hysteroscopic sterilization in the office amy garcia, md director, center for women’s surgery...
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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