Kwiminyaka, kuye kwaba neengcebiso ukuba abanye abafazi abaneentsholongwane zesifuba bangasengozini ekuphuhliseni i-lymphoma engaqhelekanga. Nangona kunjalo, ubungqina bokuqala bebuqilima, kwaye iingxelo ezivela kwimibutho efana ne-United States Yokutya kunye neDrug Administration (i-FDA) kunye ne-World Health Organization (i-WHO) yabonakalisa ukungabikho kobungqina.
Ngo-2011, i-FDA ibeka ingxelo elandelayo malunga ne-breast-inclinated-cell linked lymphoma (ALCL) ehambelana ne-breast.
Nangona i-ALCL yinto engaqhelekanga kakhulu, i-FDA ikholelwa ukuba abafazi abaneentsholongwane zesisu banokuba neyona mngcipheko omncinci wokukhula kwesi sifo kwi-capsule yesiqhekeza esekelwe ku-implant. Ngokusekelwe kwingcaciso efumanekayo, akunakwenzeka ukuqinisekisa ngokuqinisekiswa kobungqina bokuthi izibeleko zesifuba zenza i-ALCL.
Ngaloo xesha, i-FDA ibonise ukuba iziganeko ze-ALCL zazincinci kakhulu, kwanezigulane zentsholongwane. Akwazanga ukufumanisa uhlobo lokufakela, umzekelo, i-silicone versus saline, edibene nomngcipheko omkhulu. Kwakhona kwintetho ka-2011, ulwimi lwaluquka isikhokelo kubanikezeli benkonzo yezempilo, ekuboneni ukuba i-FDA ayizange icebise ukususa izibilini zesifuba kwizigulane ezingenazo iimpawu okanye ezinye izinto ezingafanelekanga, kodwa zichaza ukuba njengoko zifunde ngakumbi nge-ALCL kubasetyhini abaneentsholongwane zebele, ezi iingcebiso zitshintshe.
I-2017 Isexwayiso esivela kwi-FDA
Ngo-2017, i-FDA ihlaziye ulwazi layo kwiingxelo kunye nezenzo ezithathwe yi-WHO, i-Australian Treatment Therapeutic Administration Administration, kunye ne-Arhente yeSizwe yaseFransi yamayeza kunye neMpilo yoKhuseleko lweMpilo.
Nayi inxalenye yengxelo yamuva ye-2017 US FDA:
Ukususela ngo-2011, siye saqinisa ukuqonda kwethu le meko kwaye sivumelane ne-World Health Organisation ye-breast-implant-linked associated cell cell lymphoma (BIA-ALCL) njengenqabile ye-T-cell lymphoma engakwazi ukuphuhlisa izilwanyana ezilandelayo. Inani elichanekileyo lamatyala lisaba nzima ukunquma ngenxa yokunciphisa amaninzi ekunikeleni ingxelo kwihlabathi jikelele kunye nokungabi naso kwedatha yokuvelisa umhlaba jikelele. Ngeli xesha, uninzi lwedatha lubonisa ukuba i-BIA-ALCL ivela ngokuphindaphindiweyo emva kokufakelwa kwezibilini zesifuba kunye neendawo ezifakwe emacaleni kunokuba zineendawo ezipholileyo.
Ingaba ithetha ntoni?
Xa iingxelo ze-FDA zivunywa ngezinto ezifana nokufakelwa kwebele, ngamanye amaxesha kufuna iinkampani ezenza ezi zixhobo ukuba zenze ezinye izifundo ukuze zithole ulwazi olungakumbi malunga neengozi zemveliso. Ngale ndlela, isicatshulwa sezokwelapha singagunyazwa ngokusekelwe kububungqina obukhoyo, kodwa njengokuba idatha eyongezelelweyo iphuma, i-FDA ihlaziya ulwimi lwayo malunga neengcebiso kunye nobungozi.
Okwangoku, i-FDA iserekhodi malunga nobungozi bokufakelwa kwebele , ngeendlela eziphezulu, ukubeka uluhlu lwezona zinto zixhaphake kakhulu, kuquka:
- Isivumelwano seCapsular
- Ukusebenza kwakhona
- Ukutshintshwa ukususwa (okanye ngaphandle kokutshintshwa)
- Ukuvelisa ukuphuka
- Ukunciphisa
- Asymmetry
- Ukuqhekeka
- Ubuhlungu
- Sulelo
I-FDA iphinda icacise indlela ephantsi kakhulu kodwa yanda kakhulu yokufumanisa i-cell anti-lymphoma (ALCL).
Imihlahlandlela yakutshanje kwiNkqubo zoPhando:
Ngokombiko wonyaka we-American Society for Aesthetic Plastic Surgery, iinkqubo zokugqirha ezazibonwa ukwanda okwakubaluleke kakhulu ngo-2016 zibandakanya:
- Ukudluliselwa kwefuthe kwibele (ukuphakama kwama-41 ekhulwini)
- I-Labiaplasty (i-23 ekhulwini)
- Ukuphakama kwamatye (ukuphakama kwama-21 ekhulwini)
- Ukudluliselwa kwefuthe ebusweni (kwiiphesenti ezili-17)
- Ukususwa kwebhedlele (ukuphakama kwe-13)
Ayaziwa ukuba yimalini ulwazi malunga nomngcipheko we-lymphoma uye wabangela ukuba uphakamise ukususwa kwezibilini zebele.
Yintoni eyaziwayo malunga ne-Breast Lymphoma, ngoJikelele?
Izibeleko zamabhondi zaseprayimari, ezithetha ukuba i-lymphomas eqala ukukhula emabele, iindawo ezinomdlavuza ezinqabileyo, ezimalunga ne-0.5 ekhulwini yamathambo omhlaza kunye neepesenti ezingama-2 zamatyala e- extranodal lymphomas .
Baqala kwiisculi ze-lymphoid ze-breast-patches kunye nokutshatyalaliswa kweeseli ezimhlophe zegazi-ezijikeleze iidon kunye ne-lobes, kwaye ezininzi zee cancer zivela ngaphandle kweeseli ezimhlophe zegazi ezibizwa ngokuba yi- B-seli . Iiseli ze-B zihlobo lweeseli ezimhlophe zegazi ezinokuthi zisebenze ngezinye iinkcukacha kwaye zihluke kwiiseli ze-plasma ezivelisa umntu okhuselweyo.
Izidumbu ezivela kwelinye uhlobo lwe-white cell cell, i-T-cell, ayilula.
Umyinge weminyaka ekuqalekeni kwe-primary lemon lymphoma uneminyaka engama-57. Ngokweempawu zowesifazane onokukwazi ukuzenza, okanye ukufunyaniswa kwimimmograms kunye neesisombululo, i-lymphomas yeprayimari yezona zinto zenza into enjengezinye izicubu zebele , ngoko iimvavanyo ezizodwa zisebenzisa i-antibodies (immunohistochemistry) zibalulekile ukuxilongwa kwezi zifo. Kodwa iimvumi zihlala zingatshatanga, okanye zodwa, kwaye zichazwe kakuhle, kwaye zithi zinomgangatho obanzi kubo.
Yintoni eyaziwayo malunga neAnaplastic Large Cell Lymphoma? (ALCL)
I-Lymphomas iqokelelwe njengeHodgkin kunye ne-non-Hodgkin lymphoma, kwaye emva kwee-subtypes, emva kokuba wazi isigaba esiphezulu. I-Anaplastic enkulu yeli cell lymphoma , okanye i-ALCL, uhlobo olunqabileyo lwe- non-Hodgkin lymphoma yamaseli eT. Ingcezu encinci ye-pie xa uthetha nge-non-Hodgkin lymphomas, kwaye imela malunga neepesenti ezingama-3 zazo zonke iimeko ezingekho ze-Hodgkin i-lymphoma.
Inzala kunye nophando kwi-ALCL sele ikhuthazwe kwiminyaka yamuva ngeengxelo zamatyala e-breastmymmas amancinci afana ne-saline ne-silicone. Kule meko, iphethini eqhelekileyo kukuba into ethile yabangela ukuhlinzwa, okwabangelwa ukuxilongwa kwe-lymphoma. Ukuba kukho naziphi iimeko ze-lymphoma eziye zafunyaniswa phambi kokuhlinzwa, oku akuzange kubhengezwe ngokubanzi.
Kuqikelelwa ukuba umngcipheko wokufumana i-ALCL ngowona-1 kwabafundi abangama-500 000 abaneentsholongwane zebele. Ubudala obuqalayo bubonakala buphakathi kweminyaka engama-34 no-59, kwaye umhlaza ubonakala ukhula malunga neminyaka engama-3-7 ukusuka kwenkqubo yokufakelwa kwebele.
Ingxelo yokuqala ye-ALCL ehambelana ne-ABL yaxelwa ngo-1997. Ngxelo ye-FDA ka-2011, iimeko ezingama-60 ze-ALCL ezinxulumene nokufakelwa ziqinisekisiwe. Ukususela ngoko, inani lamatyala e-ALCL liye landa, njengoko kunenani leenkqubo zokufakelwa kwebele.
I-ALCL ichaphazela i-capsule ene-fibrous malunga nokuveliswa, nangona ngamanye amaxesha kukho ubungqina obomeleleyo, kwaye ayibandakanyi isisu sebele, ngokwazo. Kwiimeko ezininzi i-lymphoma iqala ngokuqokelela umbane ongeke uhambe ngokwawo, mhlawumbi nge-shrinkage ye-capsule ejikeleze ukuveliswa, okanye ubunzima kumda we-implant.
Ezinye iingxelo ze-FDA:
Ukususela ngoFebhuwari 2017, i-FDA yathi:
I-FDA ifumene iingxelo ezingama-359 zonyango zonyango lwe-breast implant-ehlobene ne-plastiki enkulu yeli cell lymphoma, kubandakanya ukufa kwabasithoba. Kukho iingu-231 iingxelo kunye nolwazi malunga nolwazi lomhlaba ngexesha lokunika ingxelo. Kule ndawo, iingu-203 zazikhombise izixhobo ezifakwe kwi-textured and 28 kwi-implants. Kukho iingxelo ezingama-312 kunye nedatha ekufakeni uhlobo lokuzalisa. Kule mihla, i-186 yabika ukusetyenziswa kwezimpembelelo ze-gel ezizaliswe yi-gel, kwaye i-126 yabika ukusetyenziswa kwezilwanyana ezizaliswe nge-saline.
Nangona kunjalo, kubonakala ngathi kusekho ukungaqiniseki malunga nokuba zezi zithini iingxelo, ngokuphathelele umngcipheko othile kumfazi obeneempembelelo:
Ingqalelo, ngelixa inkqubo ye-MDR iyimithombo ebalulekileyo yolwazi, le nkqubo yokuqwalasela engapheliyo iyanciphisa, kubandakanywa ingaphelelanga, engaqinisekanga, engaqinisekisiweyo, okanye i-data engabonakaliyo kwiingxelo. Ukongezelela, iziganeko okanye ukuxhaphaka kwesiganeko akunakunqunywa kule nkqubo yokunika ingxelo kuphela ngenxa yokungaphantsi kweengxelo, ukuphindwa kweengxelo zemicimbi kunye nokungabikho kolwazi malunga nenani elipheleleyo leentsholongwane zebele.
ILizwi
I-FDA isishwankathele iincwadi zonyango malunga nesi sihloko, ebonisa ukuba zonke iinkcukacha eziza kumhla zibonisa ukuba abafazi abaneentsholongwane zesisu banomlinganiselo ophantsi kakhulu kodwa ukwandisa ukukhula kwe-ALCL xa kuthelekiswa nabasetyhini abangenazo izilwanyana zesifuba.
Bayaqaphela ukuba ezininzi iimeko ze-ALCL ezinxulumene ne-breast-implanted-ALM ziphathwa ngokususwa kwe-implant kunye ne-capsule ezungeze ukuveliswa kwaye ezinye iimeko ziye zanyangwa yi-chemotherapy kunye ne-radiation. Isikhokelo sika-2017 kubaboneleli bezempilo ngokubhekiselele ekususweni kweprophylactic akufani nakwezinye izinto ezidlulileyo:
"Kuba ngokuqhelekileyo kuboniswe kuphela kwizigulane ezinokuqala kweempawu ezinjengeentlungu, izibilini, ukuvuvukala, okanye i-asymmetry, ukutshatyalaliswa kwebele yeprophylactic kwizigulane ezingenayo impawu okanye enye into engavumelekanga."
I-FDA icebisa ukuba ukuba unesibeleko sesifuba, akukho mfuneko yokutshintshwa kwenkathalo yakho yonyango kunye nokulandelelana, ukuba i-BIA-ALCL ayinqabile, kwaye nangona ingahambelani ne-BIA-ALCL, kufuneka ulandele iziphakamiso zonyango eziqhelekileyo kuquka:
- Landela imiyalelo yegqirha yakho malunga nendlela yokujonga iimpembelelo zakho zebele.
- Ukuba uqaphela nayiphi na utshintsho, qha ga mshelana nomboneleli wakho wonyango ngokukhawuleza ukucwangcisa ukuqesha.
- Yenza i- screening mammography ukuhlola kwaye ubuze i-teknoloji eqeqeshwe ngokuzenzekelayo ekwenzeni imimmogram kwizigulane ezineempembelelo zebele.
- Ukuba une-silicone ye-gel-filled implants, ufumane i-imaging magnontic resonance imaging (MRI) ukufumana ukuphuka njengoko kuphakanyiswe ngumboneleli wakho wezempilo.
- I-label ye-FDA evumelekileyo yokubethelwa kwemveliso ye-silicone-filled implants ezaliswe yi-gel ithi iMRI yokuqala kufuneka ivele emva kweminyaka emithathu emva kokutyunjwa kwemveliso kunye neminyaka emibini emva koko.
Ngolwimi olubhekiswe kwizigulane kunye nabasetyhini bacinga izilwanyana zesifuba, uxinzelelo lwe-FDA lunomxholo ococekileyo nodokotela wakho malunga neengozi eziziwayo zokufaka izimpembelelo ngaphambi kokuya kwenkqubo.
> Imithombo:
> Fleury E de FC, uRêgo MM, uRamalho LC, et al. I-granuloma eyenziwe nge-silicone ye-breast caption (SIGBIC): ukufana kunye neentlukwano kunye ne-plastiki enkulu yeli cell lymphoma (ALCL) kunye nokuxilongwa kwabo ngokwahlukileyo. Umhlaza webele: iithagethi kunye neyeza. 2017; 9: 133-140.
> United States Ukutya kunye noLawulo lweeDrug. I-Anaplastic enkulu I-Cell Lymphoma (i-ALCL) Kwabasetyhini abaneziPhicongo zeBreast: Iziphumo zokuqala ze-FDA kunye nohlalutyo.
> United States Ukutya kunye noLawulo lweeDrug. Ukufakela kwe-Breast-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).