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337,Avenue de Bruxelles

83507 La Seyne-sur-Mer

Cedex FRANCE

tlflClOJ494109810

fax33 (0)49410 9811

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INFORMATlON-PRODUIT rj L'ATTENTlON DU CHIRURGIEN IMPLANTS MAMMAIRES PRE-REMPLfS DE GEL HAVTE COHESIVITECE 0197

PRODUCT INFORMATION FOR THE ATTENTION OF SURGEONS HIGH COHESIVITY GEL PRE-FILLED BREAST IMPLANTS CE 0797

PRODUKTSINFORMATlON IU HANDEN VON CHIRURGEN DIE MIT HOCHST KOHAslVEM GEL GEFOWEN BRVSTIMPLANTATEN CE 0797

INFORMACION DEL PRODUi�'J A LA ATElllCION DE LDS CIRWANDS PROTESIS MAMARIA PRE-RELLENADA DE GEL DE ALTA COHfSIVIDAD

(Gel de silicona) CE 0797

INFORMA�AO SOBRE 0 PRODUTD A ATEN�AO DE CIRURGIDES IMPLANTfS MAMAR/oS DE GEL DE ALTA COESAO CE 0797

INFORMAIIONI SUL PRODOTTO ALL 'ATTENIIONE DEI CHIRURGHI () PROTESI MAMMARIE PRE-RIEMPITE 01 GEL AD ALTA COESIVITA'CE 0797

, INFORMATlON-PRODUIT A L'ATTENTlON DU CHIRURGIEN

IMPLANTS MAMMAIRES PRE-REMPLlS DE GEL HAUTE COHESIVITE CE 0197

DESCRIPTION DU PRODUIT Lcsimplillltsml1l11mDirespre-rompltscJegclfwlltecohCJMtt1 sane SrERflfS, APfROCENES et IJ USAGE UNIQUE. C/mqlR! Implant est pte5r!nt9 SOUl doub/r! rond.f/OMemenr umralffJ pour a�ror la stMllttl er pormIJtrro une mtliIleure asepsledamRmpU/Dfum. C/lllqUC' unite 5(1 rompo$C : • rJe I'tmplnnc compose dlme enveloppe 8fJ elastom{J(e do silicone pre-rompfie de gollwule whdsivillt • O'UII premier blister en PUG 8vet open:ule Tyvek. .. • dUll Sf:ro/1C1 blf�ftJr en PEW avec opurr:;u/c Tyw.t- qUi po!W I'Ctlquetlc d'ldent lf/cilllDn do (Imp/am et {fIS trois CllquCUf':'S/lUlocollantlrsnoce.l5alrruausuMdIIlapalientfl III de ('''''plane. Ces etlquettf!s dOJVf1nt firm compltitl!es er collea�sur IllS documcnt$ (c latif5 .tl'illlorvrmtiOllet SlJI In "C,1rr1> o'idtHllifknlion do porl.our d'/mplanl � foumio lIVCC /,imp/,ml • d'lInO' tX)//o en polypmpyJlJ/1{) cOn!ennnt : • une nolico d'ln(mmat/()fI pmnultllhlfl/f{)/en et line p!adUlrlplIliante • (meficJmd�mplafltot/On 'Ur:.'"'jJ;" Ir.dOSUiVI

.: le de portcur dimplam P.tr-)JI �c un /Jl({)8 cflolr de tellfllj en profll� (stlmdard. /Illut:, derewnslructiOf!, o5ymetrlquo) 11 surface IIsso 011 texturCO. lcs volUmes dispon/bles varion! entm 85 cc er 705 c:t le volu/JIiJ exact do J'lmpltmt figure sur ret/QUeteo d'idenrlflcatlon direuomonr apMs la ((}f&'cnct!.

Le conrJ/lrrJl1f!8menr est l:!f(t'C/� sous IIUl Iswinoires er perrrmt done par oUlI()rturC!5 su«ossill()s des de�ll bli5tws rI'omCII�'r rlmp/llnt {J III pllt/o nte (Jons /es mellleure.� wmiltions daSfJpslc et flrxs conlnmrnntl0l1 parllculll!re. lJost ne�$Sa/redc verlfiorl';ntegfite dU ptOter:ttlUf IndlvidUfJI do sfrJrilit6 awmt US8gC; 10 t6moln doil euo dtl rou/�r violo t apros stdr/llsnt/on A I'oxyde d'!!thyllme. INDICATIONS · CtUfUrOlll tJ'augmenNlllon .' 01l1J ClH1515to ilaugmmrlN II?' volumc momm.lll0 par InsertIon de /'Implant. • ChifJJIgle flu f(JwrJSlrvctlon; ,o,,�ecU'IVO a {(JIJ/llc/on df;J liJ lotolilL' OU cl'unu portio d'w/a glDnda rflllmmll/ra leslU! ou callcereJJ5e (lMsfectomle). CONTRE·/NDICATIONS les impIBn/$ lIIilmm;J/ros P./.!' fIe doivellt pa5 etrc utl/j5lis • en ca� d'fnfelllc}II • en ellS do d6stm1res SY$Mmiqtltl.�. .pOUl"unepntlcntcily.lnftln/lcDIJ'l!!tlUmtl�5ulll/"c ImlcmpfOC ou Msoo. • pour IJne patll1nte ily<llll eu D11(JBrovant das ptoblffl3cS .1VL'C dlls implllnts mammllirl!� • enCllSdc frag//l/epJycllOlogiquedelllpnticnt e.

INFORMATIONS PRE Er POST,OPERATOIRES Toure �ntmMt/Ol1 cl!lMgicJJliJ peut fJX(X:rjIJf iI res coflplkol/oos "" .•• ]' .... t Cp�l1lcile�. Les rel1ct ions voire compl/ca/lons do ro dl.�cllt(!as at ronrprlSliS. 11 doll etm cloir que les .... , ms n8 sane pas po�s.1J vie mRls paUl uno dur6e vaJioblt! .qul dtlpend r.kJ la f1<J�UfO de l'impllml. cIos protQ(;Oles "pIYIlIOlrr:�, iJc faC(oU'5 IndiViduals er des ll�nemcnlS de la WIl. Do meme on ne petit /!XcII/re i'evcnIUBIit(J rfune ruprurc. l'at t enlion de la pa tiente daltOlfea!tiriJesur j'lInportencetfmfolmerlec/llrurglendoIOOlllwJl1PfrIl>nt mlnti f IJ sm; selllS. san Imp/tint lJU SDI' EfIVironnement. SonsquecOr/1J1!5toncsoltlfmirlltJVc.nOln{XXJVfHIl:citcr,'

• et SUf!our les trounUltJsmtt nIY.i/16nr, lIgres&ion ou pressJon of1()fmtJ/e sur 10 thoraJ. l..11ccflllfque d'implantslian r elwe do fa respol!S8biMe Cill CfJlrurglen Of de 50/! lXiuipe qui doit d�fder " • dutype rJ'irnplant (SJJrfacc.lallJo8tprofll) • du lleu d'implentatlon etde la voie(/'atxJrd.

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� u;,Qlcr�����·�fe ��:�; fi:n:;'!:' 5UMmue de compllQJtlans. Sa durne de vie fI(J peur dDnr: pilsctregifrantltJ.

INFORMATIONS UEES A L'IMPIANTATION

;i%!,p�:n�i�==!I:�'roOU::::=fir tIlJn re5lul/lsab/s, done non reutfllsable. .L'eflwloppaensi/lc()f.�pclJtdt,efaclIl!ffltNItcn� pllf 'cs JI!�troments clururgilaul OIl des mumpulations ltaurmWSIlnfes wmme IllS llliremGnts trap Importants • [vller lesvoies dfitJord troplltroite$ • Uti OSPlKe Irop n1strei nt 011 un Implant crop volurninCllX doiwHlt CIt"C cvltl!s.l/s pctJ\lent occosiOl1fJe( une mlcrose decompression - l'OCCIOI/ de mt!dlclJIlleT1f5 OIl ilUUllS prodults all contact

direct de I'ImpJanl na pas eM etudioo. 11 en est do �me pour IC$ IIti/islJlions nOfHXlflvmtiOTlllClles et Ifl$ modifirotions du nIBtflliel. 1fJ5 ;1.�o;odat{OM pt 1.1 mIse en awwe conjDfnle nI/cc dll/llres instruments OIl oPPilrelllagos. Le flT1J1idcn dolt �'a�r"f do la romparibilitt! des dlffrJr(lnlS tJlfWlcnlS c/llnslecontI1Jta. • Elimif!« f(!5 tremafomes pcur diminuer les rl5f/lles d'lnfeellCJn er de coque: UWIS{!/' un dmin quand c'est possilJle en pronont som de no plIs (Jt!fCIJr /'imp /nnt • U/i!isCf un fil de suture llrlllpM • No {JiJS utiliser da (/Cri� lodes (Illlergle) • fout 616monl gi!1!�flIleUf de portiroles (COlan, comprossc ... ). fe talc 00 ilutro oontlllninant de 5\Rface tblvcntetmpro.'ailS • l.i1rstfllla mlse enplece.llest lret:I.'1Safre d'effeclUlN un conu�/e preIJ/llble de I'mtegtlte de I'enveloppe par ccmptosslOf! dl?' I�mpl ant mammnlro. Ccvx qui prerenwnr uneperfClfRlion. ul!ot1/JdllnlffJ. IInafUlto. une hemione doivont pns 6treimplontCs. • MJJanUJi:> /u/swfen pfllrfJ ou cssayor dll ftJpalCf u n Implant qui nl:! solt pas ponDitament Intact.

EFFErS.INOESIRA8LES Er COMPUCATIONS U:JllltrIf!toutolntervemlfJTIlhlrvrglcala,cuttaopI1rOtiOn com{1i!fte certRl/15risques souvenrtrlJsdr1pMdl1nt�dfJS paramotrespafSCl1ne/s. Sans qUlJ cocte Jls/onew/c eJllmusr/lll!, nO/,lSjJQlNOI1sciter; H9matome : f!JSu/to de la wagulal/on tin sang dans /�S ��f�iJ::/ :�r:!I� tfaugmonl� la possibilif6

fnfectfoo:coflSlllterlmml!dforemCnlltJ{hlrurglrm, t'il/feet/an cM6 geflf!/"Blement au lrairement. msls pout, �clJe pcmiHe. nscesslterl'axplanltJl/()fI. klumulDlion dB liqvidc : PCllt $l.JIVMir immddia/6f1/9flt apres I'intervention ouquelqutJSterllpSnprl!5. Necr(J$fJ,' rVsulfO genomlcmonr d'uno CfJmpr�sion mrome qui emp&IJC CJU g�ne I'frrlgalion des linus. ma/s peul eue dueIJUrCrBltef1l8nt.sllssoc/es. fumdfaction : tlUgmentatian de IIO/ume. Capsuleoucoquoplln··protMUqlJlJ;c·flSCuncr�lJctfonrkr l«yanimJaonwrs/e corpslltrangerqueronstituerlf1l/J/lJllr. CeIul-c/S'entoured'un8coque fil;(euse qui vs progrossfve. ment durcir et le comprlrrwr. Co durcfSSllment vst p/m CJU mroin. � 1/ ""','.At", � nai ............ . �� ",,�-. ... II.'"

"est aIM nkC$SOiro de mal/sI!( uno capsuJotcmle. 01.1 mleux.uncC8p5UlecromJefl!!OJSSJtJJntune,,¥ISCt:NrurgFcals. IWpture de I7mpfant : /.it ruprllfll de re nvelappe. favorlsoo par 1'llrrr:fenIlf!M de /'Imp/nnt, t!t/l11f una complication qui peu.t pa$Sf1( fnapelCue. 1I est Im{lOltsnt de dcmal/d(f( aut patlenres de «mwltor /elu thlrurglerr en cas da chocs ou do fom eomptilSSIM (chule, coup. lIaldents Olc .•.. ). f:t�:/=/��e r;;u;=v::a:t:t! ':1l9�:a,;':f�rc prlsonnltfOSdans la C<lp5Ulep!fiprolllflClque) et/a rupcum IJxtft1caPSUIIJ/fl1. Dans ro dormer CI.lS. il faut d/st/nguer le phenomtne de dlfTuslon en pallte quantlt!! (nodule,' s/lIconome) de la rupture /mporto nte (sillconomes dans les tiSWS/lllOislnants). Asjomdlrie " ble n que tmn /e5 efforts du r:hif1JrglDJl so fent t/a$tlnf1s IJ obtonlr tll msilloure symdtrlo. certalns flJct� conmc III coque. la dt'pl/1Qi!T./II/l[ W /'Implunt 011 lanouxnie de la plJtlcnlfl pcwent causer tmll asymOIr1e. Altdr:lllondels$()nSll1/11l6duS{Jin. Ddpl!Jcomcnl dDI'lmpltlnt : un d6plBcement peut 50 prodtJlro all CO$W choccudecoquo Sl mtle situallon dovient inconfOlt8/)IO ou a/rere la forme du sam, une fIOUVt)fllI/nremmr/onffevlOnln�jre. Desorffres Immunitlliws : 11 D eM �vOqUd que IllS implllnts l7W1ImIJiro$ peuvDnt protIOqllflf dtJs mtlfadles tJutr;rlmmullf!S. Plls : solon la pos/tJM dD nmpllint (rAtto· au prd'p«tOfal), des pl/s �l'fIm OU8 vl$llltes en prur·opCrfJIolre en cas d8r11l1lgnssenJC.nr. CiJqu'JI fauts:JW)jr� • Pendanr les mois qui sulWlnt J'opdratlCJf1, Il es(consoille d'dvltor: .'05 oxpas/lfon s a u sololl (cieatr/ee. vole d'allDld). .iaprotique sportive(position IJltro.pcctoralo) • Radlogrophia ou maromographle : III presence d'un implanr mammalre dolt !lUll slgnaTIlo au fadiDloguo • L'innUfJnce dos proth�ses mammaires en petirxJe de grossesse n'aYlInt pas �Io etudl� la patif!llte dcvra �6IT1l1ntJerl'avirlJuchlrllffJlcnllvalltd'6I1vl58yerune Imp/lIntlltlan. • En i'obsenced'6tude c JiniqllC disponfblo /J cejour, 1/ n'est pas possible de COO/lll/fro la frnquent:o OkDC/O IkIs difldr(mtes ONnpJications telics qoo 111 canlmauro capStIllIlreet ia ruplUro.

CONDITIONS Of RfTOUR DES IMPlANTS AflndegorantlrqueseSCiJrBClerlstlquestfrx/gl(J(J ne solent pas altdrees, 11 est ImpllrBtJr quo rout Implant IWI uIfI151I solf retoumd dlms un (M/ai ro{sonnoblo b Poly /mplh nl5 ProtM$es, rondltlonnd commo IJ 10 livraison.

c'estlldlf8: -dOn:iSflSc!eU"WSffllS. • danssaooTlo enpofyprapyltlfM. Cnvol acrompIJgnd d'unc pllOrocople du borrforllCIU do livrlllS(ln du OIl (!cs proollllS lOfIcome5 OIl d'lln fom/uloire P./.P de I"lIcatu dB produlU 11 demander aUJ attach"s commefc{.ouxP.I,P,

POZ/fTJ/:j:.�r:e �e���es 83507 lA SEVNE SUg MEg Cede.

FRANCE

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PRODUCT INFORMATION FOR THE .; ATTENTION OF SURGEONS

HIGH COHESIVITY GEL PRE-FILLED BREAST IMPLANTS CE 0197

PRODUCT DESCRIPTION 7f"r::;::tl,:;m�� r:st�:J'anlS Ble STERILE,

Each Implanl is prosenl()(/ unc.Iilr dOUblo UIIItmy padrag!ng InordfJltatmSUfIJstetllltylJlldtJ/lawbettefasep5fStAJrm9 handfing • Encl1unit/Slfledeof. • /he Implant, mBC1e or a high Wl!e5Jvlty gal pm-fil/ed sJl/MfI8e/a�Dm8fShelllenV()lopo . • a fllStll//sterlnPUGwitlla /jM!k·cClWl; • lJ smmd tlllsrcr In PfTG WllI1a T}'\'\M1lt cmtr whICh btmts

theimp/Bnt'S IdfntificationlnbelllndllJp. t/n!eself-adhcsJvo /a1Jels� for roopatJents' and Ihfl lmplant's fDl/ow�. These /aoo/soo'A3rooofll/cd /nandsttJCktothflsurgfcal proccdure-rolBted documents 1100 on the " i"",ool beBmr's ldanlity cMd " cnclasDd wllh rho Implant _O{KllypropylOlKJOOItCOf1Ia/ning,' . SproduCtlnformatlantMfIotftxthesJl19l!Onandonofor rllOpnlient -8n ImplantntlMfotm • 1'J follOW.up fonn • lJIl '""Iant /.Je.oJ/W's identity cNd P.i.P off� B wide mngeofs/m in profiles (standard, hlgtr, tt'Cll'IStIlJCt 85}fmI1trJCaI) With SITIXJlh IX toxlLm1 sclface. Tha volumes available vary OOf'oKlen 85 cc &: 705 cc. nre JltXl mJume of the implant is if1CiJcatcd on the Identification 1:JboI.dlrr!ctIyRlr{}frhR� PllC/QIglng is I;lImcd out undor lam/nor fIwI proross ,met t/1/lS oflOWSbysucresslvelyopeningbollrbJlSlers tolYingrhe Implant to UJoptJfil"ltlt undet tlW11f?Stccntfllif1flSO(lJrep5/S am wlllffiUt IIny pan/cu/ar contammatltln. Check the InUgriCy of the Indillidua/ sterility prnt«tor btJfom US!!; IN (OIItro/ pstD, nxm turn violet 11ftm' ethyfeneoxldestNlllzation.

IIIDICATlONS -Augmenfllt/on �: If CMSists ln iooelJsing the bmasr �1tJm/1t1If1W9hIAA!ftlcn • 6ecotlSUllCllonsurgcry:ronsct:uliverotflllrcmoWllofpott o/Oflln cn/irtJdlJmagedr:tJl'!C«t!Il'Jmamnllll)'!}/nnd (mastJlCtoIt!Y),

CONTRA·IND/CATIONS P.I.P. L:rrenst Implants must not be used • In 1110 CIJS8of Infecrloo. . in tl!c!l'S5'Dofsystom/C dISMJers • on a patient WJ/JI unsuitAble a damaged tiSSU8 covet'. • on Il pallt'mf having peviously had Il problem With broiJ5r 111V1lants • In I/lCcaseofpsyrhologiwlfrailty oft.hepatll1flt

PRf AND POST·OPERATIV£ INFORMATION Any surgery can causo {ro- and posC-cpeffitJve rompIiC<ltlons T1rc re«tlorn - mm romplicaUons - must be /1I/Jwd Ilbout and understood. It must be made clear t/Jat 100 Implants Bf8 not. fitted fOf life. but for 11 wrlob/o pcIiod which dcpcrKbonrhenatlnldfflllll1f'/Mt:,theopxaUmp«Xt1d.lt!5 ond an IndilliduBl factoo and OK'tlt5ln tile patlent's IIfIJ. In theSlJmDWIJ.l\t.h8poSSlOifitydtlIVptu"Ccannotbeext:lJJded. The patient'::; Otl8rl[{on must 00 aav.n to the Ifll{JOIUJI!aJ of informing (he surgeon or �ny em'It fl!IBting fo fJe( brel1Sts. IhrJIrrp/iJJlt5 and her MVlrmmenr. K41 may menllon dmong orhefs :

• Mammography

��..:!::,�!!..m�!",�C:ltients. fWOSSIans 01

fhelmplant.atlmtedlnlqlleCOOlE'stll1dertfleSLKgf!Ol1Bnc1 hlstt'8msfl!SlXJl1Sib/llty. wllOhIlvelocllOOS8: • tllelmplllnrr,pe (surface .• size.prof1le) • tIrJ jmpllllltotion sire oml the lmen WDjoS An Impldnt h llS.1lihtlme thatC8n OOlNXtTllWiyI15[/f71lJfod s!nGlI;tdependsonlOOposstbloocanroncoofcomp/lcDrions. Sc Its IIfelimcalnnofbe[JU8f7lfltreti.

INFORMATION gElATING TO IMPLANTATION • If thIl pscJmglng If lJpM«f (JI'�, th6/mplant mtJJC be a:midtnd nM swile and non reskfjl;Zllble and tIII!ID'«'e- nan musabie. . • The Sllimne envempa clln be caslly dlJma!JfJd by SUfIJ/c1l1 /lIstrumcnts or by fOIJf/I hBndJlng sudl DSexressivestrel'

dling • Amid (N(!fly rwmw ImtHt RrellS • IIKJid OI'f!(ly mJftOW sporos a ovrJfiy Iwgo Implants. 1"heyconcousp.necrosIs throughaxnprossfal. • nlO effect of dugs Clf otJJef' fXlXItx:i$ in dJ1l!Ct tootBCI with lI10 impi(Jf!t has not boon stJ)diod. The same opplles to non·conventional uses IJnd la mOOlffcatiOlS of tho surglr:tJJ material. to lISSIXlntlons and use In CO/yundionwith other insUllmcnlS or equipment. The medical {XaCtitlOflDr shllll ched lhe complltibillty of tho vllfious oloment5 in their CWltcxt • Eliminate 8ny hlJcm8tomn5 In ader to redIJCD dlO riSkS dlofllCtllJll8lldtheft.rI'TMt/Onofcnpsularcontracrurn.Use ddrain�fXX&ibleMtl/JetlJklngcorenott()fltf!n'll IheimpJ811t. .lJsea suilDlJlDsutlR'8lhrf1ad • Donor use lOdil8/JrJer/vatiwS (alif!fJJllI!.) • Any oleroontsgenetlltingpBltlcJDs (rot/on COffI1Xesses). tolc, or any otll« SUTfilClJ cont.IJmlnatll79 agents mu.n be prohlfJlroQ • PriOflo th9 implBnr filflng. it Is nfJCllS5,BfJ to check IfJO envelope Integrity throug/J comprossIon of thobrt!lJlt Implant. Those with peri'ordtiOns. fvBf!. looks. Iwmias must not boimpJlJlflod. • N!!1Iflt Team in pJocn ntY try to repair an implant M1/Ctl /s tlOtperfoalyfntnd.

SIDE EFFECTS AND COMPLICATIONS Uke any .swget): I/IIS opemtion f:ilftics some fl$ks whfcll ofrBn depend strongly 011 personal paramelJ.'fS. We IIIi1j metllioo amangothcrs " H:lematon/llS":rosulrs f/1'llJlUlf!r:tJagu/at/onofDlOOdl n rhe tissues and I$/ikdy to Increa� the pDSSlllIJlty 01 ftJrmatlon of ''capsularcoolfll(ll6lJ#. /nfec;tlon;imme<1i8felyconsulfyour5I.Vgeon. TlltJlnfcct:lon /SJ11flCflJllycurodthroughtTmlunent, IJut lrlcpersIm, /t may reqUIte Implant rerooval llquidllCCUlTlUlatiOl"l. l1UJyOCClJfirnrnediIJle./Y8ftGftlla opemtlon Of some tlma afttxwards. Neaosls ; fflSUlts generally from en fntemal comprmion l'<fIictJ rmvenrs Of IJlndro IhI1 tissue IJ/ooIf supply. txIt can be duo la lJSSlXJerod treatme.nlS. Tumefactlon:lncroe5ein roIume. CIlpSl.llllfOfpcrJ-prosthouccontmctlKfl,'llfsulflorganlstn·s rnacrloo LOll fireignlxxJy. In tJliSC8S8 rhe/mpllInt, rhollllter Is 5IJfTCJIJtIded by a fibrous capwlllr axrtmcltJre whid, will ���=�t��'::;;=. Acapsull.ll"ctXltrl1CtumcanbocomearclrcmalyunplDMDnt drJddlstartcho Jmp/lInt. ItsiStJl!J1IfrfJCftSSllIJfOfll'5Oft(OacDpsuloc�OfOGtcer.

���s::.��:! ��:!�:,. n:::?::",,�:- r ... ",,� "'.

it is Impolfimt to ask lhe patlcnt.s tacornufthersurgron Int:lt59oflmpactorsuongpressure(fall,klck.aa:ldenlJ.

f����r:et�zmq{;=�Ofgol arelwpt In /he pMpr05tho1ic ClIpsvtO) Dndtl100}ftrlltilp5Ulofruplllre. In IhelBttorastLitl5 it17p(Xtanl to makoudlffcrence behveenrJ/o.dlrruslon� ln :;malt�.tlCi� (rnMc: si/lCOf)(I(1J(!) ofthe slgnifiaJntruplure (.sl/ICOf/OOf1"e In UlO sUf70undlng ci55lJeS). Asymmetry . fhougtJ oil the SIJ7!IOOf1S effOfts rend ro.v.!1d5 oDtlJlnlng lhe �t prmibitl S)mI/1C1Iy. some fllr0x5 5uch os ttef«mariDnr:lcapsu/sra:tfltracflXe.ltralnplontdi5p/lJct!mer!1 Of lhc p.llient's anatomy may CDltse BSymmel/)". II/ter/lUonOf rnenlppli1scnsJtlvliy, Imp/lint dlsplMemc.nr : dlsplllalT1Jllnt lI1Ily DCWr /n caso of iftJJI1daofformaIiCXIdr:apsularcontrlICllI'O.lfllJj$$ifIiBtion boc<Jmus unoomfCJftlJble or affects Iha broad wpo. a new Sllf9!aJlprocedurolsrequlred. 1rrtml.lf1/JdlsosderS: ir fJas bean mentioned tJllltDrOOst Impllll1ts CBn CIlIIie allro-immune diseases. Fal(h : depending on tha implant's position (relro· Of pre.peclOral),fCJldsmaybeseeninpmr-opemtlveil1cosc of (JlIllonf5' thinning.

.....� What )'DU must know : r "\ • During the months (OIiMng SUlgary. we fro. , ... .lld to lM)ic{: • UJmUf8WSUflI/gh1 (SClJr.lflSIJ/lWIJY). • PI!Jylnf) span (mlm·pectola/ position). • R1Idlography or ffllllnmogr.Jplry; rhfo flldlolOg!sr has t o ba InfOlmod af tIle prosence of a breasl Implant • As the itnpllCt of Mlast Imp/BillS flUting pregnancy IJru notooensrudied.tiTepatltmtslloulda5!t.Wrurgeons IJ(/vlrobcforeclN1sldlYingl1n impfant_ WiththolarJccfc!lnlaJlsIUcJ,·csllvaiIllbJer0d8y.ltlsimpossifl/o to Imow tile iXCUffltc frequcncyofthe verlr1UScomp/lcalions Its lifeUrt"X!ciln't be guiJ/ilntecd.

RETURN CONDITIONS FOR IMPLANTS Inurlertoernmll/lI1tltsorlgll1alr.llllfal:tqistics(IffJ{Xf158fVf!d. it Is Impemllvc C!wc ony Ui1IJscd Imp/MC 5hOUld /le retumf.'d Wlthlnllrea!M1blept!liOdto�/rrpI.�nrs�(ItIdtRfpI In t/ll!sonlCWOYlIsorlielfvory.l,ll. : .In/t�l\II'Jhliit� _In Itspolypropylermboit.

=J=:'����������/Jlble from thO P.I.P. cammer�JaI ottRdlJls..

POZ/,n;.e:!�t:(J ��xtt:�s�)s 83507 lA SEYNE SUR MER '" FRANCE

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PRODUKTSINFORMATlON ZU HANDEN VON CHIRURGEN

DIE MIT HOCHST K.oHAsIVEM GEL GEFOUTEN BRUSTIMPLANTATEN CE .0197

PROOIIKrSBESCHRElBIING 016 mit hikhst IcnhlJsivem Gel gefv/lten BlUstrmplDnlaten slnd keim/( ci, ap;,rogencs und ftJr elnmallge Benutwng. JrxIes Imptanwt iJt (HIrer oinhflirllchen .weif m;flM vt'rpBdung pm�l icrt. um die SreflllftllllJ IfY:iichem und sine � keimfrele Hllndhsbung III etlnubefl Jedeflnheitbestehtnus: • Da:> Imp/anw' 1st ilUS eirwr SIJlmEllJ5tomen·HiJJID, ge(Vllt mlr 1I0lint kahlis lvem Gel ZUSlI/t1II1Oflgtzt. • fin CfSt1JS Blister 811$ par;, mll clnem �- DKIwI • fin zwclU;j Bli51er litIS PUG. m/I elnem T}Wk- . Otxtcl, IMJlal8 dlIs Idontlfil<Btlonsctlbm dos Imp/anlnls und dio dioi sclbstJr/c!bend8n I1Ol.wendlgen Erlf<tJeten rot dlo UOOrwOChUng, {(Jf die Beuewng de! Pntienrln und die fOJ!}eIJbetwI1Chung deflmpl8nrBlStriJgt.DleseftllaJtllmsoJlenerganztlWtl1lrrl und auf die fuWmenfen aufgek/ebf \KnII!n (belOgliCh Duf del' E/ngriff und ebenso aut die IdMri(lk.1tit:lfl5kllrtn tMs implantBt·TrdgofS, mll dcr Implsntllt geliefcrt). • EineDose oU$Polypropylerl, wck;hetleilslter: · tine PrCXJllllfSmfOfIDBr lansnnlei r ung fiJt den Cllirurg und elne8lldemflJrdiePatientin, ·EI "1 _. .E;,I"", antnt.Tliigefi:8rW RI,P' sthlllgt sin brelUlf With'van GrMe III'Id Profllen (Swndard 0Cief IIoIJes Prom, fIokDnstnJktlon.. DSymmeu/scII) · glllrre oder rCXltlfcrte OberfTliche ra. Die \t1Ilm1!m I/lIriferen

=����%�O:n::S:::/�":r� IdentJfikDtionserlkett, OIS Vcrpnckung i�boMl'l]11r;srOl/igt IlfItet�rromund durch Dufe inDnderfo/gender! Dffnwgen � DIfJ/ SI/stem, eflaubt dIJ$ Implalltat ill dio be.ste esepllStile 8edingungen und oufJcr 5tlnderllflSCedcung lU dfe PIll/ent/n lJJ blingcn, fslst:no!�jgd;oUII�itdes'ndividueIlM SreriIJUll5beschiJtzN wr dem Gebrauch zu kOllrroll/emn ; Der InIIlkator SDI!. tIlJdI drJr StM/IJ/trIJIJfJ dutth Athy/M, w:rildl6flb l/Ju$t1ln. ANWEfSIINGEN

it:i::::niOJ;t;!��� ::er;:::rU;rscl:' cdlli/en, • Rckomtruktiomchlrurg/e ; N.:lUJ d6r OJ1'lf'JllvM fnlfemung I1)ng<tnzerodcrteilwrliser�lcwcnoderkrolJSlJrrigen Ilrustdnlse (Mastektomie) GEGENANZ£IGfN DleP.I,P. Brustlmplantamnsollennichl �r M.t'tlfM.'

./mFalleclnerlnlr!krion.

./mFllllesyslemisdIfNUlIOIdnungcn, • FtJretnef'ntionCJnmir elncr u nla!lChlidJlenrxiollKNlolZCcn Q:1w;OO-8cwaffisung. • far e ine Plltl/Nl!ln die schon m lt Implent1Jten SchWl/�WI gMebr hat .'mfnIlIJpsycholagischwFfagllitJjtderP:Jtlenlln

PRMiRArlVE UNO POSTOPERATIVE

. 1#; tAT/ON Jerk;.. rurgi5Che Inlervorrtioo/mnnPriJoperDCiveund Poslapctllril'8 KClmpliknUonen lIeI1IIS8Clien, Ole RcaWmen oder KDmpJlkatlomn SOIIen dislaJtierr um1 'r'mt.wlden 1WI'd!n. [sscllkltJrseln, dsss d lD ImpltmtarennlchlaufLeOOnszclt $OI'IdemfiJroinevertJrftieffidlefJaucr,'dieKVIdcr impJlJnta/$best;h.QffanlnlJtplatzkltM!fden...ond(m Opcmtiomprotokollen, loWl lien indlviduellen fskrDI'M IJIId lebcmerelgnis� ObhlJngl, Monn darf dit1 Mcl9I1CllAclt e/I!l!s

PIltienUn ct'rCfJC!f, was die Infcnnlerung des Omvrgs oolriffl, bcsontIcIs miC EroI!JflISSC In ZUSlJmmenllang mic iflref tJnJstc. Ihren /mp/am8len oder Umgcbung. Ohne das:s diese Lisle �pfcnd wird. IdJnnflll wir nonnen ," -NafJl(1'l()!fophle e UrKJ bruondets TflI!.miIS, UnfIJJI8. Angrlffo odeI aTlOl'mllfcr Dn.xknufderlTharai, Dlo Implantallonslechmk hI1ngt VI1Il dlir IiBrnntwMU'l9 d8sCll/rurgslJflC/�/rJC$rMm$Db,.de[ftJnJgeObef: eOcrln¥,IDlItatstyp(DIX!IfIAche.�/JndPrdiI) • Ocr ImplDntatlorup/atz und dilllugnngsbahn ent5Chclderl soli. �

�$e�":J�:/::'�I':n��kD��� ist.Die/!rpIBn!aw.l.ebemdalJl'r/t.ann�nichtgarantNrt """"" IMPLANTATIONSINFORMATlONfN • Mtrnndfe�geOffnllroderlJmlJBdlgtfst.SDlI din ImpJanUlt als n/tht Itslmrml und n lcht wlederneri/I. s/tNbar, a/so n/eht V6IIIIN1dbarbetnJchtlltwerden, _ Die SJl/cO/lh(}lfe MM felr:ht besdJ3digt IIe"den von chiflJ« gls'chen Il1StJ1J/1ItIfltlm f1d!r I'1IfIetzenc:lcn ManlpuJatkxJcn wlr: lJJ 511Jike Stnmmgen, -ZuschmolleZlJg;JngsbDtrnensindzul'flfmCidcn. _ E,'n 1lI OOxhrIinkres RlIum oder c,'n IV gtOI3c5 Implantm slnd IU IICfmoidan, Sic kOl)nwn alno KompressJOIIS.IIf)IIIOSO """""""'. e Das Wirlcen K>Il MlKfI1wmenten Dt1IJf KII1 anckrtJn Produktcn in direktm Kontnkt mlt d8m Impl8nt1Jt ist nitht gcptiJftWDrden. Auc/tfiJrc!i9 n;cllt JrlJflVootlomJlfIfI &niJtzungen rmrJ hMJsrungsvertJnderungen. di9 Verblndungen und gcmelnsomo OUthfDhnJng miC iJ/IdCron ImtnJmcnlCnrx:1«r1ppamwren, DcrPtekt l/Wrsol/slchvon der�inlwkeltdl.!rl'lltSdl/edenenElementen/mJ(lJlltexc

..... """. _ DIo HAmotome sJnd 1V eJimini/!lf!fl dam!t elm Infeldions·lrtJ Schalcn·Ri$k(mlVvtzrmindl!m,ElnDrani51ZIJ� II'I!(I(I:S mI>gI'(.h nllln s ol/ s/ch IiOIlIChten. urn d.as ImplnnMt nlth rdurr/Jir..llxJh.

e floo 8fl9CP/JiSla Ch/rurgf5Chc Ntlflseldebenutzcn. e Ke/nJotJIIaWges O&1l'8f bcnu/zcfl (AllClrJle) • JtxJmPtJrtilleln-CflCIlgenacsElemtNll (K011e, XlltllJnsse •• ,).T8IktJmlJdef�eObcr1lamcnsondstrxkef slJ/lenunceJSagt�,

e N/emals das Impl(JnttJc das niche VOllig heil 1st, in SlJlllc lasscnlJdr:l n lcmals �,lUrepar/eren. UNERWONSCHTE WIRKUNGEN UNO KOMPlIKATIONEN. Wle reI jedem chirw!}isdien /ljterventilJ() bel11lft dlf:5C 0per9tiorl gowissc R!!ken. die oil loOn peOOnltdlllf! PammcIM sbhSlIglg slnd, Otme dBSS dlesc List.e erschfJplCllcl wirU, Mnncn wir nemen : Hamatam: ftyebn/s aus!Jt!lOflflflnes BIut. In den � undktJnntedas�ithDE/Jd!Q/nen\lOl'lSthlJlIJtI/1IlJJ1M. InfeHiOll :so1ortdenChIrt¥f}kooWltJeren,DilJlnfekt/fl1l verxhwlndetlmallgemtJlflen,I18CJIt'IlIflrBohandlung,lJb8r /ram iIWII1$iefCrtdoUCft oine£xplonrationerflJlrJcm, flasslQkeIt:s5peidl81Ul1(J : kafVI sotar nach dem IntMmtloo lJderoinigerlsltsp,lJt()fIlf$t/lOI/lI!n. Nckrosl], e»'CDt Im /lltgcrnolnen!lU$ eincr jntcmon

beh/nQe(f. atHJl'lwTlFlalsfClJgedeilalOOlllfHtCfl rodJelnen. Sdn\(Jllung: �gtl8!rung des lWumen, KDpselrxJerper/prochctlstheSchale: Rcatllondas (kf/8nismus !JC9011 dem ffMllien KIkpcr. wn dcm Impl.ontar gtlWkIef. DIe5et hlJl /l s/ch In elfIfJ fi/xU,.e SUwIe, di9 hBrtetr unct <IrVck8n INird. Dirriff iIf1lMrtJJng kit mchr odcr wenlgcr nusgepr6gt. Sic kann klIurn rxbJr weniW �ichUw seln. Elm SchalfltannsehrUlJJll1flefle/rmllt'{cEttUl1ddiJs ImplJ1ntBr defamiernn, Esistnotw:Jndlg e1n KiJpsulcktomftlzubt:lhlJndclnodcrbesscr, eiTl8KlJpsuJektomia dlpoil1 flGfJQI" lnlfwMtl on b8n0rlgt. OIl! RupW/ oines Impilln18CS .' Im FDIIe ell'r!f1l Sross: IJder KDmxess(on (Fa/l. Unfsii. Schlag.,,). istllS sehtwldltig (fir ChIrurgZUkonsult/I!IlIll,

���� I��IrC:::�nrnert konnen gawisso falrrorM will cIifIl/OJfc, r;Jia Umstcllung des Implllntats. oder dill Anatomla d(Jf Palienr irt al()(J Asymmecrieve1lflBdlefl, Verschlor:hfl!flJ1l9dcrBrust-Sensiru/itlJt. UrTJ$tellung � ImplDtJtBfS: Iwrm I'fE'9E'n clnem 5toss /Jd(J{ Sdwle paSSict'etl. KImn dlf1S6 Siluotioo unongcnehm wim rxb'dleltusrfbmloD'lh::bt /stekln:w'/nI:tJleJlknrd'Nn:iig, Immun·Umon:Jnllngen .. t'S ist schcn gesagt � dass die Bru st/ mpfantaton 8u/olmmuWJ Kranklll'lit9n vertJTSachan tannen.

falce:JeIlllCl1d«FbsII/Q1c1e$lffVJllJIltnt5 (retnrOdcr pItlpekt0(8I), .tannen Fn/m (JIJSWPI1mtiv, nachAbmogcrung slchlb .. lf lWll1M

Wit! man w/JSf(J soli : • W81ItMddetAtlnatenll8ClrderOpera(lon,r5tesb/Jr(Jlen; "�/ungM (Narl:Ja.lUfJ811!J$b8/ln) . DasSport.TreJoon (1'ClropClkIaBIePosltfoo) IV vmnelt/cn, • RadlIJfTJJphlo oder Mammogtaphle : die Amms(!l1t/eit mn Implan18ttmlOllengcme/detWlNl1en, • Ocr Emn� I0Il lkusllmpllJlJ/lltrm, wDhrmd Sdlwllngor.;cheft, Ist nlQlt geprOftllQ'l1en, cllei'tJrlenUn sollrlieMclnungllrnsChlrurgsfmgon,/J6voranolnen ImpJantntJoo lJJdl!n1wn. eOlJookfinlsthoEtfOJSt:hungzullerfagung. IStesllOOro noch !Jllmcg/ir;h die grmue HlWfigbit 00r vrK5Chiodtmen Kompill0t lonen wle dl9 MfWJllIre KM/fDktlN' unci dic RrJptllflllgcbiJn.

ZUROCKSENOUNGS8EOINGUNGEN OER IMPLANTArfN : ODmitluyaranticren.dlU$dieU�jchellnu;ht

��rr$an::i;/:'�nno:t%s;,:�r:::chr Uoferung IIIlIp3dct. an Poly Implanf! PrOlJ� MOck!Ji1schlckt werden. dlJ$ h6IBt : _ m 28JISlem e/nausPD/ypfOfJylenDoren, \.W.wId' lOI eincrKopir:dru lfe footrrclns mn dcm cxJcr rim boltmffcntkvJ ProduJrlo(n) CIder WIll eincm PIP IUfiJcJcsendlmgsular dot i'rcxJlJktun begleltat, Iln PIP Kauf/t'tlllJllIarfordem,

PO�/."l�:"��e':f:;,�/e.:eS B3507 LA SEYNE SUR MER Cede,

FRANCE

!'I : �� 1f14;1!.4; �I!:!!.� �a.

INFORMACION DEL PRODUCTO •

A LA ATENCIDN DE LOS CIRUJANOS PROTESIS MAMARIA PRE-RELLENADA DE GEL DE Ami C.oHESIVIDAD

(Gel de silicona) CE .0197 OESCRIPCldN DEL PROOUCTO

�r:J���:Je;:lIt}ko;"fS.c:$:r!Oc��/:y�! � 8JmO usa Cst1JJ 1mp/llntB es ptesentlJOO baJCl triple l1ttNIilkJonamlcnto unl tarfo pora aseglJrof III esrerllld8cl y perm/lfr una mejOf /!Sepsis manle la tnlmlpulncloo, Code un/da d 56 compone : • rJeJ 1r7fJlenle. campuestCl de una can:asa de elastomero de silicoM pte·rellenada de gel de Sllitona _ de un ptJtrI8f blJufY en PfTC corJ IJtI operr;uJo T)Wk-•

- w un S«Undo bJister en PUG COO un op«r:u/r1 T� que lieva la etiqurJtll de identifiC</(;ldn del lmpllJnte y /as tm erJrpet.tIS 8UtoadJesl\lm necessrim parS el S/!I]lIimla1lo do la padent/l y del Imp/ante. fstDS et/quetos t1ebcn S& asmp/fmtH1t11rllK Y pI1fJlIdas ent/m» tflJ IllS documentt'd rollIlIVOSlJl8lntCfWlriOOymeilll8ljt1tareidcnlificacJor) dtllportIJriMdttllrnpJMtc aoosttPcidscon olimpltmttl, .rleunDCI!lBdcpollpropllfNl(JCOrICenlonc1o: · una nola de InformaclM del proctuctQ para c/ �/nJJano y unnpDfa lapar /Mte 'llrlllflchBdelmplanwelorr • una ficlu de segulm lBn/O " una taders de fdenrlficaciOn relecive 81 patadtx del Implllrrf1l P.1,Ppmpooo una amplfll eleccldnck1 famallos y pern/es (�,lllto.rectJIl:St11JCritJn,�metrlw)oonsuperflcie lIs;, 0 texfu1JdIJ, Los VDlu/1IMeS dlspon/bII1s vlNian Mire

:!:��O;u:!:I:=ft::���=:e� dchrroferoncls, El DCMdIcIonamlenoo $0 IIWiJ a Qlbo IMjo fhdo klminM Y asl pennlre. par tJpf!ftJXltS SIUISIv.u de BmOOs bllstlIfJ lievar el Imp/ante a Is psclentfl en illS meJrxes rondlc/ones de asepsis Y emnto de CCIltllmlnadon psrtlculm, El fflIUJllrio verlflCllf la lntegridlld., prottJCtot' Indlvfdulll dtt urarllldBd IIntu d,/ wo; el pstd! de nmtrolrIftHIlfN'dttQ)lor mrxetJo rlBspulfldo la astGriIlZBgidl! por at/do de erlfena.

INOICACIONES _ClrugllldeBUmtNfto:conslste en IIl1tl1111lt8re/vo/U/fJan msmar/IJ par InsorclOn del Impl8nte eCinI!J{D(JeIeCOO5tnx:cltJfr: ronsecutlVIIB ID IIbJaclon de la cot811r1Bd Cl dB una patte de 18 g lanclula mamaria, IesfOlllJdD 0 Cancerfg9lllJ (mastocfomls),

CONTRAINOICACIONES to! lmpl8ntrn rrMmarl()lS P.IP, no debtm ser utillzados : ellnt:MOOO infocridn _eneasodtJdestJrdcnesslstdmlcos • para UlPll pacICn/C que tnnga unll coberrum tirula{ Inm1IIptBdlJorIDnsc1lJ • paIS /JIIa potitll1to que tengn pmblemas CO'l/mplartes """"ri� • en '850 de frngilld/lrl psltofoglCll Go la PIIciente tin ImpllJnto tilJne una dlN'ac(Dn de V/dB que 50 pwdo

:==:���:':!!oo� Cl!s sefgaran r lda,

INFORMACldN PR£ Y PDS·OPERAroRIA CualqullY8ln1eNeJIClM qul/llly/ca pued8 pteStmtsr �/I:IItJonm pte Y p(JHJPN1ltor'1t1�. LIl5 reacclones, vet comp/ie«iOl'l6S. dcbenserdlscutidJJ5Yr:llmfJ«!IJdld/Js. ����que !�.lmp.'anlB.'!,na,se.co!lJC8ndefXX

yrkJloslJCOOCcamienlosdtJl1l VlciD,As/CU(JIIJ. ntJsepuede excllJlr ID ewmtualldlld d8 lJM ruptura, lk!be Il!talea� a ID pot/enla 5Obro la importflnclll da informsf fJ/ cifl!lllno lJterrtJ de lWI lqule f lJconrec/m/onttJ can m/acidn IJ sus S6/t()1, suimpJan/fJ 010 quose rodes. Sin quo 1St.! lists SfM IIm ltDdlI. podemDs citar .' • Mammografla • YscbrDtodormr.marrsmos.lK:Cldcntcs.lf!p!SJdnaprosldl1 snormol fin 01 fOI8X La remltlJ de implnntacioorelCV8de III respon$IJbl lidM1 al clfI!1snD y a su equlpo que rIeIJB r1l!tlr : • r/po de ItTfJltmf1l (supetficJl1 tamafoo. perr;f) • Lug8I tie ImplBnClICiIln y 10 vfD de Illxxdlljll

INFORMACldN LlGADA A LA IMPlANTACION • SI eJ _se es ab/em 11 daIuJdo, sllmplontl1 d. £OfIslderam como no e.stl1lll y no nNlsm/Uzat1l" asr f'W' lIO te.ufIlfZIJI1/o. • LB envoIlUfD rJe sllicooS pued9 ser f�c1lmenrfl d8f18de par /os instrumentas qu ln1(glcos 0 msnipulacitJ1lSs IrfJu­mat lun/os coma esUflIm lanto5 rlemasinoo Imporfa ntes - Ellitar les vlO$ tkJ 8borrJ1Jje demaSl8do cSff!lduls e lInespaclO reru:1do 0"00 implDnle demllslsooKl/uminaro debe ev/I8/J8. Pudtm ocmI{J(UJf IlTU! mxrosJs 00 tr:lII7{JfI1S1dn _ La lKXi"n de mtJCficilmento s /J ouos produrros en cont8Cto ccn e llmpJanre f)(} ha sldo �ludll'Jdo, 19uafmDnte utlllzt1Ciont1s no rotIVfJfIC/cn8/as, modJncaciDneS del material, lUOCieciones y pt/adDS conjunfO con otros

:=�I�=:U::;�I�C�=t:de=;: _ flimif18f 10$ hsmaotom,7$ para dlsmlnuir 1(1$ ,lcsgm do inrecciOn de 1.8 CMt".!!S8. Utll/m un drensje Wllndo SII� "."ibie, tenllHldo culdllllo de no rewmrOT el l mpllJllte, • UtIIltllf CRI hila de IDCIXIl fldaptBrlo • Nautlllzllfi/erivodo$ dcyrxJo (a/erglo). - ToUos los flromvntoJ que PUCcHm geneIllr Pllnfrv los (8Igotkk!,comproSll".),tlJlcouo/ID5W11llJmll!8ntBSClfJ supelnclfl deben do scr prohit1ldos. • En cl tnOman/o do /a colococidn, os nllC85IJrio reslil1lr LI'lt:alrrolfYlNiod&/alntxlfTidadde/aCllroNlpor�ldrJ dol Implanto mamallo. Los quo (N83CfIron pm1VmcICn, tlp8rtlJfll, fuga IJ estrongulat:/6n no delJen sor ImplentarJos.

e No lktlar mmeR implBn18r1o Cl /ntentar ropar81 un Implantequo no IlStsperfectamente/ntscto

EFECTDS INOESEABLES V COMPLICACIDNES L'Dmowalqull!f/nletvenci6nquil1JtgiCA. J!jl'.9optY(lCi6n c:amp!rfIlD/gun(JSr/esgoS8menuckJ� t1cpendJentCSrk1 panJmet10S petSDIl8/t!$, Sin QUIt estD (Isra 110 sea e.rhDustl¥a pctJemosclW: Hml1JJtomiJ : /¥!SUllado d() M c""fIUl.tcidn de $8ngtC et! /()$ tt!Jickn.l cs susceptfble rJe ilumtntar Is poslbllldod de lJplNlclan de conl1DCtUTB CI!Ipw/ar: InfecclOt'/: consttltar InmediatBment81l/ cif/!1If1lO. L8 Infeccldn cede generolmenlfl 01 tralamiMla (WO pued8. si pMtis t e. rt«I}$/tlJrfIXp/DntlJcifItl. Awmul�/dn de J(qulrlo .' puadc SlIrg/1 InmedilJtalmmefo dDSpuds dD III Intorvene/on 0 a/glin tlempo dosputlS, Necrosis: rosulw fJMflfDlmenl e de una annpms/on InlemB que 1mpJd6 0 mo lestll /8 1rr/9lIt1M de /os t�id(J$ polO puBd115111 dtJbida " tItItamionto lr5O&indos. TUITI6facclon ." DumMllo del mlllm6n

C;Jp5lJlao�psvI8per/prorfjtica: es una(f!aa;iOlldel rJf!J8nismolUltMelr:uerpoe.rttmloqutlcomt/tll}9e1 imp/anle, [src /0 envue/ve en UrI8 cl3pW/(J fib-osa que VD fXO'!esi��le �ltUIdose ,rompr!m��se .. [ste

muy pow Cl md5 petcepllble. Une alp5ulD p[Jf)Of! scr muy desagrsdDblc y deformof ef ImplMte. £$ nOClJSo'J r lo enrO/1C8j realftDf unll ruplUra de In C/lpSUID 0 mwOf' una

CDp5UIIJctomllltliJtiuJtsndoufIDre.lntlJNitl1C/on, Ruptum rlfll implantl: : Coma la ruptllTll del lmpl Dnlo fallOl'iNJdhporlD ant lgOi!dJJddel lmpJanroesUf)IJ CDmpllca,idn quo puede 5",- inm1verrldJJ, es Imp:xtantc perJfr n Im JNlcie'lltes tomultaf ID clfl!l600 en C/lSO de

�,!sc:;s:; =�=a;�;}�pf::D.)

' IlllrscapsWM (plJQUellDs CIHIt/d8tk$ de {}f1llpN.!dan pres.s! en la wpsula periprotHlr;a) y la ruplura IJXfltJCapwlar. En e1 Ultimo C8SO, se debe hacB' una difrrmda enue el fer)()mono de dlfusion en pequchas cancldat1es (nDduIo ; sllIcdnomo) tie /a ruptura ;mpottDnte (sillcCOOlno en /0$ r�lcJ05 conr lguos), Aslmetr/B:spl!SBrd9que rodosllJSblfUIKZDJtJelclrqjtuVJ Q$UIn desr/flbdos a obfBnor ID mlSI1l/1 slmell/a, algunoj fbelMs COt1IO /a UpsuliI. DI d.e!p19Mm/(IfI/O delltnp'lln� o la llfIDtomffJ 00 la padcnm puedcn cxigiMf una Illirfl6tIfll A/r etac lOll CIolasnnslbllldarlClolp91Dn, Despl1J7omlenco del imp lantf! : puedo protJUfCifS(J on C9SL'l dBgo/P90 de C8PlullJC ldn. SI est.asitUDC ldn $0 vuelveno ::��%%�:::i�� la farmD del sono. liS necoSo'l·' .... 7 f::,::s�:::!:�::=�t:f::��W -

8urolMKm/J$, Pllegtm : 5e9r1n la posiciM del lmplanre (retro- 0 prB' pectoml), plloyoos pucdcn 8pllreccr � tos implantes y set' r/sllJ/m IJ ua�s de /Os $IlflQl. Los quB hsy qUe saller : • Oumnto 105 meses que siguen a la operaclon os Dt:DfU8joblS,,,,It.tJI, • La 8lf)OSIdon al sol (ciC8lfit. vflJ rJe D�e). "Lapnlct:lcDcieponlva (po5iCll1llr8tropeCtOll1I) • _R/JtJlogrllfllJ OrTl/Jf1'/O!}T?JrllJ:sedet1r!lnfrxmlllall1KJlo/ogO 18 pmsencfD de un Impllmte mamDrlCl e Ln inllutll1cf8 lis /as ptdte!lf rMmar/lIs dIlronte et embarszo no ha sido esturJiado, In J18,;ente debel'll t:OIlsuJUlflJl cifl!ll1nD8nresdededdir:;coU1llllmp/onuJClrJn. Coo 10 8�Ja do 8SIuc1iCM cffnlcos dlsponl/lles noy. no esprulb/eCOlltxerllJfrecucncillemctacielasdl(etences comp/lc8cIlJIII!S. Su dlEaclcJn de vlda no fXJede S9f garantld3,

CONOICIONES Of OH'OWCIdN DE IMPLANrES A fin rIB f}IJf1Jnt lllJ( qutI sus c;a'acter/:st/t;JJ3 de rxlgen no fe8n s lw/ldss M ImpeFi�rjlN) que CUlJlquiDt Imp/snM no ulitIZOOO5elJc1eVOOIW8rlUnpetlodoflllDflilbleDP.I.P. 8CMdiCIOfIlJdo coma IJ 5lI entrega. es decir : eCnsmrJosbllsrers. - Cn su clll' de pollprop/leno, E/ envlo se arompat1ar3 de lUIa forocopla del albBran

��t.:.P,�e':::;=c=�:re:; '�aJ: hey qoop6d/r IJ los ogellte, comen:ieles do P.I.P"

) Po�!."}.f!�r:, ��;;:,e.:es

83507 LA SfYNE SIIR MER Cedex FRANCE

Tel: 33 (0)4.94.10.98.10 Fax: 33 (0)4.94.10.98.11

• INF.ORMACAg SOBRE 0 PROPUTO A ATENCAO DE CIRURGIOES

IMPLANTES MAMARJOS DE GEL DE ALTA COEsAo CE 0197

DfSCRI(:AD DO PRDOUTD

:;l/io:��":Efil�LllADOtAPiR!iGfN1�� �e = paw !ISO ONfCO. A lJ{JfI)SMfllCtJO unlrtJrla de (adD ImpllJJltD d (aifa IlI7I acondiclonamento dupJo pIlf(J assegurar D ostt:rilidade e perm/err urn melhor m&lU5ellmonto ('111 condJcoes IJsstJpriCB. ... Cada un/claw e composto par: • ImpJanre. lXJIlS/stlnoo twm IJIImtlX1Cl elll5fOm1WJ da sllicom prov!amente cflelo wm yr.! do a/tll COt1SiI'o • UIIl pt/mc/m JDCO 'petJ1-fJff'de PErG CCJm vpdrw/o Tywk-• urn segundo SlJCO �I.f),r de PUG tom opercula fyvak"', coowndo D etlquof8 da idenllfica,Jo do imp/ante e 8S Ul!s er/queeas aulocafantes ncce55tlnal p;1rtJ 0 scgutmento postorior dll pacfente e do 1"'Pllmle. E�llIS erlquctas riel'flm �cr p":enchfrIDs e CO/jJUBS no� dlXumentos rollJUVOS a Imetv0nt;8o 0 no "cart80 do idcnrlficar:tJo de portndcrB de impIDntf!" lnc/U(dO corn 0 ImpliJnte. • UffliJ pcqllflll8 ma/ela dtJ poJlpropifeno crmrnndo: - um (olheto wm infiHmar:IJO S(JM o produfO - uma flJ;h.l lmplJlntnCiJO - uma \ .

I seyulmenlo - um CiJJ:":'_ c pOtttldOfo de implonre A PIP ofereto /JITID lI(]stn gama do tRmanllos af1l fJ(!rfis oe superlTde li5lJ ClJ tCXlurizl1da (stiIOOtJrd. {llto, dererons�, iJ$Sf�fflOO). Os VOlllf1/eS disponlllr!ls v/lrilJm enllt> 85 cc IJ 705 cc, 0 volume l1Xacto do Imp/ante e5f<l lndlcado na ell· quera de ldenUn�c.af), logo opOs a referencia. o acoodiciCO'lanmto t1a enw!agem /} e(Q:fwIoo nlIm fYl)CeSSlJ dD flul(o fllm/nar (J perm/t(J /lSSlm -StfD\II1s dIJs abeituros sucessivlls dasdois sacos - quQ o imp/anlll c/Jcg!J8 i1 pacioole oos rntllh()fos condiCGes rJa assepsia e 5efll qlloJquer ,ontamin.'il�ao particular. t nt:alSS4rio verlr/CDr a Inte{Tldade do protector IndllllduaJ de eshlrlf/dada anres da utIl/ZIJ�lJD: 0 indlcJJdor de controlo dllW1 flear roxo dopo/f do eSlerlllzacAo por dx/do de etifeno.

INDlCAC6ES • Cirurgia de aumemo: conslsto em aumentllr 0 volutrKl da mama alfllvlJs da Inscrp10 do Implanle . • Cirurgia Iet:OI1Strutiva: devlrk IJ (em�o de parle ou cowlldndc dlJ f1Iaf1la lcsionado ou cancerosa (masrecromiD)

CONTRA-INDlCA�{)ES Os fmplente5 mamar/o$ da PIP n80 d8vem ser utlJlzadDs . om �� de infrJlxbo • cm caso de desordans s/�tCmlclls - em pncientlls CDf1I ter:ido do COlHlffum frllldaqundo DU lesioswdo • VIII paciunta5 qu�Jd allfC:S t/lNriJnI urn probrllfllll tom imp/iJnC� mamiJlfos • cm ell50 dv flagilidoda psicol6glca do plIdente

INFORMA(:Ao PRl· f POS·DPERATORIA QUQ/qIJo",,"O· /a pode calo'sar compJJca� pre- 6 pos. Gpfrato' : , reaccrtcs - lJt� rompllcllCQes - dev/lm ser d/seulidb.. . wompreendldas. DtJwN6 tornar tJastanta dam que os impJantes mlo SRO (elt05 pam toda a v/da, mB5 fWl! lH11 piYfodo tkJ tMlpD vari./lI'il/. que depende da nafUleZll dO lfnplante, dos processos opc1alrJrIas e dc (ectores illdlv/duais 0 Ilcontcclrrnmrtis da IIlds do paclllntll. Do mcsmo modo. nlIo se pode &Xlufr IJ POS5lbllldsdc chJmIJ rupwra. lMvq.se cfllJmtJra arent;tJo dIJ pacMncep"1iJ a imporrRrc/a de InfOntllJf 0 dWfQItJo de rpa/qJer /lr;Q'Iredlle'lto

ainblente pt]ssaal. Podomos menclonar, cntfO curros (ar:forcs' • RadiGtenlplll _ I!. �rudo. tt'JIulntltlsmos. ncfrli!ntt!5. Ilgm�SM� OIl presslJO IJT1OfmB/5obn1o tOflJX A tlknlca de rmplanta�o f} da fBsponsnbllldade do clrur-9180 e aa sua eqlJfpa, que r&f8O de cscolhcr,' _ 0 tlPO de Implsnw (superffCIQ, tamanhO IJ perfil) • IJ locol/�80 do implantlJ e 0 modo do i�o Um Implante (em uma durQ�(Jo do vida que a priori nlJo pods $81' cs/tu/ada mm precl,VJo pols depend8 do 8Ventual IJpnfecJmenfD de romplicnroos. A sua dutatIJo de llida nso pode polsS8l 9llrl1nridIJ.

INFORMA�Ao RELATIVA A IMPLANTA(:AO • Se a emb.tJlagem IUtiver aOOm ou dantnc8da, 0 fmpl8nte deVE! ser con,idcrodo 040 estcrililadO, nSll re·�Jlerflfz6V8I e,. portanto, nlo UtilIZBIIJJ/. • 0 envdlucro do sllfcona pede (l/l;J!mente S8I dIJnific8do por lmrrumcnto:; eirUl'glcos cu P'X mlInL1:5CBl1lI!rllo lrnpt"dprlo. como a d/stonsJlG oxcOSSlva. _ [v/tlJras l1reas de iruetUlodemlJs/IJdo e:;treirll! • Cvirar lIS fJ$piJf.OS demasiadamente esttllltQs OIl 05 imp/tIIltcs t1ema�i<kklmqntD gron<!cs. Podt1m c"�r nl.'Cl'owpor r:om{.l1eSS9O. _ N80 hll esrudas 50bre 0 efeilo dIl dTOoas ou outros produros em conlBCto dlrec/o com D Implante. 0 mesmo se epl/ca /J utlllmcoos nbo convene/onaTs e a modlficaCO#)s do matelilll CifUtgiCO, lJ /lS5oci�es e U50 em COIyunlo com OIIUDS irutIlJmWltos 011 equipameflto. {J �ico dovera 8valiiJr IJ .:;ompotibif/cMde dos I'Ilrios elemcnto.s no seu conrcxto. • EfimlfUJr qW/lsquer hemalomas lJ (lm tie reauzlr 0 flsea de lnfeqJJrl 9 (�ao de caPsu/H. Sempm quep0S5fvr!1 usar um drcno ICtIdo 0 cuidHdo tJeo nbO peffumr 0 impflmro. • IJ5IJr urn flo rill wfuro aproprlodo. - N!Jo utillzsrdemDdos locledru (a/erg/a), • llcIIe serprolbido o uso de qUIlJquer e/etm!nto que pr(ICIIJw portleulos (Jlgod/lQ, eomprDSsos ... ), CQlco, ou qualquer agente rorstamlflsdOrda wfJ/Jrflc/e. _ Antnsoo apllcacao oo lmplsnte. ri necllSSllrlc veriflcar a integfldarlll do envelO{le atravrlSda compress�o do Implbnle mntnllrlo. Nao devcm scr implsntsdos os qu� tiVlYUlnp8�, (asg6es, fUgtJS GU bollrtJj. • NIllIUl dolxar ImplanUJdo nem tenrar rCf1llmr urn (mplanee quo nao os!rUa perfeiUJmcntrJ inrocco,

fFElTOS SECUNOARIOS E COMPLJCACOfS Camo quolquer oll/rll elrwgm, esto Operllfbo envoJvq aI9(Jf!S rlscas que m(J/tllS IleZe5 depenrlilm frxtt!f1l(!f!te de partJmetros pessoaK Podr!mos mencfonar algullS 00105: Hcmatontlls : le5ultam da 00lJgIJI8(:80 dO SBrtgUe nos eccl· dos e lli11ll6fltilm a poSSibllidade de (oo1li1rao de cClpsula. Irlfc�o ; cOIl5ultar 0 cJfIlf!/l/kI lmcd{iJtllmCnle. Gnla/menfG. () tmcamento cura a /nfucr30, mas. se fISt;)

j.Xlols!Jf, pode 511f flflCf1SSIlrlo rcmai'lll'" 0 implantu. AwmUrBC80 de /(qufdo : pode rsrificsr,sfl /madfatBmen19 aplls a operatlJo ou algum tempo dJlpois. �: nuultB gefJllmente dumil compreSsAo Inteme que Jrnpode DU dmeulm II irrl91lf80 do:; tt(;ldos, rmlS pode Set devldll a uatamunws ilssoclados. rlJJ7/efllqJJO : aumentD de volume

=I:l::!:.�a:e::!::' �j!;:::�.�/::r:a�";do

per UIllB c$psulll fillrosu qJJ8 endurer:e prognmlVtJmente e o wmorlme, 0 DflXCS!iO de encturecimcnto e mals DU

A capsula pode tornar·se !ll'tremamC/lCe desagladilvel IJ dlstorceI O (p1PlanllJ. Tana·se entao netesSJrlo efecflJ8r uma c.apsulectomla, ou a{nrJa, uma PJpsuler:tomla ccm noYl! IntefWnpJo elnJrylCIJ. RupWta do imp/anlD : A ruptura aD envo/uclO, (avoreC/da pela antlgulfJada do Imp/ame, il uma t:(JmpJ/CIl�tJo quI pode paS5ar dospercebidB, sendo JmportHl1le pOO/r �s PIJl;iootasqlJQ r:onsultem o SIlII ciruryiAoem ctlSO cl6 lmpatros OtJcompres1SO foITlI (queda, poncadlJs. .ac/den�s etc •.• .).

'(;t:rr;pv::,z;'(t: cfoi5 � �n7J:'��: ��1dDS nD

Wp5Ula perlprotDt:r: a ruptura ertflIQJP5UIar. fVesto alt/nra CBSO; canlll!m dlstingulr entre 0 fenCmeno de difus�o em p0UC8 quan[/dade (lllXJulo .' sf/lconoma)o a wpfVTa ImPfJlfante (sHlconomas nos mcidos llizlnhos). Assimelr/IJ ,; apr!SlJr de todos os tlsf'orp;lS do ClM9/iJo SM1nJ no 5llI1tJdo tk conscgr.slr a melhor simeuill passlvel, fll!Jllf15 foC[(;r�, t",S coma D forma� de cllpsula,D dcsflXlJrAo fIO Implllnte 01l1J onotomla da plIciantc. podem callSllt' lJss/merrln. Alt8la�o dtJ sens/bllldedo do soio OesfOC<J,So fJO Implonte " pode·se verifieD( uma deslocaWO em QJSO de ImPllcco ou farmlJ�ao de cI1psula. Sa e.sta slruacJJo C8U58r desCOJl(ono DU afecltJr a fOImlt do seio,e fI«flssi1lia lll7L!l nOVII Op8fIJCifO.

?:a�a:: f.;=;/J'!�=�a��"r�� Progas : corfouoo a pos/�80 do Imp/ante (rctra- ClU Ple­pefrrxat), pOOem aparea:r prr!gIJS vlsrvels no pds-operRftX'O em casa tte emagUlcimenro. Oq� 4 doIlC! Sllbet : � o

u;:��e

: 9s meses D segtJlr /I op�, recomendamos

· /I exposifloaosol (elelllrll, vlll de llbonJa{}l1f7J) • prat/cDr dpsprxto (pos/�O roflO-pci[orol) • /ulllflos df lmetSJlo � Radl"9fIJ!iss DU mlJmogrlJfilJs : Il rad/Illogista dellO Sf!{ snformado folmi lJ preso"fa dum Implante mlJrrMr{o . ODooqulJ ntJo ful estudos sollro O fmp;lClOdru impltmtf1S mamllrios durante IJ grovidl11, Il padenta deW! CCltlwltar 0 clrurgi�Cl anre.� de cnm/dBfar fam! unJ.!! implantac4o. DBdB a IrldisponibflldDrkJ er;;lunl dOl t15t� c/(nlc� I�O e possrvef cqmeceNII 11 froquent:/a e.Ta�ta das d/ferentes compllc� camo 8 contmcturn cnpsul8r e 11 rupfurO.

COND/�OfS DE DEVOLU(:AD DOS IMPIANTES A fim de g.arantlr 8 CDnSl!flla�tJo claS:lUB.s c8racrer'sfleBs OfI9;nnis, qUBlqUeI' implants n80 utllmldo que �IJ dtNolvido aofOlrl6CC(/(lr dt.w scrdcvvlvlcloc/eltlfOdumperfOlJo da rempo raloovel e emlJaflldo nas mesmas cond/�oes em qUf1 fol entregue. ouseJII : _ /lO$ Set/S doiSS8COS 'pool-of(' . drmtro cla rrwletadc pollproplleno A 6mbalbgsm deW! im/ulr a/ndD uma cdplb dll gtJI8 drt remessa da enrrega do produto em causa. ou uma nots dO deV'fJlutAo t/uforiliJda (a55JnadlJ) pelo representantl1 r:omcrcl.nl daPIP.

PD2;!,"J.e:.�Z� �;::;::{;es 83507 lA SEYNf SUR MER Ceelex

FRANCE Tel .- 33 (0)4.94. 10.98.10 c ..... . ?? In',.. OA ill 00 1 1

'1 ,

\u

INFORMAllONI SUL PRODOTTO ; ALL'ATTENZIONE DEI CHIRURGHI

PROTESI MAMMAR/E PRE-R/EMPITE DJ GEL AD ALTA COES/VITA' CE 0197 OfSCRIZIDNf OEl PROOOTTO

�,:�::�mn:p'fM:tC;&1f�fJ'ad a/la coos/vitll

Ognl protes, si prtljentIJ In du6 cOflfOlioni singole, in modo dIJ ass/ewamo fa slerilltll (J prm7I6ltoro UIIIJ migl/ore 115S0ftle/ta di mtJnlpolozlolle. OgnlllllitIJ � composta da .-

• Ln protes/. co$lfwita d8 UI! involucro di ciastomero di silicone pre-rlemplro d/ gol ad altJl �QCsJvit/J • Un primo "b/ister" in PfTG con operrolo TYVfK" • Un sBClllldo "bJister" In PUG con opucofo rwEK", con alriICCata fer/che/ta dl /dMtfflr.1l1Irme dIl/la pm/ml e le tfl1eticht1lt� ellto-adesive neces.sarie {NJr il decorsc post·operatorlo cIeilD p:lllente e del/a prolo$l. QUC5te f!tidletttl devono lJ:SS6llJ r:ompl/ata erJDttaca'JteSUlclorumentl re/at/vi alflnremmto e wilD "rOSSCf/J di Idon(lficazJomJ delportlltoredi prot05i" 8I1eg8ta a//<l prares/. _ UnD sctJttJia dl potlpropllCnB conrenenre : • Un prospeflo Informet/vo del prodofto • Una scheda con I darl del/a pro!rur - Una �ChadD del deCOfS(J ptJSNJ{Wlltorio - Una teSStlfll dlporrlllortl dip1tltas/. P.I,P. 0"(8 un'ampil1 gamma di mlJiure coo profit/ diVfJrsl (standard, II/to, dl ricostruziDne. ass/lnelIlr:o) superficie fisr:il! tJ te.�wrIIlJffJf. I IIO/uml dlspMlblli IInliann dill 85 erne C I 705 r;mc. IJ volume eSllrto del/a protesi e IOO/arfo �ull'etit:herta di ide/JfifiOllione. sublM dbpo 11 rifer;mllntc, fI eandilionomcmo vicne effotruafo socto Oussl laminarl e plUmetre. qumd/. nell'aprfro / succelSlvi due ··blf5tIY", di mISE!YfWE' BllapBliet1le lli'lBproII!li nalJe ml91IOri a:XKliIIOlJi d/asettftlrtl e senla rontaminazfonapartlCt1lare ControlJ_ flntqlUJ dt1I ptotIJttot& IndMdIJlIle di �trJriliu prima tltll'uso ; 1/ patch dl ccntnll10 deWJ dlven/Dte II/oln dopo III $ter/llzzaz/one IJd onfdfo dl etffMe.

INOICAZIDNI _ Par aumonto : cnmiste mJlI'aumentllre il rollRne del stlno atrravmo I'/nser/m!fflto dcl/a ptOlosi

• Pet ficeSffUllontl , CClIJSCguanre oll'allfallone dl WM parte 0 dell'/mcm gh/andola mammnfla affetUJ dl/ cancra (mDstlUtomls).

CONTROINDICAZIDNI £8 protlJ5/ mentmDrie P. I.P. non davono assere utlllullte : _ lnc850 df infez/one • In c/Jso dl d/sorrflni s!slemici

• in una pazlen[IJ con {eSSulo epldefmfco madofto 0 lose _ in una pazient6 t:fJe preclldMtomente ha allUte problem/ fn seglo'lto sll'/n5ellmento dlprotlU; • fn ClISO di fragil<t� (l$lco/ogicll d/lfJ/J (JIlliMtl!

INFoRMAZIONI PRE· f POST·OPERATORlf Tutti gli IntMmti ch/lU'gid pooLI/'ItJ t'8tJWe doIle tM"fIIltazianI rn- o post-operotuic. Lo reDzion/-edarw;holeCOf1VJ/icWonI - devono CS$8fO di$CtJs� e /;f)f1/pf8SU. Dew ImIJlC cillarl) coo le protesi non rono imp/anta!e a �ifa. too per una durata vorleblle cllr cJlpende cJlIl/il fJiJllI/ll dellaprotMl. dal protocolfl opOfllto£l, da raftOfi ltl{//vidJJ/Jl/ e d8glf event! dclfa vfca della p;Jzlenta. Allo 5truso modo, non puo es.<>e.fP OSCIUSIJ /s PoSSibllflA di (Jna mtfura. l.'aUSrtlIDml d6118p11zlentr)dt1Vem;serofXlllluata $ull'jmptJl't!nll! dilnfr:mwellchItrJrgoSIJ quoI5lMi �1O reillliro III suo seno. alle pmtl!5i e lllrllmblllll/e cirr;ostllnte. Ffa 911 alfli, posslamo menziOl!8(V1 : • Mammografia • E SOptDtWUo ognl lrBUma, incfdente, agross/one Q fJfT!sslone lInonnalo 5ul tOUKO.

u

chiturgO u del suoteom. chc r/ura .sceg/iero : ,. 11 tipa dl Implalllo (SUperfICIO, mlsure 0 PIl)(IIO) _ 11 poslllonamt!fJto delf'lmplanto 0 la via rflnSfJrlmonto. la dtrrlllaa dl vita df una protesl non pub ossere valutllta ll prlorl visto r:he dlspende delJ'ovenwo/p, sopravvenutadl r:ompllClIllonl. Portio, III Sill! dulatll dl ll/fll non fWO vs.'Ie· re gDranlltc.

INFDRMAZIONI RflArlVE ALIA PROTESI • � la r:onfuione " aptHta () dallMggiaUJ, la pmt8$1 rnsn dwu _CQfU;dara(,a sf",;lo lJ nonTIsteriliulJbile e pemnto non rlutrtJuJlbife. ,. L 'Involucro 111 silicone puO essere /acllmertre dJnneggla/o dagll st/1JfT1f!llt/ clJifUf!Jlci o dIJ rTJilnl/X1lazlonf tTlJutJJijtlllilntl come un eccessil'O stlramento. ,. Evltare zone dl Imerimento troppo strette • Evltllro spllll rroppo 5trettJ 0 prolM/ rroppo rolumlflO:KJ. f'ouebbero fausnre necrosf da rompl'I'mione. . L'azionodai farmaci o di altriprodotli ll eontatto dlrotto �oo la protesl tlDrl 9 stDW studiam. Lo stesso si pulJdiropergliltSi fJOlJ corwt1fIlionall e per le modirJdJo dal mater/aie cfllrurglr:o, per le il$,;rxllllioni 0 /"uso �ongllJnto con nltrl strumonti 0 apPDrccchiafur{J. fI modJco url/llIatore deve assicurof5i del/a rompmi/}I/iM dei vlJrl eletrlllflti divtrsi nellom contesto. • ffimirJlJrB 9/1 emllCtJmi per drminulro i rlselll al /orel/one !l' di fornUlzione di capsula. Utlllzzafe un dNJnaf)gltJ. qUllnl1O pDS$JtJile, llvcndo curn df non f(l18f(l lll prot�l. _ Urlllmlm un n/o dl stJWrll adl/gUato • Nrm utiJillale clcrlvatl lodDti (al/arus's) • Ouals/asl elemento !}efJIJf<JtOro til pllrtlcelfl! (cacOrIe. comprosse, . .) talco. o qUBJ5iasl aftTO agente con/amlnsnte d/ superflclll d6ve essetOfJ/oscnUo. • PriflJlJ del/'in.ser/tnf!11I0 dellaprDtesl, Dnecessar/ollPrlfk:Bm I'inlcgritD deIl1nvo/uCfo, attralll?�O unlJ �ompmsslone duI/a protesf. OlJOlle ch!: pf6srmrassero una perforal;one, unll lacemllone. fJ/J/t petrlltIJ, un'emln tlon derorroessere impillntate. • Non fJIllnfllfHlll1 mai posizlrmallJ 0 tenfilm di ripllraro una protlJ5i che non 1/11 perfeUlIfnente /nfllttll, EFFml INDESIDERATI E COMPLlCAZIONI Came qua/siW int9"o(lf'JCo dJ/fI8lJico, and//) tp:SliI opemzllXlO cmnptJlta alcunl r/srnl, dip. �fJP.'tm �/lIJn 5t1otlamellle dlpeflciontJ dtti ptlrametri personali. Fm gll Dltrl passlllmo rmlnzlO{tlJre : fmatoma .- r/m/t8to dfJlla caagul{JlioTJ/! dl!1 SBnpUR nel rassutl. sumtrlblln di aumentlJlll la pl15S/tJIJlth dl fom/1JliO/llJ di �C8psula " Infczione : r:onwltllf6 lmrrwdilJtammte ilchlruryo Llnfaliono lllcncgencra/meme ct4'8tD lIIfleK'l'SO UlImImLYlfD, ma so pmlsto p(Jb fiChfedere la rimol/olle deWimplanta. Actumulo di IIqu{do : puo scpragglungltfe sublfO dope I'opetorione 0 qUJllcflf! tempo 00p0. NcuOSI : ,Iw/fa generolmr:nte cia una cornpressJooe infemIJ die Impedfsce 0 auarold nrrlg.ufone del fewti. ma puo essaro dal'Uce 0 IrottamcnU lJ5soc/lJli. Tumcfllziono : DUlllCflto do' IIO/ume, C<spsula o gcr..t;/opcrl-po�w ; fJ IlI lwdo"odefl'c.wg.arrismo od (Jn carpo eSfnJflfJO, /n quosto ca.sa IB ptoWsl, (]uesr'ulrlma e C/rcondllt/J dD uTI guselo fibrosa che sf induf/sce progtesslvamente e III comprime. 11 ptOC85S0 di fndur/rruJllto t! pl{J o l/J/Jfrapronunclato. PutJ /lSSI1flJOppUilJ o mofto perc�ttiblle. 1/ guselo puo tliwnlaTe C5tt1?m1lmcntc sgrlJdllvo/e esfrxmarela protesi. f'perclo necessarlO CfflmUllft! Una fOt/(JfD r.lclfa cop5u/B " rreg/iO IXtll CllpSllJet:romla ctnrtnS."lfIh IXlBII{¥flSil r:hfnngIr.lJ. � ... .... ,wl . ...... 1,...;· ' . .......... .."J'I ..... '...,., .... '-:�I ...

"le pu() pa�sere irJ0S5()(J1Dta. PertJ C irnportanle cfl/r:r1m lll/a pa�iento di rnnSfJltllre iI cflirurgo In caso di lrauma o fOfUJ comprcsslonc (caduUI. urto. lncidonte, ccc.), DtlO tlp/ di rotturo possono veri/icarsl: IIJ roltura nfl'mtcmo del/a capsula (prccole qulJntJtn dl gel re�tono nella capsula pe1lptoretica) IJ /11 rolCfJ(II .a1fC!iIl�mO etalla 'r:�nd���!��:�':i��i%:!asog�:n��:

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S{/fCOIlfXfJlJ) dt, queI/o df grande rottura (Sillconomi n/!IUJuvti nttif}ul). Aslml1lolrin .' nOllostlJllte /IlU/gll sfof2/ {omit! dill dllfIJrgo per GrttmCtc I/J mlgl/ore SJmlllCfr/O prmlbJ/c, il/cum (atlofl

������:;r�wc%��ep��r,rr;o��=� aa:/:;::�:�i

Allernz;O/JlI de/lo scmibilitll del:sono

�s":�t�radeU::��';�);�::='l�� f:�:�mre sftuaz/(me tilventiJ scomodll o lJ/tOfa la f(JtTfJll de/ �na, slrflrn/6 (Jf1(es5Ilrio unnuClvo /fJlf!fVl!nta. Oi:sorrJini immuni/ar; : l! stl1/o rilcII8/0c/1I.l /c prowsi mammaliv passono proWX;/I(O delle nmlawe e!llo/mlmmi

PieghO : sccondo la posilione dolla pmtosJ (rerTO 0 PlC' �f{orlJleJ, llef/e plcghc pDssona msere IIWblll IDI SP.f!a dopo J'Jnrervento lll earo dl d/rrmgrfmento. CoW OCecsM SSpcrO :

."") • Oumnte j Intls/ cM seguono J'illfemmrO e cons" ollltoro : �

• le ospaslzJonfal sole (cleo/rlce. viIJ dl inSOllmento) · le 'Qllillllll sportll.(] (pos/ZfoncfClro'PQIlOfllle) · l lJagn/ • RlIdfOf)filfia 0 mammogrllllll : flJ pmsClllil di una prote�i mDlllmaria dlJYO emJto sll9l1alatD IJI radlolago. • L 'InrluenzlJ delle protes! flMmffl(Jfje In per/odD dl gravlddnta mmi1 stata sncor8 SltldI8ca. Lil paz/enle dowa chiedew conslglio al chlfUrge plfmll dl ronsfdorllrc un /nttll'VMftJ. In ll5$IJnlit d/uno studio climco disponibl/e In qJlf1SfO memento, non IJ posSlbile eonoscero la frequenza f1S8tfa dclfC divcoo wmpliCDlioniwmela cootrottUfD della ClJfJ5Urn e la ro/lura.

CoNOIZIONI 01 RESTITUZIONf DfLIA PROTESI AI nne dl gllfllltl/rll CM le clJ(IJfl(!fl�tlch/} ell origlnC ftl.m

::�r:;;r:./�7:�tt�r�:;;;;::�:a�:: �u�:�� t;:�:� aI/a "Poly Imp/anI PrClltreseS', con(Cllonala COIm! In OIlglne. cloo: • nei woJ du e "bllstc(s� - ncllo sca:ofa df pollplopllcnc, if PIledlcurl drlwll lnclUdcre una eoplD del documcnro dl trasparto'l di>l o dl1lprorioltl rtJ{lltillJ lI eli lJn frsrmIJlnrl{'J e/i res/itulfono daiprodtJttf. d/$ponib/lt! prt!5S0 g/i ne/cm comtnl!fCialidcl/o P./.P.

Poly Implants ProthIJSe,) $37, Avenue de Bruxelles \.

83507 LA SEYNE SUR MER Cedex FRANCE

Tel .- 33 (0)4.94.10.98.10 Fax .- 33 (0)4.94.10.98.11