A FDA Amalimbikitsa Zizindikiro Zolimba Zochenjeza Paziphuphu Zam'mimba Kufotokozera Zowopsa

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Bungwe la U.S. Food and Drug Administration (FDA) likuphwanya malamulo oika m’mawere. Bungweli likufuna kuti anthu alandire machenjezo olimba komanso zambiri paziwopsezo zonse zomwe zingachitike chifukwa cha zida zamankhwala izi, malinga ndi malangizo omwe atulutsidwa lero.

M'mawu ake okonzekera, a FDA akulimbikitsa opanga kuti awonjezere zolemba za "chenjezo la bokosi" pamapiritsi onse am'mawere a saline ndi silicone. Kulemba kotereku, kofanana ndi machenjezo omwe mumawawona pamapaketi a ndudu, ndiye chenjezo lamphamvu kwambiri lofunidwa ndi FDA. Amagwiritsidwa ntchito kuchenjeza ogulitsa ndi ogula za zoopsa zomwe zimadza chifukwa cha mankhwala ndi zida zamankhwala. (Zokhudzana: Zinthu 6 Zomwe Ndaphunzira Kuchokera ku Boob Boob Job)

Poterepa, machenjezo omwe ali m'bokosi angapange opanga (koma, chofunikira, ayi ogula, azimayi omwe amalandila zodzikongoletsera m'mawere) kudziwa zovuta zomwe zimakhudzana ndi ma batala opangidwa ndi mawere, monga kutopa kwanthawi yayitali, kupweteka kwamalumikizidwe, komanso khansa yosawerengeka yomwe imadziwika kuti implant--poplant large-cell lymphoma (BIA-ALCL). Monga tanenera kale, theka la milandu yonse ya BIA-ALCL yomwe inanenedwa ku FDA yapezeka mkati mwa zaka zisanu ndi ziwiri mpaka zisanu ndi zitatu pambuyo pa opaleshoni yoika m'mawere. Ngakhale khansa yamtunduwu ndiyosowa, yatenga kale akazi osachepera 33, malinga ndi FDA. (Zokhudzana: Kodi Matenda Oyikira M'mawere Ndiwowona? Chilichonse Chomwe Muyenera Kudziwa Zokhudza Mkhalidwe Wotsutsana)

Pamodzi ndi machenjezo omwe ali m'bokosi, a FDA akulangizanso kuti opanga ma bere akuphatikizapo "mndandanda wazosankha wodwala" pazolemba pazogulitsa. Mndandandandawo ungafotokoze chifukwa chake zopangira mawere sizinthu za moyo wonse ndikudziwitsa anthu kuti mayi m'modzi mwa akazi asanu ndi awiri ayenera kuwachotsa pasanathe zaka 8 mpaka 10.

Kulongosola mwatsatanetsatane zakuthupi kulimbikitsidwanso, kuphatikiza mitundu ndi kuchuluka kwa mankhwala ndi zitsulo zolemera zomwe zimapezeka ndikumasulidwa ndi zomerazo. Pomaliza, a FDA akuwonetsa kukonzanso ndikuwonjezera zolemba pamawu pazowunikira kwa amayi omwe ali ndi ma implants odzaza gel osakaniza kuti awonere kuphulika kapena kung'ambika pakapita nthawi. (Zokhudzana: Kuchotsa Zoyikira M'mawere Nditatha Kuchitidwa Mastectomy Kawiri Pomaliza Kunandithandiza Kubwezeretsa Thupi Langa)

Ngakhale malingaliro atsopanowa ndi ovuta ndipo sanakwaniritsidwe, a FDA akuyembekeza kuti anthu atenga nthawi kuti awunikenso ndikugawana malingaliro awo m'masiku 60 otsatira.

"Kutengedwa kwathunthu tikukhulupirira kuti malangizo awa, pomaliza pake, apangitsa kuti pakhale zolemba zabwino zopangira mawere zomwe pamapeto pake zithandizira odwala kumvetsetsa phindu ndi zoopsa zake, zomwe ndizofunikira kwambiri popanga zisankho zokhudzana ndi zosowa za odwala ndi moyo," Amy Abernethy, MD, Ph.D., ndi Jeff Shuren, MD, JD-FDA wachiwiri kwa Commissioner ndi mkulu wa FDA's Center for Devices and Radiological Health, motsatira - adalemba mawu ogwirizana Lachitatu. (Zogwirizana: Ndachotsa Ziphuphu Zanga M'chifu Ndikumva Bwino Kuposa Zomwe Ndili Ndi Zaka.)

Ngati ndi pamene machenjezo awa ayamba kugwira ntchito, komabe, sadzakhala ololedwa. "Pakapita nthawi yopereka ndemanga pagulu, malangizowo akamalizidwa, opanga angasankhe kutsatira malangizowo m'chitsogozo chomaliza kapena angasankhe njira zina zolembera zida zawo, malinga ngati zolembazo zikugwirizana ndi malamulo ndi malamulo a FDA," adatero. anawonjezera Dr. Abernethy ndi Shuren. Mwanjira ina, malangizo oyeserera a FDA ndi malingaliro chabe, ndipo ngakhale / atatero ndi zikamalizidwa, opanga sangafunike mwalamulo kutsatira malangizowo.

Kwenikweni, zidzakhala kwa madokotala kuwerengera machenjezo kwa odwala awo, omwe angatero ayi onani ma implants muzopaka zawo musanachite opaleshoni.

Pamapeto pa tsikuli, izi ndizomwe zikuyenera kuchita ndi a FDA. Popeza kuti anthu opitilira 300,000 amasankha kuyika zipsera za m'mawere chaka chilichonse, ndi nthawi yoti anthu amvetse bwino zomwe amalembetsa.

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