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INDEPENDENT REVIEW
OFTRANSVAGINAL
MESH IMPLANTS
Analysis of NHS information on
surgery for stress urinary
incontinence and pelvic organ prolapse
in Scotland
Contents
1 Introduction
1 Treatmentfortheseconditions
1 IndependentReviewofTransvaginalMeshImplants
2 RoutineNHSinformation
2 OperationsprovidedinScotlandforstressurinaryincontinenceandpelvicorganprolapse
2 Operationsprovidedforstressurinaryincontinence
4 Operationsprovidedforpelvicorganprolapse
6 Problemsaftersurgeryforstressurinaryincontinenceorpelvicorganprolapse
7 Problemsfollowingoperationsforstressurinaryincontinence
9 Summaryoffindingsforstressurinaryincontinenceoperations
10 Problemsfollowingoperationsforpelvicorganprolapse
12 Summaryoffindingsforpelvicorganprolapseoperations
12 Whatdoesallthismeanforwomenanddoctors?
13 KeyMessages
13 Authors
13 Acknowledgements
1Independent Review of Transvaginal Mesh Implants
Introduction
StressurinaryincontinenceandpelvicorganprolapsearebothproblemsexperiencedbymanywomeninScotland.Stressurinaryincontinenceistheleakingofurinewhenthebladderisunderpressure,forexamplewhencoughing,sneezing,
orduringexercise.Pelvicorganprolapseiswhenoneormoreofthepelvicorgans(bladder,uterus/womb,orlowerbowel)bulgesintothevagina.Thiscanleadtodiscomfortanddifficultygoingtothetoilet.
Treatment for these conditions
Thereareanumberofdifferentwaysoftreatingstressurinaryincontinenceandpelvicorganprolapse.Theseincludelosingweight,teachingwomenspecificexercisestostrengthenthemusclesinthatarea(‘pelvicfloorexercises’),andsurgery.
Therearedifferenttypesofoperationsfortreatingtheseconditions.Someofthenewertypesofoperationsinvolvetheuseofmeshimplants.Meshimplants(oftencalled‘tapes’whenusedforincontinence)arepiecesofnet-likematerialinsertedintoawoman’sbodytoprovidesupporttonearbyorgans.
Theoperationsusingmeshmayhavesomeadvantagesovernonmeshoperations.Using
mesh/tapesforincontinencecanallowtheunderlyingproblemtobetreatedwithasmalleroperation.Usingmeshforprolapsemaystrengthentheoperationandlowerthechancethattheoriginalproblemwillcomeback.
Theuseofmeshmayalsobringrisks.Forexample,itisknownthatsomewomenwhohavehadmeshsurgerydevelopproblemssuchaspersistentpainormesherosionwherethemeshworksitswaythroughthecoveringskin.
Thisuncertaintymeansthatitcanbedifficultforwomenanddoctorstoknowwhichtypesofoperationforincontinenceorprolapseleadtothebestresults.
Independent Review of Transvaginal Mesh Implants
In2014,theScottishGovernmentsetuptheIndependentReviewofTransvaginalMeshImplants(‘theReview’).TheReviewwasaskedtoexaminethesafetyofmeshsurgeryforstressurinaryincontinenceandpelvicorganprolapse.
TheInformationServicesDivision(ISD),partoftheNHSinScotland,wasaskedtohelpthe
ReviewbyexaminingroutineNHSinformationcollectedonpatientstreatedfortheseconditions.Thisreportgivesasummaryoftheanalysisthatwascarriedoutandwhatwasfound.FullinformationisavailableintheReview’sfinalreport.
2 Independent Review of Transvaginal Mesh Implants
Routine NHS information
WhenpatientsreceivecarefromtheNHSinScotland,asummaryoftheirtreatmentissenttoISD.Forexample,wheneverapatientisdischargedhomefollowingahospitaladmission,aroutinehospitaldischargerecordcontaininginformationonwhythepatientwasadmittedandanyoperationstheyreceivedwhilstinhospitalissenttoISD.ISDhasbeencollectingthistypeofinformationsincethe1960s.
TheroutineinformationcollectedbyISDisusedforavarietyofpurposesincluding:
© helpingtheNHSinScotlandtoplanhealthservicesandcheckthequalityofcarethatisbeingprovided;
© supportingresearchintoimportantquestionsabouthealthandhealthcare.
ISDfollowsverystrictruleswhenworkingwithpatients’healthinformation.Forexample,ISDdoesnotpublishanyinformationaboutanindividual.ISDalsoensuresthattheroutinehealthinformationitholdsisascompleteandaccurateaspossible.
Operations provided in Scotland for stress urinary incontinence and pelvic organ prolapse
Forthisstudy,ISDusedroutinehospitaldischargerecordstoidentifythedifferentoperationsprovidedforstressurinaryincontinenceandpelvicorganprolapseinScotlandbetween1997/98and2013/14.Specifictypesofoperationthatwereprovidedinreasonablyhighnumberswereincludedintheanalysis.
Ingeneral,onlysingleoperationswereincludedintheanalysis.‘Single’meansthatthewomandidnothaveanyadditional/secondoperationforincontinenceorprolapseatthesametimeastheoperationbeingexamined.Itisquitecommonforwomentohavemorethanoneoperationatthesametimehoweverifcomplications
subsequentlydevelopitcanbedifficulttoknowwhichoperationcausedtheproblem.Onlysingleoperationswereincludedsothatthestudycouldfocusontherisksofeachparticularoperationseparately.
Ingeneral,onlyfirstoperationswereincludedintheanalysis.‘First’meansthatthewomanhadnothadanyotheroperationforincontinenceorprolapseinthepreviousfiveyears.Onlyfirstoperationswereincludedbecausetheriskofcomplicationsmaybequitedifferentforawomanhavingarepeatoperation,anditwasimportantthatthestudydidnotmixoperationswithdifferentlevelsofrisk.
Operations provided for stress urinary incontinence
OpencolposuspensionwasthemainoperationprovidedinScotlandforstressurinaryincontinenceinthelate1990s.Tape(mesh)procedureswereintroducedaround2000/01andquicklybecamethemostcommonoperationtypeforthiscondition,howeverthenumberoftape
proceduresdonefellsubstantiallyinthelastyearincludedintheanalysis(2013/14).Urethralinjectiontherapyandsuprapubicslingoperationshavebeenprovidedinlownumbersthroughoutthetimeperiodincludedintheanalysis.
3Independent Review of Transvaginal Mesh Implants
Numbers of first, single operations for stress urinary incontinence by year
Operationsprovidedduringapatient’sadmissiontohospitalarerecordedonroutinehospitaldischargerecordsusingOPCSClassificationofInterventionsandProcedurescodes.Between1997/98and2005/06,thecodesavailabledidnotspecifywhichkindoftapeoperationhadbeenprovided.AfterApril2006,newcodesallowedtheparticulartypeoftapeoperation(retropubicortransobturator)toberecorded.
4 Independent Review of Transvaginal Mesh Implants
Operations provided for pelvic organ prolapse
Anteriorandposteriorcolporrhaphies(first,singleoperations)havebeenprovidedinincreasingnumbersoverthetimeperiodincludedintheanalysis.Anteriorandposteriormeshcolporrhaphiescanbeidentifiedinhospitaldischargerecordsfrom2007/08onwards.RelativelysmallnumbersofmeshcolporrhaphieshavebeenprovidedinScotlandsincethen,andnumbersprovidedhavefalleninthemostrecentyears.
Sacrospinousfixationoperationshaveincreasedsubstantiallyoverrecentyears.Meshopensacrocolpopexieshavebeenprovidedinmoderatenumbersoverthetimeperiodincludedintheanalysis.Meshinfracoccygealcolpopexiescanbeidentifiedinhospitaldischargerecordsfrom2006/07onwards.Relativelysmallnumbershavebeenprovidedsincethen,andnumbersprovidedhavefalleninthemostrecentyears.Moderatenumbersof(first,single)vaginalhysterectomiesforpelvicorganprolapsehavebeenprovidedoverthetimeperiodincludedintheanalysis.
Sacrospinousfixation,sacrocolpopexy,andinfracoccygealcolpopexyareusuallyprovidedforprolapseofthetopofthevaginafollowingahysterectomy.Theseoperationswerethereforeincludedifthewomanhadhadaprevioushysterectomy(butnootheroperationforincontinenceorprolapseinthepreviousfiveyears).Inaddition,theseoperationsarerarelydoneassingleoperationssoISDincludedthemiftheyweredoneatthesametimeasatraditional(nonmesh)colporrhaphy(butnootherincontinenceorprolapseoperation).
Vaginalhysterectomycanbedoneforprolapseorotherproblemssuchasheavyperiods.Onlyvaginalhysterectomiesdoneforprolapsewereincludedintheanalysis.
5Independent Review of Transvaginal Mesh Implants
Numbers of first single operations for pelvic organ prolapse by year
6 Independent Review of Transvaginal Mesh Implants
Problems after surgery for stress urinary incontinence or pelvic organ prolapse
Main problems
ISDlookedatthreemainproblemsthatcandevelopafteranoperationforstressurinaryincontinenceorpelvicorganprolapse.Thesewere:
© immediatecomplications;
© latercomplications;
© furtherincontinenceorprolapsesurgery.
Immediate complications
‘Immediatecomplications’meansthatatleastonecomplicationwasrecordedonthesamehospitaldischargerecordastheoperationbeing
examined;inotherwordsthewomandevelopedacomplicationwhenshewasstillinhospitalfollowingherfirstoperation.
Later complications
‘Latercomplications’meansthatatleastonecomplicationwasrecordedonasubsequenthospitaldischargerecord;inotherwordsthewomanhadbeendischargedhomethenreadmittedforacomplicationatalaterdate.Ingeneral,readmissionsforlatercomplicationswere
countediftheyhappenedwithinfiveyearsoftheoperationbeingexamined.Complicationsthatwouldbeexpectedtodevelopquicklyafteranoperationwereonlycountedifthereadmissionwaswithinthreemonthsoftheoperation.
Further incontinence or prolapse surgery
‘Furtherincontinenceorprolapsesurgery’meansthatatleastoneoperationforeitheroftheseconditionswasrecordedonasubsequenthospitaldischargerecord;inotherwordsthewomanhadbeendischargedhomeafterherfirstoperation
thenreadmittedforanotherstressurinaryincontinenceorpelvicorganprolapseoperationatalaterdate.Allreadmissionsforfurthersurgerywerecountediftheyhappenedwithinfiveyearsoftheoperationbeingexamined.
What is a ‘complication’?
‘Complications’includedthefollowing:© problemsdirectlyrelatedtotheoperationsuchasdamagetothebladderordifficultypassingurine;
© excessivebleeding;
© infection;
© pain;
© partialortotalremovalofmesh(latercomplicationsonly).
Onlycomplicationsthatweretreatedinhospitalwereincludedintheanalysis.Complicationstreatedinoutpatientclinicsoringeneralpracticewerenotincluded.
Additional problems
ISDalsolookedatthefollowingadditionalproblemsthatcandevelopafterincontinenceorprolapsesurgery:© readmissionsforlatercomplicationsorfurtherincontinenceorprolapsesurgery;
© readmissionsforanyreason;
© referralstoanoutpatientpainclinic;
© prescriptionsforstrongpainreliefmedicationthatcontainedanopiatesuchascodeine;
© death.
7Independent Review of Transvaginal Mesh Implants
Thisreportshowstheresultsrelatingtothethreemainproblemsonly.Fullresults,including
thoserelatingtotheadditionalproblems,areavailableintheReview’sfinalreport.
The risk of developing problems after an operation
Theriskofdevelopingproblemsafteranoperationforstressurinaryincontinenceorpelvicorganprolapsedependsonthetypeofoperationdoneandonanumberofotherfactorssuchas:© ageofthewoman;
© howmanyadditionalhealthproblemsshehas;
© howexperiencedthesurgeondoingtheoperationis.
Tocomparetherisksspecificallyassociatedwithdifferenttypesofoperation,itisimportanttotakeaccountoftheseotherfactorsthatmaybeinfluencingthenumberofproblemsseen.
Forexample,ifolderwomenwithalotofadditionalhealthproblemstendtohavemeshcolporrhaphiesratherthanstandard(nonmesh)colporrhaphies,wewouldexpecttoseemoreproblemsaftermeshoperationsevenifmeshcolporrhaphywasnotinitselfanymoreriskythanstandardcolporrhaphy.
Statisticalmethodscanbeusedtotakeaccountofalltheotherfactorsthatmayinfluencethenumberofproblemsseenafterdifferenttypesofoperationandallowusfocusonthedifferencesthatareduespecificallytothetypeofoperationthatwasprovided.
Problems following operations for stress urinary incontinence
Theriskofdevelopingproblemsafterthedifferenttypesofstressurinaryincontinenceoperationincludedintheanalysisisshownbelow.
Thisisthetotalnumberofreadmissionsthatwouldoccuronaverageif200womenwereeachmonitoredforfiveyearsafterhavingtheirstressurinaryincontinenceoperation.
8 Independent Review of Transvaginal Mesh Implants
Theincreaseordecreaseinriskofthevariousproblemsfollowingeachtypeofoperationcomparedtothatexperiencedbywomenundergoingopencolposuspension,thecommonestnonmeshoperation,isshownbelow.
Thesefinalresultshaveusedstatisticalmethodstotakeaccountofvariousfactorsthatmayinfluencethelevelofproblemsseenafteroperationsasdiscussedabove.Thefactorsthathavebeenaccountedforarewomen’sage,deprivationlevel,andadditionalhealthproblems;
theexperienceofthesurgeon;andthetypeofhospitalprovidingtheoperation.
Takingthesefactorsintoaccountmeansthattheremainingdifferencesinriskarenotduetothosefactorsandarelikelytoreflectgenuinedifferencesinriskassociatedwiththedifferenttypesofoperation.
Tohelpinterpretthesefigures,a50%decreaseinriskisthesameastheriskbeinghalved,anda100%increaseinriskisthesameastheriskbeingdoubled.
�Green�indicatessignificantlylowerriskthanthatseenafteropencolposuspension
�Redindicatessignificantlyhigherriskthanthatseenafteropencolposuspension
9Independent Review of Transvaginal Mesh Implants
Summary of findings for stress urinary incontinence operations
Operationsforstressurinaryincontinencethatinvolveoperatingthroughtheabdomen(opencolposuspensionandsuprapubicsling)carriedthehighestriskofimmediatecomplications.Infectionsandproblemsdirectlyrelatedtotheoperationwerethemostcommonimmediatecomplicationsfollowingalltypesofstressurinaryincontinenceoperations.
Eachofthespecifictypesofoperationforstressurinaryincontinenceincludedintheanalysiscarriedasomewhathigherriskofbeingreadmittedforalatercomplicationthanopencolposuspension.Thehigherriskoflatercomplicationsseenforurethralinjectiontherapymaybeduetotheveryhighriskofneedinganotherincontinenceoperationafterthistypeofsurgery(seebelow),aseverynewoperationcarriesnewriskofcomplications.Longertermproblemsdirectlyrelatedtotheoperation,infections,and(formeshoperations)furthersurgerytoremovethemesh,werethemostcommonlatercomplicationsseenafteroperationstotreatstressurinaryincontinence.
Urethralinjectiontherapycarriedamuchhigherriskofbeingreadmittedforfurtherincontinenceorprolapsesurgeryoverthefiveyearsfollowingtheinitialoperationthanopencolposuspension.Suprapubicslingoperationscarriedasomewhathigherriskofneedinganotheroperation,andtapeoperationscarriedasomewhatlowerrisk.Thetypeoffurthersurgeryneededwasdifferentforthedifferenttypesofstressurinaryincontinenceoperation.Almostallfurtheroperationsfollowingurethralinjectiontherapywereforstressurinaryincontinence,suggestingthatthefirstoperationdidnotcompletelycurethewoman’sincontinence.Bycontrast,aroundhalfoffurtheroperationsfollowingopencolposuspensionwereforstressurinaryincontinenceandhalfwereforpelvicorganprolapse,suggestingthatprolapseproblemsdevelopedafterthecolposuspension.Aftersuprapubicslingsandtapeoperations,around75%offurtheroperationswereforincontinenceand25%forprolapse.
10 Independent Review of Transvaginal Mesh Implants
Problems following operations for pelvic organ prolapse
Theriskofdevelopingproblemsafterthedifferenttypesofpelvicorganprolapseoperationincludedintheanalysisisshownbelow.
Thisisthetotalnumberofreadmissionsthatwouldoccuronaverageif200womenwereeachmonitoredforfiveyearsafterhavingtheirpelvicorganprolapseoperation.
Theincreaseordecreaseinriskofthevariousproblemsfollowingeachtypeofoperationcomparedtothatexperiencedbywomenundergoinganteriorcolporrhaphy(thecommonestnonmeshoperation)isshownontheright.
Asdescribedbefore,thesefinalresultshaveusedstatisticalmethodstotakeaccountofthevariousotherfactorsthatmayinfluencethelevelofproblemsseenaftertheseoperations.Thedifferencesshownarethereforelikelytoreflectgenuinedifferencesinriskassociatedwiththedifferenttypesofoperation.
11Independent Review of Transvaginal Mesh Implants
�Green�indicatessignificantlylowerriskthanthatseenafteranteriorcolporrhaphy
�Red�indicatessignificantlyhigherriskthanthatseenafteranteriorcolporrhaphy
12 Independent Review of Transvaginal Mesh Implants
Summary of findings for pelvic organ prolapse operations
Amongthepelvicorganprolapseoperationsincludedintheanalysis,opensacrocolpopexy,infracoccygealcolpopexy,andvaginalhysterectomycarriedthehighestriskofimmediatecomplications.Ingeneral,infectionsandproblemsdirectlyrelatedtotheoperationwerethemostcommonimmediatecomplicationsfollowingprolapseoperations.Excessivebleedingwasalsoquitecommonafteropensacrocolpopexyandvaginalhysterectomy.
Meshcolporrhaphies(anteriorandposterior),sacrospinousfixation,opensacrocolpopexy,andinfracoccygealcolpopexyallcarriedconsiderablyhigherriskofbeingreadmittedforacomplicationoverthefiveyearsfollowingtheinitialoperationthannonmeshanteriorcolporrhaphy.Longertermproblemsdirectlyrelatedtotheoperation
and(formeshoperations)furthersurgerytoremovethemeshwerethemostcommonlatercomplicationsseenafteroperationstotreatpelvicorganprolapse.
Meshanteriorcolporrhaphy,sacrospinousfixationandopensacrocolpopexycarriedahigherriskofbeingreadmittedforfurtherincontinenceorprolapsesurgeryoverthefiveyearsfollowingtheinitialoperationthannonmeshanteriorcolporrhaphy.Nonmeshposteriorcolporrhaphycarriedasomewhatlowerriskofbeingreadmittedforfurthersurgerycomparedtononmeshanteriorcolporrhaphy.Around80%ofthefurtheroperationsprovidedaftereachtypeofpelvicorganprolapseoperationwereforprolapse,andaround20%wereforstressurinaryincontinence.
What does all this mean for women and doctors?
Thisstudyhasusedroutinelyavailablehealthinformationtolookat:© thenumberofoperationsprovidedinScotlandforstressurinaryincontinenceandpelvicorganprolapse;
© howoftenwomenhavingthedifferenttypesofoperationdevelopproblemsaftertheirsurgery.
Someinformationontherisksassociatedwithdifferenttypesofoperationforstressurinaryincontinenceandpelvicorganprolapsewasavailablepriortothisstudy.
Forexample,therehavebeenanumberofclinicaltrialsdirectlycomparingdifferenttypesofincontinenceorprolapseoperations.Clinicaltrialsareimportanttoimprovingunderstandingofhowwelloperationsworkhowevertheytendtoonlyincludepatientswhoarerelativelyhealthyandonlylookforproblemsdevelopingquitequicklyafterthesurgery.
Inaddition,intheUK,ifapatientdevelopsaproblemaftersurgeryduetoamedicaldevicesuchasameshimplant,thepatient’sdoctorisrequiredtonotifytheproblemtotheappropriatesafetyregulatorsuchastheMedicinesandHealthcareProductsRegulatoryAgency.Thisisanimportantsystembutitislikelythatnotallproblems,particularlylesssevereproblems,arenotifiedinthisway.
ThisstudyaddstotheseothertypesofinformationbylookingatoperationsprovidedaspartofroutineNHScareinScotlandandlookingtoseehowmanyproblemsdevelopoverthefiveyearsaftertheoperation.
Whenthinkingabouttheresultsofthisstudyitisimportanttorememberthatingeneralonlyfirst,singleoperationsforstressurinaryincontinenceorpelvicorganprolapsewereincludedandthatonlylatercomplicationsthatweresevereenoughtorequireareadmissiontohospitalwereincluded.
13Independent Review of Transvaginal Mesh Implants
Key Messages
© Nooperationiswithoutrisk.Itisimportantforwomenanddoctorstohaveclearinformationaboutthedifferentrisksassociatedwithdifferenttypesofoperation.Thiswillhelpthemdecidewhichoperationwillbebestforanyparticularwoman.
© Theriskofimmediatecomplications,latercomplications,andneedingfurthersurgeryforstressurinaryincontinenceorpelvicorganprolapsediffersbetweenthedifferenttypesofoperationexamined.Aspecifictypeofoperationcancarryarelativelyhighriskofoneoftheseproblems(forexampleimmediatecomplications)butarelativelylowriskofadifferentproblem(forexamplelongertermcomplications).
© Moreextensiveoperations,forexamplethoseinvolvingoperatingthroughtheabdomenorahysterectomy,tendtocarrythehighestriskofimmediatecomplications.
© Comparedtoopencolposuspension,tape(mesh)operationsforstressurinaryincontinencetendtocarryasomewhathigherriskoflatercomplicationsbutasomewhat
lowerriskofneedingfurtherincontinenceorprolapsesurgery.Thishighlightsthedifficultchoicesfacingwomenanddoctorsasitisdifficulttodecideiforwhenthehigherriskofcomplicationswouldoutweighthelowerriskoffurthersurgery.
© Comparedtoopencolposuspension,urinaryinjectiontherapycarriesamuchhigherriskofneedingfurthersurgeryandanassociatedhigherriskoflatercomplications.
© Meshcolporrhaphiescarryasubstantiallyhigherriskoflatercomplicationsthannonmeshcolporrhaphies.Meshcolporrhaphiesalsocarryahigherriskofneedingfurthersurgeryforincontinenceorprolapsethannonmeshcolporrhaphies.
© Sacrospinousfixation,opensacrocolpopexy,andinfracoccygealcolpopexyforprolapseofthetopofthevaginaallcarryahigherriskoflatercomplicationsthananteriorcolporrhaphy.Sacrospinousfixationandopensacrocolpopexyalsocarryahigherriskofneedingfurtherincontinenceorprolapsesurgerythananteriorcolporrhaphy.
Authors
Dr Rachael Wood |ConsultantinPublicHealthMedicine|ISDDr Joanne Morling |SpecialtyregistrarinPublicHealthMedicine|ISD
Acknowledgements
Wewouldliketothankthefollowingpeoplefortheirhelpwiththisreport:
Dr Colin Fischbacher |ClinicalDirector|ISDJoyce Dalgleish |CommunicationsManager|ISDJakub Adamow |PublicationsDesigner|ISDProfessor Cathryn Glazener |ProfessorofHealthServicesResearch|UniversityofAberdeen
August 2015
Information Services DivisionNHSNationalServicesScotland
GyleSquare 1SouthGyleCrescent EdinburghEH129EB
01312757777 [email protected]
