Surgical Technique Single Incision POP Repair System Content ID: B-90-42(Rev 02), 11 August 2020 DescriptionDescription 2 2 This Thispublication publication describes describes detailed detailed recommended recommended procedures procedures for usingfor using Calistar Calistar S. S. This Thisbrochure brochure must must be readbe read and andunderstood understood prior prior to first to Calistarfirst Calistar S implantation. S implantation. It offersIt o ffersguidance guidance that thatyou youshould should heed, heed, but, but,as with as with any anysuch such technical technical guide, guide, each each surgeon surgeon must must con -con- sidersider the pather ticularparticular needs needs of each of each patient patient and andmake make appropriate appropriate adjustments adjustments when when and andas required. as required. FurtherFur thertraining training material material is available is available at Promedon at Promedon’s online’s online platfo platform: rwwm: www.promedon-urologypf.com.w.promedon-urologypf.com. In caseIn case of doubt of doubt with with regard regard to the to surgicalthe surgical technique, technique, we recommendwe recommend participation participation in a inworkshop a workshop prior prior to firstto surgefirst surgery. Pleasery. Please contact contact your your local local Promedon Promedon representative representative or distributor or distributor for fuforrther fur therinfo rinfomation.rmation. TableTable of of Content Content TABTLEAB OLEF COONF CTEONNTETSN TS 2 2 INDIINCADTIICONS,ATIONS, PRE CPRAUTECAUTIONSIONS AND AND WARN WARNINGISN GS 3 3 INTENINTDENEDD USEDE US E 3 3 INDINICADTIONICATIONS S 3 3 CONTRAINCONTRAINDICADTICIONATIONS S 3 3 WARNINGSWARNINGS AN DAN PRED CPREAUCTAUIONTIONS S 4 4 PATIPAENTITEN INTF OINRMFOARMTIONATI ONAN DAN ADFT AERCFTERCAREA RE 5 5 IMPLANIMPLANT CART CDAR D 5 5 GENEGERNEALR IANFOL INFORMARMTIOANTI O N 7 7 CALCISATARLIS TSAR KI ST KIT 7 7 FUNCFUNCTIONALITIONALITY OFTY TOFHE T RETRAHE RETRACTABCLTEAB INSELE INSERTIONRTION GUI GUIDE D E 8 8 FUNCFUNCTIONALITIONALITY OFTY TOFHE T KNOTHE KNOT PUSHE PUSHER R 8 8 SURSUGICRGALIC TAELC THNIQUECHNIQUE E 9 9 PREOPERPREOPERATIVAET CIVONSIDERE CONSIDERATIONATIONS S 9 9 POSIPOSITIONINTIONING G 9 9 SURGISURGICALC STEPAL STEPS S 9 9 SectSioenct I:io nFull I: Fullthickn thiessckn vaessgin vaaginl waal llwa dissell dctisseionct io n 10 -1011 -11 SectSioenct IIio: nM IIes: Mh esImhp lanImptalantiotan tion 12 -1220 -20 AckAcknowlenowledgmedgnmets:nts: PromeProdomendo acknn aocknwleodgwleedgs thees tfheollo fwolloingw ingsurg surgeonse onsfor hfoisr suphis posuprtpo inr tth ine thdeev edleopvemlopentm eontf t hoifs this surgicsuragicl technal techniqueiq guueid gue:id Peri: v .-PDriov.-z.D oDz.r. mDre.d m. ehad.b hail. bGil.e rGt Nerat umNaaumnnann InIdindicactioations,n s,Preca Precautionsutions and and W Waranirningnsgs 3 3 IntendedIntended use use CalistarCalistar S is Sintended is intended for transvaginalfor transvaginal reestablishment reestablishment and andreinforcement reinforcement of the of physiologicthe physiologic anatomyanatomy of the of femalethe female pelvic pelvic floor floor in the in definedthe defined patient patient population. population. IndicationsIndications CalistarCalistar S is Sindicated is indicated for thefor treatmentthe treatment of anterior of anterior pelvic pelvic organ organ prolapse prolapse in non-fe in non-fertile rwomentile women¹ ¹ withwith or without or without apical apical vaginal vaginal wall wall involvement involvement in both, in both, • recurrent• recurrent pelvic pelvic organ organ prolapse prolapse and and • prima• primary pelvicry pelvic organ organ prolapse, prolapse, when when other other surgical surgical procedures procedures are expectedare expected to fail to (i.e.fail (i.e.complex complex primaprimary prolapse)ry prolapse) defined defined by the by presencethe presence of at of least at least two tworisk factors:risk factors: • levator• levator avulsion avulsion inju rinjuy ry • family• family histo history ofr ypelvic of pelvic organ organ prolapse prolapse • enlarged• enlarged genital genital hiatus hiatus • advanced• advanced stage stage POP POP (≥POP-Q (≥POP-Q stage stage 3) 3) • pelvic• pelvic floor floor muscle muscle weakness weakness • multiparity• multiparity • younger• younger age age(<60 (<60 years years of age) of age) • collagen• collagen deficiency deficiency • co-morbidities• co-morbidities which which increase increase the intraabdominalthe intraabdominal pressure pressure such such as: as: • high• high body body mass mass index index • chronic• chronic obstructive obstructive pulmona pulmonary diseasery disease • chronic• chronic asthma asthma • chronic• chronic constipation. constipation. ContraindicationsContraindications CalistarCalistar S must S must not benot usedbe used in: in: • Fe• rtileFe rwomentile women • Patients• Patients with with active active or latent or latent infection infection of the of vagina,the vagina, cervix ce rorvix uterus or uterus • Patients• Patients with with previous previous or current or current vaginal, vaginal, cervical cervical or uterine or uterine cancer cancer • Previous,• Previous, current current or planned or planned pelvic pelvic radiation radiation therapy therapy • Known• Known allergy allergy to polypropylene. to polypropylene. ¹ Non-fe¹ Non-fertile rwomentile women are definedare defined as women as women in menopause in menopause (def: (def: absenceabsence of menstruationof menstruation for atfor leastat least one oneyear) year) or iatrogenicor iatrogenic causescauses (e.g. (e.g. hysterectom hysterectomy, sterilization)y, sterilization) which which exclude exclude women women permanentlypermanently from from becoming becoming pregnant. pregnant. WWaraningsrnings and and precautions precautions 4 4 The Theimplantation implantation of Calistarof Calistar S unfeasible.S unfeasible. The Therisk forrisk organfor organ inju -injuvaginal- vaginal inse rinsetionsrtions for atfor leastat least six six shouldshould be basedbe based on aon thorough a thorough ry causedry caused by meshby mesh removal removal may may weeks weeks after after surge surgery. ry. patientpatient assessment assessment as wellas wellas theas thebe higherbe higher than than the thebenefits benefits resul resul- - patientpatient’s individual’s individual characteristics characteristics ting tingfrom from this thisremoval. removal. Adverse Adverse Handling Handling of the of devicethe device and andpreferences. preferences. Please Please consider consider events events (e.g. (e.g. pain) pain) may may be persisbe persis- •- DO• DONOT NOT handle handle the theimplant implant the thefollowing following wa rningswarnings and andpre -pretent- tenteven even after after successful successful removal removal with with pointed, pointed, serrated, serrated, or sharpor sharp cautionscautions in thein thedecision decision for surfor - surof- theof mesh.the mesh. Therefore, Therefore, each each case case objects objects since since any anydamage, damage, per -per- geryge, clinicalry, clinical aspects, aspects, during during the theshould should be decidedbe decided individually individually at atforation, foration, or tearing or tearing can cancause cause de- de- surgicalsurgical procedure procedure or handling or handling of ofthe surgeonthe surgeon’s discretion.’s discretion. vice vicedamage damage and andor deficienc or deficiency. y. the devicethe device to avoid to avoid complications: complications: • A•void Avoid excessive excessive tension tension of the of the • Calistar• Calistar S must S must ON ONLY beLY usedbe used Surgical Surgical procedure procedure and andaftercare aftercareimplant.implant. by surgeonsby surgeons experienced experienced in trans in trans- •- DO• DONOT NOT deviate deviate from from the imthe- imMaximum- Maximum precautiona precautionary measuresry measures vaginalvaginal pelvic pelvic floor floor reconstruction. reconstruction.plantationplantation procedure procedure as described as described must must be takenbe taken when when connecting connecting • The• Thesurgical surgical technique technique brochu brochu- in- thein thesection section SURGICAL SURGICAL PRO PRO- the- theTAS TandAS andAAA AAA with with the theinser inser- - re (B-90-42)²re (B-90-42)² must must be readbe read and andCEDURE CEDURE of thisof thisIfU andIfU andsurgical surgical tion tionguides guides in order in order to ensure to ensure the the understoodunderstood PRIOR PRIOR to first to implantafirst implanta- technique- technique brochure brochure and andconsider consider integrity integrity of the of anchors.the anchors. tion tionof Calistar of Calistar S. S. patients’patients’ individual individual anatomical anatomical • A•void Avoid excessive excessive pressure pressure in the in the variationsvariations since since aberrations aberrations can canwrong wrong direction direction during during TAS TASand and ClinicalClinical aspects aspects and anddecision decision for forcause cause per forationperforation or inju or rinjuy ofr ysur of- surAAA- AAA placement. placement. surgesurgery ry roundingrounding tissue tissue and andorgans, organs, e.g. e.g. • T•obacco Tobacco use, use,poorly poorly controlled controlled blood blood vessels, vessels, nerves, ner ves,ureters, ureters, ure- ureGeneral- General aspects aspects diabetesdiabetes mellitus, mellitus, genital genital atroph atrophy, ythra,, thra, bladder bladder or bowelor bowel to avoidto avoid • DO• DONOT NOT use usethe theproduct product if if BodyBody Mass Mass Index Index > 30, > 30,and andcon -concomplications,- complications,