Standardized Practice Reduces Complications in Breast Augmentation: Results with the First 290 Consecutive Cases Versus Non-standardized Comparators
Adriano Santorelli, Ferdinando Rossano,
Barbara Cagli, Stefano Avvedimento, Ali Ghanem & Sergio Marlino
Aesthetic Plastic Surgery
ISSN 0364-216X
Aesth Plast Surg
DOI 10.1007/s00266-018-1291-y
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AesthPlastSurg
https://doi.org/10.1007/s00266-018-1291-y
StandardizedPracticeReducesComplicationsinBreast Augmentation:ResultswiththeFirst290ConsecutiveCases VersusNon-standardizedComparators
AdrianoSantorelli1,2 • FerdinandoRossano3 • BarbaraCagli4 • StefanoAvvedimento5 • AliGhanem6 • SergioMarlino1,2
Received:17September2018/Accepted:1December2018
Abstract Background Severalsystematicmethodsforbreastaugmentationhavebeenpublished,providingkeyprinciples andtechnicalstepsforminimizingcomplicationsand optimizingpatientsatisfaction.Theaimofthisstudywas tocomparecomplicationratesinpatientsreceivingabreast augmentationperformedusingastructured,standardized approachversuscomparatorpatientsoperatedonwithouta standardizedapproach.
Methods Thiswasasingle-center,retrospectivereviewof 290consecutivebreastaugmentationsperformedbetween October2016andSeptember2017basedonastandardized technique(Randquist’s‘‘fiveP’s’’combinedwithAdams’ 14-pointplan),and235comparatorswhounderwentbreast augmentationspriortostandardizationbetweenApril2014 andSeptember2016.Allstudysubjectswerefemales aged C 18years,undergoingbilateralbreastaugmentation,eitheraloneorinthecontextofaugmentation
Electronicsupplementarymaterial Theonlineversionofthis article(https://doi.org/10.1007/s00266-018-1291-y)containssupplementarymaterial,whichisavailabletoauthorizedusers.
& AdrianoSantorelli santoadri@me.com
1 PlasticSurgery,HealthPark,ViaMichelangeloSchipa40, 80122Naples,Italy
2 PlasticSurgery,ClinicaGrimaldi, SanGiorgioaCremano,Naples,Italy
3 HealthandProgress,Benevento,Italy
4 CampusBio-Medico,UniversityofRome,Rome,Italy
5 PlasticSurgeryPrivatePractice,Naples,Italy
6 CentreforCutaneousResearch,BlizardInstituteofCelland MolecularScience,London,UK
SpringerScience+BusinessMedia,LLC,partofSpringerNatureandInternationalSocietyofAestheticPlasticSurgery2018
mastopexyorimplantreplacement.Variousimplantranges wereusedbeforestandardization;most(94.8%)ofthe standardizedproceduresusedNatrelle devices.Follow-up lastedfor C 12months.
Results Significantlyfewerpatientsinthestandardized surgerygroupexperiencedcomplications(14.5%, n =42) comparedwiththenon-standardizedgroup[29.4%, n =69; Chisquare=6.57;degreesoffreedom(df)=1; p =0.01041].Complicationrateswerealsosignificantly lowerinthestandardizedsurgerygroupforeachofthe threetypesofbreastaugmentationsurgeryassessedseparately.Reoperationrateswithstandardizedandnon-standardizedsurgerywere4.1%(n =12)and11.9%(n =28), respectively(Chisquare=6.4; df =1; p =0.01145). Patientsatisfactionwasincreasedpost-surgeryinboth groups.
Conclusions Theuseofastructured,standardized approachtobreastaugmentationreducedtheriskofpostoperativecomplications.
LevelofEvidenceIV Thisjournalrequiresthatauthors assignalevelofevidencetoeacharticle.Forafull descriptionoftheseEvidence-BasedMedicineratings, pleaserefertotheTableofContentsortheonline InstructionstoAuthors www.springer.com/00266.
Keywords Breastaugmentation FiveP’s 14-Pointplan
Introduction
Breastaugmentationisoneofthemostpopularaesthetic surgeriesworldwide.IntheUSA,ithasbeenthemost commonlyperformedaestheticsurgeryineveryyearsince 2006,andthenumberofprocedurescontinuestoriseby about4%eachyear[1].
Reportedcomplicationratesafterbreastaugmentation varywidely,butcommonadverseeventsmayoccurin morethan20%ofpatientsatsomepointduringfollow-up [2].Tominimizecomplicationsandoptimizepatientsatisfaction,varioussystematicmethodsforbreastaugmentationhavebeenpublished,elucidatingkeyprinciplesand technicalstepstofollowthroughoutpre-,peri-andpostoperativeprocesses[3–6].
Forexample,Randquistandcolleagueshavedeveloped theprincipleofthe‘‘fiveP’s’’(patientselection,proportionalthinking,preoperativeplanning,performance,and postoperativecare),whichtheybelievecanhelptoensure predictablelong-termoutcomesandreducecomplication rates[4].Meanwhile,Adamsandcolleagueshavedevelopeda14-pointplanforminimizingbacterialloadatthe timeofsurgery[5].Thisisimportantbecausebacteria/ biofilmonbreastimplantsurfaceshavebeenimplicatedas animportantcauseofcomplications[7].Useofthe 14-pointplanmayreducethedevelopmentofcapsular contractureandotherdownstreamcomplications,including breastimplant-associatedanaplasticlarge-celllymphoma (BIA-ALCL)[5].
However,whilethesemethodsmaybeassociatedwith lowcomplicationratesinthehandsoftheiroriginators, thereisalackofdatatoshowwhethertheimplementation ofthesetechniquescanreducecomplicationsinthehands ofsurgeonswhohavepreviouslynotfollowedastructured methodology.
Toimprovethestandardizationofourownprocesses, wehavebeenusingRandquist’sfive5P’sandthe14-point planproposedbyAdamsandcolleaguesinallbreast augmentationcasessinceOctober2016.Theaimsofthe presentstudyweretoexaminethecomplicationrateamong 290consecutivebreastaugmentationscarriedoutusingthe standardizedmethodandtocompareitwiththecomplicationratefrom235breastaugmentationsperformedinthe periodimmediatelypriortostandardization.
MaterialsandMethods
StudyDesign
Thiswasaretrospectivereviewofdatafrom525patients undergoingbreastaugmentationatasinglecenterbetween April2014andSeptember2017.Patientsweredividedinto twogroups.The‘standardizedsurgery’groupunderwent breastaugmentationfollowingasystematicapproach, basedonthefiveP’sofRandquist[4]andthe14-pointplan ofAdamsandcolleagues[5];theseindividualswere operatedonbetweenOctober2016andSeptember2017. The‘non-standardizedsurgery’groupunderwentbreast augmentationatthesamecenterwithoutuseofa
standardizedapproach;thesepatientswereoperatedon betweenApril2014andSeptember2016.Thestudywas approvedbytheInstitutionalReviewBoardandwasconductedinaccordancewiththeDeclarationofHelsinki.
Patients
Allstudysubjectswerefemalesaged C 18years,undergoingbilateralbreastaugmentation,eitheraloneorinthe contextofaugmentationmastopexyorimplantreplacement.Implantscouldberoundoranatomicalinshape. Writteninformedconsentwasobtainedpreoperatively.
Patientsincludedinboththestandardizedandnon-standardizedsurgerygroupshadaminimumof12months offollow-up.
SurgicalTechniques
Inthenon-standardizedsurgerygroup,preoperativemeasurementswereadaptedfromTebbetts[8, 9].Theposition ofthenewinframammaryfold(IMF)wasusedtoguide surgery,andthenippletoIMFdistancewascalculatedin relationtotheimplantweightandnotimplantwidth.The surgicalincisionwasmadeintheareolaunlessthiswastoo small,inwhichcasetheincisionwasplacedintheIMF. Implantpocketsweremadeinthesubglandular,submuscular,ordualplane,basedonthecoveragethatcouldbe giventotheprosthesis.Bluntdissectionwascompleted withfingers,andresidualfiberswerethencauterized. Hemostasiswasnotprospective.Drainswereplaced,and thentheimplantswerewashedwithbetadineandinserted directlyintothepocket.Adoublesubcutaneous-to-cutaneoussuturewasappliedwithoutfixingthefold.Wounds werecoveredwithultracompressiveTensoplast bandages (BSNmedical,Hamburg,Germany).Drainswereremoved 24or48hpostoperatively.Bandagesweretakenoffafter 5days,andamedicalbraapplied.Single-antibiotictreatmentwithcefotaxime2gwasgiventoallpatientsat inductionandfor1weekstartingonthedayaftersurgery.
Inthestandardizedsurgerygroup,preoperativeplanning wasperformedaccordingtothemethodproposedby Randquist[4].Anumberofmeasurementsweretakento informimplantselectionandthepositioningofthenew IMF,including:basewidth(assessedfromtheanterior axiallinetothelateralpartofthe‘notouchzone’);nippleto-IMFdistance(measuredundermaximumstretchfrom thelowerpartofthenippletotheexistingIMF);intermammarydistance(maintainedat C 3cmtoavoidcomplications);sternalnotch-to-nippledistance;andsoft-tissue pinchtest(performedinthemedialupperpoleofthe breast,andplayinganimportantroleindeterminingsubmuscularorsubglandularimplantplacement).Thenew nipple-to-IMFdistancewascalculatedasimplantwidth
Fig.2 Breastaugmentation: non-standardized.A25-year-old womanpre-surgery(a–c)andat 4years(d–f)afterbreast augmentationwithanatomical 320-gdevicesinserteddual planeviaaninframammaryfold incision.Althoughthepatient wassatisfiedwiththeresult,the surgeonwasnothappywiththe symmastia
Complicationsweredocumentedthroughoutthefollowupperiod.Ratesofreoperationwerealsorecorded.Patient satisfactionwiththeirbreastswasassessedpreoperatively andat12monthspost-surgeryonascaleof0(verynegative)to10(verypositive).
StatisticalAnalysis
Descriptivestatisticsareprovidedthroughout.Forcontinuousvariables,meansandstandarddeviationshavebeen calculated;forcategoricalvariables,absolutefrequency andpercentagearegiven.
StatisticalanalyseswereperformedusingRversion1.0.143(RFoundationforStatisticalComputing, Vienna,Austria).Potentialassociationsbetweentheprocedure(standardizedornon-standardizedsurgery)andthe developmentofcomplications,reoperations,andpatient satisfactionwereassessedusingtheChi-squaretestor
Welchtwo-sample t test.Thedifferenceswereconsidered significantforvaluesof p \ 0.05.
Results
BaselineCharacteristicsandSurgicalSpecifications
Atotalof525patientsmettheinclusioncriteria:235inthe non-standardizedsurgerygroupand290inthestandardizedsurgerygroup.Atbaseline,thetwogroupshada comparablemeanage(32.0 ± 8.1vs.31.9 ± 8.1years, respectively),weight(59.2 ± 7.2vs.58.4 ± 7.8kg),and BMI(21.8 ± 2.6vs.21.7 ± 2.7kg/m2).
Inthenon-standardizedsurgerygroup,138patients (58.7%)underwentbreastaugmentation,76(32.3%)had anaugmentationmastopexy,and21(8.9%)received implantreplacement.Inthestandardizedsurgerygroup,
Fig.3 Breastaugmentation: standardized.A19-year-old womanpre-surgery(a–c)andat 1year(d–f)afterbreast augmentationwithNatrelle410 MX225gdevicesinserteddual planeviaaninframammaryfold incision
193patients(66.6%)underwentbreastaugmentation,65 (22.4%)hadanaugmentationmastopexy,and32(11.0%) receivedimplantreplacement.
Baselinecharacteristicsinthedifferentpatientgroups areshowninTable 1.Thesearebroadlycomparable betweenthetwogroups.
Thespecificationsoftheimplantsusedinthenon-standardizedandstandardizedsurgerygroupsaresummarizedinTable 2.Thenon-standardizedsurgerygroup receivedvarioustypes,mostcommonlyfromAllergan (n =91,38.7%;largelyfromtheBreastandCUIranges), BellaGel(n =68,28.9%;shapeddevices),orPerthese (n =50,21.3%;rounddevices).Bycontrast,thestandardizedsurgerygroupmostlyreceivedAllerganimplants fromtheNatrelle rangeofmacrotextureddevices (n =275,94.8%).
Meanfollow-upwas15months(range12–19months) inthestandardizedsurgerygroup,and32months(range 12–36months)inthenon-standardizedsurgerygroup.
Representativebefore-and-afterphotographsfrom patientsinthenon-standardized(Figs. 1, 2)andstandardizedgroups(Figs. 3, 4, 5)areprovided.
Complications
Complicationsoccurredin29.4%(n =69/235)ofpatients inthenon-standardizedsurgerygroup.Significantlyfewer patientsoperatedonaccordingtothestandardizedsurgical protocolexperiencedcomplications[14.5%; n =42/290; Chisquare=6.57;degreesoffreedom(df)=1; p =0.0104](Fig. 6;Table 3).
Complicationrateswerealsosignificantlylowerinthe standardizedsurgerygroupforeachofthethreetypesof
Fig.4 Breastaugmentation: standardized.A32-year-old womanpre-surgery(a–c)andat 1year(d–f)afterbreast augmentationwithNatrelle410 MX370gdevicesinserteddual planeviaaninframammaryfold incision
breastaugmentationsurgeryassessedseparately(Fig. 6; Table 3).Amongpatientsreceivingaugmentationalone, complicationsoccurredin25.4%(n =35/138)ofthose whounderwentnon-standardizedsurgeryand15.0% (n =29/193)ofpatientsinthestandardizedgroup(Chi square=4.87; df =1; p =0.0273).Inpatientsreceiving augmentationmastopexy,complicationsoccurredin32.9% (n =25/76)ofthenon-standardizedgroupand16.9% (n =11/65)ofthestandardizedgroup(Chisquare=3.90; df =1; p =0.0483).Finally,amongpatientsreceiving implantreplacement,complicationsoccurredin42.9% (n =9/21)ofthenon-standardizedgroupand6.3%(n =2/ 32)ofthestandardizedgroup(Chisquare=8.23; df =1; p =0.0041).
Inthenon-standardizedsurgerygroup,themostcommoncomplicationswerewounddehiscence(n =25; 10.6%),seroma(n =10;4.3%),implantbottomingout
(n =9;3.8%),implantrotation(n =6;2.6%),andimplant dislocation(n =6;2.6%)(Table 3).Inthestandardized surgerygroup,themostcommoncomplicationswere implantbottomingout(n =7;2.4%),wounddehiscence (n =6;2.1%),seroma(n =6;2.1%),highimplant(n =5; 1.7%),andpseudoptosis(n =5;1.7%).
Thereoperationratewas11.9%(n =28/235)inthenonstandardizedsurgerygroup,comparedwith4.1%(n =12/ 290)inthestandardizedsurgerygroup(Chisquare=6.4; df =1; p =0.0114).
PatientSatisfaction
Inbothgroups,irrespectiveofthetypeofsurgeryundertaken,patientsatisfactionwiththeirbreastswaslowpreinterventionandwassubstantiallyimprovedat12months post-surgery(Table 4).However,theseimprovements
Fig.5 Breastaugmentation: standardized.A27-year-old womanpre-surgery(a–c)andat 1year(d–f)afterbreast augmentationwithNatrelle410 MF375gdevicesinserteddual planeviaaninframammaryfold incision
weregreaterinthestandardizedsurgerygroupcompared withnon-standardizedsurgery,andthisreachedstatistical significanceinpatientsundergoingbreastaugmentation alone(meanscoreimprovedfrom2.60to8.30withnonstandardizedsurgeryandfrom1.53to9.23inthestandardizedsurgerygroup; p \ 0.0001).
Discussion
Breastaugmentationisapopularaestheticsurgicalintervention,butdespitenewoperativetechniques,itisstill associatedwithahighriskofcomplications[2, 6].Many factorscanincreasethisrisk,includingthespecificrequests ofpatients,whichmayincorrectlyconditionthechoiceof prosthesisbythesurgeon[10].Otherfactors,suchas smokingorthepresenceofcomorbiditieslikediabetes,can
alsoincreasetheriskofcomplicationsafterbreastaugmentation[11, 12].Hence,theexpertiseofthesurgeonin assessingrisk,selectingtheappropriateimplants,and managingtheprocessfrombeginningtoendremainscrucialinminimizingcomplicationsandmaximizingpatient satisfaction[2, 3].
Inrecentyears,severalmethodshavebeendevelopedto reducecomplications[3–6].Wehavetestedtwoofthese methodsincombination—Randquist’sfive5P’sandthe 14-pointplanofAdamsetal.[4, 5].Comparedwithnonstandardizedcomparators,useofthestandardizedtechniquessignificantlyreducedthecomplicationrate(14.5% vs.29.4%)andthefrequencyofreoperation(4.1%vs. 11.9%).Complicationratesremainedsignificantlylower withstandardizedversusnon-standardizedsurgeryforeach ofthethreetypesofsurgeryconsidered(augmentation alone,augmentationmastopexy,andimplantreplacement).
Fig.6 Complicationrates. Ratesofcomplicationsinthe entirestudypopulation(a),and inthebreastaugmentation(b), augmentationmastopexy(c), andimplantreplacement (d)groupsconsidered separately
Althoughfollow-upwaslongerinthenon-standardized group,mostcomplicationsoccurredduringthefirstyear, andhencefollow-updurationisnotamajorfactorin explainingthelowercomplicationrateinthestandardized surgerygroup.
Theseresults,fromanexperiencedsurgeonadoptinga standardizedmethodology,alignwithrecentdatafroma youngsurgeonimplementingasystematicapproachatthe startofhiscareer:Hehadacomplicationrateof14.8%and areoperationrateof8.7%across620breastaugmentations [13];ratesdidnotdiffersubstantiallyaccordingtoimplant shape(roundvs.anatomical)[14].
Thereareseveralaspectsofthestandardizedmethod thatmayhavecontributedtothereductionincomplications observedinthepresentwork.WithregardtothefiveP’s, keyinnovationscenterontheconceptofcarefulpatient selectiontakingintoaccountmentalstate(firstP),andalso respectforindividualphysicalproportions(secondP), whichthenrelatetothemaximumexpansionoftheimplant pocket[4].Suchexpansioncanbecalculatedbyapplying theformulasprovidedbyRandquist.Thismethodology alsoprovidesrecommendationsonstandardizingelements ofthesurgery(incision,pocketdissection,implants, suturing,etc.)andpostoperativecare.
Withrespecttothe14-pointplan,thesestepsdefinea surgicalstrategytoreducebacterialcontamination,which hasbeenshowntobeassociatedwithdevelopmentof
capsularcontractureandBIA-ALCL[5, 15–17].Key aspectsofthisplanincludetheuseofmultipleantibiotics towashtheimplantandpocket,minimizationoftrauma, andreducedusageoftoolsthatcanintroducebacteria(such assizersanddrains)[5].Useofthesetechniquesinmore than21,000surgeries,withameanfollow-upof11.7years, wasassociatedwithacapsularcontracturerateof2.2%and nopatientsdevelopedBIA-ALCL[5].Althoughtheuseof texturedimplantshasbeenassociatedwithanincreased riskofBIA-ALCLinotherstudies[18],itremainsvery rareandtheriskiscounterbalancedbytheadvantagesof thesedevices.Inthepresentstudy,therewereonly2cases ofgradeIII/IVcapsularcontractureinthe290patients undergoingstandardizedsurgery(0.7%);however,followupwastooshorttoassessBIA-ALCL.
ThechangesfromanareolarincisioninmostofthenonstandardizedsurgeriestoanIMFincisioninallofthe standardizedsurgeriescouldalsohaveplayedarolein reducingcomplications.Previousworksuggeststhatthe IMFincisionmaybeassociatedwithlowerratesofcapsularcontractureandimplantmalposition,possiblyby allowingamorepreciseandatraumaticdissectionandby limitingexposuretotissuecolonizedwithbacteria[19].
Aspartofthestandardizationprocess,wemovedaway fromusingavarietyofimplantmanufacturerstowardusing asinglesupplier(AllerganNatrelle).Themacrotextured surfaceofthesedeviceshasbeendesignedtomaximize
Table3 Complications
Non-standardizedsurgeryStandardizedsurgery
Allpatients (N =235) Augmentation (N =138)
Aug. mastopexy (N =76)
Replacement (N =21) Allpatients (N =290) Augmentation (N =193)
Aug. mastopexy (N =65)
Replacement (N =32)
Total69(29.4)35(25.4)25(32.9)9(42.9)42(14.5)29(15.0)11(16.9)2(6.3)
Wound dehiscence
25(10.6)9(6.5)11(14.5)5(23.8)6(2.1)2(1.0)3(4.6)1(3.1)
Seroma10(4.3)7(5.1)3(3.9)06(2.1)6(3.1)00
Implant bottoming out
Implant rotation
Implant dislocation
9(3.8)8(5.8)1(1.3)07(2.4)5(2.6)2(3.1)0
6(2.6)4(2.9)1(1.3)1(4.8)1(0.3)1(0.5)00
6(2.6)2(1.5)1(1.3)3(14.3)0000
Hematoma4(1.7)04(5.3)02(0.7)2(1.0)00
Doublebubble deformity
Capsular contracturea
2(0.9)1(0.7)1(1.3)04(1.4)2(1.0)2(3.1)0
2(0.9)1(0.7)1(1.3)02(0.7)1(0.5)01(3.1)
Highimplant1(0.4)1(0.7)005(1.7)4(2.1)1(1.5)0
Implant wrinkling 1(0.4)1(0.7)000000
Implant extrusion 1(0.4)1(0.7)000000
Delayed wound healing
Partialnipple necrosis
1(0.4)01(1.3)02(0.7)2(1.0)00
1(0.4)01(1.3)00000
Pseudoptosis00005(1.7)3(1.6)2(3.1)0
Implant rupture 00001(0.3)1(0.5)00
Symmastia00001(0.3)01(1.5)0
Dataare n (%) aBakergradeIII/IV
Table4 Patientsatisfaction
Non-standardizedsurgeryStandardizedsurgery p valuea Pre-surgery12monthspost-surgeryPre-surgery12monthspost-surgery
Breastaugmentation2.608.301.539.23 \ 0.0001
Augmentationmastopexy2.537.251.858.650.0640
Implantreplacement3.477.213.508.360.5765
Dataaremeansassessedonascaleof0(verynegative)to10(verypositive) aStandardizedversusnon-standardizedat12monthspost-surgery
tissueadhesionand,hence,reducedevicemobility[20]. Logically,decreasedimplantmobilityshouldreducerates ofimplantrotation,dislocationandwrinkling[20],and
indeed,inthepresentseries,onlyonesuchcomplication wasobservedwiththestandardizedsurgerybasedon macrotexturedimplants(acaseofimplantrotation).By
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