Sekuyiminyaka kube khona amacebo athi abanye besifazane abanezimpande zesifuba bangase babe engozini yokuthuthukiswa kwe-lymphoma engavamile. Kodwa-ke, ubufakazi bokuqala kwakungenangqondo, futhi izitatimende ezivela ezinhlanganweni ezifana ne-United States Food and Drug Administration (FDA) kanye neWorld Health Organization (WHO) bezibonise ukungabi nobufakazi.
Ngo-2011, i-FDA ibeka isitatimende esilandelayo mayelana ne-aplantma-ALM) ehlanganiswa ne-anti-cell anti-cell lymphoma (ALCL):
Nakuba i-ALCL ingavamile kakhulu, i-FDA ikholelwa ukuthi abesifazane abanezifuba zesifuba bangase babe nengozi encane kakhulu kodwa eyanda kakhulu yokuthuthukisa lesi sifo kulesi sikhuphuka esivamile eduze nokufakelwa. Ngokusekelwe kolwazi olutholakalayo, akunakwenzeka ukuqinisekisa ngokuqinisekisa ukuthi izibalo zokubeletha zibangela i-ALCL.
Ngaleso sikhathi, i-FDA iphinde ikhombise ukuthi izigameko ze-ALCL zazincane kakhulu, ngisho nasezigulini zokufaka izibeletho. Abakwazanga ukuthola uhlobo lokufakelwa, isibonelo, i-silicone versus saline, ehlanganiswe nengozi enkulu. Futhi esitatimendeni sika-2011, lolu limi lwaluhlanganisa isiqondiso kubahlinzeki bezempilo, okuphawula ukuthi i-FDA ayizange iphakamise ukususa izimila zesifuba ezigulini ezingenazo izimpawu noma ezinye izinto ezingavamile, kodwa futhi zithi njengoba zifunda kabanzi nge-ALCL kwabesifazane abanezimpande zesifuba, lezi izincomo zingashintsha.
Isexwayiso sika-2017 esivela ku-FDA
Ngo-2017, i-FDA ivuselele ulwazi layo ngemuva kwemibiko kanye nezenzo ezithathwe yi-WHO, i-Australian Therapeutic Goods Administration, kanye neFrench National Agency for Medicine and Health Products Safety.
Nansi ingxenye yamuva isitatimende sika-2017 US FDA:
Kusukela ngo-2011, siye saqinisa ukuqonda kwethu kwalesi simo futhi siyavumelana ne-World Health Organisation ye-World Health Organisation ye-breast-linked associated cell-lymphoma (BIA-ALCL) efana ne-T-cell lymphoma engavamile engathuthuka okulandelayo. Inani eliqondile lamacala lihlala lilukhuni ukunquma ngenxa yokulinganiselwa okuphawulekayo ekubikeni komhlaba wonke kanye nokuntuleka kwedatha yokuthengisa yokufaka umhlaba wonke. Ngalesi sikhathi, idatha eminingi ibonisa ukuthi i-BIA-ALCL ivela ngokuphindaphindiwe ngokulandelwa kwezibeletho zesifuba ngezindawo ezifakiwe kunokuba kunezindawo ezibushelelezi.
Kusho ukuthini?
Lapho izinkinga ze-FDA zivunyelwa izinto ezifana nezimila zebele, ngezinye izikhathi kudinga izinkampani ezenza la madivayisi enze olunye ulwazi ukuze uthole ulwazi oluthe xaxa mayelana nezingozi zomkhiqizo. Ngale ndlela, idivayisi yezokwelapha ingavunyelwa ngokusekelwe ebufakazini obukhona, kodwa njengoba idatha eyengeziwe iphuma, i-FDA ibuyekeza ulimi lwayo ngokuxwayisa nezingozi.
Njengamanje, i-FDA iserekhodi mayelana nezingozi zokufakelwa kwesisu , ngenqubo ephezulu, ukufaka kuhlu izinkinga ezivame kakhulu kuqala, kuhlanganise:
- Isivumelwano se-Capsular
- Ukuphindaphinda
- Ukususwa kokutshala (noma ngaphandle kokufaka esikhundleni)
- Faka ukuphuka
- Ukunciphisa
- I-Asymmetry
- Ukuthuka
- Ubuhlungu
- Ukutheleleka
I-FDA iphinde ibone ukuthi kuncane kakhulu kodwa kwandisa amathuba okuthola ukuthi unesifo esikhulu se-cell lymphoma (ALCL).
Izindinganiso Zamuva Ezinqubo Zokuhlinza:
Ngokombiko wonyaka wezibalo we-American Society ye-Aesthetic Plastic Surgery, izinqubo zokuhlinza ezabona ukwanda okuphawulekayo ngo-2016 zazihlanganisa:
- Ukudluliswa kwamafutha esibelethweni (amaphesenti angama-41)
- Labiaplasty (amaphesenti angama-23)
- Ukuphakama kwamathambo (phezulu kwamaphesenti angu-21)
- Ukudluliswa kwamafutha ebusweni (amaphesenti angu-17)
- Ukukhishwa kwesisu (ukukhuphuka kuka-13)
Ayaziwa ukuthi izinga luni lwazi mayelana nengozi ye-lymphoma liye lafaka isandla ekukhusheni ekukhusheni izimpande zebele.
Yini Eyaziwa Nge-Breast Lymphoma, Ngokujwayelekile?
Ama-lymphomas ebelethweni, okusho ukuthi i-lymphomas eqala ukukhula emabeleni, i-cancer engavamile kakhulu, emele cishe ngamaphesenti angu-0.5 amacala ekhanda webele kanye nama-2 amaphesenti ama- extranodal lymphomas .
Baqala emathisini e-lymphoid ama-breast-patches kanye nokuhlakazeka kwamaseli amhlophe egazi-okuzungeze amadokodo kanye ne-lobes, futhi iningi lala makhankaso livela ngaphandle kwamangqamuzana egazi amhlophe aziwa ngokuthi ama- B-cells . Ama-B-amangqamuzana angamaseli amhlophe egazi angase asebenze ngezinye izikhathi ahlukaniswe namaseli e-plasma akhiqiza ama-anti-anti-immune system.
Izicubu ezivela kolunye uhlobo lwegazi elimhlophe, ama-T-cells, azivamile.
Isilinganiso seminyaka ekuqaleni kwe-primary breast lymphoma uneminyaka engu-57. Ngezimpawu owesifazane angase abe nayo, noma okutholakele kumammograms kanye scans, izibeletho zamabele eziyinhloko zenza okufana nezinye izicubu zesifuba , ukuhlolwa okukhethekile ukusebenzisa ama-antibodies (i-immunohistochemistry) kubalulekile ekutholeni lezi zicubu. Kodwa izicubu ngokuvamile zingashadile, noma zodwa, futhi zichazwe kahle, futhi kuthiwa zinekhwalithi eqinisiwe kubo.
Yini eyaziwa nge-Anaplastic Large Cell Lymphoma? (ALCL)
Ama-lymphomas ahlukaniswe ngokuyinhloko njengeHodgkin non-Hodgkin lymphoma, bese kuthiwa yi-subtypes, uma wazi isigaba esiyinhloko. I-Anaplastic enkulu cell lymphoma , noma i-ALCL, iyinhlobo engavamile ye- non-Hodgkin lymphoma yamathambo e-T. Ingxenye encane kakhulu ye-pie uma ukhuluma nge-non-Hodgkin lymphomas, futhi imele cishe amaphesenti amathathu azo zonke izigameko ezingekho ze-Hodgkin lymphoma.
Intshisekelo nokucwaninga ku-ALCL kuye kwanyuswa eminyakeni yamuva ngembiko yamacala we-primary breast lymphomas ehlotshaniswa nokufakelwa kwesifuba se-saline nesicone. Kulezi zimo, iphethini evamile ukuthi into eyenza ukuhlinzeka, okwaholela ekuhloleni i-lymphoma. Uma noma yiziphi izimo ze-lymphoma ezitholwe ngaphambi kokuhlinzwa, lokhu akukabikwa kabanzi.
Kulinganiselwa ukuthi ingozi yokuthola i-ALCL ingu-1 kwabesifazane abangu-500 000 abanezimpande zesifuba. Ubudala obuqalayo bubonakala buphakathi kweminyaka engu-34 no-59, kanti umdlavuza ubonakala ukhula phakathi neminyaka engama-3-7 kusukela ngesikhathi senqubo yokufakelwa kwebele.
Isimo sokuqala se-ALCL ehlanganiswa ngamabele sabika ngo-1997. Ngombiko ka-2011 we-FDA, amacala angu-60 e-ALCL ahlotshaniswa nokufakelwa aqinisekisiwe. Kusukela ngaleso sikhathi, inani lamacala e-ALCL liye landa, njengoba linenani lezinqubo zokufakelwa kwebele.
I-ALCL iyathinta i-capsule enobuthi nxazonke, nakuba ngezikhathi ezithile kunesisindo esiqinile, futhi asibandakanyi izicubu zesifuba, ngokwayo. Ezimweni eziningi i-lymphoma iqala ngeqoqo lomswakama olungasuki ngokwalo, mhlawumbe nge-shrinkage ye-capsule ezungeze ukufakelwa, noma umthamo ohlangothini lwe-implant.
Ezinye izindaba ze-FDA:
Kusukela ngoFebruwari 2017, i-FDA yathi:
I-FDA yathola imibiko yezokwelapha ezingu-359 ze-breast implant-ehlobene nama-cell prototype esikhulu lymphoma, okuhlanganisa nokufa okungu-9. Kukhona imibiko engu-231 nedatha emininingwaneni yomhlaba ngesikhathi sokubika. Kulezi zingu-203 zazikhona izimpande ezifakiwe futhi ezingu-28 ezifakiwe ezibushelelezi. Kunemibiko engu-312 nedatha ekufakeni uhlobo lokugcwalisa. Kulaba, abangu-186 babike ukuthi ukusetshenziswa kwe-implants egcwele i-gel, futhi abangu-126 babika ukusetshenziswa kwezimila ezigcwele u-saline.
Kodwa-ke, kubonakala sengathi kusekhona ukungaqiniseki ngalokho okushiwo yile mibiko, ngokuphathelene nengozi ethize kumfazi onesiphakamiso:
Okuphawulayo, ngenkathi uhlelo lwe-MDR luwumthombo obalulekile wokwaziswa, lolu hlelo lokuqapha olunezinkinga luba nemingcele, kufaka phakathi idatha engaphelele, engacacile, engaqinisekisiwe, noma engathandekiyo emibikweni. Ngaphezu kwalokho, izigameko noma ukusabalala komcimbi akunakunqunywa kusuka kule nqubo yokubika kuphela ngenxa yokubikwa okungahle kwenzeke, ukubika okuphindaphindiwe kwemicimbi, nokuntuleka kolwazi mayelana nenani lazo zonke izibeletho zesifuba.
Izwi elivela
I-FDA ifingqa izincwadi zezokwelapha ngalesi sihloko, okubonisa ukuthi yonke imininingwane kuze kube yimanje ibonisa ukuthi abesifazane abanezimpande zesifuba banobungozi obuphansi kakhulu kodwa banda kakhulu bokuthuthukisa i-ALCL uma kuqhathaniswa nabesifazane abangenayo impilantshi yebele.
Bayazi ukuthi izimo eziningi ze-ALCL ezihlotshaniswa ngamabele ziphathwa ngokususwa kwe-implant kanye ne-capsule ezizungezile ukufakelwa kanti ezinye izimo ziye zaphathwa yi-chemotherapy nemisebe. Isiqondiso sika-2017 kubahlinzeki bezempilo mayelana nokususwa kwe-prophylactic akufani kakhulu nokubuyekezwa kwangaphambili:
"Ngenxa yokuthi ngokuvamile kutholakale kuphela kwiziguli ezinezimpawu ezinjengezinhlungu, izimpumputhe, ukuvuvukala, noma i-asymmetry, ukukhishwa kwesifuba se-prophylactic ekusunguleni iziguli ngaphandle kwempawu noma okunye okungavamile."
I-FDA iluleka ukuthi uma unezimpande zesifuba, akudingeki ukuba ushintshe ukunakekelwa kwakho kwezempilo njalo nokulandela, ukuthi i-BIA-ALCL ayidlangalaleni, kanti nakuba ingacacile ku-BIA-ALCL, kufanele ulandele izincomo zezokwelapha ezijwayelekile ezifaka:
- Landela imiyalelo kadokotela wakho mayelana nokuthi ungabheka kanjani izimpande zakho zesifuba.
- Uma ubona noma yiziphi izinguquko, xhumana nomhlinzeki wakho wokunakekelwa kwezempilo ngokushesha ukuhlela i-aphoyintimenti.
- Thola isimiso sokuhlola i-mammography bese ucela i-technician eqeqeshwe ngokukhethekile ekwenzeni imilmogram ngeziguli ezinezimpande zesifuba.
- Uma une-implants egcwele i-gel egcwaliswe ngamathumba, thola i-imaging ye-resonance yamagnetic ngezikhathi ezithile (i-MRI) ukuthola ukuphuka njengoba kunconywa umhlinzeki wakho wokunakekelwa kwezempilo.
- I-label ye-FDA evunyelwe umkhiqizo we-silicone-implants egcwele isifuba egcwele i-gel ithi iMRI yokuqala kufanele ivele eminyakeni emithathu emva kokuhlinzwa okufakelwayo futhi njalo ngemva kweminyaka emibili.
Ngolunye ulimi olubhekiswe ezigulini nabesifazane ngokucubungula izibeletho zesifuba, ukucindezeleka kwe-FDA kunengxoxo enhle nodokotela wakho mayelana nezingozi eziyaziwayo zokufaka izimpande ngaphambi kokuqhubeka nenqubo.
> Imithombo:
> Fleury E de FC, uRêgo MM, uRamalho LC, et al. I-granuloma eyenziwe ngamakhelisi we-capsule (i-SIGBIC) yokufakela isifuba: ukufanana nokungafani ne-amplastic cell lymphoma (ALCL) ne-diagnosis. Umdlavuza webele: Amasu kanye nokuTherapy. 2017; 9: 133-140.
> United States Ukudla Nezidakamizwa Zokuphatha. I-Anaplastic Large Cell Lymphoma (ALCL) Kwabesifazane Ngezimpande Zomzimba: Ukutholakala kokuqala kwe-FDA nokuhlaziywa.
> United States Ukudla Nezidakamizwa Zokuphatha. Ukufakelwa kwebele-Okuhlangene ne-Anaplastic I-Cell Cell Lymphoma (i-BIA-ALCL).