botulinum toxin : dermal filler consent form · 2017-10-06 · •known hypersensitivity to...

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INSTRUCTIONS This is an informed consent document that has been prepared to help inform you concerning hyaluronidase injections and the risks involved. It is important that you read this information carefully and completely. Please read each page and sign the consent at the bottom prior to your treatment. INTRODUCTION Hyaluronidase 1500 units is a prescription only formulation, licensed and commonly used to boost absorption or dispersal of drugs injected into the skin and has an off license use in aesthetic medicine. Hyaluronic Acid (HA) fillers are sterile gels consisting of non-animal stabilised hyaluronic acid for injection into the skin to correct facial lines, wrinkles and folds, for lip enhancement and for shaping facial contours. Hyaluronidase is an enzyme which breaks down hyaluronic acid. Hyaluronic acid is the component of dermal fillers, but is also naturally occurring in the skin and soft tissues. Occasionally dermal fillers need to be dissolved when the treatment outcome is unacceptable, when an adverse reaction to the implant has occurred, or there is a possibility of vascular occlusion and/or impending necrosis (tissue death) which could lead to the compromise of healthy tissue. RISKS OF HYALURONIDASE INJECTIONS Every procedure involves a certain amount of risk, and it is important that you understand that risks involved. An individual’s choice to undergo a procedure is based on the comparison of the risk to potential benefit. Although the majority of patients do not experience these complications, you should discuss each of them with your practitioner to make sure you understand the risks, potential complications, and consequences of hyaluronidase injections. Hyaluronidase is an enzyme which breaks down hyaluronic acid fillers, but it can also break down naturally occurring hyaluronic acid present in the body, the results can be unpredictable and the effect dramatic. There will be loss of volume and there can be some skin laxity which in itself may not provide a good aesthetic result. Although some of the effects can be immediate, it can take up to 14 days for the final results to be seen and the treatment may need to be repeated. Allergic reactions; administration can result in anaphylaxis, a severe allergic reaction which in itself is life threatening and requires immediate medical attention. Allergic reactions occur at a frequency of 0.05% - 0.69%. CAUTIONS & CONTRAINDICATIONS (To be checked with patient prior to treatment)

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Page 1: Botulinum Toxin : Dermal Filler Consent Form · 2017-10-06 · •Known hypersensitivity to ingredients or any of its excipients e.g. Lidocaine • Anticoagulant use (e.g. Warfarin/Aspirin)

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)

Page 2: Botulinum Toxin : Dermal Filler Consent Form · 2017-10-06 · •Known hypersensitivity to ingredients or any of its excipients e.g. Lidocaine • Anticoagulant use (e.g. Warfarin/Aspirin)

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

Page 3: Botulinum Toxin : Dermal Filler Consent Form · 2017-10-06 · •Known hypersensitivity to ingredients or any of its excipients e.g. Lidocaine • Anticoagulant use (e.g. Warfarin/Aspirin)

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

Page 4: Botulinum Toxin : Dermal Filler Consent Form · 2017-10-06 · •Known hypersensitivity to ingredients or any of its excipients e.g. Lidocaine • Anticoagulant use (e.g. Warfarin/Aspirin)

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.