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HerniaSurgicalMeshImplants

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)