Iyo FDA Inokurudzira Yakasimba Nyevero Mazita Pane Mazamu Anodyara Kutsanangura Njodzi

Zvemukati

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IU.S.Food and Drug Administration (FDA) iri kupwanya pasi zviputi zvemazamu. Sangano iri rinoda kuti vanhu vagamuchire yambiro yakasimba uye zvimwe zvakawanda nezve njodzi dzinogona kuitika uye matambudziko ane chekuita nemidziyo iyi yekurapa, sekureva kwegwaro idzva raburitswa nhasi.

Mukurudziro yayo yekunyorwa, iyo FDA iri kukurudzira vagadziri kuti vawedzere "boxed yambiro" mavara pane ese saline uye silicone gel-akazadzwa mazamu anodyara. Mhando iyi yekunyora, yakafanana neyambiro yaunoona pakurongedza fodya, ndiyo nzira yakasimba yekunyevera inodiwa neFDA. Iyo inoshandiswa kuzivisa vanopa uye vatengi nezve njodzi dzakakomba dzinosanganiswa nemamwe madhiragi nemidziyo yekurapa. (Zvakafanana: 6 Zvinhu Zvandakadzidza Kubva Kubasa Rangu Rokubhowa)

Mune ino kesi, yambiro dzebhokisi dzaizoita vagadziri (asi, zvakakosha, kwete vatengi, aka vakadzi vanonyatso gamuchira mazamu ekudyara) vachiziva nezve matambudziko ane chekuita nekuiswa mazamu, sekuneta kusingaperi, kurwadziwa kwemajoini, uye kunyangwe rudzi rwegomarara isingawanzodaidzwa kuti breast implant-yakabatana anaplastic hombe-cell lymphoma (BIA-ALCL). Sezvatakambotaura, hafu yezviitiko zvese zveBIA-ALCL zvinotaurwa kune iyo FDA zvakaonekwa mukati memakore manomwe kusvika masere mushure mekuvhiyiwa zamu. Kunyange rudzi urwu rwegomarara ruchiwanzoitika, rwakatotora hupenyu hwevakadzi vanosvika makumi matatu nematatu, maererano neDFA. (Yakabatana: Chipfuva Chinoisa Chirwere Chaicho? Zvese Zvaunoda Kuti Uzive Nezve Kukakavara Mamiriro)

Pamwe pamwe nenyevero dzakaiswa mubhokisi, iyo FDA iri kurairawo kuti vagadziri vemazamu vanodyara vanosanganisira "murwere sarudzo yekutarisa" pane zvigadzirwa zvigadzirwa. Rondedzero yacho ingatsanangure kuti nei zvipukanana zvemazamu zvisiri zvekushandisa kweupenyu hwese uye kuzivisa vanhu kuti mukadzi mumwe chete pavashanu anozoda kuti vabviswe mukati memakore masere kusvika gumi.

Tsananguro yezvemukati yakadzama iri kukurudzirwa zvakare, kusanganisira mhando uye huwandu hwemakemikari nemasimbi anorema akawanikwa uye akaburitswa nemaimplants. Chekupedzisira, iyo FDA inopa zano rekuvandudza nekuwedzera ruzivo rwekunyorwa pakuongorora kurudziro yevakadzi vane silicone gel-yakazadzwa implants kuti vatarise chero kuputika kana kubvarura nekufamba kwenguva. (Yakabatana: Kubvisa Kwangu Mazamu Anodyara Mushure meKaviri Mastectomy Pakupedzisira Yakandibatsira Kudzosera Muviri Wangu)

Kunyangwe aya mazano matsva akaomarara uye asati achifanira kupedziswa, iyo FDA inotarisira kuti veruzhinji vachatora nguva yekuzviongorora nekugovana pfungwa dzavo mumazuva makumi matanhatu anotevera.

"Tichitorwa sese isu tinotenda iyi dhizaini nhungamiro, kana yekupedzisira, ichaguma nekunyoreswa zvirinani kwemazamu anodyara izvo zvinozopedzisira zvabatsira varwere kunzwisisa zvirinani mabhenefiti nenjodzi, chinova chikamu chakakosha mukuita sarudzo dzehutano dzinoenderana nezvinodiwa nevarwere. uye mararamiro, "Amy Abernethy, MD, Ph.D., naJeff Shuren, MD, JD - FDA mutevedzeri komishinari uye director weCDAA's Center for Devices uye Radiological Health, zvakateerana-vakanyora muchibvumirano chakabatana neChitatu. (Yakabatana: Ini ndawana Zvipfuva zvangu zveMazamu zvakabviswa uye ndinzwe zvirinani pane zvandakaita Mumakore.)

Kana uye uye kana yambiro iyi ikatanga kushanda, zvakadaro, hazvizove zvekumanikidzwa. "Mushure menguva yekutaura kwevanhu, kana hutungamiriri hwapedzwa, vagadziri vangasarudza kutevedzera kurudziro iri mukutungamira kwekupedzisira kana ivo vangasarudza dzimwe nzira dzekuisa mazita avo, chero bedzi kunyora kwacho kuchiteerana nemirau nemirau yeDAA," akawedzera Dr. Abernethy naShuren. Mune mamwe mazwi, iyo FDA's dhizaini nhungamiro ingori kurudziro, uye kunyangwe kana / kana ivo vari yapera, vagadziri havafanirwe kudikanwa zviri pamutemo kuti vatevedzere nhungamiro.

Chaizvoizvo, zvichave kuna vanachiremba kuti vaverenge yambiro kuvarwere vavo, vangangodaro kwete ona maimplants mupakeji yavo vasati vavhiyiwa.

Pakupera kwezuva, zvisinei, iyi zvirokwazvo inhanho munzira kwayo neFDA. Tichifunga nezve chokwadi chekuti vanhu vanopfuura mazana matatu ezviuru vanosarudza kutora zamu gore rega, inguva yekuti vanhu vanzwisise chaizvo zvavari kusaina.

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