ostium
Delivery catheter withdrawn away from micro-insert into operating channel of hysteroscope
Image 3
Gold band is aligned outside the tubal ostium,
Green release catheter withdrawn to expand the micro-insert
Image 4
Micro-insert properly positioned and deployed across utero-tubal junction
References: N/A
Rev history:
Gold Band 13

14. Reports from 2001 through July 2010
JMIG ,
MAUDE
Reports from 2001 through July 2010
436,927 kits
63 reports
Phase ll and Pivotal Trials
Manufacturer and User Facility Device Experience

15. Essure Nickel Sensitivity Change in FDA Contraindication July 2011
497,306 kits and 92 reports
Removal of contraindication for known hypersensitivity to nickel confirmed by skin test
Removal of warning for suspected hyper- sensitivity to pursue confirmatory skin test
New warning for suspected hyper-sensitivity
The removal of a contraindication for patients with known hypersensitivity to nickel as confirmed by skin test
The removal of a warning for patients with a suspected hypersensitivity to nickel to pursue a confirmatory skin test
The addition of a warning for patients with suspected hypersensitivity to nickel
Given the clinical relevance of data gathered from the Essure clinical trials and a decade of commercial use, the following label modifications were approved by the US Food and Drug Administration on July 1, 2011.
Removed Contraindications statement:
“Known hypersensitivity to nickel confirmed by skin test (see Warnings section below for patients with hypersensitivity to nickel.)”
Removed Warnings statement:
“Patients with suspected hypersensitivity to nickel should undergo a skin test to assess hypersensitivity prior to an Essure placement procedure (see Contraindications section above for patients with known hypersensitivity to nickel).”
New Warnings statement:
“The Essure micro-insert includes nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device. 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.”
The new labeling was supported by the following information:
Nickel sensitivity was not an exclusion criterion in the Essure clinical trials and no short-term adverse events occurred that suggested that the micro-insert was allergenic
A review of nine years of commercial experience/adverse events reported did not demonstrate a causal relationship between nickel sensitivity and wearing the Essure micro-insert
The number of reported adverse events related to possible allergic reaction to the Essure micro-insert is extremely low; less than 1 in 5,000

16. Essure Nickel Sensitivity New FDA Warning July 2011
“The Essure micro-insert includes nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device. 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.”
The removal of a contraindication for patients with known hypersensitivity to nickel as confirmed by skin test
The removal of a warning for patients with a suspected hypersensitivity to nickel to pursue a confirmatory skin test
The addition of a warning for patients with suspected hypersensitivity to nickel
Given the clinical relevance of data gathered from the Essure clinical trials and a decade of commercial use, the following label modifications were approved by the US Food and Drug Administration on July 1, 2011.
Removed Contraindications statement:
“Known hypersensitivity to nickel confirmed by skin test (see Warnings section below for patients with hypersensitivity to nickel.)”
Removed Warnings statement:
“Patients with suspected hypersensitivity to nickel should undergo a skin test to assess hypersensitivity prior to an Essure placement procedure (see Contraindications section above for patients with known hypersensitivity to nickel).”
New Warnings statement:
“The Essure micro-insert includes nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device. 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.”
The new labeling was supported by the following information:
Nickel sensitivity was not an exclusion criterion in the Essure clinical trials and no short-term adverse events occurred that suggested that the micro-insert was allergenic
A review of nine years of commercial experience/adverse events reported did not demonstrate a causal relationship between nickel sensitivity and wearing the Essure micro-insert
The number of reported adverse events related to possible allergic reaction to the Essure micro-insert is extremely low; less than 1 in 5,000

17. Adiana System FDA Approved 2009
Radio Frequency Generator
Monopolar electrosurgery – Position Detection Array
Requires non-electrolyte fluid medium
Consideration for hyponatremia
Step-by-step guidance
Time and temperature of energy controlled
No reported injuries due to RF in clinical trial

18. Adiana Delivery Catheter
No Perforations in Clinical Trial
Diameter 1.34 mm
Inserted 1.4 cm into Tube
Matrix at Distal Tip
Position Detection Array (PDA)
Confirms position of catheter
Aids matrix placement ~ 1 cm
RF Electrode -- Bipolar
Delivers energy 60 seconds
5 mm in length
PDA
Matrix
The adiana sterilization method is a combination of controlled thermal damage to the lining of the fallpian tube followed by insertion of a biocompatible matrix. Under hysteroscopic guidance, the catheter is placed into the fallopian tube. Once in the intramural portion of the tube, position is confirmed with the position detection array. This is designed to monitor uniform contact with the tissue throughout the energy delivery portion of the procedure. The radio frequency electrode array delivers energy to the fallopian tube for approximately 1 minute over a distance of 5 mm. The catheter is withdrawn and the matrix is deployed within the area of thermal injury which is 3.5 mm in length. Thermal injury to the tubal epithelium which aids epithelial ingrowth into the matrix.
RF Electrode
1 Cytyc Surgical Products Panel Adiana Briefing Information for December 14, 2007 , FDA Panel Page 88-89
2 Cytyc Surgical Products Panel Adiana Briefing Information for December 14, 2007 FDA Executive Summary, Page 5

19. Adiana Biocompatible Implant
The matrix is a non-absorbable biocompatible silicone elastomer that facilitates epithelial ingrowth and tubal occlusion.
Inert Silicone Matrix
Epithelial In-growth

20. Technology Comparison Overview
Essure1
Adiana2
Potential Occlusion Length
20 mm
3.5 mm
Distention Media
Saline
Glycine, Sorbitol, Mannitol
Generator Required No
Yes
Pregnancies in Clinical Trial 12
Confirmation Test
HSG tubal occlusion & device placement
HSG tubal occlusion
Visible on X-Ray/HSG
Device within Uterine Cavity
Visual Confirmation of Placement
Product Shelf Life
3 Years
1 Year
Adiana no instruction for device placement confirmaiton
1 Essure Instructions for Use
2 Vancaille et al, A 12-Month Prospective Evaluation of Transcervical Sterilization Using Implantable Polymer Matrices, Obstetrics & Gynecology . 112(6): , December 2008
3 Cytyc Surgical Products Panel Adiana Briefing Information for December 14, 2007 FDA Panel, Page 905

21. Reported Pregnancies in Clinical Trials Among Subjects Who Completed Evaluation
Year
One
Two
Three
Four
Five
6 - 9
Total Pregnancies
Essure1 (N=745) 02
trial complete
Year
One
Two
Three
Four
Five
6 - 9
Pregnancies to date
Adiana3,4
(N=645) 65
1 ectopic 3 2* 1* ?? 12
The five year effectiveness rate for the essure is 99.84% (failure rate of .16%). This makes the Essure the most reliable of the permanent birth control methods available. The 2 year cumulative 2 year failure rate for the adiana is 1.82% (second only to the spring clip in the CREST trial data at 2.38%)
Essure - Number of patients completing follow up visits (page 15 of Phase II and of Pivotal):
1 year    2 year    3 year    4 year    5 year
Phase II    196       194         182         176         60
Pivotal      461       435         423         403         386
1 Phase II Trial Final Report, Page 33 and Pivotal Trial Final Report, Page 75
2 4 patients were pregnant at the time of Essure placement (luteal phase). Ref: Final Pivotal Study Report, page 54
3 Cytyc Surgical Products Panel Adiana Briefing Information for December 14, 2007 FDA Panel, Page 596
4Adiana Instructions for Use, AW Rev 3
5 5 additional Adiana pregnancies in patients who were told not to rely on the device. Cytyc Surgical Products Panel Adiana Briefing Information for December 14, 2007 FDA Panel, FDA Executive Summary, Page 51
*Based on patients that have completed follow up. Not all patients have completed 4 and 5 year follow up. 21

22. Adiana Black Box Warning
The black box warning refers to the five additional pregnancies that occurred in the Adiana pivotal trial in patients who were told NOT to rely on the device. These 5 pregnancies were not included in the 12 pregnancies reported in the trial in patients who were told to rely on the device.
If included, failure rate would be 2.81%
5 Additional Pregnancies in Clinical Trial
Women told NOT to rely on the device for contraception
NOT included in the 12 pregnancies reported
Adiana Instructions for Use, AW Rev 3

23. Essure Confirmation Test HSG 3 Months
Bilateral Placement
Bilateral Occlusion

24. Adiana Confirmation Test HSG 3 Months
Bilateral Occlusion

25. HSG Patency Rate (%) 3 month HSG 6 month Essure1 3.5% 0% Adiana2 8.8%
5.6%
Same as slide 16 but a table versus a graph, pick your preferred format and hide/delete the other.
Essure: n=656
3 mos: 23
6 mos: 0
Final: 0
Adiana: n = 604
3 mos: 53
6 mos: 26 (not all tubes were re-evaluated at 6 months
Final: 34
1 Essure Instructions for Use
2 Adiana data from Panel Briefing Information for December 14, 2007 FDA Panel, Clinical Report page 586

26. Tubal Occlusion Confirmation Test
Hysterosalpingogram (HSG)
Positive and valuable part of the Essure/Adiana
Bilateral placement and occlusion for Essure
Bilateral occlusion for Adiana
Provides patient piece of mind
Provides physician piece of mind
Covered by insurance
Every patient knows of a story in which someone got pregnant after a tubal ligation or vasectomy. The confirmation test is a valuable part of the essure procedure and reassures them that they will not have an unplanned pregnancy.
You can compare this to the three month wait for a vasectomy or the three to six month wait for spotting to subside following the placement of an IUD.

28. Two Year Failure Rates Pregnancies/1000 women
(1.82%)
(.07%) 1 2 2 2 3
1 Essure Effectiveness Report (data December 16, 2004), page 14
2 Peterson, H.B., et al, The risk of pregnancy after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization. Am J Obstet Gynecol Apr;174(4):1161-8
3 Cytyc Surgical Products Panel Adiana Briefing Information for December 14, 2007 FDA Panel Executive Summary, Pages 32, 34

29. Essure Typical Use Pregnancy Rate = .12% Non- Compliance 44% 74%
No ECT
44%
No Info.
Pending
26%
Prior to
ECT 8%
Luteal Phase 7%
Physician
Off Label 7%
Pregnancy Rate = .12%
Non-
Compliance
44%
74%
Education & Follow-up
As reported to the FDA in the 2008 PMA annual report (1998 through Dec 2008) there have been 305 reported pregnancies out of 259,746 procedures.

30. Successful Hysteroscopic Sterilization
Continuous Distention of the Uterine Cavity
Clear Visualization
Uterine cavity
Tubal ostia
Confident Hysteroscopist
Supportive Staff
Under cont distention add 119 content
It begins with hysteroscopy basics!

31. Optimize Visualization
Cycle Timing
Early proliferatve phase
Cycle day 4 – 10
Decreased risk of luteal pregnancy
Reduced endometrial tissue
Enhanced visualization of ostia
Hormonal Effect
OCP’s, Depo Provera, Mirena

32. Distention Medium Saline Pressure bag 3 liters (1 liter) Warm
Cystoscopy tubing
Back-up available

33. Instruments

34. Instruments

35. Pre-Procedure Medication
Misoprostil
200 microgram per vagina hrs. prior
If cervical softening is needed
NSAIDS
Ibuprofen 800 mg PO hs and am prior
Ketoralac 30 mg IM 15 – 30 min. prior
Anxiolytic
Diazepam 10 mg PO 1 hour prior
Narcotic
Hydrocodone 5/500 mg 1 hour prior

36. Pre-Procedure Local Anesthesia
Tenaculum Site
1% lidocaine (w or w/o epi)
2 cc at 12 o’clock
Paracervical Block
4 and 8 o’clock
Intrauterine
1% lidocaine
Placed with insemination catheter
Approximately 10 cc

37. RCT 1% Lidocaine vs Saline for PCB Significant Lower Pain Scores
Obstetrics & Gynecology Vol. 115, NO.1, January 2010
RCT 1% Lidocaine vs Saline for PCB
Significant Lower Pain Scores
Tenaculum placement
Traversing external cervical os
Traversing internal cervical os
No Difference for Device Placement

38. Vaginoscopic Hysteroscopy Procedure
Consideration for misoprostil
No Speculum Needed
Betadine Vagina
No Anesthesia
Fill Posterior Fornix with Saline
Consider the patient!!

39. Post-Procedure Medication
NSAID’s
Ibuprofen prn
Narcotic
Extra given if cervix is dilated

40. Procedure Moderate Lithotomy Bimanual Exam Open-Sided Speculum
Boot stirrups
Bimanual Exam
Open-Sided Speculum
Pederson
Clean Cervix
Bedadine swabs
Single Toothed Tenaculum
Vaginoscopy is possible
Placement of Local Anesthesia
Assure Cervical Diameter
Cervical dilation to 5 mm (6 mm for nulliparous)
Parous cervix seldom needs dilation

41. Procedure Place Hysteroscope Remove Speculum Access Cavity
Remove Tenaculum
Assess Ostia
Prior to opening device package
Place Devices
Photo document
Check Cervix
Assess Patient Comfort

42. Additional Tips Minimize Movement Do Not Sound
Do Not Over Dilate Cervix
Vocal Anesthesia
Atmosphere
Music
Soft Lighting
Warm Blanket
Position Monitor for Patient Viewing
Provide Photo for Patient

43. Post-Procedure Documentation
Number of Visible Coils
Scope/Procedure Time
Fluid Deficit
Unusual Anatomy
Difficult Placement
Patient Comfort
Patient Counseling

44. Avoid Pregnancies Contraception Avoid Luteal Phase
Before and after procedure
Avoid Luteal Phase
Cycle timing
Pre-procedure Urine hCG
3 Month HSG
Bilateral placement/occlusion Essure
Bilateral occlusion Adiana
Follow-up Protocol 08/2011
330 procedures
1 had a hysterectomy
8 never able to contact
12 have received 2nd letter
9 have received 1st letter
90% Completed HSG

45. Hysteroscopic Sterilization Coding
ICD-9
V25.2
Interruption of fallopian tubes or vas deferens
CPT
58565
Bilateral fallopian tube cannulation to induce occlusion by placement of permanent implants

46. Reimbursement 90 Day Global 2011 Essure $1,250.00 Adiana $ 800.00
In-Patient (21), Out-Patient (22), ASC (24)
Hysteroscopic Sterilization
58565
2011 RVU
Medicare
CF 34.01
125% CF
12.9 $ $
Non-Facility/Office (11)
56.66
$ 1,927.00
$ 2,408.76
Essure $1,250.00
Adiana $

47. HSG Coding ICD-9 CPT V26.51 Tubal ligation status
V Follow-up exam following other surgery
CPT
58340
Catheterization and introduction of saline or contrast media for sonohysterography or hysterosalpingogram
74740
Hysterosalpingogram radiologic supervision interpretation
Professional component only

48. Training Office Personnel
Train with Equipment
Reprocessing and handling of hysteroscope
Set-up of equipment
Know How to Trouble-shoot
Be Comfortable with Procedure
Arrange for Staff Observation
Patient counseling
Actual procedure
Have a Written Protocol