I-FDA Incoma Amalebula Esixwayiso Anamandla Kokufakwa Kwebele Ukuchaza Izingozi

-Delile

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Ukuphathwa Kwezokudla Nezidakamizwa e-U.S. I-FDA kuqeda ukufakelwa amabele. I-ejensi ifuna abantu bathole izexwayiso ezinamandla nemininingwane eminingi ngazo zonke izingozi nezinkinga ezingaba khona ezihambisana nalezi zinsiza zezokwelapha, ngokusho kwemihlahlandlela emisha esalungiswa ekhishwe namuhla.

Ezincomweni zayo ezisalungiswa, i-FDA inxusa abakhiqizi ukuthi bengeze amalebula "ayisixwayiso esinebhokisi" kuzo zonke izimila zebele ezigcwele usawoti kanye ne-silicone. Lolu hlobo lokulebula, olufana nezixwayiso ozibona ekufakweni kukagwayi, luwuhlobo oluqine kakhulu lwesixwayiso oludingwa yi-FDA. Isetshenziselwa ukwazisa abahlinzeki nabathengi ngezingozi ezinkulu ezihambisana nezidakamizwa ezithile kanye namadivayisi wezokwelapha. (Okuhlobene: Izinto Ezi-6 Engizifundile Emsebenzini Wami We-Botched Boob)

Kulokhu, izexwayiso ezifakwe ebhokisini zizokwenza abenzi (kepha, okubalulekile, hhayi abathengi, abesimame abathola empeleni ukufakelwa amabele) bazi ngezinkinga ezihambisana nokufakelwa kwebele okubunjiwe, njengokukhathala okungamahlalakhona, ubuhlungu bamalunga, kanye nohlobo lomdlavuza olungavamile olubizwa nge-implant-associated associated-cell-cell lymphoma (BIA-ALCL). Njengoba sike sabika ngaphambilini, ingxenye yawo wonke amacala e-BIA-ALCL abikwe ku-FDA atholwe phakathi neminyaka eyisikhombisa kuya kweyisishiyagalombili ngemva kokuhlinzwa kokufakelwa kwebele. Yize lolu hlobo lomdlavuza lungandile, seluthathe izimpilo zabesifazane okungenani abangama-33, ngokusho kwe-FDA. (Okuhlobene: Ingabe Ukugula Kokufakelwa Kwebele Kuyiqiniso? Konke Odinga Ukukwazi Ngesimo Esiyimpikiswano)

Kanye nezixwayiso ezisemabhokisini, i-FDA iphinde yeluleke ukuthi abakhiqizi bokufaka amabele bafake "uhlu lokuhlola lwesiguli" kumalebula womkhiqizo. Uhlu lokuhlola luzochaza ukuthi kungani ukufakwa kwamabele kungewona amathuluzi okuphila konke futhi kwazise abantu ukuthi owesifazane oyedwa kwabahlanu uzodinga ukuthi basuswe phakathi neminyaka engu-8 kuye kwengu-10.

Incazelo enemininingwane yezinto nayo iyatuswa, okuhlanganisa izinhlobo nenani lamakhemikhali nezinsimbi ezisindayo ezitholwe zaphinde zakhishwa izimila. Ekugcineni, i-FDA iphakamisa ukuvuselela nokwengeza imininingwane yokulebula kuzincomo zokuhlola zabesifazane abanezimonyo ezigcwaliswe ngo-gel ezinama-silicone ukubuka noma yikuphi ukuqhuma noma ukudabuka ngokuhamba kwesikhathi. (Kuhlobene: Ukulahla Izimila Zami Zebele Ngemva Kokuhlinzwa Okuphindwe Kabili Ekugcineni Kwangisiza Ukuba Ngibuyise Umzimba Wami)

Yize lezi zincomo ezintsha zinzima futhi kusamele ziphothulwe, i-FDA inethemba lokuthi umphakathi uzothatha isikhathi ukuzibuyekeza futhi wabelane ngemicabango yabo ezinsukwini ezingama-60 ezizayo.

"Uma sithathwa sisonke sikholelwa ukuthi lo mhlahlandlela osalungiswa, lapho ungowokugcina, uzoholela ekubhaleni okungcono kokufakelwa kwamabele okuzogcina kusize iziguli ukuthi ziqonde kangcono izinzuzo nezingozi zokufakwa kwebele, okuyingxenye ebaluleke kakhulu ekwenzeni izinqumo zokunakekelwa kwezempilo ezihambelana nezidingo zeziguli kanye nendlela yokuphila, "u-Amy Abernethy, MD, Ph.D., noJeff Shuren, MD, JD-iphini likakhomishani omkhulu we-FDA kanye nomqondisi we-FDA's Center for Devices and Radiological Health, ngokulandelana - babhale esitatimendeni ngokuhlanganyela ngoLwesithathu. (Okuhlobene: Ngithole Ukufakwa Kwamabele Kwami Kususwe Futhi Ngizizwe Ngcono Kuneminyaka Enginayo.)

Uma lezi zixwayiso ziqala ukusebenza futhi, kodwa-ke, ngeke ziphoqeleke. "Ngemuva kwesikhathi esithile sokuphawula komphakathi, uma isiqondiso sesiqediwe, abakhiqizi bangase bakhethe ukulandela izincomo esiqondisweni sokugcina noma bangakhetha ezinye izindlela zokulebula amadivayisi abo, inqobo nje uma ukulebula kuhambisana nemithetho neziqondiso ezisebenzayo ze-FDA," wanezela uDkt. U-Abernethy kanye noShuren. Ngamanye amazwi, iziqondiso ezisalungiswa ze-FDA ziyizincomo nje, futhi noma ngabe/nini kukhona kuqediwe, abakhiqizi ngeke kudingeke ngokomthetho ukuthi balandele imihlahlandlela.

Ngokuyisisekelo, kuzoba ngodokotela ukuthi bafundele iziguli zabo izexwayiso, okungenzeka ukuthi zikhona hhayi bona okutshalwe emaphaketheni abo ngaphambi kokuhlinzwa.

Ekupheleni kosuku, noma kunjalo, lokhu kuyisinyathelo sendlela efanele yi-FDA. Njengoba kunikezwe iqiniso lokuthi abantu abangaphezu kuka-300,000 bakhetha ukuthola okufakelwa amabele minyaka yonke, sekuyisikhathi sokuthi abantu baqonde kahle ukuthi babhaliselani.

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