I-FDA ilumkisa ngokuchasene nokusebenzisa ipeni ye-hyaluronic acid yokuzaliswa komlomo

Uhlaziyo (ngomhla we-13 ku-Okthobha 2021): I-US Food and Drug Administration ikhuphe incwadana yeendaba yokhuseleko njengempendulo kumonzakalo owenziwe kukutofa izigcwalisi ngezixhobo ezifana neepeni ze-hyaluronic acid.Ingxelo ye-8 ka-Oktobha yabhekiswa kubathengi kunye neengcali zonyango kwaye yabalumkisa ngengozi ehambelana nezi zixhobo ezingavunywanga, ezisandul 'ukuthandwa kwimidiya yoluntu, kwaye zinike izimvo malunga noko kufuneka kwaye akufanele kwenziwe kunye ne-dermal fillers.Cebisa ukuba wenze ntoni.
"I-US Food and Drug Administration (FDA) ilumkisa uluntu kunye neengcali zezempilo ukuba zingasebenzisi izixhobo ezingenanaliti ezifana neepeni ze-hyaluronic acid ukuze zitofe i-hyaluronic acid (HA) okanye ezinye izihluzi zomlomo kunye nobuso, ezibizwa ngokuba zii-dermal fillers okanye iiFillers. ,” ezi zixhobo zikhankanyiwe kwingxelo, kwaye i-arhente yathi zisebenzisa uxinzelelo oluphezulu ukunyanzelisa iifayili kunye nezinye izinto emzimbeni."I-FDA iyaqonda ukuba ukusebenzisa isixhobo esingenanaliti ukutofa umlomo kunye nezizaliso zobuso kunokubangela ukwenzakala okukhulu kwaye, kwezinye iimeko, umonakalo osisigxina eluswini, emilebeni okanye emehlweni."
Phakathi kweengcebiso kubathengi, i-FDA incoma ukuba ungasebenzisi izixhobo ezingenanaliti kuzo naziphi na iinkqubo zokuzalisa, ungathengi okanye usebenzise iifayili ezithengiswa ngokuthe ngqo kuluntu (kuba zisebenzisa i-prescription kuphela), kwaye ungazijobi okanye abanye abo bathengiswe ngokusemthethweni. sebenzisa naziphi na iinkqubo zokuzalisa.Isixhobo senza umlomo kunye nokuzaliswa kobuso.Kubasebenzi bezempilo, izindululo ze-FDA zibandakanya ukungasebenzisi izixhobo zokutofa ezingenanaliti ukwenza naziphi na iinkqubo zokuzalisa izithambiso, ukungadluliseli izizalisi ezivunywe yi-FDA ezivunyiweyo zedermal kwizixhobo ezingenanaliti yokutofa, kunye nezitofu ezitofwayo ezingasebenzisi iidermal fillers ezingavunywanga yi-FDA剂产品。 Iimveliso zearhente.
“I-FDA iyaqonda ukuba izixhobo ezingenanaliti nemilebe nobuso ezisetyenziswa kwezi zixhobo zithengiswa ngqo kuluntu kwi-intanethi kwaye zikhuthaza ukusetyenziswa kwazo kumajelo onxibelelwano ukunyusa umthamo wemilebe, ukuphucula ukushwabana kwemibimbi, nokutshintsha impumlo.Imilo kunye nezinye iinkqubo ezifanayo, "ingxelo ifundekile, yongeza ukuba izigcwalisi ezivunyiweyo ze-FDA zinokusetyenziswa kuphela ngeesirinji ezinenaliti okanye iicannulas.“Izixhobo ezingenanaliti ezitofwayo ezisetyenziselwa iinjongo zokuthambisa azinako ukunika ulawulo olwaneleyo ekubekweni kweemveliso ezitofwayo.Iimveliso zokuzalisa imilebe nobuso ezithengiswa ngokuthe ngqo kubathengi abakwi-Intanethi zinokosulelwa yimichiza okanye izinto ezosulelayo. ”
I-FDA yathi iingozi ziquka ukopha okanye ukugruzuka;usulelo lwebhaktheriya, umngundo okanye intsholongwane evela kwiifayili okanye izixhobo ezingenanaliti;usulelo lwezifo phakathi kwabantu abasebenzisa isixhobo esingenanaliti esinye;imithambo yegazi evalekileyo ekhokelela ekufeni kwezicubu, ubumfama okanye ukufa uhlangothi;amava;Uxinzelelo lwesixhobo esingenanaliti sibangela umonakalo emehlweni;ukubunjwa kwamaqhuma esikhumbeni;ukuguquka kwesikhumba;kunye neentshukumo zokwaliwa.I-arhente ibeka esweni iingxelo zeziphumo ebezingalindelekanga kwaye yongeza ukuba akuvumelekanga ukuthengisa izixhobo zonyango ezichazwe ngugqirha ngaphandle komyalelo kwaye zinokuba phantsi kwezohlwayo zoluntu okanye zolwaphulo-mthetho.
Ukongeza ekufuneni ngokukhawuleza ukhathalelo kumboneleli wezempilo onelayisensi kwimeko apho ukusetyenziswa kwezixhobo ezingenanaliti ezifana neepeni ze-hyaluronic acid kubangela ukusabela okungalunganga, i-FDA ikwabongoza ukuba uqhagamshelane neMedWatch, ulwazi lokhuseleko lwe-arhente kunye nenkqubo yokunika ingxelo yesiganeko esibi. imiba.
Kwintwasahlobo ephelileyo, kwiintsuku ezimbalwa zokuqala zobhubhane, ucwangco lokuhlala ekhaya lwahlala lusebenza, iinkonzo ezingabalulekanga zanqunyanyiswa, kwaye i-DIY yathatha intsingiselo entsha.Xa iimaski zinqabile, sisebenzisa idenim esele isidla umhlala-phantsi kunye nezikhafu ezinganxitywanga ukuze sizenzele ezethu.Ukuvalwa kwezikolo, satshintshela utishala impahla, sadlala ngobuchule ngamaqonga amaninzi afunekayo okufundisa abantwana bebanga lokuqala esofeni.Sibhaka ezethu isonka.Zipeyinte ezethu iindonga.Sinyamekele eyethu igadi.
Mhlawumbi olona tshintsho lukhulu lwenzekile kwintsimi yobuhle ejolise kwinkonzo ngokwesiko, kuba abantu baye bafunda ukucheba iinwele zabo kwaye bazenzele iimanicure zodwa.Abona bagqithisileyo abo benza unyango lwesikhumba lwe-DIY, olufana nokususwa kwe-mole (engalunganga kumanqanaba amaninzi), kwaye nangakumbi iinaliti zokuzalisa ezibuhlungu-nangona i-dermatologists kunye noogqirha beplastiki sele bebuyele kwishishini , Kodwa lo mkhwa usekho unyaka.
Ukukhuthaza le ntshukumo, iTikTok kunye neYouTube ziye zaba ngamaziko okusebenza angahluzwanga kwabo bafuna ukutofa i-hyaluronic acid (HA) emilebeni, impumlo, kunye nesilevu besebenzisa isixhobo esifumaneka ngokulula esibizwa ngokuba yi-hyaluronic acid pen.
Ezi zixhobo zingenanaliti zifumaneka kwi-Intanethi kwaye zisebenzisa uxinzelelo lomoya ukutyhala iasidi ye-hyaluronic eluswini.Xa kuthelekiswa neenaliti kunye ne-cannulas ezisetyenziselwa oogqirha ukuba bafake iifayili, iipeni ze-hyaluronic acid zinolawulo oluncinci kwisantya kunye nobunzulu bokuhanjiswa kwe-HA."Olu luxinzelelo olungalawulwayo, olungenakulinganiswa, ngoko ngokwenene unokufumana amanqanaba ahlukeneyo oxinzelelo ngokuxhomekeke kwi-press," kusho uZaki Taher, MD, ibhodi eqinisekisiweyo yedermatologist e-Alberta, eCanada.
Kwaye kukho umahluko omkhulu phakathi kweempawu.Kwiividiyo zeYouTube kunye neTikTok, ezinye zeepeni ze-hyaluronic acid esiziphandileyo zabonakala zifaka imveliso emilebeni kwaye zibonakala zibuthathaka kakhulu ukuba zingagqobhoza ulusu (sicinga ukuba zisetyenziswe ngokufanelekileyo).Abanye bafumana izilumkiso zokuphononongwa ngamandla abo kwaye bacebise abathengi ukuba bangazisebenzisi kuyo nayiphi na indawo yobuso.
Kwiimeko ezininzi, ezi peni zihlala zivela kuphononongo lwe-intanethi-amaxabiso aqala malunga ne-50 yeedola ukuya kumakhulu ambalwa eedola-ibango lokukwazi ukungena malunga ne-5 ukuya kwi-18 millimeters ubunzulu, kwaye ngexabiso elimalunga ne-1,000 ukuya kwi-5,000 yeponti nganye yesikwere. intshizi (PSI).Hema Sundaram, MD, ugqirha wesikhumba ovunywe yibhodi eFairfax, eVirginia, wathi: “Ngokwembono efanelekileyo, umlinganiselo woxinezeleko ebusweni uqikelelwa kuma-65 ukuya kuma-80 PSI, yaye amandla embumbulu ali-1 000 PSI nangaphezulu.”kunye neRockville, eMaryland.Nangona kunjalo, uninzi lwezi zixhobo ziqinisekisa amava angenabuhlungu ngandlela ithile.
Ipeni ye-Hyaluron imodareyithwa emva kwesirinji yejethi ephathwa ngesandla, enokuthi ifake amayeza angamanzi (afana ne-insulin kunye ne-anesthetics) esikhumbeni ngaphandle kwenaliti."Malunga neminyaka eyi-20 edlulileyo, ndaziswa kwezi [uhlobo] lwezixhobo," kusho uL. Mike Nayak, MD, ugqirha oqinisekisiweyo webhodi yeplastiki yobuso eFrontinac, eMissouri, osandul 'ukubetha kwi-Instagram Hyaluronic acid pen.“Kukho ipeni ye-anesthesia yendawo [iyinto] efanayo, isixhobo esilayishwe entwasahlobo-ukhupha i-lidocaine, ucinezele i-trigger, kwaye iya kuvelisa amathontsi ahamba ngokukhawuleza.Banokungena ngokukhawuleza kumphezulu wolusu. ”
Namhlanje, i-US Food and Drug Administration (FDA) ivume iisirinji ezimbalwa zejethi kumachiza athile kakhulu-umzekelo, enye evunyiweyo yokutofa izitofu ezithile zokugonya umkhuhlane-kwaye okuthakazelisayo, ezinye zazo ziyi-hyaluronic acid-pen Abangaphambili babonelele ekuqaleni. ubungqina bento iingcali zethu ezibiza ngayo iingxaki zendalo ngolu hlobo lwesixhobo."Iingxelo zophando malunga nesitofu sokugonya se-intradermal syringe zibonisa ukuba kunzima ukulawula ngokuqhubekayo ubunzulu kunye nendawo yesitofu [kwaye] indawo yokutofa idla ngokubangela ukugruzuka okongeziweyo kunye nokudumba ngexesha lenaliti," utshilo u-Alex R. Thiersch.Igqwetha elimele ishishini lobuhle kunye nomseki weMed Spa Association of America.
Nangona kukho ukufana phakathi kweesirinji zejethi zonyango kunye neepeni zokuthambisa zehyaluronic acid, isithethi seFDA uShirley Simson usiqinisekisile ukuba “ukuza kuthi ga ngoku, iFDA ayikavuma ukuba iisirinji ezingenanaliti zitofelwe ngeasidi yehyaluronic.”Ukongeza, uye wachaza ukuba "kuphela ababoneleli bezempilo abanelayisenisi abavumileyo ukusetyenziswa kweenaliti okanye i-cannula yezihluzi zedermal kwezinye iimeko.Akukho mveliso yedermal filler ivunyiweyo ukuba isetyenziswe zizigulana okanye ekhaya. ”
Abalandeli beepeni ze-hyaluronic acid banokuthi ukuba amachiza athile, afana ne-epinephrine kunye ne-insulin, athathwa njengekhuselekile kwiinaliti ze-DIY, kutheni i-HA?Kodwa kwezo meko zamkelekileyo kwezamayeza, uGqr. Nayak wathi: “Wawunikwa inaliti, unikwe isirinji, unikwe i-insulin—wandule ke ufumane nolwalathiso lwengcali yezonyango eyayibek’ esweni [inkqubo ].”Nge-HA, ipeni ye-hyaluronic acid ayivunywanga yi-FDA;kungabikho ukubeka iliso;kwaye ngokuqhelekileyo ujolise ubuso, ngenxa yenkqubo yayo ye-vascular, i-injection iyingozi ngaphezu kwethanga okanye igxalaba.Ukongeza, uGqr. Nayak wongezelela ukuba ngenxa yokuba "abantu abasebenzisa ezi peni abanako [ngokusemthethweni] ukuthenga iifayili ezivunywe yi-FDA, bathenga iifayili ezimnyama kwi-intanethi."
Enyanisweni, uphando olutshanje olupapashwe kwiphephancwadi i-Dermatologic Surgery lufumene ukuba iifayili zomgunyathi ziyingxaki eqhelekileyo, kunye ne-41.1% yoogqirha abaphononongwa baye badibana neenaliti ezingavavanywanga kunye nezingaqinisekiswanga, kunye ne-39.7% yoogqirha baye baphatha izigulane ezineziganeko ezimbi ezibangelwa iinaliti.Elinye iphepha elipapashwe kwiJenali yeAmerican Academy of Dermatology ngo-2020 likwakhankanye ukonyuka kwezitofu ze-Intanethi ezingalawulekiyo kunye "nendlela eyonyukayo yokutofa i-neurotoxins kunye nezihluzi ezingalawulwayo phantsi kwesikhokelo se-YouTube tutorials".
UKatie Beleznay, MD, ugqirha wezilwanyana ovunywe yibhodi eVancouver, eBritish Columbia, wathi: “Abantu banenkxalabo enkulu malunga nokuba abantu bafaka ntoni kwezi penti.”“Malunga nobunyumba kunye nokuzinza [kwezigcwalisi ezikwi-intanethi] Kukho iingxaki ezininzi kwixesha elilindelweyo lokuphila.”Ngokungafani ne-HA ehlala ijojowe ngabagqirha be-dermatologists kunye noogqirha beplastiki abaqinisekiswa yikomiti, "Ezi mveliso azizange zihlaziywe ngokungqongqo ukhuseleko lwe-FDA, ngoko ke abathengi abanakukwazi ukuba bahlobile," kusho ikomiti.USarmela Sunder, MD, wongezelela.-Ugqirha oqinisekisiweyo weplastiki yobuso eBeverly Hills.Kwaye ngenxa yokuba izigulane eziqhelekileyo zingenakukwazi ukuziqhelanisa nokuhlukana phakathi kwee-HAs ezahlukeneyo-indlela i-viscosity kunye ne-elasticity yabo inquma ngayo ukusetyenziswa ngokufanelekileyo kunye nokubekwa, okanye indlela i-cross-linking yabo ekhethekileyo ekuchaphazela ngayo ukuvuvukala kunye nokuqina-bayazi njani ukuba zeziphi iigels ngokwenene Ngaba kuya kubakho ipeni okanye eyona milebe ikhangeleka ngokwendalo okanye iinyembezi okanye izidlele?
Kwezi nyanga zimbalwa zidlulileyo, inkitha yeedermatologists eziqinisekisiweyo zebhodi kunye noogqirha botyando beplastiki balumkise abalandeli babo kumajelo eendaba ezentlalo malunga nemingcipheko emininzi eyayanyaniswa neepeni ze-hyaluronic acid kunye nenaliti ye-DIY yokuzalisa ngokubanzi..
Ephambili kwintlawulo yi-American Society of Dermatological Surgery (ASDS).NgoFebruwari, umbutho ukhuphe isilumkiso sokhuseleko lwesigulane kwaye wachaza kwingxelo yokuba baye baqhagamshelana ne-FDA malunga nokhuseleko lwe-hyaluronic acid pen phenomenon.NgoMatshi walo nyaka, iAmerican Academy of Dermatology yakhupha ingxelo efanayo, ilumkisa ngelithi “nangona kusenokuhenda ukutofa izizalisi zehyaluronic acid ezithengwe kwi-Intanethi ebusweni okanye emilebeni usebenzisa isixhobo esingenanaliti ‘do-it-yourself’, kodwa ukwenza oko kunokuba neziphumo ezibi kwimpilo. ”
Nangona iingxaki zokuzalisa zinokuthi zenzeke nakwii-injection ezinamava kakhulu, i-FDA-evunyiweyo yi-hyaluronic acid fillers, efana neJuvéderm, Restylane, kunye ne-Belotero, iqinisekiswa yibhodi eqeqeshiweyo yedermatologists kwaye iyaqonda i-anatomy kunye notyando lweplastiki Inaliti kagqirha okanye i-cannula ithathwa kakhulu. ikhuselekile kwinaliti.Ukuba kukho iingxaki, zinokuchongwa kwaye zitshintshwe.“I-Bulkers lunyango oluhle kakhulu-zidume kakhulu kwaye [zino]neliseka kakhulu-kodwa kufuneka uyazi into oyenzayo,” umongameli we-ASDS kunye nogqirha oqinisekisiweyo webhodi wase-Boston uMathew Avram The MD waphinda wathi, “Ziyingozi ukuba zitofelwe kwindawo engafanelekanga—kukho iingxelo zobumfama, istroke nezilonda [zolusu] ezinokonakalisa inkangeleko.”
Ngokuqhelekileyo, "indawo engalunganga" kunzima ukwahlula kwindawo echanekileyo.UGqr. Nayak wathi: “Inxalenye encinane eya kwicala elifanelekileyo okanye kwicala elingelilo ngumahluko phakathi kwenxalenye enkulu yemilebe yakho nempumlo enezirhintyela okanye engenalo iilophu.”Wongeze ngelithi ngenxa yokungachaneki ngokwaneleyo kweengxelo zosiba, “nokuba ndinayo [enye], kwaye andisoze ndicinge ukuyisebenzisa ukutofa izigcwalisi kuba ndiyoyika ukuba andikwazi ukulawula eyona ndawo ikhoyo imveliso.”(Ukungaphumeleli kwakutshanje kwepeni ye-hyaluronic acid ephathwayo liqela likaDkt Nayak yinto awayibiza ngayo " Umzekelo we "imeko engcono kakhulu", enokuthi ibangelwa ukuhanjiswa kwemveliso engazinzanga yesixhobo: i-filler ecacileyo yeBB isasazekile phezu kwemilebe yomguli.)
Nangona iinkampani ezingenakubalwa zivelisa iipeni ze-hyaluronic acid, kwaye kubonakala ngathi kukho iiyantlukwano ezifihlakeleyo phakathi kweemodeli-ingakumbi ezinxulumene nobunzulu bokuhanjiswa kunye noxinzelelo kunye nemilinganiselo yesantya kwisibhengezo-iingcali zethu zigxininisa ukuba ziqhutywa ngeendlela zoomatshini ezifanayo Kwaye zizise. iingozi ezifanayo.“Ezi peni ziyakhathaza, kwaye andicingi ukuba ndikhe ndaphawula ukuba nayiphi na [enye] yezi peni ngokuqinisekileyo ingcono kunenye, kwaye akukho sesikweni kubantu abangenalo uqeqesho lwezonyango kwaye baqhelene kakhulu nokwakheka kobuso,” uGqr. Sander Yitsho.
Kungenxa yoko le nto i-DIY eyisiseko yezi zixhobo izenza zibe yingozi kakhulu-enyanisweni, "zithengiswa kubantu abangafanelekanga ukuba bafake iinaliti zokuzalisa kwaye baqalise ukuzinyanga," uGqr Sundaram wongezelela.
Umtsalane wabuza uDkt. Sunder, uDkt. Sundaram, kunye noDkt. Kavita Mariwalla, MD ukuba bahlole ezinye iipeni ze-hyaluronic acid ezibonwa kumajelo asekuhlaleni.Njengoko kulindeleke, ukungabikho kweenaliti akuthethi ukuba akukho ngxaki: iipeni ze-hyaluronic acid zingasongela impilo yethu kunye nokubonakala ngeendlela ezininzi ezibalulekileyo.
Xa ijeli ihlasela okanye inxinzelela imithambo, ivimba ukuhamba kwegazi kwaye inokubangela ukuxobuka kwesikhumba, ubumfama okanye ukubetha kwentliziyo, ukuvaleka kwemithambo kwenzeka-eyona ngxaki imbi yokuzalisa."Umonakalo we-Vascular uhlala uyingxaki nayiphi na i-injection yokuzalisa, kungakhathaliseki ukuba i-filler ifakwe njani emzimbeni," kusho uDkt Sander.“Nangona abanye abaxhasi beepen [kumajelo eendaba ezentlalo] bekholelwa ukuba ipeni ayinakungena emithanjeni yegazi njengenaliti, ngoko [akunakwenzeka] ukuba kubangele isiganeko semithambo, kusekho umngcipheko omkhulu wokonakala kwemithambo ngenxa yokunyanzeliswa kwesithambiso. ngesitya.”
UGqr. Taher wabona i-vascular occlusion ebangelwa inaliti ye-DIY ngepeni ye-hyaluronic acid.“Imeko endiye ndadibana nayo-yayiyingxaki yokwenyani yemithambo,” utshilo.“Ndibone ifoto ndaza ndathi, ‘Kufuneka ungene ngoko nangoko.’” Kumlebe ongasentla wesigulana, sabona ukujika kombala omfusa wemithambo efuna ukutshintshwa (uyakubona apha, kwiPSA. kuYouTube emva konyango).Ngemijikelo emibini ye-enzayim etofwayo ebizwa ngokuba yi-hyaluronidase, wakwazi ukunyibilikisa ihlwili waza wasindisa ulusu lomguli.
Imithambo emininzi engundoqo yobuso ibaleka nje iimilimitha ezimbalwa ngaphantsi kobuso bolusu.Ugqr. bayaluphala baze banciphe."Kumanqaku athile omlomo ophantsi, i-ultrasound imaging ibonise ukuba ubunzulu bemithanjana engaphantsi kwesikhumba buphakathi kwe-1.8 ukuya kwi-5.8 mm," wongezelela.Kwisifundo esifanayo, ubunzulu bomthambo owondla umlomo ophezulu ukusuka kwi-3.1 ukuya kwi-5.1 mm."Ngoko ke, i-HA i-pressurized jet esuka kwipeni ye-hyaluronic acid kufuneka ikwazi ukuqhagamshelana nomthambo womlomo ophezulu, umthambo womlomo ophantsi kunye nezinye izakhiwo ezibalulekileyo," uGqr Sundaram waphetha.
Xa ujonga isifundo sosiba se-HA kuYouTube, uGqr. Sundaram wayekhathazekile kukubona impendulo yenkampani ixelela umhlalutyi “Ewe, ungasebenzisa ipeni ukunyanga iitempile,” kodwa kungcono udibane nogqirha ukuze ufumane ubuchule obuchanekileyo.NgokukaGqr. Sundaram, "Ngokuphathelele ubumfama obubangelwa yinaliti yokuzalisa, itempile yindawo ebalulekileyo yomngcipheko ebusweni kuba imithambo yegazi esetempileni idityaniswe nemithambo yegazi ebonelela ngamehlo.Umthambo ophambili wetempile, umthambo ongaphezulu wexeshana, Ubaleka ngaphakathi kwezicubu ezinentambo phantsi kwesikhumba, umaleko wamafutha kule ndawo ubhityile,” okwenza kube lula ukuwuvala, ngakumbi ukuba isirinji ayazi ukuba iphi.
“Inaliti yoxinzelelo eneneni ingu-zero ebusweni,” utshilo uMarwalla.Ukuze kuncitshiswe iingxaki ezifana ne-vascular occlusion kunye nokugruzuka okuqhelekileyo, "Sisoloko sifundisa ugqirha ukuba ajobe ngokukhawuleza ngoxinzelelo oluphantsi."
Nangona kunjalo, ipeni ye-asidi ye-hyaluronic ixhomekeke kumandla anamandla kunye nesantya sokuhambisa isigcwalisi esikhumbeni."Xa isixhobo singenayo inaliti njengendawo yokungena, imveliso ngokusisiseko idinga ukutyhala phantsi koxinzelelo oluphezulu kangangokuba inokukrazula okanye ikrazule ulusu," utshilo uGqr. Sander.Kwimeko yesitofu somlomo, "ngalo lonke ixesha uxinzelelo olubalulekileyo lusetyenziswa kwi-mucosa ebuthathaka, kuya kubangela ukwenzakala kunye nokulimala okutyumkileyo ukuya kwinqanaba elithile - kwaye kungekhona nje ulusu, kodwa kunye nemithambo yegazi engaphantsi, njengabaninzi [ Ipeni yeasidi yeHyaluroniki] Imivumbo kwividiyo yotyando ingqina oku.Ngenxa yomonakalo we-mucosal, uxinzelelo oluphezulu olungeniswa kwimveliso lunokubangela ukwakheka kwexesha elide. "
UDkt. Sundaram uthelekisa ii-injection ze-HA kunye neepeni ze-hyaluronic acid "kwiimbumbulu ezizaliswe" kwaye uthelekise ukuxhwaleka abakwenzayo kunye nomonakalo wokubambisana obangelwa xa iibhulethi zangempela zidutshulwa kwizicubu zomntu."Ingqiqo isixelela ukuba ukuba utyhala imbumbulu enesantya esiphezulu eluswini phantsi koxinzelelo olukhulu lomoya, iya kubangela ukwenzakala kwezicubu."
"Ezi peni azikwazi ukunika unyango olulawulwayo noluqikelelweyo," utshilo uGqr. Sundaram, "kuba ukunyanzeliswa kwefayili esikhumbeni phantsi koxinzelelo oluphezulu kunokubangela ukuba isasazeke ngokungalindelekanga kwaye ngokungahambi kakuhle."Ukongeza, uye wabonisa ukuba xa ulusu lungaphakathi Ukuvuvukala kuqale ngexesha lonyango, "Ukudumba kuya kufihla ubume bokwenyani bemilebe-ukuba ubeka phi ezi zinto, awusenakho ukuchaneka."
Kutshanje uye wanyanga umntu osebenzisa ipeni ye-hyaluronic acid “owayenomlebe ongentla mkhulu kakhulu kunomlebe ongezantsi, kwaye elinye icala lomlebe ongasentla lalilikhulu kakhulu kunelinye icala, kwaye laligruzukile kwaye lineqhuma,” utshilo.
UGqr. Sundaram uphinde wabonisa ukuba ipeni enobunzulu obukhulu bentengiso inokuchukumisa izihlunu ezithile, ezifana nezihlunu ezihambisa umlomo."I-Ultrasound scans yemilebe yomzimba ophilayo-ichaneke ngakumbi kunezifundo ze-cadaver-zibonisa ukuba i-orbicularis oris i malunga ne-4 millimeters ngaphantsi kwesikhumba," wachaza.Ukuba ipeni yeasidi ye-hyaluronic ifaka izihlunu kwizihlunu, "ukumanzi kwayo kunokubangela umngcipheko owongezelelweyo wokuzalisa izigaqa kunye namaqhuma, kunye nokufuduswa okungaphezulu kwesithako esihlala sibizwa ngempazamo njenge'migration'," utshilo.
Kwelinye icala, ukuba ii-HAs ezithile—iintlobo ezomeleleyo nezityebileyo—zitofwa ngokunzulu kakhulu ngeepeni zokubhala ezingalindelekanga, zisenokubangela iingxaki, ezinjengamaqhuma abonakalayo neetinti eziluhlaza."Ezinye zezinto ezifakwe kwiipeni zijiyile kwaye zixananazile," utshilo uGqr. Sundaram."Ukuba uzitofe ezi ngaphezulu, uya kufumana isiphumo sikaTyndall, [oku] kukutshintsha kombala oluhlaza okubangelwa kukusasazwa kokukhanya."
Ukongeza kubunzulu bengxaki yosiba kunye nepateni yokusasazwa, “inyaniso yokuba [bafakela] iimveliso njengepilisi enye okanye indawo yokugcina impahla, endaweni yokubeka imigca yentshukumo eqhubekayo, yingxaki ngokwembono yokhuseleko kunye nobuhle.“UGqr.Watsho uSand."Isirinji enamava ayigcini imveliso, ngakumbi emilebeni."
UMarwalla watyikitya wathi: “Andizange [ndisebenzise] ubuchule obuqhubekayo benaliti ye-bolus ukuze nditofe imilebe-ayibukeli nje into engeyoyamvelo, kodwa isigulana siva amaqhuma namaqhuma.”UGqr. Sunder wabonisa ukuba inaliti ye-bolus iyakwandisa "i-vascular Umngcipheko womonakalo okanye umonakalo wezicubu.
Ingozi apha ivela kwimithombo emibini-into engaqinisekanga injected kunye ne-hyaluronic acid pen ngokwayo.
Njengoko kukhankanyiwe ngaphambilana, “mhlawumbi eyona nto ixhalabisayo kuzo zonke iingxaki kukugcwalisa ngokwako,” watsho uGqr. Sander.Ukongeza kwinto enokwenzeka yongcoliseko okanye ukukrexeza, “Ndikwanexhala lokuba abanye abantu abangathathi ntweni basenokungayiqondi imiba phakathi kweasidi ye-hyaluronic esetyenziselwa ukusetyenziswa kwezihloko [ezifana neserum] kunye ne-hyaluronic acid yokwenyani esetyenziselwa inaliti.Ngaba Ukwaziswa kweemveliso zezihloko eluswini okanye kwimifinya yezi peni kunokubangela iingxaki ezihlala ixesha elide ezifana nokusabela komzimba wangaphandle okanye ukwakheka kwegranuloma,” enokuba nzima ukuyilungisa.
Nokuba umntu ngandlel’ ithile ukwazile ukufumana isigcwali se-HA esisulungekileyo, esisemthethweni, ukusibeka epeni kuya kuvula enye inkonkxa yeentshulube."Kufuneka badlulisele isigcwalisi ukusuka kwisirinji yabo yasekuqaleni ukuya kwi-ampoule epeni," utshilo uGqr. Sundaram.“Le yinkqubo enamanyathelo amaninzi—qhagamshela isirinji yokudlulisela kwinaliti, zoba isihluzi, kwaye usitshize kwi-ampoule—lonke ixesha isenziwa, kukho umngcipheko wosulelo.”
UGqr. Sunder wongezelela, "Nangona lo msebenzi wenziwa kwindawo yonyango, ukudluliselwa akuyi kuba yinyumba.Kodwa ukwenza olu tyando kwikhaya lomntu kukulungiselela ukosuleleka.”
Ke kukho umba we-DIY wokubulala iintsholongwane.“Ipeni nganye inamalungu asuswayo.Umbuzo ngulo, sicoceke kangakanani isixhobo ngokwaso?Watsho uMariwala.“Ezi nkampani zifuna ukuba utofe izinto ezivela kwimithombo engaziwayo nezizinzileyo eluswini lwakho.Kuthekani ngesixhobo esinomqolo kunye nenxalenye ekufuneka icocwe?Sebenzisa isepha kunye namanzi kwaye uyomise kwi-dishwasher?Akubonakali ngathi.Ukhuseleko kum.”
UGqr. Sundaram uthe njengoko uninzi lwabantu ngaphandle kwabasebenzi bezonyango bengaqhelananga nokuntsonkotha kobuchule be-aseptic, "kusenokwenzeka ukuba izigulana ekugqibeleni zisebenzise i-HA engeyiyo inzala kwaye ziyityhale eluswini."
UGqr. Beleznay uthe iziphathamandla zezempilo zaseKhanada zikhuphe isilumkiso sokhuseleko loluntu kwezi peni ngo-2019. Njengomzekelo wamanyathelo anokwenzeka okukhusela uluntu ekuzikhuseleni, wasixelela ukuba ukuthengiswa kweepeni ze-hyaluronic acid kuthintelwe eYurophu. .Ngokutsho kwesilumkiso sokhuseleko salo mbutho, ukongezelela ekulumkiseni abemi ngeengozi ezibandakanyekileyo, iHealth Canada ikwafuna abo bathenga kumazwe angaphandle, abasasazi, nabenzi beepeni zeasidi ihyaluronic ukuba “bayeke ukuzithengisa ezi zixhobo yaye ifuna ukuba zonke iinkampani ezifanelekileyo zikhumbule ezo zisemarikeni.izixhobo”.
Xa sibuza uSimson ukuba i-US FDA ithatha amanyathelo okurhoxisa ezi zixhobo kwimarike okanye ithintele abavelisi ukuba bangazithengisela izinto zokuthambisa, waphendula wathi: “Njengomgaqo-nkqubo, i-FDA ayixoxi ngobume bolawulo lweemveliso ezithile ngaphandle kokuba yi Iinkampani ezinoxanduva lweemveliso ezinjalo ziyasebenzisana.Nangona kunjalo, ukuza kuthi ga ngoku, akukho naliti engenanaliti yamkelweyo ukuba ifakwe i-hyaluronic acid ngeenjongo zokuthambisa.
Ukuqwalasela uluhlu lweengozi ezichazwe ziingcali zethu zonyango kunye nokungabikho kwangoku kwedatha kwizixhobo ze-DIY, kunzima ukucinga ukuba ipeni ye-hyaluronic acid iya kuvunywa yi-FDA.“Ukuba umntu ufuna ukwenza ezi peni zibe semthethweni, kufuneka siqhube uphononongo olulawulwayo lwenaliti yentloko ukuya entloko-ukuvavanya [ukuvavanya] ukhuseleko, ukusebenza kakuhle, ukuthembeka, kunye nemiphumo yexesha elifutshane neyexesha elide,” watsho ugqirha.USundaram wabonisa.
Ngelixa silindele ngethemba umthetho wepeni ye-hyaluronic acid yase-US, thina kwa-Allure siyakubongoza ukuba uthobele izilumkiso zeengcali zethu kwaye unganikezeli kwiimbono ezimbi zakutsha nje kumajelo asekuhlaleni.Ingxelo eyongezelelweyo nguMarci Robin.
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© 2021 Condé Nast.onke Amalungelo Agciniwe.Ngokusebenzisa le webhusayithi, uyasamkela isivumelwano sethu somsebenzisi kunye nomgaqo-nkqubo wabucala kunye nengxelo yeekuki, kunye namalungelo akho abucala aseCalifornia.Njengenxalenye yobudlelwane bethu kunye nabathengisi, i-Allure inokufumana inxalenye yentengiso kwiimveliso ezithengiweyo ngewebhusayithi yethu.Ngaphandle kwemvume ebhaliweyo yangaphambili kaCondé Nast, izixhobo ezikule webhusayithi azinakukotshwa, zisasazwe, zisasazwe, zigcinwe okanye zisetyenziswe ngenye indlela.Ukukhetha intengiso


Ixesha lokuposa: Dec-14-2021