Kungani i-Restylane Contour isigcwalisi esinemijovo esigunyazwe yi-FDA “iguqula umdlalo”

Izinga kanye nendawo yonke yezigcwalisi zesikhumba ezijovwayo ziye zaba ngcono eminyakeni yamuva nje, futhi imijovo efanelekile iyakwazi ukudala imiphumela emihle ngayo.Manje, odokotela besikhumba kanye nodokotela abahlinzayo bepulasitiki banezinketho ezintsha zokwelapha iziguli ezifuna ukuthuthukiswa kwezihlathi zemvelo.UGalderma umemezele ukuthi i-Restylane Contour, ilungu elisha lomndeni womjovo we-Restylane hyaluronic acid (HA), isanda kugunyazwa yi-US Food and Drug Administration (FDA) ukukhulisa izihlathi zabantu abadala kanye nokulungisa amaphutha ebusweni.21 Ngamanye amazwi, it Ingajovwa endaweni esihlathini ukuze kwandiswe ivolumu oyifunayo kanye nokuma.
I-Restylane Contour iphawula okokuqala ngqa ukuthi ubuchwepheshe be-XpresHAN obuphathelene bugunyazwe ukuthi busetshenziswe ezihlathini e-United States (ubuchwepheshe sebuvele butholakalela izihlathi e-Europe futhi buthengiswa ngaphansi kwegama elithi Restylane Volyme eYurophu.) “Lokhu kuyingqayizivele ngoba idala ijeli eguquguqukayo, ebushelelezi, ehlanganiswe nesikhumba nezicubu ezithambile, ama-lift kanye nama-plups ngendlela engokwemvelo kakhulu," uSmita Ramanadham, udokotela ohlinzayo wepulasitiki oqinisekiswe ibhodi eNew Jersey, etshela uBait."Ijeli inamandla futhi izohamba nesimo sobuso bakho ukuze uthole umphumela wemvelo esiwufunayo sonke."Nakuba uRamandham ethe izigcwalisi ezikhona ezifana ne-Restylane Lyft kanye ne-Juvéderm Voluma zinhle kakhulu ekuthuthukiseni izihlathi, i-Restylane Contour nayo Inenzuzo eyengeziwe yokuguquguquka ngokweqile futhi ingahamba nawe ukuze uthole umphumela wemvelo kakhulu.
“Ukunamathela kweContour kungcono kakhulu kumaphutha aphakathi kobuso,” kusho u-Andrew Jacono, udokotela ohlinzayo wepulasitiki ogunyazwe yibhodi eNew York City, ngomehluko phakathi kwale nketho entsha nemikhiqizo ekhona emakethe.
U-Stacy Chimento, udokotela wesikhumba oqinisekiswe ibhodi e-Miami, ujabule kakhulu ngalokho okulethwa yi-Restylane Contour, etshela ukuthi ukuhlanganiswa okuhle kwemikhiqizo yokuyenga kuzokwenza abahlinzeki bakwazi ukudala "izithuthukisi ezicashile nezinhle" endaweni yehlathi phakathi nendawo kanye nohlangothi lwe- ubuso.“Izikhathi eziningi, ngiba nomuzwa wokuthi imikhiqizo yethu ye-HA etholakalayo njengamanje ayikwazi ukubekezelela izinkulumo ezinamandla.Ngiyabona ukuthi lokhu kuzoshintsha imithetho yegeyimu yokwakheka kobuso nokuxhumana.
Omele i-Galderma utshele u-Allure ukuthi inqubo yokugunyaza i-FDA izothatha cishe izinyanga eziyisishiyagalombili.Emavikini ambalwa alandelayo, isirinji izoba nethuba lokuthenga i-Restylane Contour ngokuzijwayeza kwayo futhi ibambe iqhaza ekuqeqesheni i-Galderma.
Mayelana nokuthi izophathwa kanjani i-Restylane Contour, uRamanadham uthe isihloliwe izinaliti namacannula futhi yabonakala iphumelela kukho kokubili umjovo nezindlela zokulethwa."Ekugcineni, ukusetshenziswa kwezinaliti noma ama-cannula kuzoncika kuma-syringe ahlinzeka ngalezi zinsizakalo kanye nezintandokazi zabo," wanezela, nakuba u-Jacono ethi ukusebenzisa ama-cannula ukujova i-Restylane Contour kufanele kunciphise amathuba okulimaza.
Ngakho-ke ingabe ikulungele wena nezinjongo zakho zobuhle?"I-Restylane Contour iyisinqumo esihle ezigulini ezifuna ukuthuthukisa umthamo wezihlathi zabo kodwa zifuna ukubukeka kwemvelo," kusho uRamanadham, enezela ukuthi angakwazi ukufaka esikhundleni samafutha alahlekile ngenxa yokuguga noma ukulahlekelwa isisindo, noma angakwazi ukunikeza ivolumu kanye ne-contour. Abantu abafuna ama-cheekbones aphezulu."Lokhu futhi kuyisigcwalisi esihle ezigulini zethu ezisencane ngoba kuhlala kuvumelana nezimo futhi kunamandla, futhi kunganikeza imiphumela yemvelo ecashile ngaphandle kokubukeka kwe-horrible'filler'."
I-Restylane Contour ingasetshenziswa futhi njengendlela ehlukile yesikhashana yalabo abacabangela izinketho zokuhlinzwa unomphela, njengokuxhunyelelwa kwamafutha, ukufakwa ezihlathini, noma ukuhlinzwa okuncanyelwayo kuka-Jacono ukuze kubekwe kabusha izihlathi ezixegayo nokubuyisela umthamo, ngokufinyelela okuncane endizeni ejulile ukuze kunwetshwe ukuphakamisa ubuso."Ama-Bulkers anganikeza isixazululo sesikhashana sokunciphisa umthamo omncane, kodwa ukuze uthole izixazululo ezihlala isikhathi eside zokunciphisa umthamo omaphakathi noma onzima, kunconywa ukusebenzisa i-endoscope ukuze uqalise ngokushesha inqubo yokuhlinzwa," esho.
Ngakolunye uhlangothi, i-Chimento ikhetha ama-fillers kunezinketho ezihlala isikhathi eside ezifana nokuxhunyelelwa kwamafutha."Ngokuvamile, kuthatha izinqubo eziningi zokudlulisa amafutha ukuze uthole imiphumela engcono kakhulu," etshela u-Bait.“Ngizithanda kakhulu izixazululo ezingezona unomphela ngoba kuyindlela ephephile engathuthukiswa njengoba kudingeka.Ngikhetha ama-HA fillers ngoba anembe kakhudlwana futhi ayabikezelwa.”
Nakuba imiphumela yayo iphephile futhi ibikezelwa, i-Restylane Contour, njengawo wonke ama-dermal fillers, inezingozi ezithile.U-Galderma ubika ukuthi imiphumela emibi evame kakhulu ukulimaza, ububomvu, ukuvuvukala, ubuhlungu, ukuzwela nokuluma endaweni yomjovo.
Mayelana nokutholakala, ummeleli wakwaGalderma utshele u-Allure ukuthi iziguli kulindeleke ukuthi zithole ukwelashwa kwe-Restylane Contour ekuqaleni kukaJulayi.Intengo incike kusirinji yakho kanye nenani lemikhiqizo esetshenzisiwe, kodwa ungasebenzisa imali engaphezu kuka-$1,000;i-dermatologist eqinisekisiwe yebhodi, udokotela ohlinzayo wepulasitiki, noma udokotela ohlinzayo wepulasitiki yobuso angakusiza ukuthi unqume uhlelo olungcono kakhulu lokwelapha ukuze uzuze imiphumela oyifunayo.Ekugcineni, ngisho noma uya kudokotela ukuze ucele ngokuqondile i-Restylane Contour, bangase basikisele izinketho ezahlukene.
"Izinhlobonhlobo zokugcwalisa emakethe zisivumela ngempela ukuthi sikhethe isigcwalisi esibhekana ngqo nokukhathazeka kweziguli zethu," kusho uRamanadham."Kusisiza ukuthi sifinyelele izinhloso zabo ngokuphumelelayo."
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© 2021 Condé Nast.wonke Amalungelo Agodliwe.Ngokusebenzisa le webhusayithi, wamukela isivumelwano sethu somsebenzisi nenqubomgomo yobumfihlo kanye nesitatimende sekhukhi, kanye namalungelo akho obumfihlo e-California.Njengengxenye yokubambisana kwethu nabathengisi, i-Allure ingase ithole ingxenye yokuthengisa emikhiqizweni ethengwe ngewebhusayithi yethu.Ngaphandle kwemvume ebhaliwe yangaphambili ka-Condé Nast, okokusebenza kule webhusayithi akumele kukopishwe, kusatshalaliswe, kudluliswe, kugcinwe kunqolobane noma kusetshenziswe ngenye indlela.Ukukhetha isikhangiso


Isikhathi sokuthumela: Jul-13-2021