NOVEMBERIDECltWBIER 2bC
`
`OFFICIAL PUBLICATION OF THE AMERICAN SOCIETY FOR AESTHETIC PLASTIC SURGERY
`OFFICIAL ENGLISH·LANGUAGE JOURNAL:
`BRAZILIAN SOCIETY OF PLA5TIC SURGERY
`COLOMBIAN SOCIETY OF PLASTIC, AESTHETIC. MAXILLOFA'CIAL ANO HA.NO SURGERY
`COSTA RICAN ASSOCIATION OF" PLASTIC, RECONSTRUCTIVli. AND AESTHETIC SURGERY
`DUTCH SOCIETY FOR AESTHETIC PLASTIC SURGERY
`)SRA.CL SOCIETY f"OR PLASTIC SURGEONS
`JAPAN SOCIETY OF AESTHETIC PLASTIC SURGERY
`KOREAN SOCIETY FOR AESTHETIC PLA5TIC SURGERY
`ME'tlCAN ASSOCIATION OF PLASTIC. AESTHETIC ANO RECONSTRUCTIVE SURGERY
`SOCIETY OF PLASTIC AND RECONSTRUCTIVE SURGEONS OF THAILAND
`www.aosthetlGaUrge,yJownal.eom
`
`Exhibit 1012
`Prollenium v. Allergan
`
`

`

`HOT TOPICS
`
`Injrrti11g Purao·cn Plu , into the ~a olab ial F olcL :
`Pr liinjnary Oh ervat ion · o f FDA Trial
`
`Bllsecl o n purtieipa tion in ongoing FUr\ t rilll ,. lht•
`a uthor pr,·,t>nls his initial impression, of Purugr n l'l m,
`fo r tr e ut m,·11t o f th!' nu sulubial fo ld s. Pu ragt·n a 11d ·
`Purag,·n Pim, ( \le ntor Corp. .
`a111a Burl111ra. C \ ) arr
`doubll"-t·r o,--lin ked ~ .\ . II \ produt·tb. Dt'pemling 1111
`douJ1le r ro,➔-linking for duration of t·ff<·c·t. i.J1; tc11d of a
`varying purli1·l1· size, may a llow for usl' of one filler ul
`all lcvd ~ in tilt' soft Lis~uc . Othc-r ft·uture, ol1,1·rHtl by
`th e a utho r in th t' dinira l se ltin i: included recluec·d
`injr t'lion pain, minima l !'rythema an d ll·nclerm•"· typi(cid:173)
`ca lly lJ t o 12 mon tlh • durat io n of ,·ffret. and high
`palit>nt , a tiofiwtinn . (Aesthetic Surg J 2006;26:741 -748.)
`
`In rhe Unired States, bovine collagen was essenrially
`
`the only soft rissue filler on the market from the
`1980s unril JUSt a i.:w year~ ago. In many orht:"r
`counmcs, however, a wide variety of in1ecrable materi(cid:173)
`als ha vc been long unhzed for 50ft tissue filhng. 1·2
`Perhaps rhc mosr widely used subst.ince roday 1s poly(cid:173)
`meril:cd chains of hyaluronan, hyaluronic acid ( HA).
`Starting with the early 1996 Sweden e-cpericnce, and
`,preading from Europe ro rhe resr of the world, physi(cid:173)
`cians have used cross-linked, non-animal rnurce
`hraluronic acid (1 ASHA).
`A large body of NASHA clinical experience has grown
`with generally . excellent results. In
`the
`ovember/
`December 1999 issue of Aesthet,c Surgery Journal,
`Troilius 1 reported his initial favorablt.: e-cperience in more
`than 200 p.irienrs, using Rcstrlane (Q.\lcd, Inc ..
`'J). a NASHA preparanon (mean pamde
`Eatontown,
`size 525 µ) single cross-linked with ether bonds by 1,4-
`butanediol diglycidyl ether (BODE).
`In December 2003. the Food and Drug Administration
`{FDA) approved Resrylane, the first Rt!Stylane filler to be
`approved in the United Stares, and by January 2005, clinical
`u'lC had become common. Advantage, of Resrylane includt:
`longer lasting effecrs than bovine collagen, improved con(cid:173)
`tounng Jnd volume augmenration, increased parienr san -
`fu1.,1on, and freedom from allergy resnng. -\ major disadvan(cid:173)
`tage of many HA preparations 1s the pain associated wirh
`mjecrion and rhe need for several differenr preparations
`
`Brian M. Kinney, MD,
`MSME, Los Angeles, CA, IS .,
`b0Jrtl-cm1fied p/usr,, surgeon
`.,,,J .,,, ASAPS mrmber.
`
`ha~ed on parridc ~i,,e (300 to
`650 µ) to allow for injection
`a r various rissue depths.
`Additionally, while duration
`of effet.., is longer than with
`bovine collagen, it srill falls
`short of ideal. Resrylane Fine
`Lmcs
`is recommended for
`superfidal use, Rcstylanr for
`deeper use, and Resrylane
`SubQ and/or Perlane are rec(cid:173)
`ommended for use deeper
`than the dermis. However, of
`these pre par .irions, only
`Resrylane is cleared for marketing in the United Stares. All
`of these produc~ cont.iin a concentration of 20 mg/mL.
`Hylaform (Allergan Inc., Irvine. CA) use single cross(cid:173)
`l,nking by d1vmyl ~ulphone (DVS). has a mean particle
`size of 692 µ. and hJs not gained s1gmficant marker share
`m the Umted Srares. Juvaderm (Allergan Inc., Irvine, CA),
`a higher-concenrrarion ASHA preparation w1rh a mean
`particle size of about -94 µ, was approved by rhe FDA in
`June 2006 and 1s 1ust commg ro marker. A major stated
`claim is rhat Juvaderm is nor a gel-particle suspension
`but, insread, a malleable smooth gel that flows more easi(cid:173)
`ly and with a higher level of control. There arc several
`areas m which improved capab1lmes are dl!31rable. Use of
`a single rype of injectable at multiple ti sue depths w1th
`onl y I syringe and l hypodermic skin puncture, little or
`no pain associared with rhe injection, and longer dura(cid:173)
`tion uf effect are important advantages.
`
`Materials and Methods
`
`The half-life of non-cross-linked, naturall>• occurring
`hyaluronan in the body 1s 2 ro 4 days, and ,tbour one
`third is turned over per day. Alteration of the physical
`and chemical propemes is required for durarion of effecr
`in the ~oft tissues. In creating a synrheric analog, one can
`categorize at least 5 different rrpes for HA products:
`I. Liquid HA
`2. Syrup-like HA with higher v1scos1~•
`3. A mix oi syrup-like HA and weakl>• srahil,zed HA
`particles
`
`AES THErlC SU"GERY JOURNAL ... N OYE M92A / 0£ CE MBER 2006
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`74 1
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`HOT TOPICS
`
`-1.
`
`,\ high cun~cnrranon of 11.\ parric.:I.,, 111rh I IA con(cid:173)
`cenrranon of hea1 ii> uo,,-linkcd I IA molecule,.
`Puragcn (1\lcnror C nrp., '>,tnt,1 l~;irh.ua, CAI fall,
`1nro th!\ CJtegur). '·•
`'i. A high c.:nm:enrrJnon o( HA parric.:le, 111th high con(cid:173)
`~enrrarion ot mmim,111> modified IL\ mol,:cule,. fhc
`Re,f)·l.ine f,1m1l) of tillers falls 1nro th!\ caccgor).
`One method of inac,1'ing dur.mon of effccr is ro
`vary particle si1c, JS i\ demonstrated in rhe Resrylanc
`f.1rnily. Another 1s ro airer chc: chemMq of cross-ltnl..-
`111g by creating double-c.:ross-linkcd chains with crhcr
`honds and ester bonds. Puragcn and Puragcn Plus
`(,\.lenror Corp., Santa Ba rbara , CA) .ire double-cross(cid:173)
`linked NA HA producr,. The esrcr honds confer
`1nc.:reased srab1ltry in virru b) res1st111g the enz) ma tic.:
`degr::idauon by hraluro111d.1sc and by protecting the
`ether bond, during srcrili,arion. The ether honcls arc
`hydrophobic and res1sr c,uymam: degradation. The
`first chemical reaction i, performed ar high pH w1rh I.
`2, 7 , 8-d1epo,y,xtane (0[0), a h)•drophohir epox,de
`rhat huild, an HA network through ether bonds
`hctween hydroxyl groups. The second chemical low-pl I
`re.1~1:ion, using the same .tgcnt (DEO). turrhcr crns,(cid:173)
`lmks carboxyl groups w
`iorm ester bonds. The
`1ncn.:asccl chemical sr,1bilicy allow, for the addition of
`ltdocJme 0.3"o for J rclati,ely p.1111-frcc
`injection.
`f-'nh:inced ,rabil1ty 111 ,1,0 ,tnd slower dcgradJ11on in
`,irro Jre Jc.:h1e,cd by douhlc cro ,-link111g. Solid ( 13
`nuclear magnetic resonanc.:e scanning in doublc-cro5s(cid:173)
`linkcd HA shnws a methylene hridgc compared with
`,tandard HA. 1 The em:r bond is confirmed by 1-ouner
`transform 111frarcd specrrometr) (Ff-lR).'
`Using a gel with a smaller Jvcragc pamde siLC (220 µ)
`111;1> create a smoother injection (more conr111uous .:ippli(cid:173)
`canon of pressure) . .\ gel wirh higher ,·iscosit} may
`rcquirt! more pre,surc ro 1n1ec.:r. Depcnd111g on double
`cross-link111g tor durarion of effect, instead (>t a vaf) mg
`particle size, ma)' ,1llow for use of I tiller a r ,111 level, in
`rht: ,oft ns,ue.
`PurJgen Plus hiocomp.uibiliry ,rud1es wen: per(cid:173)
`formed, including skin sen,mlation 111 rhe gumeJ pig (no
`posiri, c re,pomcs) and intradermal implanr,1tion in the
`guinea pig (m111or minal reacnons of er~ thema seen cl mi(cid:173)
`ca II) and anri-mllammacory and g1anr celb seen on
`hhrnpathology. mmimal or undetectable Jt 27 weeks,
`~1rnilar ro 2 compar::iror produces). Also, rbcre was no
`c.:ytotox1c1ry 111 the 1\ mc, rc,t Jr conccnrranons up ro
`5000 µg. no C) coto,.1c1f)
`in , 1rro 111 :in agJt o, erl.1y
`a,~a~·. no mur,1gene is in ~1tro in J chromosomal aberra(cid:173)
`tion rcsr, no unscheduled D:--IA synthesis in nm,. no
`
`pymge111rity (ISO 10993-11), .111d no htmolv\i, . . o
`m·cro\l,. fibros1,. or granulom,1 were obscrn:d.
`the
`l'urJgcn "J, introduced 11110 the m.1rl..cr 111
`1:- uropc:in U111on ,tnd m,tn} c.:ounrne, .iround the world
`in rhc ,prin!! of 21)05. Ir, formulanon i, s11nil.tr to
`PurJgen Plus. c,rcpr rhJt II dtlC, nor conr,tm lidocainc.
`Puragen Plus h.1, hcen undcrgomg !-'DA cli111cal mal,
`s111cc January 2005 111 the Un1tctl States. l:.ach m11lilitcr of
`Puragen Plus contain!> 20 mg of ether and c,rcr cro,s(cid:173)
`linJ..ecl odium hyaluronare 20 mg, sodium chloride 8.5
`mg, d1sodium hydrogen orrhophosphare dehydrate 0.22
`mg, sodlllm di hydrogen phosphate dihrdrarc· 0.04 5 mg,
`licloc.1inc HCI 0.3%, and water for injection.
`
`FDA Clinical Trials
`
`FiH: ccnrers led by 3 dermatologists and 2 plastic sur(cid:173)
`geons participated in rhe unginal l·DA dinicJI trials. In
`the original (first) stud} group, pa n cnts were randomized,
`Re,rylanc was 111jectcd into une nJ~olabial fold (. LI:-).
`and J>uragen Plu,, mm rhe other .. one of the 5 centers
`·had enough panrncs ro reach st:iri,rical significance and
`re!>ulr, ha\"c been blindcd from center ro ccmcr.
`In rhc conr111u1ng access (second I stud}. Puragen Plus
`wa, 1111ccrcd inm both !':L.h. final dara an,1ly,1, h,1s nor
`been completed. Herc, I report 111111al clinical impressions
`bJsccl on rhe experience of I ccnrer in rhe cnnrinu111g
`acce,s ,rudy. In fururl' pubhcarions. I will prcsenr rhc
`compiled d,ua. Stud) p.iramcrers mcludcd blood draw.
`phorogr,1phs. 2
`independent oh,ervcrs 111
`the 1111t1JI
`study, I ob crvcr (only ) in rhc co1111nu111g access srudy. a
`pam a,sc,!>mcnr ,._Jfc • • md :\'LI-' scoring on a 6-part
`L emperle scale. I ollow-up rook place at 14 JJys (when a
`,ccund 111jec.:tion wa, .illowccl), .ind ar I, 4, 6, 9, and 12
`months 111 the first ,rucly group and a r 1-1 dJys, a nd I, 6,
`9, and 12 monrh, 111 the second ,tudy group.
`In rhe initial stud> group each panent \Hire an C}' C
`mas!.. . .:ind m borh srucl1es each patient wa, in1ccrcd after
`a ,kin prep of .ilc.:ohol only. !-'or borh ,rudic,, only
`patients with a I emperle scale of 2 ro -I were ,1llowcd co
`pamc1patc. E xclus1011 criteria mcluded c1·erc skin d1s(cid:173)
`ea,e (cg, eczem.1, p,onasis. ,everc acne, or ro,aceal, sy -
`remic disease,, history of NL!:-
`injection within 18
`months, use of m·tinoin w1th1n 4 weeks, use of boru
`linum mx111 wirhin 6 monrhs. or 1.i.,er rcsurtacmg within
`12 month,. Blond w:t\ drawn .11 baselme, .30 d.1rs after
`rhc la,r 111jcc.:t1on, ,111d ,11 rhe 6-rnonrh v1sir.
`Pane,m were mjecred 111 che :-:LI-. deep ,rnd supcrfi(cid:173)
`c1all1•, from the alar hase inferior to the oral commissurc
`.1s dicc.1ted by fold .111atom)'. In rhc tir~t ~rudy group, 2
`ml were allowed on c,1ch side during the fir,r ~e. s1011,
`
`742
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`AES THETIC S URGERY JOURNAL - N OVEM8£R l 0ECEMBE.R 2006
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`

`Hor TOPICS
`
`•
`... •'
`
`0
`•.
`
`,...
`
`.
`.,,
`.
`
`~
`
`-
`
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`"
`
`.
`
`--~ .......... ·. ~-
`.
`.
`.
`
`.
`
`Flgure 1. A, PretrecJtmtmt t·tert of a 4 I ·yc.1r-<JIJ U'fJ"1JJII. e., Posttuwtnu.•111 l'lt.'tt' I month /ulluu·mg P1m.Jg,•11 f'lus m1tcl1011 11t1u the: 1wsafub,ul fa/d;,.
`C, PosttreJlm.t•nt 1·1eu, ~(kr 1 m<mtbs. D, Po1trreu1met1t 1•1eu: J(ter b 1tmnths . E, Po~tt,c111ment 1·1t'u· J{tn q 1111J1tths. F, P0$1/rtutnumt t lt'tl' .1/tc-r 1 )'t!Jr.
`P.mmr h.Jd tr.Jnstenl pustm/<'<ftOII ~ th,:,,w rl,.ir I.isled from I ro l J.i,·s.
`
`-~; ,,ji
`
`J,i,r-dml! PurJJ<C"tl Pim mlu the , ·.,solab,.J/ folds,
`P,cl,m,n.,n ()/,,mull•»>$ of FDA Tnal
`
`A ES THtr:T I C S VRGE. AY J OU RNA L
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`HOT TOPICS
`
`Ftgure 2. A, Prttrcatmem 1•1cu1 u/ J J9•)'t!ar•olJ II omJ11 B, f'osttrtatmt 11t v,ew I momh {ollo1ung P11r,1g,m Plus ltl/t:tfmn mta the n«solab,.1/ fo/Js
`C, Posttreutmcttl 1·1eu .1/ter J mu,rtbs. D, Post1r~.itmn1t 1·1tw .Jjrer 6 mcmtl,s, E, Posttre,11mt nt t'tt'f<' ujter Y mn mhs. Tht pdtumt J,ud Jt•~p folds: J u,• Id
`1•0/ume lm11t,11mn.s she dtd 11ot undt!Tgo c.:omp/, .. tt corrtctlOtt m tither fultl: bmt•ei,~r. 1htrt rs brouJ ptts1st,mct o/ HA JI h momhs.
`
`744
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`AES T H E T I C SURGERY J OU RNA L
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`Vo/,mrt' :!6. ,um!Nr 6
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`HOT TOPICS
`
`Figure 3 .. A, Pretrutment t'tt'll' nf J .5--,·eJr-ol«/ 111'111. B, l'ostfTt!Jtment 11,ew 1 mo11tb J(ter P11rax,•n Plus tnJec·t,nn zntn the ntJ.sul.ib1.1l /1Jld.s. C,
`Post1re,1hne111 uew t1/"ter 3 months. D, Posttrtdtment 111tu1 11/tn- t, ,uonrhs. Ch,11/e,,gmg tret1tn1ent of cJ tl11n 111.1/e ,mtJker rl.'110 uses mJoor tJmtmR
`e,1mpmt.·11t 2 In l t1111es WtL•kly: rntilts t1rc bdou• ,Wl'td'(t'.
`
`and I ml was allowed on each side during rhe se..:ond
`ses,ion Jr 14 days. In rhc se..:ond srud> group, 3 ml were
`. 11lowcd on each side durmg rhe fir,r ,c,s,on, and 2 ml
`,,en: allowed on each side during the second session at
`14 days. There were no further in1ecttons m either study
`group, and follow-up continued for I yc:ir. Full face and
`clo~e-up phoros were r:1kt:n of each parienr at each visn
`in the anterior-posterior, oblique, and l:1tcr:il views on
`each side. Photos were taken under rhe same lighting
`condinons, Jga1nst a Canfidd-issued blue fC\."turcd felr
`background w1rh a Canon G2 D1giral camera ~ct on a
`fluorcsccnr 2 white halam:t scrring.
`There were 11 patients in rhc firsr group and 2, 111 the
`second group. In the tirsr group, I p.menr was lmr to fol·
`low-up at 6 months when her boyfriend wffcrcd \t:,crc
`medical prohlems requiring ho~p1talizarion and mtem1ve
`care. In rhe second group, I patient was losr co follow-up
`
`due ro rhe inconvenience of arrending posrin1ect1on
`appoinrmenrs .
`All paticm wen: injected b> lmear rhrcading, and l
`or 2 received supplemenrarion h> i~olated ~crial puncture
`111 madequarely filled areas. Bt>cause rhe length of rhe
`needle was les~ rhan rhe lengrh oi rhe
`·lF, more than I
`punccure was required in all patients. All pattenN under(cid:173)
`went massage 11nmed1arely ah-er injecuon until smoorh
`conrours were achieved.
`
`Results and Discussion
`
`Wirhour formal ,tarisrical analysis, I can make only
`gcneral clinical ohservarions. Overall sarisfacrmn among
`p.1rienr~ was very high. No patient had a vi\ible nodule
`ar any visir, pcrhap, Jue ro 1mmediar.: massage on inmal
`in1ect1on. The gel can be manipulated and conroured ea\•
`ii>'· although on no occasion wa~ 1r expre\,ed from rhc
`
`ln1ectin~ Pur.;1K_e11 P/1,s into tht" N.m,LJ/na/ ft,/Js:
`Pu/111m1Jry Obs,r1•JIIOt1S .. , rnA Tr1JI
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`Al!STMl!fl C SURGERY J OU RNA L
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`HOT TOPICS
`
`Figure 4 . A, Prt'trt•Jtme,,, l'lt'W u/ J 4·4-\'ear u/J man. B, Posllrt:atmr nt i,1ru, I month .1fttr P11rJge 11 l'ltd m1ect10,i mto the "'Jsolub,al fo/Js .
`. C, Po.>llrrutmt•nt 1·1.eu· a{frr J mo11tl1s. D, Posrtrti1tme11t new J(tr!r 6 months. Cl,Jl/engmg tr~dtt11t.!nt of J ht!JP')'·set ma/~ 1utl1 .111 el.rel/~111 result.
`
`skin through the puncture sue. Not surprisingly, there
`\\ ,1\ minimal ro no pain 111 essenuallr evcrr patienr
`m1ccrcd w1rh Puragen Plus. and less pain in every pancnr
`tnJc'-ted \\ ith Puragcn Pim compared wuh p:menrs
`iniecrcd w1rh Rcsr)'bnc. In hmh groups, mild injecnon
`Cr} thcm,1 of a ,1milar magn1rudc and s1m1lar to that seen
`w1rh orhcr I IA preparations occurred in about one third
`ot pJncm~ and lasrc:d I co 2 da} s. o pancnr expressed
`rcgrcr ar undergoing rhe imrial 1111ecnon 111 any locanon.
`On ~econd 1111ccnon in rhc initial group, all pancnrs
`e,prc~,cd .1 preference for ,I lidocainc-conrainini:: HA.
`Due ro ,•olumc luniratwn,, complete correcnon ot rhe
`NI F wa, nor po~\ihlc in cvcrr paricnr. However, phoro(cid:173)
`gr,1phic documcntanon allowed comp~rison of mirial
`injci:rion results and IJre visits ar 6, 9, and 12 monrhs.
`In my hands. judging suhJL'Ctavely. Puragen feel~
`~lighrly more v1~co11, on injecrion and require~ more
`
`pressure than 11111:cting Re:: rylanc, bur I was able ro adapt
`to rhis difference qu ickly. From rhc firsr paricnr, on in1
`nal inspecrion, mjccnon rcsulrs on eirher side were sirm
`lar. Of rhc 36 parienrs ar 6 monrhs, all expressed mrere,r
`in undergoing addmonal mjecnon wirh rhc lidocaine
`conraming HA, if it were a\'a1lablc ar rhc completion ul
`rhc ~rudy or cleared by rhe FDA.
`One parie111 undcrgomg lip mje(rion had a 2-da,
`episode of lip swcllmg documcnred by phorography 1
`months afrcr 1111ection. Sulfa allergic, she artrihuced ,r ro
`dnnl..mg red wmr conr,11ning ,ulph1tc,. o trcarmcnr
`wa\ gi, en, and she recovered from rhc epi,odt: withour
`,cquell.w. Afrcrwa rd,, she expressed a desire for add1·
`nonal 1n1ecrion in chc hps and LF should mjecriom
`bl'comc avail.1ble. In rhe second srudv group, 2 pmienr,
`rcporred rr:ms1ent episodes ( I ro 2 day~) of minor
`swelling hcrwccn rhc I- and 6-monrh v1sirs. hur chose
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`HOT TOPICS
`
`Ftgure 5. A, PretreJtment ,,,er,• of d
`i7- )'ear.-old 1<·nm .i111. B, Pn,urrdtment t•iew I month J{ter Purc1,tn Plus m1rc:tmn mtu the na~ot1bldl fulds.
`C, Posllreatmenl , ,ni· cJ{ter 6 months. D, P<>S1trea1111en1 l'lt.'"-' ufter 9 m mt1hs. E, Posttredtm ent t•1eu· w/trr l l month~.
`
`lrr1ttt1nJ.: P11rdlttn P(u., mto the ~ ,;w,Jabwl I-olds:
`Pr,J,,,,,"""' ()/,J<.,, Jllc>nJ of N>A Tri.ii
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`A I SfH ltTtC SU R G ER Y J OU R NAL -
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`HOT TOPICS
`
`3 TroIIIas C. Solt t,ssue r,11ers-wha1 options are ava,Iaole today>
`Jlesthet1c Su,g J 1999:19:505-507
`
`d Verpaele A, Strand A. Restylane SubQ, a non-animal stdb1lozed
`hyaluronlc ac,d gel ror soft 1,ssue augmenl at,on of the m,d and lower
`race. Aesthe11c su,g J 2006;26{suppl);S10-Sl 7.
`
`5 Zhao XB. Frase1 JE, Alexander C. 5\n1heS1s and charactenzauon of a
`novel double crossllnked nyaluronan hydrogel. J Mater Set Mater
`Med. 2002:13·1q6.
`
`6. Zhao XB J B,omater Sci. Polymer ed. In press.
`
`Reprint requests: Brian M Kinney, MD. MSME. 2080 Century Park E .•
`Su11e 1110. Los Angeles. CA 90067-2009.
`Copyngtll e 2006 by The American Society tor Aesthetic Plastic Surgery,
`Inc.
`
`1090-820X/ S32.00
`
`dol:10 .10 16/J asj. 2006.10.008
`
`nor to report it unn l the 6-monrh ,·1, 1t hccJu\e they con·
`s1d1:red it m he 111coni.cqucnnal. One of thc,e p.ttient~
`suggested the , wdl111g wa, due ro g.udc11111g outdoors in
`hor wcathrr and hat! 1. mnre ep,,ndr~ ber" t't!l the i;. ant!
`'J monrh , 1s1t. In addmon. I day ,1frcr the 9-momh v1s1r.
`she experienced Jn addinonal episode 111 the absence of
`exertion in hot weather (documented h)' phoro~r:iphs)
`thJt lastec.l 2 c.13} S, Trans1enr nodul.mt), C[}thenu, anc.l
`tenderness surfaced overnight and dissipated without
`1nrervennon in 2 da)'s. This p,irienr changed her mind,
`now staring that she would nor undergo addinonal injec(cid:173)
`nons after a 9-month experience.
`r-. lorc than h,tlf of the panenrs had excellent persis(cid:173)
`tence at 9 monrhs, and about one quarter had moderate
`persistence even at 12 month . Only I or 2 patients
`n.:sorbed the Puragen as early as seen in the 6-month pic(cid:173)
`tures. Rea,onable 111formed consent would be to predict
`9 ro 12 month~ of persistence (Figures I ro SJ.
`
`Conclusions
`
`I can make a fc,, prel11ninary ob<.cn•anons before rhe
`formal data analysis; however, much is yet co be deter(cid:173)
`mmed. Injection 1s m1111mally pamful due co rhe pr~ence
`of ltdocame.
`inc to rwclve month~ of duration of effect
`can gcncr.1lly he cX"pecrcd based on my climcal experi(cid:173)
`cm:c. Erythema, tenderness, and pain are m1111mal. Patient
`acct:ptancc 1s excellent and ,amfocnon 1s exrrcmclr high.
`Ukelihooc.l of no<lularirr and ocher potential complica(cid:173)
`non, await large-scale follow-up srud1cs.
`The parnclc ,11c 1, ,mailer rhan in other HA prcpara(cid:173)
`ttmh .inc.I th1' whjeccivcl) allows use of a ,inglc syringe
`co 1111cct , upcrfa:ially, 111 1111crmcd1,11t: depth~. and deeply
`w1tho u1 expecr.ttion of lumpiness, protrusion, or promi(cid:173)
`nence. Bccausc II ts the cross-linking, and nor the particle
`si,e, rhac dictates rhe duratton of effect, only I rype of
`syringe 1s required for llllt!Ctmn at v,irious depths for cor(cid:173)
`rection. The small parttcle size may allow for bertcr mas(cid:173)
`s.:iging anc.l manipulauo n of the material immediately
`afrcr 111jc.:rion, hue no hlinded conrrol studies have been
`performed ro confirm thi, . If and when there is FDA
`approval, furrhcr clinical experience will reveal the com(cid:173)
`piece picture. ■
`
`I ht• ,1111/w r u•a, pr11d /,v Me11wr tJS II co11s11/1.i11t tv /)(•r(orm
`tin:; d1111cr1l Irr.ii.
`
`References
`1 Kinney BM. Hughes CE SOit tossue fillers an overv,ev, Aesthe11c
`Su,g J 2001,21 :469-471
`2 Bergeret Galley C. Compa11son ot reso,bable soft tissue fillers.
`Aesthcr,c su,g J 2004 .24 33-46.
`
`748
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`A l! STH E T IC SURGERY J O URNAL - N O VE:MBER / 0EC£MBER 2006
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`V,ilmttt' 26. 1\ uml~r 6
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