I-FDA icebisa iiLebhu eziLumkisayo eziQinisekileyo kwiiNdawo zokuFaka amabele ukucacisa iingozi

Umxholo

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I-US Food and Drug Administration (i-FDA) ichitha ukufakelwa kwamabele. I-arhente ifuna ukuba abantu bafumane izilumkiso ezinamandla kunye neenkcukacha ezingaphezulu malunga nazo zonke iingozi ezinokwenzeka kunye neengxaki ezinxulumene nezi zixhobo zonyango, ngokwezikhokelo ezitsha zoyilo ezikhutshwe namhlanje.

Kwizindululo zayo zoyilo, i-FDA ibongoza abenzi ukuba bongeze iilebheli "zesilumkiso" kuyo yonke ityiwa yesaline kunye neesilic ezele. Olu hlobo lweelebheli, olufana nezilumkiso ozibonayo kwiphakheji yecuba, lolona hlobo lomeleleyo lwesilumkiso olufunwa yi-FDA. Isetyenziselwa ukwazisa ababoneleli kunye nabathengi malunga neengozi ezinkulu ezinxulumene namachiza athile kunye nezixhobo zonyango. (Idibeneyo: 6 Izinto endizifundileyo kwiBobob Boob Job)

Kule meko, izilumkiso zebhokisi ziya kwenza abavelisi (kodwa, okubalulekileyo, hayi abathengi, aka abasetyhini abafumana ukufakelwa amabele) bayazazi iingxaki ezinxulunyaniswa nezinto ezifakwe kwisifuba ezinombala, njengokukhathala okungapheliyo, iintlungu ezidibeneyo, kunye nohlobo olunqabileyo lomhlaza obizwa ngokuba kukufakwa kwebele-okunxulunyaniswa ne-aplastic enkulu-cell lymphoma (BIA-ALCL). Njengoko besikhe saxela ngaphambili, isiqingatha sazo zonke iimeko ze-BIA-ALCL ezichazwe kwi-FDA ziye zafunyaniswa kwisithuba seminyaka esixhenxe ukuya kwesibhozo emva kokwenziwa kotyando lwebele. Ngelixa olu hlobo lomhlaza lunqabile, sele luthathe ubomi babasetyhini ubuncinci abangama-33, ngokwe-FDA. (Inxulumene: Ngaba ukuTyala ngokuBeleka ukuGula kuyinyani? Yonke into ekufuneka uyazi malunga neMeko yokuPhikisana)

Kunye nezilumkiso zebhokisi, i-FDA ikwacebisa ukuba abavelisi bokufakelwa kwebele babandakanye "uluhlu lokukhangela isigqibo sesigulane" kwiilebhile zemveliso. Uluhlu lokutshekisha luya kuchaza ukuba kutheni ukufakelwa kwebele kungezizo izixhobo zobomi bonke kwaye kwazise abantu ukuba ibhinqa eli-1 kwaba-5 kuya kufuneka lisuswe kwisithuba seminyaka esi-8 ukuya kweli-10.

Inkcazo yezinto eneenkcukacha iyacetyiswa, kubandakanya iintlobo kunye nobungakanani beekhemikhali kunye nesinyithi esinzima esifunyenwe saza sakhutshwa kukufakwa. Okokugqibela, i-FDA icebisa uhlaziyo kunye nokongeza ulwazi lokulebhelisha kwizindululo zovavanyo lwabasetyhini abane-silicone ezaliswe ngejeli ukuze babukele nakuphi na ukugqabhuka okanye ukukrazula ixesha. (Inxulumene: Ukulahla ukufakelwa kwamabele emva kweMastectomy ephindwe kabini ekugqibeleni kwandinceda ukuba ndibuyise uMzimba wam)

Ngelixa ezi ngcebiso zintsha zinzima kwaye kusafuneka zigqitywe, i-FDA inethemba lokuba uluntu luya kuthatha ixesha lokuzijonga kwaye babelane ngeengcinga zabo kwiintsuku ezingama-60 ezizayo.

"Sithathwe sisonke sikholelwa ukuba olu khokelo luyilwayo, xa lugqityiwe, luya kukhokelela ekubhalweni ngcono kokufakelwa kwamabele okuya kuthi ekugqibeleni kuncede izigulana ziqonde ngcono izibonelelo zokufakelwa kwebele kunye nemingcipheko, eyona nto ibalulekileyo ekwenzeni izigqibo zokhathalelo lwempilo ezihambelana neemfuno zezigulane. kunye nendlela yokuphila, "u-Amy Abernethy, MD, Ph.D., kunye noJeff Shuren, MD, JD-FDA usekela-khomishina oyintloko kunye nomlawuli weZiko le-FDA lezixhobo kunye neMpilo yeRadiological, ngokulandelelana-babhale kwingxelo edibeneyo ngoLwesithathu. (Eyeleleneyo: Ndikhutshiwe ukufakelwa kwesifuba sam kwaye ndiziva ndingcono kunale minyaka ndinayo.)

Ukuba kwaye xa ezi zilumkiso ziqala ukusebenza, nangona kunjalo, aziyi kunyanzeliswa. "Emva kwexesha lezimvo zoluntu, nje ukuba isikhokelo sigqityiwe, abavelisi banokukhetha ukulandela iingcebiso kwisikhokelo sokugqibela okanye banokukhetha ezinye iindlela zokulebhelisha izixhobo zabo, ukuba nje ukubhalwa kuhambelana nemithetho nemigaqo esebenzayo ye-FDA," Wongeze uGqr. uAbernethy noShuren. Ngamanye amagama, izikhokelo eziyilwayo ze-FDA zizindululo nje, kwaye nokuba / nini zi kugqityiwe, abavelisi akuyi kunyanzeleka ngokusemthethweni ukuba balandele izikhokelo.

Ngokusisiseko, kuya kuba ngoogqirha ukuba bafunde izilumkiso kwizigulana zabo, abanokuthi bazenze hayi bona ii-implants kwi-package yazo phambi kotyando.

Ekupheleni kosuku, nangona kunjalo, ngokuqinisekileyo eli linyathelo kwicala elifanelekileyo le-FDA. Ngenxa yokuba ngaphezulu kwama-300,000 abantu bakhetha ukufumana ukufakelwa kwamabele minyaka le, lixesha lokuba abantu baqonde kanye le nto bayityikityayo.

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