Hysteroscopic Sterilization in the Hysteroscopic Sterilization in the

OfficeOfficeAmy Garcia, MDAmy Garcia, MD

Director, Center for Women’s SurgeryDirector, Center for Women’s Surgery

Assistant Professor, University of New MexicoAssistant Professor, University of New MexicoDepartment of Obstetrics and GynecologyDepartment of Obstetrics and Gynecology

Division of UrogynecologyDivision of Urogynecology

Albuquerque, New MexicoAlbuquerque, New Mexico

DisclosureDisclosure

Conceptus, IncConceptus, Inc ConsultantConsultant SpeakerSpeaker

Minerva SurgicalMinerva Surgical ConsultantConsultant

Ethicon Women’s Health and UrologyEthicon Women’s Health and Urology ConsultantConsultant

Ethicon EndoSurgeryEthicon EndoSurgery Speaker Speaker

Why Hysteroscopic Sterilization Why Hysteroscopic Sterilization in the Office?in the Office?

Patient ComfortPatient Comfort Patient Financial Burden LessenedPatient Financial Burden Lessened

Office co-pay vs. outpatient co-payOffice co-pay vs. outpatient co-pay Co-insurance, self-payCo-insurance, self-pay

Health System Financial Burden LessenedHealth System Financial Burden Lessened Improved reimbursement for physiciansImproved reimbursement for physicians

Reduced RiskReduced Risk No general anesthesiaNo general anesthesia No incisionsNo incisions

Patient ConveniencePatient Convenience Physician ConveniencePhysician Convenience

What Women Want forWhat Women Want forPermanent Birth ControlPermanent Birth Control

Safest Available Procedure Safest Available Procedure

ReliableReliable

Quick RecoveryQuick Recovery

In-Office AvailabilityIn-Office Availability

Office Co-payOffice Co-pay

Women Whose Families Are Women Whose Families Are CompleteComplete

Family Planning PerspectivesFamily Planning PerspectivesVolume 30, Number 1, January/February 1998 Volume 30, Number 1, January/February 1998 Unintended Pregnancy in the United StatesUnintended Pregnancy in the United States

Hysteroscopic Sterilization Hysteroscopic Sterilization HistoryHistory

Female Sterilization Female Sterilization TrendTrend

JMIG 2009;16:22-7

In-Office Hysteroscopic vs. In-Office Hysteroscopic vs. LS TLLS TL

JMIG 2005;12:318-22JMIG 2005;12:318-22

Essure in the Office with Local Essure in the Office with Local AnesthesiaAnesthesia

• Ketorolac Ketorolac

• 60 mg IM60 mg IM

• 30 min. pre30 min. pre

• ParacervicalParacervical

• 10 mL10 mL

• 2% Lidocaine2% Lidocaine

10 Minutes

Essure SystemEssure SystemFDA Approved 2002FDA Approved 2002

Fully deployed micro-insert

DryFlow® Introducer

ergonomic handle

delivery catheter micro-insert

Micro-insert DesignMicro-insert Design

PET FiberPET Fiber

Dynamic Dynamic Expanding Expanding Superlastic Nitinol Superlastic Nitinol Outer CoilOuter Coil

Device Length: 3.85 cmDevice Length: 3.85 cmWound Down Outer Diameter: 0.8 mmWound Down Outer Diameter: 0.8 mmExpanded Outer Diameter: 1.5 – 2.0 mmExpanded Outer Diameter: 1.5 – 2.0 mm

Stainless Steel Stainless Steel InnercoilInnercoil

Essure PlacementEssure Placement

Gold Gold BandBand

1. Ostia visualized 2. Delivery Catheter Positioned

3. Release Catheterwith Gold Band

4. Micro-insert Positioned

MAUDEMAUDE Reports from 2001 through July Reports from 2001 through July

20102010 436,927 kits436,927 kits 63 reports63 reports

Phase ll and Pivotal Trials Phase ll and Pivotal Trials

JMIG 2011 18, 475-482JMIG 2011 18, 475-482

Essure Nickel SensitivityEssure Nickel SensitivityChange in FDA Contraindication July Change in FDA Contraindication July

20112011

497,306 kits and 92 reports497,306 kits and 92 reports Removal of contraindication for known Removal of contraindication for known

hypersensitivity to nickel confirmed by hypersensitivity to nickel confirmed by skin testskin test

Removal of warning for suspected hyper-Removal of warning for suspected hyper-sensitivity to pursue confirmatory skin sensitivity to pursue confirmatory skin testtest

New warning for suspected hyper-New warning for suspected hyper-sensitivitysensitivity

Essure Nickel SensitivityEssure Nickel SensitivityNew FDA Warning July 2011New FDA Warning July 2011

“ “The Essure micro-insert includes nickel-The Essure micro-insert includes nickel-titanium alloy, which is generally titanium alloy, which is generally considered safe. However, in vitro testing considered safe. However, in vitro testing has demonstrated that nickel is released has demonstrated that nickel is released from this device. Patients who are allergic from this device. Patients who are allergic to nickel may have an allergic reaction to to nickel may have an allergic reaction to this device, especially those with a history this device, especially those with a history of metal allergies. In addition, some of metal allergies. In addition, some patients may develop an allergy to nickel patients may develop an allergy to nickel if this device is implanted. Typical allergy if this device is implanted. Typical allergy symptoms reported for this device include symptoms reported for this device include rash, pruritus, and hives.”rash, pruritus, and hives.”

Adiana SystemAdiana SystemFDA Approved FDA Approved

20092009

Radio Frequency Radio Frequency GeneratorGenerator Monopolar electrosurgery – Monopolar electrosurgery – Position Position

Detection ArrayDetection Array Requires non-electrolyte fluid mediumRequires non-electrolyte fluid medium Consideration for hyponatremiaConsideration for hyponatremia

Step-by-step guidanceStep-by-step guidance Time and temperature of energy Time and temperature of energy

controlledcontrolled No reported injuries due to RF in clinical No reported injuries due to RF in clinical

trialtrial

Adiana Delivery CatheterAdiana Delivery Catheter

No Perforations in Clinical TrialNo Perforations in Clinical Trial

Diameter 1.34 mmDiameter 1.34 mm

Inserted 1.4 cm into TubeInserted 1.4 cm into Tube

Matrix at Distal TipMatrix at Distal Tip Position Detection Array (PDA)Position Detection Array (PDA)

Confirms position of catheterConfirms position of catheter Aids matrix placement ~ 1 cmAids matrix placement ~ 1 cm

RF Electrode -- BipolarRF Electrode -- Bipolar Delivers energy 60 secondsDelivers energy 60 seconds 5 mm in length5 mm in length

1 1 Cytyc Surgical Products Panel Adiana Briefing Information for December 14, 2007 , FDA Panel Page 88-89Cytyc Surgical Products Panel Adiana Briefing Information for December 14, 2007 , FDA Panel Page 88-8922 Cytyc Surgical Products Panel Adiana Briefing Information for December 14, 2007 FDA Executive Summary, Page 5 Cytyc Surgical Products Panel Adiana Briefing Information for December 14, 2007 FDA Executive Summary, Page 5

Matrix

PDA

RF Electrode

Adiana Biocompatible Adiana Biocompatible ImplantImplant

Inert Silicone MatrixInert Silicone Matrix

Epithelial In-growthEpithelial In-growth

Technology Comparison Technology Comparison OverviewOverview

1 Essure Instructions for Use2 Vancaille et al, A 12-Month Prospective Evaluation of Transcervical Sterilization Using Implantable Polymer Matrices, Obstetrics & Gynecology . 112(6):1270-1277, December 20083 Cytyc Surgical Products Panel Adiana Briefing Information for December 14, 2007 FDA Panel, Page 905

Reported Pregnancies in Clinical TrialsReported Pregnancies in Clinical TrialsAmong Subjects Who Completed EvaluationAmong Subjects Who Completed Evaluation

Year Year OneOne

Year Year TwoTwo

Year Year Three Three

Year Year Four Four

Year Year FiveFive

Year Year 6 - 96 - 9

Total Total PregnanciesPregnancies

Essure1 (N=745)

02 0 0 0 0 00

trial complete

1 Phase II Trial Final Report, Page 33 and Pivotal Trial Final Report, Page 752 4 patients were pregnant at the time of Essure placement (luteal phase). Ref: Final Pivotal Study Report, page 543 Cytyc Surgical Products Panel Adiana Briefing Information for December 14, 2007 FDA Panel, Page 5964Adiana Instructions for Use, AW-03216-001 Rev 35 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.

Year Year OneOne

Year Year TwoTwo

Year Year Three Three

Year Year Four Four

Year Year FiveFive

Year Year 6 - 96 - 9

Pregnancies Pregnancies to date to date

Adiana3,4

(N=645)65

1 ectopic 3

1 ectopic0 2* 1* ?? 12

Adiana Black Box Adiana Black Box WarningWarning

5 Additional Pregnancies in Clinical Trial5 Additional Pregnancies in Clinical Trial Women told NOT to rely on the device for Women told NOT to rely on the device for

contraceptioncontraception NOT included in the 12 pregnancies reportedNOT included in the 12 pregnancies reported

Adiana Instructions for Use, AW-03216-001 Rev 3Adiana Instructions for Use, AW-03216-001 Rev 3

Essure Confirmation Essure Confirmation Test HSG 3 MonthsTest HSG 3 Months

Bilateral Placement

Bilateral Occlusion

Adiana Confirmation TestAdiana Confirmation TestHSG 3 MonthsHSG 3 Months

Bilateral Occlusion

HSG Patency Rate (%)HSG Patency Rate (%)

11 Essure Instructions for Use Essure Instructions for Use22 Adiana data from Panel Briefing Information for December 14, 2007 FDA Panel, Clinical Report page 586 Adiana data from Panel Briefing Information for December 14, 2007 FDA Panel, Clinical Report page 586

Tubal Occlusion Confirmation Tubal Occlusion Confirmation TestTest

Hysterosalpingogram (HSG)Hysterosalpingogram (HSG) Positive and valuable part of the Positive and valuable part of the

Essure/Adiana Essure/Adiana Bilateral placement and occlusion for Bilateral placement and occlusion for

EssureEssure Bilateral occlusion for AdianaBilateral occlusion for Adiana Provides patient piece of mindProvides patient piece of mind Provides physician piece of mindProvides physician piece of mind Covered by insuranceCovered by insurance

Two Year Failure RatesTwo Year Failure RatesPregnancies/1000 women Pregnancies/1000 women

1 1 Essure Effectiveness Report (data December 16, 2004), page 14 Essure Effectiveness Report (data December 16, 2004), page 14 22 Peterson, H.B., et al, The risk of pregnancy after tubal sterilization: findings from the U.S. Peterson, H.B., et al, The risk of pregnancy after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization. Collaborative Review of Sterilization. Am J Obstet Gynecol. 1996 Apr;174(4):1161-8Am J Obstet Gynecol. 1996 Apr;174(4):1161-8

33 Cytyc Surgical Products Panel Adiana Briefing Information for December 14, 2007 FDA Panel Cytyc Surgical Products Panel Adiana Briefing Information for December 14, 2007 FDA Panel Executive Summary, Pages 32, 34Executive Summary, Pages 32, 34

1 2 2 2 3

(.07%)

(1.82%)

Essure Typical UseEssure Typical Use

No ECTNo ECT44%44%

No Info.No Info.PendingPending

26%26%

Prior to Prior to ECTECT 8%8%

Luteal Phase Luteal Phase 7%7%

PhysicianPhysicianOff Label 7%Off Label 7%

As reported to the FDA in the 2008 PMA annual report (1998 As reported to the FDA in the 2008 PMA annual report (1998 through Dec 2008) there have been 305 reported pregnancies through Dec 2008) there have been 305 reported pregnancies out of 259,746 procedures. out of 259,746 procedures.

Pregnancy Rate Pregnancy Rate = .12%= .12%

Pregnancy Rate Pregnancy Rate = .12%= .12%

Non-Non-ComplianceCompliance

44%44%74% 74% Education & Education & Follow-up Follow-up

Successful Hysteroscopic Successful Hysteroscopic SterilizationSterilization

Continuous Distention of the Uterine Continuous Distention of the Uterine CavityCavity

Clear Visualization Clear Visualization Uterine cavity Uterine cavity Tubal ostiaTubal ostia

Confident HysteroscopistConfident Hysteroscopist SSupportive Staffupportive Staff

It begins with hysteroscopy It begins with hysteroscopy basics!basics!

It begins with hysteroscopy It begins with hysteroscopy basics!basics!

Optimize VisualizationOptimize Visualization

Cycle TimingCycle Timing Early proliferatve phaseEarly proliferatve phase Cycle day 4 – 10Cycle day 4 – 10 Decreased risk of luteal Decreased risk of luteal

pregnancypregnancy Reduced endometrial tissueReduced endometrial tissue Enhanced visualization of ostiaEnhanced visualization of ostia

Hormonal EffectHormonal Effect OCP’s, Depo Provera, MirenaOCP’s, Depo Provera, Mirena

Distention MediumDistention Medium

SalineSaline Pressure bagPressure bag 3 liters (1 liter)3 liters (1 liter) WarmWarm Cystoscopy tubingCystoscopy tubing Back-up availableBack-up available

InstrumentsInstruments

InstrumentsInstruments

Pre-Procedure Pre-Procedure MedicationMedication

Misoprostil Misoprostil 200 microgram per vagina 10-12 hrs. 200 microgram per vagina 10-12 hrs.

priorprior If cervical softening is neededIf cervical softening is needed

NSAIDSNSAIDS Ibuprofen 800 mg PO hs and am priorIbuprofen 800 mg PO hs and am prior Ketoralac 30 mg IM 15 – 30 min. priorKetoralac 30 mg IM 15 – 30 min. prior

AnxiolyticAnxiolytic Diazepam 10 mg PO 1 hour priorDiazepam 10 mg PO 1 hour prior

NarcoticNarcotic Hydrocodone 5/500 mg 1 hour priorHydrocodone 5/500 mg 1 hour prior

Pre-Procedure Local Pre-Procedure Local AnesthesiaAnesthesia

Tenaculum SiteTenaculum Site 1% lidocaine (w or w/o epi)1% lidocaine (w or w/o epi) 2 cc at 12 o’clock2 cc at 12 o’clock

Paracervical BlockParacervical Block 1% lidocaine (w or w/o epi)1% lidocaine (w or w/o epi) 4 and 8 o’clock4 and 8 o’clock

IntrauterineIntrauterine 1% lidocaine1% lidocaine Placed with insemination Placed with insemination

cathetercatheter Approximately 10 ccApproximately 10 cc

RCT 1% Lidocaine vs Saline for PCBRCT 1% Lidocaine vs Saline for PCB

Significant Lower Pain ScoresSignificant Lower Pain Scores Tenaculum placementTenaculum placement Traversing external cervical osTraversing external cervical os Traversing internal cervical osTraversing internal cervical os

No Difference for Device PlacementNo Difference for Device Placement

Obstetrics & Gynecology Vol. 115, NO.1, January 2010Obstetrics & Gynecology Vol. 115, NO.1, January 2010

Vaginoscopic Vaginoscopic HysteroscopyHysteroscopy

ProcedureProcedure

Consideration for misoprostilConsideration for misoprostil

No Speculum NeededNo Speculum Needed

Betadine VaginaBetadine Vagina

No AnesthesiaNo Anesthesia

Fill Posterior Fornix with SalineFill Posterior Fornix with Saline

Consider the patient!!Consider the patient!!

Post-Procedure Post-Procedure MedicationMedication

NSAID’sNSAID’s Ibuprofen prnIbuprofen prn

NarcoticNarcotic Extra given if cervix is dilatedExtra given if cervix is dilated

ProcedureProcedure Moderate Lithotomy Moderate Lithotomy

Boot stirrupsBoot stirrups Bimanual ExamBimanual Exam Open-Sided SpeculumOpen-Sided Speculum

PedersonPederson Clean CervixClean Cervix

Bedadine swabsBedadine swabs Single Toothed TenaculumSingle Toothed Tenaculum

Vaginoscopy is possibleVaginoscopy is possible Placement of Local AnesthesiaPlacement of Local Anesthesia Assure Cervical DiameterAssure Cervical Diameter

Cervical dilation to 5 mm (6 mm for Cervical dilation to 5 mm (6 mm for nulliparous)nulliparous)

Parous cervix seldom needs dilationParous cervix seldom needs dilation

ProcedureProcedure

Place HysteroscopePlace Hysteroscope Remove SpeculumRemove Speculum Access CavityAccess Cavity Remove TenaculumRemove Tenaculum Assess OstiaAssess Ostia

Prior to opening device packagePrior to opening device package Place DevicesPlace Devices

Photo documentPhoto document Check CervixCheck Cervix Assess Patient ComfortAssess Patient Comfort

Additional TipsAdditional Tips

Minimize MovementMinimize Movement

Do Not SoundDo Not Sound

Do Not Over Dilate CervixDo Not Over Dilate Cervix

Vocal AnesthesiaVocal Anesthesia

AtmosphereAtmosphere MusicMusic Soft LightingSoft Lighting Warm BlanketWarm Blanket

Position Monitor for Patient ViewingPosition Monitor for Patient Viewing

Provide Photo for PatientProvide Photo for Patient

Post-Post-Procedure Procedure

DocumentatioDocumentationn Number of Visible CoilsNumber of Visible Coils

Scope/Procedure TimeScope/Procedure Time

Fluid DeficitFluid Deficit

Unusual Anatomy Unusual Anatomy

Difficult PlacementDifficult Placement

Patient ComfortPatient Comfort

Patient CounselingPatient Counseling

Avoid PregnanciesAvoid Pregnancies

ContraceptionContraception Before and after procedureBefore and after procedure

Avoid Luteal PhaseAvoid Luteal Phase Cycle timingCycle timing

Pre-procedure Urine hCGPre-procedure Urine hCG 3 Month HSG3 Month HSG

Bilateral placement/occlusion EssureBilateral placement/occlusion Essure Bilateral occlusion AdianaBilateral occlusion Adiana

Follow-up Protocol 08/2011Follow-up Protocol 08/2011 330 procedures330 procedures 1 had a hysterectomy1 had a hysterectomy 8 never able to contact8 never able to contact 12 have received 212 have received 2ndnd letter letter 9 have received 19 have received 1stst letter letter

90% Completed HSG90% Completed HSG90% Completed HSG90% Completed HSG

Hysteroscopic Sterilization Hysteroscopic Sterilization

CodingCoding ICD-9 ICD-9

V25.2V25.2 Interruption of fallopian tubes or vas Interruption of fallopian tubes or vas

deferensdeferens

CPTCPT 5856558565 Bilateral fallopian tube cannulation to Bilateral fallopian tube cannulation to

induce occlusion by placement of induce occlusion by placement of permanent implantspermanent implants

ReimbursementReimbursement90 Day 90 Day GlobalGlobal

90 Day 90 Day GlobalGlobal2011201120112011

Essure $1,250.00Essure $1,250.00Adiana $ 800.00Adiana $ 800.00

Essure $1,250.00Essure $1,250.00Adiana $ 800.00Adiana $ 800.00

HSG CodingHSG Coding

ICD-9ICD-9 V26.51 Tubal ligation statusV26.51 Tubal ligation status V67.09 Follow-up exam following other V67.09 Follow-up exam following other

surgerysurgery

CPTCPT 58340 58340

Catheterization and introduction of saline or contrast Catheterization and introduction of saline or contrast media for sonohysterography or hysterosalpingogrammedia for sonohysterography or hysterosalpingogram

74740 74740 Hysterosalpingogram radiologic supervision interpretationHysterosalpingogram radiologic supervision interpretation

74740-26 74740-26 Professional component onlyProfessional component only

Training Office Training Office Personnel Personnel

Train with EquipmentTrain with Equipment Reprocessing and handling of Reprocessing and handling of

hysteroscope hysteroscope Set-up of equipmentSet-up of equipment

Know How to Trouble-shootKnow How to Trouble-shoot Be Comfortable with ProcedureBe Comfortable with Procedure

Arrange for Staff ObservationArrange for Staff Observation Patient counselingPatient counseling Actual procedureActual procedure

Have a Written ProtocolHave a Written Protocol