Botulinum Toxin : Dermal Filler Consent Form · 2017-10-06 · •Known hypersensitivity to...

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Transcript of Botulinum Toxin : Dermal Filler Consent Form · 2017-10-06 · •Known hypersensitivity to...

INSTRUCTIONSThisisaninformedconsentdocumentthathasbeenpreparedtohelpinformyouconcerninghyaluronidaseinjectionsandtherisksinvolved.Itisimportantthatyoureadthisinformationcarefullyandcompletely.Pleasereadeachpageandsigntheconsentatthebottompriortoyourtreatment.INTRODUCTIONHyaluronidase1500units isaprescriptiononly formulation, licensedandcommonlyusedtoboostabsorption or dispersal of drugs injected into the skin and has an off license use in aestheticmedicine.Hyaluronic Acid (HA) fillers are sterile gels consisting of non-animal stabilised hyaluronic acid forinjectionintotheskintocorrectfaciallines,wrinklesandfolds,forlipenhancementandforshapingfacialcontours.Hyaluronidase isanenzymewhichbreaksdownhyaluronicacid.Hyaluronicacid isthecomponentofdermalfillers,butisalsonaturallyoccurringintheskinandsofttissues.Occasionallydermalfillersneedtobedissolvedwhenthetreatmentoutcomeisunacceptable,whenanadversereactiontotheimplanthasoccurred,orthereisapossibilityofvascularocclusionand/orimpendingnecrosis(tissuedeath)whichcouldleadtothecompromiseofhealthytissue.RISKSOFHYALURONIDASEINJECTIONSEveryprocedureinvolvesacertainamountofrisk,anditisimportantthatyouunderstandthatrisksinvolved.Anindividual’schoicetoundergoaprocedureisbasedonthecomparisonoftherisktopotentialbenefit.Althoughthemajorityofpatientsdonotexperiencethesecomplications,youshoulddiscusseachofthemwithyourpractitionertomakesureyouunderstandtherisks,potentialcomplications,andconsequencesofhyaluronidaseinjections.Hyaluronidaseisanenzymewhichbreaksdownhyaluronicacidfillers,butitcanalsobreakdownnaturallyoccurringhyaluronicacidpresentinthebody,theresultscanbeunpredictableandtheeffectdramatic.Therewillbelossofvolumeandtherecanbesomeskinlaxitywhichinitselfmaynotprovideagoodaestheticresult.Althoughsomeoftheeffectscanbeimmediate,itcantakeupto14daysforthefinalresultstobeseenandthetreatmentmayneedtoberepeated.Allergicreactions;administrationcanresultinanaphylaxis,asevereallergicreactionwhichinitselfislifethreateningandrequiresimmediatemedicalattention.Allergicreactionsoccuratafrequencyof0.05%-0.69%.CAUTIONS&CONTRAINDICATIONS(Tobecheckedwithpatientpriortotreatment)

• Knownhypersensitivitytoingredientsoranyofitsexcipientse.g.Lidocaine• Anticoagulantuse(e.g.Warfarin/Aspirin)• Pregnancy/Breastfeeding• Infectedskinareae.g.coldsores/cellulitisetc

PATIENTCONSENT

DERMALFILLERANDBOTULINUMTOXININJECTIONSGeneralinformation-IconfirmthatIconsenttoreceivingtreatmentusingthemedicalproductsthatmypractitionerhasrecommendedtome.-Ihavebeeninformedthatthetreatmentiscarriedoutbyinjectionforthecorrectionofdermalfillertreatment(s)orwhenthereisapossibilityofvascularocclusionorimpendingnecrosiswhichcouldleadtocompromiseofhealthytissue.-Ihavebeengivensufficientinformationtoenablemetounderstandtheuseoftheseproductsfortheapprovedindications.-Iunderstandthatthoughcomplicationsareuncommon,theydosometimesoccur.Itispossiblethatsideeffectsnotdescribedmayoccurandindeedthatacomplicationnotpreviouslyreportedmayoccurforthefirsttime.-IunderstandifIsufferanyadversereactionsthatarenotexpected,orconcernme,Imustcontacttheclinic.Anappointmentwillbemadeformetobeseen.Thecliniccannottakeresponsibilityforcomplicationsorresultsthathavenotbeenreported,assessed,documentedandmanagedinatimelyfashion.-Ihavealsoreceivedinformationregardingcontraindicationstotheadministrationofproductsandpotentialsideeffects.-IunderstandthatwhilstIhavebeenadvisedastoaprobableresult,thisshouldnotbeinterpretedasaguarantee.-IconfirmthatIhavebeenprovidedwithverbalandwritteninformationaboutthistreatmentwhichincludesaftercareandfollowupadvice.-Iagreetofollowtheaftercareadviceandunderstandthisreducesriskofadversereactionsandhelpsensureoptimumresults.Generalinformationabouthyaluronidase-Hyaluronidase1500unitshasanoff-licenseuseinaestheticmedicineandexceptinthecaseofemergencyadministrationrequiresthepatienttoundergoaskinpatchtestatleasttwentyminutespriortotheprocedurebeingundertaken.Theskinpatchtestiscarriedoutbyinjectinghyaluronidaseintothesubcutaneoustissueoftheforearmandobservedforsignsofreaction(i.e.hivesorwheals).Ifapositivepatchtestresultisobserved,treatmentwithhyaluronidasecannotbecarriedout.Erythemaorrednessandslightvasodilationmaybeexpected.-Iunderstandthattherewillbelossofvolumeandtherecanbesomeskinlaxitywhichinitselfmaynotprovideagoodaestheticresult.-Althoughsomeoftheeffectscanbeimmediate,Iunderstandthatitcantakeupto14daysforthefinalresultstobeseenandthetreatmentmayneedtoberepeated.-Iunderstandthathyaluronidaseadministrationcanresultinanaphylaxisandhavebeengivenfullcounsellingandtheopportunitytodiscussthetreatmentwithhyaluronidase,conservativetreatmentoptionsorleavingthedermalfillertobreakdownnaturallywhichmaytakeseveralmonthsdependentonthetypeoffillerusedandtheareatreated.-TheuseofandtheindicationsfortheadministrationofhyaluronidasehavebeenexplainedtomebymypractitionerandIhavehadtheopportunitytohaveallquestionsansweredtomysatisfaction.-Afterthetreatmentsomeothercommoninjection-relatedreactionsmightoccur.Thesereactionsincluderedness,swelling,pain,itching,bruisingandtendernessattheinjectionsite.Theyhave

generallybeendescribedasmildtomoderateandtypicallyresolvespontaneouslyafewdaysafterinjection.Bruisingmayoccasionallybemoresignificant.-IacknowledgethatIwillhavetoremainattheclinicforthirtyminutesaftertheproceduresothatIcanbeobservedbythemedicalstaffandthatIwillneedtoreturntotheclinic2-3weeksaftertreatmenttoassessiffurtherhyaluronidaseistobeadministered.Photography-Iunderstandthatphotographswillbetakenthroughoutmytreatmentplanandwillformpartofmyconfidentialtreatmentrecords.Payment-IunderstandandagreethatallservicesrenderedtomearechargeddirectlytomeandthatIampersonallyresponsibleforpayment.Ifurtheragreeintheeventofnon-payment,tobearthecostofcollection,and/orcourtcostandreasonablelegalfees,shouldthisberequired.DataProtection-IunderstandinformationaboutmewillbetreatedasconfidentialandaccesstoitrestrictedinaccordancewiththeDataProtectionAct,unlessspecificpermissionsgiven.-Iunderstandthattheremaybecircumstancesinwhichmymedicalrecordswillneedtobesharedwithappropriateprofessionalstaff,suchasinthecaseofanemergencyorcomplication.IacknowledgethatIhavereadtheClinicTerms&Conditions,andtheforegoinginformedconsent,understandit,acceptthesefactsandagreetothetreatmentwithitsassociatedrisks.Iherebygiveconsenttoperformthisandallsubsequenttreatmentswiththeaboveunderstood.Iherebyreleasetheaestheticspractitioner,thepersoninjectingthehyaluronidaseandthefacilityfromliabilityassociatedwiththisprocedure.