Inthiswebsite,theFDAdescribeshernias,thedifferenttreatmentoptionstorepairherniasandrecommendationsfor
patientsthatareconsideringsurgeryfortheirhernias.TheFDAwantstohelppatientsmakeinformeddecisionsabout
theirhealthcareandtofacilitateadiscussionbetweenpatientsandtheirsurgeons.
WhatisaHernia?
Aherniaoccurswhenanorgan,intestineorfattytissuesqueezesthroughaholeoraweakspotinthesurrounding
muscleorconnectivetissue.Herniasoftenoccurattheabdominalwall.Sometimesaherniacanbevisibleasan
externalbulgeparticularlywhenstrainingorbearingdown.
TypesofHernias
Themostcommontypesofherniasare:
Inguinal:occursintheinnergroin
Femoral:occursintheupperthigh/outergroin
Incisional:occursthroughanincisionorscarintheabdomen
Ventral:occursinthegeneralabdominal/ventralwall
Umbilical:occursatthebellybutton
Hiatal:occursinsidetheabdomen,alongtheupperstomach/diaphragm
CausesofHernias
Mostherniasarecausedbyacombinationofpressureandanopeningorweaknessofmuscleorconnectivetissue.
Thepressurepushesanorganortissuethroughtheopeningorweakspot.Sometimesthemuscleweaknessis
presentatbirthbutmoreoftenitoccurslaterinlife.Anythingthatcausesanincreaseinabdominalpressurecan
causeahernia,includingobesity,liftingheavyobjects,diarrheaorconstipation,orpersistentcoughingorsneezing.
Poornutrition,smoking,andoverexertioncanweakenmusclesandcontributetothelikelihoodofahernia.
TreatmentOptionsforHernias
HerniarepairsarecommonmorethanonemillionherniarepairsareperformedeachyearintheU.S.Approximately
800,000aretorepairinguinalherniasandtherestareforothertypesofhernias.1
NonSurgical
WatchfulWaitingYoursurgeonwillwatchtheherniaandmakesurethatitisnotgettinglargerorcausing
problems.Althoughsurgeryistheonlytreatmentthatcanrepairhernias,manysurgicalproceduresareelective
foradultinguinalhernias.Watchfulwaitingisanoptionforpeoplewhodonothavecomplicationsorsymptoms
withtheirhernias,andifrecommendedbytheirsurgeon.
Surgical
LaparoscopicThesurgeonmakesseveralsmallincisionsintheabdomenthatallowsurgicaltoolsintothe
openingstorepairthehernia.Laparoscopicsurgerycanbeperformedwithorwithoutsurgicalmesh.
OpenRepairThesurgeonmakesanincisionneartheherniaandtheweakmuscleareaisrepaired.Open
repaircanbedonewithorwithoutsurgicalmesh.Openrepairthatusessutureswithoutmeshisreferredtoas
primaryclosure.Primaryclosureisusedtorepairinguinalherniasininfants,smallhernias,strangulatedor
infectedhernias.
Herniashaveahighrateofrecurrence,andsurgeonsoftenusesurgicalmeshtostrengthentheherniarepairand
reducetherateofrecurrence.Sincethe1980s,therehasbeenanincreaseinmeshbasedherniarepairsby2000,
nonmeshrepairsrepresentedlessthan10%ofgroinherniarepairtechniques.
Theuseofsurgicalmeshmayalsoimprovepatientoutcomesthroughdecreasedoperativetimeandminimized
recoverytime.However,recoverytimedependsonthetypeofhernia,thesurgicalapproach,andthepatients
conditionbothbeforeandaftersurgery.
Informationfoundinmedicalliteraturehasconsistentlydemonstratedareducedherniarecurrenceratewhensurgical
meshisusedtorepairtheherniacomparedtoherniarepairwithoutsurgicalmesh.Forexample,inguinalhernia
recurrenceishigherwithopenrepairusingsutures(primaryclosure)thanwithmeshrepair2.
Despitereducedratesofrecurrence,therearesituationswheretheuseofsurgicalmeshforherniarepairmaynotbe
recommended.Patientsshouldtalktotheirsurgeonsabouttheirspecificcircumstancesandtheirbestoptionsand
alternativesforherniarepair.
SurgicalMesh
Surgicalmeshisamedicaldevicethatisusedtoprovideadditionalsupporttoweakenedordamagedtissue.The
majorityofsurgicalmeshdevicescurrentlyavailableforuseareconstructedfromsyntheticmaterialsoranimaltissue.
Surgicalmeshmadeofsyntheticmaterialscanbefoundinknittedmeshornonknittedsheetforms.Thesynthetic
materialsusedcanbeabsorbable,nonabsorbableoracombinationofabsorbableandnonabsorbablematerials.
Animalderivedmesharemadeofanimaltissue,suchasintestineorskin,thathasbeenprocessedanddisinfectedto
besuitableforuseasanimplanteddevice.Theseanimalderivedmeshareabsorbable.Themajorityoftissueusedto
producethesemeshimplantsarefromapig(porcine)orcow(bovine)source.
Nonabsorbablemeshwillremaininthebodyindefinitelyandisconsideredapermanentimplant.Itisusedtoprovide
permanentreinforcementtotherepairedhernia.Absorbablemeshwilldegradeandlosestrengthovertime.Itisnot
intendedtoprovidelongtermreinforcementtotherepairsite.Asthematerialdegrades,newtissuegrowthis
intendedtoprovidestrengthtotherepair.
HerniaRepairSurgeryComplications
BasedonFDAsanalysisofmedicaldeviceadverseeventreportsandofpeerreviewed,scientificliterature,themost
commonadverseeventsforallsurgicalrepairofherniaswithorwithoutmesharepain,infection,hernia
recurrence,scarliketissuethatstickstissuestogether(adhesion),blockageofthelargeorsmallintestine
(obstruction),bleeding,abnormalconnectionbetweenorgans,vessels,orintestines(fistula),fluidbuildupatthe
surgicalsite(seroma),andaholeinneighboringtissuesororgans(perforation).
Themostcommonadverseeventsfollowingherniarepairwithmesharepain,infection,herniarecurrence,adhesion,
andbowelobstruction.Someotherpotentialadverseeventsthatcanoccurfollowingherniarepairwithmeshare
meshmigrationandmeshshrinkage(contraction).
ManycomplicationsrelatedtoherniarepairwithsurgicalmeshthathavebeenreportedtotheFDAhavebeen
associatedwithrecalledmeshproductsthatarenolongeronthemarket.Pain,infection,recurrence,adhesion,
obstruction,andperforationarethemostcommoncomplicationsassociatedwithrecalledmesh.IntheFDAsanalysis
ofmedicaladverseeventreportstotheFDA,recalledmeshproductswerethemaincauseofbowelperforationand
obstructioncomplications.
Pleaserefertotherecallnoticeshere(/MedicalDevices/Safety/AlertsandNotices/ucm203886.htm)formore
informationifyouhaverecalledmesh.Formoreinformationontherecalledproducts,pleasevisittheFDAMedical
DeviceRecallwebsite
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/medicaldevicesafety/recalls.cfm).Pleasevisitthe
Medical&RadiationEmittingDeviceDatabase
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm)tosearchaspecifictypeofsurgicalmesh.
Ifyouareunsureaboutthespecificmeshmanufacturerandbrandusedinyoursurgeryandhavequestionsabout
yourherniarepair,contactyoursurgeonorthefacilitywhereyoursurgerywasperformedtoobtaintheinformation
fromyourmedicalrecord.
1
Rutkow,I.M.(2003).DemographicandSocieconomicAspectsofHerniaRepairintheUnitedStatesin2003.
SurgicalClinicsofNorthAmerica83(5):104551,vvi.
2
.http://www.facs.org/public_info/operation/brochures/hernrep.pdf
(http://www.facs.org/public_info/operation/brochures/hernrep.pdf)
MoreinHerniaSurgicalMeshImplants
(/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm)
InformationforPatients
(/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/ucm317438.htm)
FDAActivities
(/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/ucm317440.htm)
OtherResources
(/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/ucm317443.htm)
ReportingProblemstotheFDA
(/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/ucm317444.htm)