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FDASafetyCommunication:UPDATEonSeriousComplicationsAssociatedwithTransvaginalPlacementof SurgicalMeshforPelvicOrganProlapse
DateIssued:July13,2011 Audience: Healthcareproviderswhoimplantsurgicalmeshtorepairpelvicorganprolapseand/orstressurinaryincontinence Healthcareprovidersinvolvedinthecareofpatientswithsurgicalmeshimplantedtorepairpelvicorganprolapse and/orstressurinaryincontinence Patientswhoareconsideringorhavereceivedasurgicalmeshimplanttorepairpelvicorganprolapseand/orstress urinaryincontinence MedicalSpecialties:gynecology,urogynecology,urology,generalsurgery,internalmedicine,familypractice,emergency medicine Device: Surgicalmeshisamedicaldevicethatisgenerallyusedtorepairweakenedordamagedtissue.Itismadefromporous absorbableornonabsorbablesyntheticmaterialorabsorbablebiologicmaterial.Inurogynecologicprocedures,surgicalmesh ispermanentlyimplantedtoreinforcetheweakenedvaginalwalltorepairpelvicorganprolapseortosupporttheurethrato treaturinaryincontinence. Background: PelvicOrganProlapse Pelvicorganprolapse(POP)occurswhenthetissuesthatholdthepelvicorgansinplacebecomeweakorstretched.Thirtyto fiftypercentofwomenmayexperiencePOPintheirlifetimewith2percentdevelopingsymptoms.WhenPOPhappens,the organsbulge(prolapse)intothevaginaandsometimesprolapsepastthevaginalopening.Morethanonepelvicorgancan prolapseatthesametime.OrgansthatcanbeinvolvedinPOPincludethebladder,theuterus,therectum,thetopofthe vagina(vaginalapex)afterahysterectomy,andthebowel. StressUrinaryIncontinence Stressurinaryincontinence(SUI)isaleakageofurineduringmomentsofphysicalactivity,suchascoughing,sneezing, laughing,orexercise. Purpose: OnOct.20,2008,theFDAissuedaPublicHealthNotificationandAdditionalPatientInformationonseriouscomplications associatedwithsurgicalmeshplacedthroughthevagina(transvaginalplacement)totreatPOPandSUI. BasedonanupdatedanalysisofadverseeventsreportedtotheFDAandcomplicationsdescribedinthescientificliterature,the FDAidentifiedsurgicalmeshfortransvaginalrepairofPOPasanareaofcontinuingseriousconcern. TheFDAisissuingthisupdatetoinformyouthatseriouscomplicationsassociatedwithsurgicalmeshfortransvaginalrepairof POPare notrare.ThisisachangefromwhattheFDApreviouslyreportedonOct.20,2008.Furthermore,itisnotclearthat transvaginalPOPrepairwithmeshismoreeffectivethantraditionalnonmeshrepairinallpatientswithPOPanditmay exposepatientstogreaterrisk.ThisSafetyCommunicationprovidesupdatedrecommendationsforhealthcareprovidersand patientsandupdatestheFDAsactivitiesinvolvingsurgicalmeshforthetransvaginalrepairofPOP. TheFDAcontinuestoevaluatetheeffectsofusingsurgicalmeshtorepairSUIandwillcommunicatethesefindingsatalater date. Fordetailedinformation,pleasesee:UrogynecologicSurgicalMesh:UpdateontheSafetyandEffectivenessofTransvaginal PlacementforPelvicOrganProlapse.1 SummaryofProblemandScope: IntheOct.20,2008FDAPublicHealthNotification,thenumberofadverseeventsreportedtotheFDAforsurgicalmesh devicesusedtorepairPOPandSUIfortheprevious3yearperiod(20052007)wasover1,000.Sincethen,fromJan.01, 2008throughDec.31,2010,theFDAreceived2,874additionalreportsofcomplicationsassociatedwithsurgicalmeshdevices usedtorepairPOPandSUI,with1,503reportsassociatedwithPOPrepairsand1,371associatedwithSUIrepairs.Althoughit iscommonforadverseeventreportingtoincreasefollowinganFDAsafetycommunication,weareconcernedthatthenumber ofadverseeventreportsremainshigh. From20082010,themostfrequentcomplicationsreportedtotheFDAforsurgicalmeshdevicesforPOPrepairincludemesh erosionthroughthevagina(alsocalledexposure,extrusionorprotrusion),pain,infection,bleeding,painduringsexual intercourse(dyspareunia),organperforation,andurinaryproblems.Therewerealsoreportsofrecurrentprolapse,neuro muscularproblems,vaginalscarring/shrinkage,andemotionalproblems.Manyofthesecomplicationsrequireadditional intervention,includingmedicalorsurgicaltreatmentandhospitalization. InordertobetterunderstandtheuseofsurgicalmeshforPOPandSUI,theFDAconductedasystematicreviewofthe publishedscientificliteraturefrom19962011toevaluateitssafetyandeffectiveness.Thereviewshowedthattransvaginal POPrepairwithmeshdoesnotimprovesymptomaticresultsorqualityoflifeovertraditionalnonmeshrepair.TheFDA continuestoevaluatetheliteratureforSUIsurgeriesusingsurgicalmeshandwillreportaboutthatusageatalaterdate. Inparticular,theliteraturereviewrevealedthat: MeshusedintransvaginalPOPrepairintroducesrisksnotpresentintraditionalnonmeshsurgeryforPOPrepair. MeshplacedabdominallyforPOPrepairappearstoresultinlowerratesofmeshcomplicationscomparedtotransvaginal

POPsurgerywithmesh. Thereisnoevidencethattransvaginalrepairtosupportthetopofthevagina(apicalrepair)orthebackwallofthe vagina(posteriorrepair)withmeshprovidesanyaddedbenefitcomparedtotraditionalsurgerywithoutmesh. Whiletransvaginalsurgicalrepairtocorrectweakenedtissuebetweenthebladderandvagina(anteriorrepair)with meshaugmentationmayprovideananatomicbenefitcomparedtotraditionalPOPrepairwithoutmesh,thisanatomic benefitmaynotresultinbettersymptomaticresults. TheFDAsliteraturereviewfoundthat erosionofmeshthroughthevaginaisthe mostcommonandconsistentlyreported meshrelatedcomplicationfromtransvaginalPOPsurgeriesusingmesh.Mesherosioncanrequiremultiplesurgeriestorepair andcanbedebilitatingforsomewomen.Insomecases,evenmultiplesurgerieswillnotresolvethecomplication. Meshcontraction(shrinkage)isa previouslyunidentifiedriskoftransvaginalPOPrepairwithmeshthathasbeenreportedin thepublishedscientificliteratureandinadverseeventreportstotheFDAsincetheOct.20,2008 FDAPublicHealth Notification.Reportsintheliteratureassociatemeshcontractionwithvaginalshortening,vaginaltighteningandvaginalpain. Bothmesherosionandmeshcontractionmayleadtoseverepelvicpain,painfulsexualintercourseoraninabilitytoengagein sexualintercourse.Also,menmayexperienceirritationandpaintothepenisduringsexualintercoursewhenthemeshis exposedinmesherosion. ThecomplicationsassociatedwiththeuseofsurgicalmeshforPOPrepairhavenotbeenlinkedtoasinglebrandofmesh. RecommendationsforHealthCareProviders: AsstatedintheOct.20,2008PublicHealthNotification,theFDAcontinuestorecommendthathealthcareprovidersshould: Obtainspecializedtrainingforeachmeshplacementtechnique,andbeawareoftherisksofsurgicalmesh. Bevigilantforpotentialadverseeventsfromthemesh,especiallyerosionandinfection. Watchforcomplicationsassociatedwiththetoolsusedintransvaginalplacement,especiallybowel,bladderandblood vesselperforations. Informpatientsthatimplantationofsurgicalmeshispermanent,andthatsomecomplicationsassociatedwiththe implantedmeshmayrequireadditionalsurgerythatmayormaynotcorrectthecomplication. Informpatientsaboutthepotentialforseriouscomplicationsandtheireffectonqualityoflife,includingpainduring sexualintercourse,scarring,andnarrowingofthevaginalwallinPOPrepairusingsurgicalmesh. Providepatientswithacopyofthepatientlabelingfromthesurgicalmeshmanufacturerifavailable. Inaddition,theFDAalsorecommendsthathealthcareproviders: Recognizethatinmostcases,POPcanbetreatedsuccessfullywithoutmeshthusavoidingtheriskofmeshrelated complications. Choosemeshsurgeryonlyafterweighingtherisksandbenefitsofsurgerywithmeshversusallsurgicalandnon surgicalalternatives. Considerthesefactorsbeforeplacingsurgicalmesh: Surgicalmeshisapermanentimplantthatmaymakefuturesurgicalrepairmorechallenging. Ameshproceduremayputthepatientatriskforrequiringadditionalsurgeryorforthedevelopmentofnew complications. Removalofmeshduetomeshcomplicationsmayinvolvemultiplesurgeriesandsignificantlyimpairthepatients qualityoflife.Completeremovalofmeshmaynotbepossibleandmaynotresultincompleteresolutionof complications,includingpain. MeshplacedabdominallyforPOPrepairmayresultinlowerratesofmeshcomplicationscomparedtotransvaginal POPsurgerywithmesh. Informthepatientaboutthebenefitsandrisksofnonsurgicaloptions,nonmeshsurgery,surgicalmeshplaced abdominallyandthelikelysuccessofthesealternativescomparedtotransvaginalsurgerywithmesh. NotifythepatientifmeshwillbeusedinherPOPsurgeryandprovidethepatientwithinformationaboutthespecific productused. Ensurethatthepatientunderstandsthepostoperativerisksandcomplicationsofmeshsurgeryaswellaslimitedlong termoutcomesdata. RecommendationsforPatients: BeforeSurgery BeawareoftherisksassociatedwithsurgicalmeshfortransvaginalrepairofPOP.Knowthathavingameshsurgerymayput youatriskforneedingadditionalsurgeryduetomeshrelatedcomplications.Inasmallnumberofpatients,repeatsurgery maynotresolvecomplications. AskyoursurgeonaboutallPOPtreatmentoptions,includingsurgicalrepairwithorwithoutmeshandnonsurgicaloptions,and understandwhyyoursurgeonmayberecommendingtreatmentofPOPwithmesh. Inaddition,askyoursurgeonthesequestionsbeforeyouagreetohavesurgeryinwhichsurgicalmeshwillbeused: Areyouplanningtousemeshinmysurgery? WhydoyouthinkIamagoodcandidateforsurgicalmesh? Whyissurgicalmeshbeingchosenformyrepair? WhatarethealternativestotransvaginalsurgicalmeshrepairforPOP,includingnonsurgicaloptions? Whataretheprosandconsofusingsurgicalmeshinmyparticularcase?Howlikelyisitthatmyrepaircouldbe successfullyperformedwithoutusingsurgicalmesh? Willmypartnerbeabletofeelthesurgicalmeshduringsexualintercourse?Whatifthesurgicalmesherodesthrough myvaginalwall?

Ifsurgicalmeshistobeused,howoftenhaveyouimplantedthisparticularproduct?Whatresultshaveyourother patientshadwiththisproduct? WhatcanIexpecttofeelaftersurgeryandforhowlong? WhichspecificsideeffectsshouldIreporttoyouafterthesurgery? Whatifthemeshsurgerydoesntcorrectmyproblem? IfIdevelopacomplication,willyoutreatitorwillIbereferredtoaspecialistexperiencedwithsurgicalmesh complications? IfIhaveacomplicationrelatedtothesurgicalmesh,howlikelyisitthatthesurgicalmeshcouldberemovedandwhat couldbetheconsequences? Ifasurgicalmeshistobeused,istherepatientinformationthatcomeswiththeproduct,andcanIhaveacopy? AfterSurgery Continuewithyourannualandotherroutinecheckupsandfollowupcare.Thereisnoneedtotakeadditionalactionif youaresatisfiedwithyoursurgeryandarenothavingcomplicationsorsymptoms. Notifyyourhealthcareproviderifyouhavecomplicationsorsymptoms,includingpersistentvaginalbleedingor discharge,pelvicorgroinpainorpainwithsex,thatlastafteryourfollowupappointment. Letyourhealthcareproviderknowyouhavesurgicalmesh,especiallyifyouplantohaveanothersurgeryorother medicalprocedures. Talktoyourhealthcareprovideraboutanyquestionsyoumayhave. IfyouhadPOPsurgery,butdonotknowwhetheryoursurgeonusedmesh,askyourhealthcareprovideratyournext scheduledvisit. FDAActivities: TheFDAisworkinginseveralareastoassessandimprovethesafetyandeffectivenessofurogynecologicmeshproducts.The FDAwill: ConvenetheObstetricsGynecologyDevicesPaneloftheMedicalDeviceAdvisoryCommittee,onSeptember89, 2011.Thepanelwilldiscussandmakerecommendationsregardingthesafetyandeffectivenessoftransvaginalsurgical meshforPOPandSUI. Exploreregulatorysolutionstoanswerquestionsaboutthesafetyandeffectivenessofurogynecologicmeshproducts thatarenowbeingmarketedandthosethatwillbereviewedformarketinginthefuture. ContinuetomonitoradverseeventsreportedtoFDAassociatedwithsurgicalmeshusedtorepairPOPandSUI,aswell asassessinganyandalldataasitbecomesavailable. ReportingProblemstotheFDA: PromptreportingofadverseeventscanhelptheFDAidentifyandbetterunderstandtherisksassociatedwithmedicaldevices. Ifyoususpectaproblemwithsurgicalmesh,weencourageyoutofileavoluntaryreportthroughMedWatch,theFDASafety InformationandAdverseEventReportingprogram.HealthcarepersonnelemployedbyfacilitiesthataresubjecttotheFDA's userfacilityreportingrequirements2shouldfollowthereportingproceduresestablishedbytheirfacilities.Device manufacturersmustcomplywiththeMedicalDeviceReporting(MDR)regulations3. TohelpuslearnasmuchaspossibleabouttheadverseeventsassociatedwithsurgicalmeshtorepairPOPandSUI,please includethefollowinginformationinyourreports,ifavailable: Manufacturer'sname Productname(brandname) Catalognumber Lotnumber Size Dateofimplant Dateofexplant(ifmeshwasremoved) Detailsoftheadverseeventandmedicaland/orsurgicalinterventions(ifrequired) Typeofprocedure(e.g.,anteriororposteriorrepair,sacralcolpopexy,slingprocedureforSUI) Surgicalapproach:(e.g.,vaginal,abdominal,laparoscopic) Reasonformeshimplantation:(e.g.,POPoftheuterus,bladder,rectum,vaginalapexorbowel,SUI) Specificpostoperativesymptomsexperiencedbythepatientwithtimeofonsetandfollowuptreatment ContactInformation: Ifyouhavequestionsaboutthiscommunication,pleasecontacttheDivisionofSmallManufacturers,Internationaland ConsumerAssistance(DSMICA)atDSMICA@FDA.HHS.GOV,8006382041or3017967100. ThisdocumentreflectstheFDAscurrentanalysisofavailableinformation,inkeepingwithourcommitmenttoinformthepublic aboutongoingsafetyreviewsofmedicaldevices.

AdditionalInformation
UrogynecologicSurgicalMeshImplants4 UrogynecologicSurgicalMesh:UpdateontheSafetyandEffectivenessofTransvaginalPlacementforPelvicOrgan Prolapse(July2011)(PDF243KB)5 PressRelease:Surgicalplacementofmeshtorepairpelvicorganprolapseposesrisks6

FederalRegisterNotice:UrogynecologicSurgicalMesh7 FederalRegisterNoticeAmendment:UrogynecologicSurgicalMesh8 PageLastUpdated:06/18/2013 Note:Ifyouneedhelpaccessinginformationindifferentfileformats,seeInstructionsforDownloadingViewersandPlayers. AccessibilityContactFDACareersFDABasicsFOIANoFearActSiteMapTransparencyWebsitePolicies U.S.FoodandDrugAdministration 10903NewHampshireAvenue SilverSpring,MD20993 Ph.1888INFOFDA(18884636332) EmailFDA ForGovernmentForPress CombinationProductsAdvisoryCommitteesScience&ResearchRegulatoryInformationSafetyEmergencyPreparedness InternationalProgramsNews&EventsTrainingandContinuingEducationInspections/ComplianceState&LocalOfficials ConsumersIndustryHealthProfessionalsFDAArchive

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1. /downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf 2. /MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm2005737.htm 3. /MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm2005737.htm 4. /MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm 5. /downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf 6. /NewsEvents/Newsroom/PressAnnouncements/ucm262752.htm 7. http://www.gpo.gov/fdsys/pkg/FR20110714/pdf/201117695.pdf 8. http://www.gpo.gov/fdsys/pkg/FR20110815/pdf/201120644.pdf