Kwa zaka zambiri, pakhala zizindikiro zomwe amayi ena omwe ali ndi mawere a m'mawere angakhale pangozi kuti apange chitukuko chochepa. Komabe, umboniwu poyamba unali wovuta, ndipo mawu ochokera ku mabungwe monga United States Food and Drug Administration (FDA) ndi World Health Organization (WHO) adasonyeza kuti alibe umboni.
Mu 2011, a FDA amanena mawu otsatirawa okhudza kupachikidwa kwa m'mawere omwe amagwirizana ndi maselo akuluakulu a lymphoma (ALCL):
Ngakhale kuti ALCL ndi yosavuta kwambiri, a FDA amakhulupirira kuti amayi omwe ali ndi mawere a m'mawere akhoza kukhala ndi chiopsezo chochepa kwambiri chokhalira ndi matendawa mu kapupa wamagazi pafupi ndi kuyika. Malingana ndi zomwe zilipo, sizingatheke kutsimikizira ndi chiwerengero chotsimikizirika kuti zizindikiro za m'mawere zimayambitsa ALCL.
Panthawi imeneyo, a FDA adasonyezanso kuti chiwerengero cha ALCL chinali chochepa, ngakhale odwala. Iwo sankatha kudziwa mtundu wa kuyika, mwachitsanzo, silicone versus saline, yomwe inali yogwirizana ndi chiopsezo chachikulu. Komanso mu chiganizo cha 2011, chinenerocho chinaphatikizapo chitsogozo kwa opereka chithandizo, pozindikira kuti a FDA sanalangize kuchotsa ma implants pachifuwa kwa odwala popanda zizindikiro kapena zovuta zina, komanso kunena kuti pamene adaphunzira zambiri za ALCL mwa amayi omwe ali ndi mawere a m'mawere, awa Malangizo angasinthe.
Msonkhano wa 2017 Wochokera kwa FDA
Mu 2017, a FDA adasintha malingaliro ake potsata ndondomeko ndi zochitika zomwe WHO, Australian Therapeutic Goods Administration, ndi French National Agency for Medicines and Health Products Safety.
Pano pali gawo laposachedwa 2017 US FDA:
Kuchokera mu 2011, takhala tikulimbitsa chidziwitso cha vutoli ndikugwirizana ndi a World Health Organisation of the breast-implant-associated prophylaxis cell lymphoma (BIA-ALCL) monga T-cell lymphoma yomwe imatha kukhala ndi zotsatira za m'mawere. Nambala yeniyeni ya milandu imakhala yovuta kudziwa chifukwa cha kuchepa kwakukulu kupoti la padziko lonse ndi kusowa kwa deta yopezera malonda padziko lonse. Panthawiyi, deta zambiri zimasonyeza kuti BIA-ALCL imachitika kawirikawiri potsatira kuyika kwa mawere a m'mawere m'malo opangidwa ndi maonekedwe m'malo mokhala ndi malo osalala.
Zikutanthauza chiyani?
Pamene FDA ikuvomerezedwa ndi zinthu monga ma implants, nthawi zina zimafuna makampani omwe amapanga zipangizozi kuti apange maphunziro ena kuti apeze zambiri zokhudza ngozi za mankhwalawa. Mwanjira iyi, chipangizo chachipatala chingavomerezedwe malingana ndi umboni womwe ulipo, koma ngati deta yowonjezera imatulukira, a FDA amasintha chinenero chawo pazochenjeza ndi zoopsa.
Panopo, a FDA amadziwika za kuopsa kwa ma implants a m'mawere , ndi njira yapamwamba, kutchula zovuta zambiri poyamba, kuphatikizapo:
- Chigwirizano cha Capsular
- Reoperation
- Kukonzekera kuchotsedwa (popanda kapena kusinthidwa)
- Yambani kupasuka
- Kusintha
- Asymmetry
- Kutaya
- Ululu
- Kutenga
A FDA amanenanso kuti pangakhale chitsimikizo chochepa kwambiri chopezeka kuti ali ndi aplastic lalikulu cell lymphoma (ALCL).
Njira Zatsopano Zopangira Opaleshoni:
Malinga ndi lipoti la pachaka la American Society for Aesthetic Plastic Surgery, opaleshoni yomwe inkachitika kwambiri mu 2016 inali ndi:
- Mafuta amasamutsira pachifuwa (okwera 41 peresenti)
- Labiaplasty (okwera 23 peresenti)
- Kukwezera zinyama (mmwamba 21 peresenti)
- Mafuta amasamutsira nkhope (okwera 17 peresenti)
- Kuchotsa m'mimba (kutuluka kwa 13)
Sidziŵika kuti ndi chidziŵitso chotani ponena za ngozi ya lymphoma yomwe yathandizira kuti kuchotsa ma implants.
Kodi Amadziwika Zokhudza Breast Lymphoma, Mu General?
Mafupa oyambirira a m'mawere, omwe amatanthauza kuti ma lymphomas amayamba kukula m'mawere, ndi ochepa kwambiri khansa, omwe amaimira pafupifupi 0,5% ya matenda a khansa ya m'mawere ndi 2 peresenti ya milandu yotchedwa extranodal lymphomas .
Amayamba m'magazi a ma lymphoid a m'mawere ndi kumwazikana kwa maselo oyera a m'magazi-omwe ali pafupi ndi mazira ndi lobes, ndipo ambiri mwa khansawa amachokera ku maselo oyera omwe amadziwika kuti B-maselo . B-maselo ndi mtundu wa maselo oyera omwe nthawi zina amawamasulira ndi kuwasiyanitsa ndi maselo a m'magazi opangidwa ndi anti-wodwala a chitetezo cha mthupi.
Matenda omwe amachokera ku mtundu wina wa selo loyera la magazi, T-maselo, ndi osowa.
Avereji ya zaka zomwe amayamba pa primary primary lymphoma ndi zaka 57. Malinga ndi zizindikiro zomwe mkazi angakhale nazo, kapena zomwe zimapezeka pa mammograms ndi scans, mawere oyambirira a m'mawere a m'mawere amachititsa mofanana kwambiri ndi zotupa za m'mawere , choncho kuyesera kokha kugwiritsa ntchito ma antibodies (immunohistochemistry) n'kofunikira kuti azindikire izi. Koma zotupa nthawi zambiri zimakhala zosakwatiwa, kapena zokhazokha, ndipo zimatchulidwa bwino, ndipo zimanenedwa kukhala ndi khalidwe losungunuka kwa iwo.
Kodi Amadziwika Bwanji About Anaplastic Large Cell Lymphoma? (ALCL)
Mafupa amtunduwu amadziwika kuti Hodgkin ndi Hodgkin lymphoma, ndipo kenako ndi subtypes, mutadziwa gawo lalikulu. Anaplastic lalikulu cell lymphoma , kapena ALCL, ndi mtundu wosakhala wa Hodgkin lymphoma wa T cells. Ndi kagawo kakang'ono kakang'ono ka tchizi pamene mukukamba za maimymphoma omwe si a Hodgkin, ndipo amaimira pafupifupi 3 peresenti ya milandu yonse yomwe ilibe ya Hodgkin.
Chidwi ndi kafukufuku ku ALCL zakhala zikuwonjezeka m'zaka zaposachedwa ndi malipoti a milandu ya mawere oyambirira a m'mawere oyamwitsa amchere opangidwa ndi saline ndi silicone. Pazochitikazi, kawirikawiri chitsanzo chinali chakuti china chake chinayambitsa opaleshoni, chomwe chinayambitsa matenda a lymphoma. Ngati matenda ena aliwonse a lymphoma adapezeka kale asanachite opaleshoni, izi sizinafotokozedwe.
Akuti mwina kutenga ALCL ndi 1 mwa amayi 500,000 omwe ali ndi implants. Ukalamba ukuyamba ukuoneka kuti uli pakati pa zaka 34 ndi 59, ndipo khansara imawonekera mkati mwa zaka 3 mpaka 7 kuchokera nthawi yomwe mazira amayamba.
Chiwerengero choyamba cha ALCL chogwiriridwa ndi amuna chija chinalengezedwa mu 1997. Mu lipoti la 2011 la FDA, milandu 60 ya ALCL yokhudzana ndi kuikidwa inatsimikiziridwa. Kuchokera nthawi imeneyo, chiwerengero cha ALCL chawonjezeka, monga momwe chiwerengero cha machitidwe opangira mawere akuyendera.
ALCL imakhudza kapsule ya fibrous pafupi ndi kuyika, ngakhale nthawi zina imakhala yayikulu, ndipo siimaphatikizapo minofu ya m'mawere. Nthaŵi zambiri lymphoma imayamba ndi mchere wambiri womwe sumawoneka wokha, mwinamwake uli ndi shrinkage ya capsule pafupi ndi kuyika, kapena misa kumbali ya kuyika.
Nkhani zina za FDA:
Kuyambira mu February 2017, a FDA adati:
FDA inalandira makompyuta okwana 359 a chipangizo chachipatala chokhudza mawere apulojekiti aakulu a cell lymphoma, kuphatikizapo imfa zisanu ndi zinayi. Pali malipoti 231 ndi deta pazomwe mukudziwa pa nthawi ya malipoti. Mwa awa, 203 anali opangidwa ndi makina opangidwa ndi matayala ndipo 28 ali ndi zida zosalala. Pali malipoti okwana 312 ndi deta yowonjezera mtundu wodzaza. Mwa amenewa, 186 inanena za kugwiritsa ntchito mapiritsi odzaza gelsi, ndipo 126 anafotokoza kugwiritsa ntchito mankhwala odzaza saline.
Komabe, zikuwoneka kuti pakadalibe kusatsimikizika za zomwe mauthengawa akutanthauza, ponena za chiopsezo chapadera kwa mkazi yemwe ali ndi implants:
Zindikirani, pamene MDR ndiyo njira yamtengo wapatali yowunikira, izi zimakhala zoperewera, kuphatikizapo zosakwanira, zosalondola, zosadziwika, zosasinthika, kapena zotsutsana ndi deta. Kuonjezera apo, zochitika kapena kuchulukana kwa chochitika silingathe kudziwika kuchokera ku kachitidwe kameneka kokha chifukwa cha kufotokozera kwapadera, kufotokoza mobwerezabwereza za zochitika, ndi kusowa kwa chidziwitso chokhudza chiwerengero cha ma implants.
Mawu Ochokera
A FDA anamasulira mwachidule mabuku a zachipatala pa nkhaniyi, kusonyeza kuti zonse zomwe zilipo lero zikusonyeza kuti amayi omwe ali ndi mawere a m'mawere amakhala ndi chiopsezo chochepa koma chowonjezeka cha ALCL poyerekeza ndi amayi omwe alibe ma implants.
Amadziŵa kuti ALCL yochulukirapo mawere amathandizidwa ndi kuchotsedwa kwa mankhwalawo ndi kapsule ozungulira mzerewo ndipo zina zinachitidwa ndi chemotherapy ndi radiation. Chitsogozo cha 2017 kwa othandizira zachipatala chokhudzana ndi kuchotsedwa kwa mankhwala sichinthu chosiyana kwambiri ndi kusintha kwapita kale:
"Chifukwa chakuti kawirikawiri amadziwika okha mwa odwala omwe ali ndi zizindikiro zoyambirira monga zowawa, ziphuphu, kutupa, kapena kutaya thupi, prophylactic breast implant kuchotsa odwala popanda zizindikiritso kapena zina zosavomerezeka sizikuvomerezeka."
A FDA akulangizitsa kuti ngati muli ndi ma implants, palibe chifukwa chosinthira chithandizo chamankhwala ndi chidziwitso, kuti BIA-ALCL ndi yochepa, ndipo ngakhale kuti si yeniyeni kwa BIA-ALCL, muyenera kutsatira ndondomeko zoyenera zachipatala kuphatikizapo:
- Tsatirani malangizo a dokotala anu momwe mungayang'anire ma implants anu.
- Ngati muwona kusintha kulikonse, funsani wothandizira zaumoyo wanu mwamsanga kukonza dongosolo.
- Khalani ndi chizoloŵezi chowonera mammography ndikufunsani katswiri wamakono omwe amaphunzitsidwa bwino kuti azichita mammogram pa odwala omwe ali ndi mawere a m'mawere.
- Ngati muli ndi mapiritsi odzazidwa ndi mavitamini a silicone, pangani mafilimu opanga maginito (MRI) nthawi zonse kuti muzindikire kupweteka monga momwe akulimbikitsirani ndi wothandizira zaumoyo wanu.
- Chipangizo cha FDA chomwe chimagwiritsidwa ntchito polemba ma implants odzaza mazira a silicone, chimanena kuti MRI yoyamba iyenera kuchitika patatha zaka zitatu kuchokera pamene opaleshoni imayamba ndipo zaka ziwiri zotsatira.
M'chinenero chimene amauzidwa kwa odwala komanso amayi omwe amaganizira za mawere a m'mawere, a FDA amakakamiza kukambirana bwino ndi dokotala wokhudzana ndi zoopsa zomwe zimachitika musanayambe.
> Zotsatira:
> Fleury E de FC, Rêgo MM, Ramalho LC, et al. Kachilombo kameneka kamene kamayambitsa khungu (SIGBIC): mafananidwe ndi kusiyana ndi aplasitiki yaikulu ya cell lymphoma (ALCL) komanso kusiyana kwawo. Khansa ya m'mawere: Zolinga ndi mankhwala. 2017; 9: 133-140.
> United States Administration Chakudya ndi Mankhwala. Anaplastic Large Cell Lymphoma (ALCL) Mu Akazi ndi Matenda a Chiberekero: Zomwe Zakafukufuku za FDA Zakafukufuku ndi Kufufuza.
> United States Administration Chakudya ndi Mankhwala. Kachilombo ka Abambo-Kothandizidwa ndi Anaplastic Large Cell Lymphoma (BIA-ALCL).