MSD IMPLANON User manual

GLOBALTRAINING
IMPLANON
GLOBAL TRAINING
IMPLANON™: Reference Guide

applicator seal
obturator support
obturator
applicator
location of IMPLANON
cannula
IMPLANON
4 cm
needle
How to Insert IMPLANON
 •Inser tionofIMPLANONshouldbeperformedunder
asepticconditions,andonlybyahealthcareprovider
whoisfamiliarwiththeprocedure.
 •Inser tionofIMPLANONisperformedwiththespecially
designedapplicator.Theuseofthisapplicatordiffers
substantiallyfromthatofaclassicalsyringe.Adrawing
ofadismantledapplicatoranditsindividualcomponents
(eg,cannula,obturator,andneedlewithdouble-angled
bevel)isshowninthisleaettoclarifytheirspecicfunctions.
 •TheprocedureusedforinsertionofIMPLANON
isoppositetogivinganinjection.Wheninserting
IMPLANON,theobturatormustremainxedwhilethe
cannula(needle)isretractedfromthearm.
 •Allowthesubjecttolieonherbackwithhernon-dominant
arm(thearmwhichthewomandoesnotuseforwriting)
turnedoutwardandbentattheelbow.
 •Tominimizetheriskofneuralorvasculardamage,
IMPLANONshouldbeinsertedattheinnersideofthe
non-dominantupperarmabout8to10cmabovethe
medialepicondyleofthehumerus.
 •IMPLANONshouldbeinsertedsubdermally,
ie,justundertheskin(subcutaneously).
 •WhenIMPLANONisinsertedtoodeeply
(intramuscularlyorinthefascia),thismaycause
neuralorvasculardamage.Toodeepinsertions
havebeenassociatedwithparesthesia(dueto
neuraldamage)andmigrationoftheimplant(due
tointramuscularorfascialinsertion),andinrare
caseswithintravascularinsertion.Moreover,when
theimplantisinsertedtoodeeply,itmaynotbe
palpableandlocalizationand /orremovalcanbe
difcultlater.
 •Marktheinsertionsite.
 •Cleantheinsertionsitewithanantiseptic.
 •Anesthetizewithananestheticspray,orwith2mLoflidocaine
(1%)appliedjustundertheskinalongthe“insertioncanal.”
 •Removethesteriledisposableapplicatorcarrying
IMPLANONfromitsblister.
 •Whilekeepingtheshieldontheneedle,visuallyverifythe
presenceoftheimplant,seenasawhitebodyinsidethe
needletip.Iftheimplantisnotseen,tapthetopofthe
needleshieldagainstarmsurfacetobringtheimplantinto
theneedletip.Followingvisualconrmation,theimplant
shouldbeloweredbackintotheneedlebytappingitback
intotheneedletip.Theneedleshieldcannowberemoved.
 •Pleasenotethattheimplantcanfalloutoftheneedleprior
toinsertion.Therefore,alwaysholdtheapplicatorinthe
upwardposition(ie,withtheneedlepointedupward)until
thetimeofinsertion.Thisistopreventtheimplantfrom
droppingout.Keeptheneedleandtheimplantsterile.
Ifcontaminationoccurs,anewpackagewithanewsterile
applicatormustbeused.
ApplicatorforIMPLANON
IMPLANON™:ClinicalInformation
 •IMPLANONisasubdermal,long-acting,progestagen-only
contraceptiveeffectiveforupto3years.
 •ThemechanismsofactionofIMPLANONincludeinhibition
ofovulationandincreasesintheviscosityofcervicalmucus.
 •Efcacydoesnotdependondaily,weekly,ormonthly
self-administration.
  – IMPLANONiseffectivefromdayone,wheninser ted
accordingtoinstructionsinthelabel.
 •Nomethodofcontraceptionis100%effective—
IMPLANONisover99%effectivewheninserted
correctly. 1
  – Studiesshowacontinuationrateof82%after1yearofuse.2
  – 11%ofwomenstudieddiscontinuedIMPLANONdue
tobleedingirregularities.
•Bleedingirregularitiesmayincludeamenorrheaorinfrequent,
frequent,and/orprolongedbleeding.Information,counseling,
andtheuseofableedingdiarycanimprovethewoman’s
acceptanceofableedingpattern.
•FollowingremovalofIMPLANON,thehormoneisbelow
detectablelevelswithin7days.3
Bone Mineral Density
 •AcomparativestudyofIMPLANONandanon-hormonal
IUDshowedthatbonedensityremainedunalteredover
2years,withnodetectabledifferencebetweenusersof
eachcontraceptivemethod.
Breast Milk
 •AvailabledataindicatethatIMPLANONmaybeusedduring
lactationsinceitdoesnotinuencetheproductionor
thequalityofbreastmilk.However,itisimpor tanttobe
awarethatsmallamountsofetonogestrelareexcretedin
breastmilk.
 •InclinicalstudiesuseofIMPLANONhadnoeffectonthe
productionorqualityofbreastmilkinnursingmothers.
Adverse Events
•Headache
 •Weightincrease
 •Acne
 •Breastpain
 •Irregularmenstruation
 •Vaginalinfections
Contraindications
•UseofIMPLANONiscontraindicatedinpatientswith:
  – Knownorsuspectedpregnancy
  – Activevenousthromboembolicdisorder
  – Presenceofhistoryoflivertumors
(benignormalignant)
  – Presenceorhistoryofseverehepaticdiseaseaslong
asliverfunctionvalueshavenotreturnedtonormal
  – Knownorsuspectedsex-steroidsensitivemalignancies
  – Undiagnosedvaginalbleeding
  – Hypersensitivitytotheactivesubstanceortoanyof
theexcipientsofIMPLANON
Drug Interactions
 •Interactionscanoccurwithmedicinalproductsthat
inducemicrosomalenzymes,specicallycytochrome
P450enzymes,whichcanresultinincreasedclearance
ofsexhormones(eg,phenytoin,barbiturates,primidone,
bosentan,carbamazepine,rifampicin,andHIVmedication
[eg,ritonavir,nelnavir,nevirapine,efavirenz],andpossibly
alsooxcarbazepine,topiramate,felbamate,griseofulvin,and
theherbalremedySt.John’swort).
  Womenontreatmentwithanyofthesedrugsshould
temporarilyuseabarriermethodinadditiontoIMPLANON.
  Pleaserefertotheregulatory-approvedfullPrescribing
Informationforadditionalinteractions.
Pregnancy
 •IMPLANONisnotindicatedduringpregnancy.Ifpregnancy
occursduringuseofIMPLANON,theimplantshouldbe
removed.
 •Animalstudieshaveshownthatveryhighdosesof
progestagenicsubstancesmaycausemasculinizationof
femalefetuses.Extensiveepidemiologicalstudieshave
revealedneitheranincreasedriskofbirthdefectsin
childrenborntowomenwhousedoralcontraceptives
(OCs)priortopregnancy,norofateratogeniceffectwhen
OCswereinadvertentlyusedduringpregnancy.Although
thisprobablyappliestoallOCs,itisnotclearwhetherthis
isalsothecaseforIMPLANON.
KeyPointsforPatientCounseling
•Womenarelikelytohavechangesintheirmenstrual
bleedingpatternwithIMPLANON.Thesemayinclude
changesinbleedingfrequency,intensity,orduration;
however,thebleedingpatternexperiencedduringthe
rst3monthsisbroadlypredictiveoffuturebleeding
patternsformanywomen.
 •Amenorrheawasreportedinabout1of5women
whileanother1of5womenreportedfrequentand/or
prolongedbleeding.
 •Dysmenorrheatendedtoimprovewhileusing
IMPLANON.
 •Appropriatecounselingmaymakebleedingchangesmore
acceptableforwomen.
 •Keycounselingpointsinclude:
  – Discussionofthelikelihoodofalterationsinbleedingpatterns
  – Discussionoftherisks,benets,andpossiblesideeffects
 •Explaintheinsertionandremovalprocedures;emphasize
thattheimplantshouldalwaysbepalpableandthatscars
orcomplicationsmayoccur.
 •Ifpossible,providepatienteducationmaterials.
 •Allowsufcienttimeforthepatienttoreviewthe
educationalmaterials,consideroptions,andaskquestions.
PAGE: 1References: 1–Graesslin2008,2–Blumenthal2008,3–Davies1993 PAGE: 2

 •Stretchtheskinaroundtheinser tionsitewiththumband
indexnger(Figure1).
 •Inser trstonlythetipoftheneedle,slightlyangled(~20°)
(Figure2).
 •Releasetheskin.
 •Lowertheapplicatortoahorizontalposition(Figure3).
 •Whileliftingtheskin,gentlyinserttheneedletoitsfull
length.Donotexer tforce.Theneedleshouldbeinserted
paralleltotheskintoensurethatIMPLANONisinserted
superciallyjustundertheskin(Figure4).
 •Keeptheapplicatorparalleltothesurfaceoftheskin.
 •Whentheimplantisplacedtoodeeply,
paresthesiaandmigrationoftheimplantmay
occur.Moreover,removalcanbedifcultlater.
 •Breakthesealoftheapplicator(Figure5).
 •Turntheobturator90°(Figure6).
 •Fixtheobturatorwith1handparalleltothearmandwith
theotherhandslowlyretractthecannula(needle)outof
thearm(Figure7).
• Neverpushagainsttheobturator.
 •Checktheneedlefortheabsenceoftheimplant.After
retractionofthecannula,thegroovedtipoftheobturator
shouldbevisible(Figure8).
 •Alwaysverifythepresenceoftheimplantby
palpationandalsohavethewomanpalpateit
herself.
 •Incasetheimplantcannotbepalpatedorwhenthe
presenceoftheimplantisdoubtful,othermethodsmustbe
appliedtoconrmitspresence.Suitablemethodstolocate
theimplantarerstofallultrasound(USS)andsecondly
magneticresonanceimaging(MRI).Priortotheapplication
ofUSSorMRIforthelocalizationofIMPLANON,itis
recommendedtoconsultMSDforinstructions.
 •Incasetheseimagingmethodsfail,itisadvisedtoverifythe
presenceoftheimplantbymeasuringtheetonogestrellevel
inabloodsampleofthesubject.Inthiscase,MSDwillalso
providetheappropriateprocedure.
• UntilthepresenceofIMPLANONhasbeen
conrmed,acontraceptivebarriermethodmust
beused.
 •Applysterilegauzewithapressurebandagetoprevent
bruising.
 •FillouttheUserCardandhandittothepatientto
facilitateremovaloftheimplantlater.
 •Theapplicatorisforsingleuseonlyandmustbeadequately
disposedof,inaccordancewithlocalregulationsforthe
handlingofbiohazardouswaste.
LocalizingIMPLANON
 •Localizationisanessentialcomponentoftheinsertion
andremovalprocess.Palpationistherststepinthe
localizationprocess.
Alwayslocalizebypalpation:
– Immediatelyafterinser tion
– Immediatelypriortoremoval
 •Iftheimplantisnotpalpableafterinsertion,conrmits
presenceinthearmwithimagingtechniques(USS,MRI)as
soonaspossible.Thepatientmustuseaback-upmethod
ofcontraceptionuntilthepresenceofIMPLANONhas
beenconrmed.
 •Exploratorysurgeryforthepurposeofremoving
IMPLANONwithoutknowledgeoftheexactlocationof
theimplantisstrictlydiscouraged.
 •IMPLANONisnotradiopaqueandisnotvisibleonX-ray
orCTimages.
 •AlthoughIMPLANONisvisibleonMRIimages,ultrasound
isthepreferredimagingmethodbecauseitisleastinvasive.
AfterlocalizingtheimplantusingUSS,removalcanbe
completedwiththeassistanceofUSSguidance.
 •CharacteristicsofIMPLANONonUSS:
– Sharpacousticshadowbelowtheimplantinthe
transverseposition
– Implantisasmallechogenicspot(2mm)whenviewedin
thetransverseposition
 •MRI-Implantappearsasahypodensearea.Itisespecially
importanttodifferentiatetheimplantfrombloodvessels.
HowtoRemoveIMPLANON
 •RemovalofIMPLANONshouldbeperformedonlybya
healthcareproviderwhoisfamiliarwiththeprocedure.
PriortoremovalcarefullyreadthefullPrescribing
Information.
 •Indicationsforremoval
– Patientrequest
– Medicalindication
– Attheendof3yearsofuse
 •Ifthewomandoesnotwishtobecomepregnant,another
contraceptivemethodshouldbestartedimmediately
(returntonormalmenstrualcyclemaybeveryrapid).
 •Counselthepatientthoroughlypriortoremovalof
IMPLANON.
 •Anon-palpableimplantshouldalwaysrstbelocalizedby
eitherUSSorMRIbeforeremovalisattempted.Incase
ofdoubt,thepresenceofIMPLANONcanbeveriedby
etonogestreldetermination.
 •Exploratorysurgerywithoutknowledgeoftheexact
localizationoftheimplantisstrictlydiscouraged.Removalof
deeplyinsertedimplantsshouldbeconductedwithcaution
inordertopreventdamagetodeeperneuralorvascular
structuresinthearmandbeperformedbyhealthcare
providersfamiliarwiththeanatomyofthearm.
PAGE: 3PAGE: 4
Figure1 Figure2
Figure3 Figure4
Figure5 Figure6
Figure7 Figure8

PAGE: 5PAGE: 6
•Ifthetipoftheimplantisnotvisible,gentlyinsertaforceps
intotheincisionandgrasptheimplant(FiguresGandH).
Withasecondforceps,carefullydissectthetissuearoundthe
implant.Theimplantcanthenberemoved(FigureI).
•Closetheincisionwithabutteryclosure.
•Applysterilegauzewithapressurebandagetoprevent
bruising.
•Therehavebeenoccasionalreportsofdisplacementofthe
implant;usuallythisinvolvesminormovementrelativetothe
originalposition.Thismaycomplicatelocalizationoftheimplant
bypalpation,USS,and/orMRI,andremovalmayrequirea
largerincisionandmoretime.
•IfthewomanwouldliketocontinueusingIMPLANON,anew
implantmaybeinsertedimmediatelyaftertheoldimplantis
removed(see“HowtoreplaceIMPLANON”).
•IfthewomandoesnotwishtocontinueusingIMPLANON
anddoesnotwanttobecomepregnant,anothercontraceptive
methodshouldberecommended.
HowtoReplaceIMPLANON
 •ReplacementofIMPLANONshouldonlybeperformed
underasepticconditionsandonlybyahealthcareprovider
whoisfamiliarwiththeinsertionandremovalprocedure.
 •Immediatereplacementcanbedoneafterremovalof
thepreviousimplantasdescribedin“HowtoRemove
IMPLANON.”
 •TheproceduretoreplaceIMPLANONissimilartothe
insertionproceduredescribedinthesection“HowtoInsert
IMPLANON.”Thenewimplantcanbeinsertedinthesame
armandoftenthroughthesameincisionfromwhichthe
previousimplantwasremoved.Ifthesameincisionisbeingused,
thefollowinginstructionsmustalsobetakenintoaccount.
•Thesmallincisionoftheremovalprocedurecanbeused
astheentrancefortheneedleofthenewapplicator.
•Anesthetizetheinsertionsitewith2mLlidocaine(1%)
appliedjustundertheskincommencingattheremovalincision
alongthe“insertioncanal.”
•Duringreplacement,inser tingtheneedletoitsfulllengthis
crucial;failuretodosowillresultinapartlyvisibleimplant
intheremovalincisionintheskin.
 •Thepreciselocationoftheimplantisindicatedonthe
UserCard.
 •Locatetheimplantbypalpationandmarkthedistalend.
  (FigureA).
 •Washtheareaandapplyanantiseptic.
 •Anesthetizethearmwith0.5-1mLlidocaine(1%)atthesite
ofincision,whichisjustbelowthedistalendoftheimplant.
Note:Applytheanestheticundertheimplant.Application
abovetheimplantmakestheskinswell,whichmaycause
difcultiesinlocatingtheimplant(FigureB).
 •Pushdowntheproximaltiptoxtheimplant;abulgemay
appear,indicatingthedistalendoftheimplant.Startingbelow
thedistaltiptotheimplant,makealongitudinalincisionof2
mmtowardthedistaltipoftheimplant(FigureC).
 •Gentlypushtheimplanttowardstheincisionuntilthetipis
visible.Grasptheimplantwithforceps(preferably“mosquito”
forceps)andremoveit(FigureD).
 •Ifthetipoftheimplantisnotvisible,theremightbeformationof
brotictissuearoundtheimplant.Thebrotictissuecanbesplit
bycontinuingtocuttowardthedistaltipuntilthetipisclearly
visible.Removetheimplantwithforceps(FiguresEandF).
HowtoRemoveIMPLANON
FigureA
FigureD
FigureE FigureF
FigureB
FigureC
FigureG FigureH
FigureI

BeforeadministeringIMPLANON™,pleasereadtheaccompanying
PrescribingInformation.
Copyright©2013MerckSharp&DohmeB.V.,asubsidiaryofMerck&Co.,Inc.,WhitehouseStation,NJ,USA.
Allrightsreserved.WOMN-1086671-000008/13