{"id":8003,"date":"2019-11-25T14:30:23","date_gmt":"2019-11-25T19:30:23","guid":{"rendered":"http:\/\/localhost:10028\/uncategorized\/fda-breast-implant-cancer-risk\/"},"modified":"2019-11-25T14:30:23","modified_gmt":"2019-11-25T19:30:23","slug":"fda-meme-implant-kanser-riski","status":"publish","type":"post","link":"https:\/\/napolilaw.lemonadestand.org\/tr\/article\/fda-meme-implant-kanser-riski\/","title":{"rendered":"FDA: Meme \u0130mplant\u0131 Kanser Riski"},"content":{"rendered":"<p>Ge\u00e7en ay, ABD G\u0131da ve \u0130la\u00e7 \u0130daresi adl\u0131 taslak k\u0131lavuz yay\u0131nlad\u0131. <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/breast-implants-certain-labeling-recommendations-improve-patient-communication\" target=\"_blank\" rel=\"noopener\">\u201cMeme \u0130mplantlar\u0131 - Hasta \u0130leti\u015fimini \u0130yile\u015ftirmek \u0130\u00e7in Belirli Etiketleme \u00d6nerileri\u201d<\/a> salin ve silikon jel dolgulu meme implantlar\u0131 alan hastalar\u0131n \u00fcr\u00fcn ve riskleri hakk\u0131nda tam olarak bilgilendirilmelerini sa\u011flamak i\u00e7in \u00e7e\u015fitli \u00f6neriler i\u00e7eriyordu.<\/p>\n<p>Taslak k\u0131lavuz, meme implantlar\u0131 kanser ve di\u011fer hastal\u0131klarla ili\u015fkilendirildi\u011finden, ya\u015fam\u0131 tehdit eden risklere dikkat \u00e7ekmek i\u00e7in re\u00e7eteli ila\u00e7 etiketlemesi i\u00e7in en g\u00fc\u00e7l\u00fc FDA uyar\u0131s\u0131 olan kutulu bir uyar\u0131 \u00f6nermektedir.<\/p>\n<p>FDA, kutulu uyar\u0131n\u0131n \u015fu \u015fekilde okunmas\u0131n\u0131 \u00f6nerir: &quot;meme implantlar\u0131 \u00f6m\u00fcr boyu cihaz olarak kabul edilmez;&quot; \u201ckomplikasyon geli\u015ftirme \u015fans\u0131 zamanla artar;\u201d &quot;baz\u0131 komplikasyonlar daha fazla ameliyat gerektirecektir;&quot; veya &quot;meme implantlar\u0131 BIA-ALCL geli\u015ftirme riskiyle ili\u015fkilendirilmi\u015ftir ve sistemik semptomlarla ili\u015fkilendirilebilir.&quot;<\/p>\n<p>2011 y\u0131l\u0131nda FDA, Meme \u0130mplant\u0131 ile \u0130li\u015fkili Anaplastik B\u00fcy\u00fck H\u00fccreli Lenfoma (BIA-ALCL) olarak bilinen hastal\u0131\u011f\u0131 tan\u0131mlad\u0131.<\/p>\n<p>Bu kanser ba\u011f\u0131\u015f\u0131kl\u0131k sistemini etkiler ve genellikle implantlar\u0131 \u00e7evreleyen skar dokusunda veya s\u0131v\u0131da bulunur.<\/p>\n<p>Semptomlar ameliyattan y\u0131llar sonra ortaya \u00e7\u0131kabilir ve meme implant\u0131 b\u00f6lgesinde \u015fi\u015flik ve a\u011fr\u0131y\u0131 i\u00e7erebilir. Ba\u015far\u0131l\u0131 tedavi, implant\u0131n cerrahi olarak \u00e7\u0131kar\u0131lmas\u0131n\u0131 gerektirir.<\/p>\n<p>Bu kanser, b\u00fcy\u00fck \u00f6l\u00e7\u00fcde ABD&#039;de yayg\u0131n olmayan dokulu meme implantlar\u0131yla ili\u015fkilidir.<\/p>\n<p>Temmuz ay\u0131nda FDA, Allergan&#039;\u0131n nadir g\u00f6r\u00fclen kanserle ba\u011flant\u0131l\u0131 BIOCELL dokulu meme implantlar\u0131 ve doku geni\u015fleticileri i\u00e7in S\u0131n\u0131f I geri \u00e7a\u011f\u0131rma (en ciddi geri \u00e7a\u011f\u0131rma) talep etti.<\/p>\n<p>\u015eirket, d\u00fcnya \u00e7ap\u0131ndaki t\u00fcm \u00fcr\u00fcnlerini geri \u00e7a\u011f\u0131rd\u0131. Allergan meme implantlar\u0131 olan hastalar, d\u00fcnya \u00e7ap\u0131ndaki t\u00fcm BIA-ALCL vakalar\u0131n\u0131n 84%&#039;sini ve lenfomaya ba\u011fl\u0131 33 \u00f6l\u00fcm\u00fcn on ikisini olu\u015fturuyordu.<\/p>\n<p>Hem salin hem de silikon jel dolgulu implantlar\u0131 olan hastalarda kanserin yan\u0131 s\u0131ra sistemik semptomlar veya Meme \u0130mplant Hastal\u0131\u011f\u0131 (BII) bildirilmi\u015ftir. Bu semptomlar haf\u0131za kayb\u0131, yorgunluk, zihinsel bulan\u0131kl\u0131k, k\u0131zar\u0131kl\u0131k ve eklem a\u011fr\u0131s\u0131n\u0131 i\u00e7erir.<\/p>\n<p>Mart ay\u0131nda halka a\u00e7\u0131k bir dan\u0131\u015fma panelinde, meme implant\u0131yla ilgili hastal\u0131klar ve kanser ya\u015fam\u0131\u015f hastalar, kad\u0131nlar\u0131n meme b\u00fcy\u00fctme veya rekonstr\u00fcksiyon ameliyat\u0131na karar verirken ald\u0131klar\u0131 bilgi eksikli\u011fi konusundaki endi\u015felerini dile getirdiler.<\/p>\n<p>G\u00f6\u011f\u00fcs implant\u0131 hastalar\u0131n\u0131n takip MRG&#039;leri planlamalar\u0131 ve implantlar\u0131n\u0131 s\u00fcrekli olarak izlemeleri gerekti\u011fi gibi \u00f6nemli bilgiler genellikle hastalara iletilmez.<\/p>\n<p>Panel toplant\u0131s\u0131ndaki bir kad\u0131n, meme implantlar\u0131ndan sonra \u00e7ocuk sahibi olma konusundaki endi\u015felerini dile getirdi ve meme implantlar\u0131ndan ya\u015fad\u0131\u011f\u0131 hastal\u0131\u011f\u0131n iki o\u011flunda sa\u011fl\u0131k sorunlar\u0131na bile yol a\u00e7m\u0131\u015f olabilece\u011finden korktu\u011funu a\u00e7\u0131klad\u0131.<\/p>\n<p>Tan\u0131kl\u0131klar nihayetinde FDA&#039;y\u0131, \u015fu anda kamuoyunun yorumuna ve incelemesine a\u00e7\u0131k olan bu taslak k\u0131lavuzu yay\u0131nlamaya te\u015fvik etti.<\/p>\n<p>Kutulu bir uyar\u0131 \u00f6nerisinin yan\u0131 s\u0131ra, FDA bir hasta karar kontrol listesi \u00f6nerdi.<\/p>\n<p>Hastalara, her an komplikasyonlar ortaya \u00e7\u0131kabilmesine ra\u011fmen, meme implantlar\u0131n\u0131n genellikle on ila yirmi y\u0131l civar\u0131nda bir kullan\u0131m \u00f6mr\u00fc oldu\u011fu konusunda bilgi vermek \u00f6nemlidir.<\/p>\n<p>Meme rekonstr\u00fcksiyon cerrahisinde kullan\u0131lan doku geni\u015fleticiler sadece alt\u0131 aydan daha k\u0131sa s\u00fcre cilt veya kas alt\u0131nda kalmal\u0131d\u0131r.<\/p>\n<p>\u0130mplantlar v\u00fccutta ne kadar uzun s\u00fcre kal\u0131rsa, komplikasyon ve hastal\u0131k riski o kadar artar.<\/p>\n<p>ge\u00e7iren kad\u0131nlar\u0131n y\u00fczde yirmisi <a href=\"\/tr\/article\/meme-kanseri-turleri\/\">meme b\u00fcy\u00fctme<\/a>n ameliyat, sekiz ila 10 y\u0131l i\u00e7inde implantlar\u0131n\u0131n \u00e7\u0131kar\u0131lmas\u0131n\u0131 gerektiren komplikasyonlar ya\u015far.<\/p>\n<p>Meme implant\u0131 hastalar\u0131n\u0131n en az y\u00fczde birinde meydana gelen komplikasyonlar aras\u0131nda y\u0131rt\u0131lmalar, emzirememe, meme a\u011fr\u0131s\u0131, asimetri, kaps\u00fcl kontrakt\u00fcr\u00fc, kire\u00e7lenme, hematom, iltihaplanma, ekstr\u00fczyon, k\u0131r\u0131\u015fma ve s\u00f6nme say\u0131labilir.<\/p>\n<p>Bazen komplikasyonlar ek ameliyatlar, \u00e7\u0131karma veya de\u011fi\u015ftirmeler gerektirir.<\/p>\n<p>Taslak k\u0131lavuz ayr\u0131ca silikon jel dolgulu meme implant\u0131 y\u0131rt\u0131lma tarama \u00f6nerileri, materyaller ve cihaz a\u00e7\u0131klamalar\u0131 ve bir hasta cihaz kart\u0131 \u00f6nermektedir.<\/p>\n<p>MRG&#039;ler, salin veya silikon jel dolgulu meme implantlar\u0131ndaki y\u0131rt\u0131klar\u0131 tespit etmenin en etkili yoludur. Salin ve silikon jel dolgulu implantlar, ABD&#039;de mevcut olan tek meme implant\u0131 t\u00fcr\u00fcd\u00fcr.<\/p>\n<p>Her ikisinin de silikon bir d\u0131\u015f tabakas\u0131 vard\u0131r, ancak salin implantlar\u0131n i\u00e7i salinle, silikon jel dolgulu implantlar\u0131n i\u00e7i ise silikon jel ile doldurulur.<\/p>\n<p>Bu implantlar, meme boyutunu art\u0131rmak veya meme dokusunu de\u011fi\u015ftirmek i\u00e7in meme dokusunun veya g\u00f6\u011f\u00fcs kas\u0131n\u0131n alt\u0131na yerle\u015ftirilir.<\/p>\n<p>R\u00fcpt\u00fcr, d\u0131\u015f silikon tabakas\u0131nda bir y\u0131rt\u0131lma veya delik olu\u015ftu\u011funda meydana gelir ve deflasyon, salin meme implant\u0131nda bir s\u0131z\u0131nt\u0131 meydana geldi\u011finde meydana gelir.<\/p>\n<p>Bu, do\u011fal olarak implant\u0131n ya\u015flanmas\u0131ndan veya fiziksel bask\u0131dan ve kaba kullan\u0131mdan (mamogram veya cerrahi prosed\u00fcr s\u0131ras\u0131nda oldu\u011fu gibi) kaynaklanabilir.<\/p>\n<p>Bazen meme boyutunu veya \u015feklini kaybetti\u011finde fark edilir, ancak tamamen alg\u0131lanamayan \u201csessiz bir y\u0131rt\u0131lma\u201d da meydana gelebilir.<\/p>\n<p>FDA, meme implant\u0131 hastalar\u0131na ilk ameliyattan \u00fc\u00e7 y\u0131l sonra ve ard\u0131ndan her iki y\u0131lda bir MRI taramas\u0131 yapt\u0131rmalar\u0131n\u0131 \u00f6nerir. E\u011fer y\u0131rt\u0131lma meydana geldiyse, implant cerrahi olarak \u00e7\u0131kar\u0131lmal\u0131d\u0131r.<\/p>\n<p>Her y\u0131l meme implant\u0131 yapt\u0131ran 300.000 kad\u0131n\u0131n \u00e7o\u011fu son derece memnun.<\/p>\n<p>2018&#039;de meme b\u00fcy\u00fctme, ABD&#039;deki en pop\u00fcler kozmetik cerrahiydi. G\u00f6\u011f\u00fcs implant\u0131yla ilgili bir hastal\u0131k ne kadar nadir olursa olsun, hastalar\u0131n hayatlar\u0131n\u0131 de\u011fi\u015ftirecek bu karar\u0131 vermeden \u00f6nce tamamen bilgilendirilmeleri \u00f6nemlidir.<\/p>\n<p>Bilgi sahibi olmak i\u00e7in \u015furaya g\u00f6z at\u0131n: <a href=\"https:\/\/www.thepsf.org\/research\/registries\/nbir\" target=\"_blank\" rel=\"noopener\">Ulusal Meme \u0130mplant\u0131 Sicili<\/a>.<\/p>\n<p>G\u00f6\u011f\u00fcs implantlar\u0131n\u0131zla ilgili komplikasyonlar\u0131 bildirmek i\u00e7in \u015fu adrese gidin: <a href=\"https:\/\/www.fda.gov\/safety\/medwatch-fda-safety-information-and-adverse-event-reporting-program\" target=\"_blank\" rel=\"noopener\">MedWatch<\/a> ve cihaz ad\u0131n\u0131, \u00fcreticinin ad\u0131n\u0131 ve komplikasyonlar\u0131n veya gerekli cerrahi m\u00fcdahalelerin ayr\u0131nt\u0131lar\u0131n\u0131 i\u00e7erir.<\/p>","protected":false},"excerpt":{"rendered":"<p>Ge\u00e7en ay, ABD G\u0131da ve \u0130la\u00e7 \u0130daresi, hastalar\u0131n a\u015fa\u011f\u0131dakileri almas\u0131n\u0131 sa\u011flamak i\u00e7in \u00e7e\u015fitli tavsiyeler i\u00e7eren &quot;Meme \u0130mplantlar\u0131 - Hasta \u0130leti\u015fimini Geli\u015ftirmek \u0130\u00e7in Belirli Etiketleme \u00d6nerileri&quot; adl\u0131 taslak k\u0131lavuz yay\u0131nlad\u0131\u2026<\/p>","protected":false},"author":3,"featured_media":8004,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[774],"tags":[816,820,978],"class_list":["post-8003","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-napoli-shkolnik-news","tag-defective-products","tag-product-liability","tag-fda-warning"],"acf":[],"page_builder_type":"gutenberg","gutenberg_data":[],"_links":{"self":[{"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/posts\/8003","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/comments?post=8003"}],"version-history":[{"count":0,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/posts\/8003\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/media\/8004"}],"wp:attachment":[{"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/media?parent=8003"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/categories?post=8003"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/tags?post=8003"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}