I-AspireAssist iyisisetshenziswa sokulahlekelwa kwesisindo se-FDA esivunyelwe i-FDA evumela iziguli ukuba zithengise ingxenye yesisu sesisu emva kokudla ukuze kube lula ukulahlekelwa isisindo. Ngezinye izikhathi kuthiwa yi- spire ekusizeni ukulahlekelwa isisindo noma ipompo yesisu yokulahlekelwa isisindo , idivayisi ithole izibuyekezo ezixubile emphakathini wezempilo.
Sibutsetelo
Kukhona amadivaysi amaningana angawahlinzeki avunyelwe yi-Food and Drug Administration ukusiza ukwedlula ngokweqile nokugqithisa abantu abalahlekelwa isisindo.
I-AspireAssist ingenye yazo. Ukwamukelwa yi-FDA ngo-2016, kusiza ukunciphisa inani lamakhalori abanjwe ngumzimba ukuze kwenzeke isisindo.
Idivaysi yokupompa isisu ivunyelwe kuphela ezigulini ezine- body mass index (BMI) ezinama-35 kuya ku-55. Laba bantu abane- Class II kuya ekutheni ukukhuluphala ngokweqile futhi abaphezulu kakhulu engozini enkulu yezifo uma kuqhathaniswa nabantu abavamile .
Kodwa nje ukuphefumula akukwenzi ube ngumuntu omele ukhetho lwepopu yase-Aspire. Uma ucabangela le divayisi, kufanele usuvele uzame izindlela zendabuko yokulahlekelwa kwesisindo ngaphandle kwempumelelo. Futhi kufanele uzimisele ukushintsha indlela yakho yokuphila . Ukululekwa kunikezwa ukukusiza ukuthi ushintshe uhlobo lokudla odlayo, ubungakanani bokudla odlayo neminye imikhuba yansuku zonke. Ekugcineni idivayisi isusiwe futhi yimikhuba yokuphila eyokusiza ukuthi ugcine amakhilogremu ngokuhle.
Kuneziguli ezithile ezingezona abakhethiweyo be-AspireAssist.
Lokhu kufaka:
- Iziguli ezinegazi eliphakeme elingalawuleki
- Iziguli ezinzima ukugwinya noma ukugaya ukudla
- Iziguli eziye zathola ukwelapha imisebe esifubeni noma isibindi
- Iziguli ezinesilonda esiswini esiqhubekayo noma ubuhlungu besisu
- Abantu abanesifo samaphaphu noma senhliziyo
- Futhi iziguli ezinezinkinga zokudla, kuhlanganise no-bulimia, ubusuku bokudla kwesifo, noma ukuzonda ukudla
Kokubili i-FDA kanye ne-Aspire Bariatrics iwebhusayithi inikeza uhlu oluthe xaxa lweziguli ezingafanele zisebenzise idivayisi.
Indlela Esebenza ngayo
Akudingeki ukuba uhlinzekwe ukufaka isimiso sokumisa isisu. Inqubo yenziwa nge-endoscope, ngakho-ke ukufakwa okuncane kuphela kuyadingeka. Uzoba ngaphansi kwe-twilight (light) sedation phakathi nenqubo futhi kuthatha cishe imizuzu engu-15 ukwenza. Iningi leziguli liyakwazi ukuhamba ehhovisi likadokotela zingakapheli amahora amabili.
Uma idivayisi ye-Aspire Assist isendaweni, uzoba ne-flat, disc-shaped inkinobho (i-Skin-Port) ngaphandle kwesisu sakho esixhuma kwi-tube (i-A-tube) ngaphakathi kwesisu sakho. Ngemuva kokuba udle ukudla, ulinde imizuzu engama-20-30 ngaphambi kokuxhuma idivayisi encane eqondayo yokupaka ku-Skin-Port yakho. Idivaysi ikuvumela ukuthi ungabi nalutho ngamaphesenti angama-30 walokho okudliwayo endlini yangasese noma enye indawo yokulahlwa. Inqubo yokukhipha ithatha cishe imizuzu emi-5-10 ukuqedela futhi kufanele yenziwe endaweni yangasese njengendawo yokugezela.
Ngenxa yokuthi uchithe ingxenye enkulu yokudla oyidla ngesikhathi sokudla, umzimba wakho awuwutholi lawo makhalori. Lokhu kukusiza ukuthi udale ukulahleka kwekhalori okudingekayo ekulahlekeni kwesisindo kanti ezinye iziguli zinciphisa umphumela.
Uzothola ukuhlolwa kwezokwelapha kanye nokwelulekwa kokuphila ngenkathi unayo idivayisi endaweni. Imikhuba enempilo oyifunayo ngesikhathi sokululekwa ingakusiza ukuba ugcine i-AspireAssist isisindo sakho sokulahlekelwa kwesisindo ngemuva kokuthi idivayisi isusiwe.
Kulindelwe ukulahlekelwa kwesisindo
Njengawo noma iyiphi idivayisi yokulahlekelwa isisindo noma uhlelo, imiphumela yakho iyoxhomeka ekunameleni kwakho ohlelweni. Kunezinkambiso ozothola ngemuva kokuthi ipompo isendaweni ezokusiza ukuthi ulahlekelwe isisindo ngempumelelo. Isibonelo, iziguli zeluleka ukuba zifune ukudla kwazo kancane kancane ukuze zenze inqubo yokuthutha. Ukudla okuphansi, okucabangayo nakho kwenza ubuchopho buqaphele izimpawu zokugcwala ukuze udle ukudla okuncane.
Lapho abacwaningi befunda ukulahlekelwa isisindo ngedivaysi, bafanisa iziguli ezathola isisu sezisu kanye nokwelulekwa kwesisindo kulabo abaye bathola ukwelulekwa yedwa. Kuphelele, iziguli ezingu-171 zacutshungulwa, ezingu-111 zazo zifakwe ipompo.
Ngemuva konyaka owodwa, iziguli ezine-AspireAssist zalahlekelwa ngamapounds angu-31.2 (cishe amaphesenti angu-12 esisindo somzimba wabo noma amaphesenti angu-31 esisindo somzimba esiningi ngokweqile). Iziguli ezinezincomo zodwa zalahlekelwa isilinganiso samakhilogremu angu-9 (cishe amaphesenti angu-10 esisindo saso ngokweqile noma amaphesenti angu-3.5 esisindo somzimba wabo wonke). Iziguli kula maqembu womabili zibone ukuthuthukiswa okuncane ezimweni ezihlobene nokukhuluphala, kuhlanganise nesifo sikashukela, umfutho wegazi ophakeme kanye nekhwalithi yokuphila. Izifundo ziyaqhubeka ukubona ukuthi zingaki iziguli ezigcina ukulahlekelwa kwesisindo esikhathini eside.
Okuqhamuka uma udla imishanguzo
Ungabhekana neminye imiphumela emibi uma ukhetha ukusebenzisa isimiso sokumisa isisu sokulahlekelwa isisindo. Ngokusho kwe-FDA, izinqubo ze-endoscopic zihlotshaniswa nezingozi ezibandakanya ubuhlungu, ukuvinjelwa kwesisu, ukuguqulwa, ukuphuma kwegazi, ukutheleleka, ukuhlukunyezwa, ukuhlanza, noma izinkinga zokuphefumula ezihlobene nokuhlala.
Kodwa Ukuphathwa Kwezokudla Nezidakamizwa kuthi futhi imiphumela emibi kakhulu ebonakalayo ekuhlolweni kwemitholampilo yayihlobene nesayithi lokufaka izilimo eziyizigaxa. Imiphumela emibi yayihlanganisa ukuphuma, ukucasula nokutheleleka. Ezinye izikhalazo zazihlanganisa ubuhlungu, isicanucanu kanye / noma ukuhlanza, ukuhlukunyezwa kwesisu, nokuguquka kwemikhuba yezifo.
Izindleko
Okwamanje i-Aspire Assist ayihlanganiswa nezinhlelo eziningi zomshuwalense. Lokhu kusho ukuthi uzodingeka ukhokhe ephaketheni lwedivayisi, ukunakekelwa kwezempilo kanye nokwelulekwa kokuphila. Inani eliphelele le-AspireAssist ukulahlekelwa kwesisindo kulinganiselwa ukuthi lizovela ku-$ 8,000 kuya ku-$ 13,000.
Ukubuyekeza nokukhathazeka
Ngoba i-AspireAssist isebenzisa okungewona wendabuko futhi abanye bangase bathi "indlela eyedlulele" ukukusiza ukuthi ulahlekelwe isisindo, kube khona ukukhathazeka okuvezwe abanye ochwepheshe emphakathini wezempilo. Ezinye iziguli nazo zingase zibe nemibuzo mayelana nokuthi i-vacuum yokulahlekelwa isisindo ilahlekile noma ayikho yini ephephile nokuthi ngabe izosebenza ngempela yini noma cha.
Esinye sezikhathazo ezivame kakhulu kuhlobene nezinguquko zokuphila. Abathengi nabachwepheshe bezempilo bayazibuza ukuthi le divayisi iyasiza yini ngempela abantu ukuba bashintshe imikhuba yabo yokudla noma uma nje kubanika indlela elula yokulahla amakholori angaphezu kwalokho. Abanye bangase bazibuze ukuthi iziguli zingase zidle ukudla okuningi ngenxa yalokho.
U-Aspire Bariatrics uthi cha. Ngokusho kwewebhusayithi yabo, "Akukho bufakazi emiphakathini yethu yeziguli ezisebenzisa iziguli kusetshenziswa idivayisi njengesizathu sokudla okungaphezulu, noma ukudla okuningi ukukhokhela ama-calories ashubile. Empeleni, idatha yemitholampilo ibonisa ukuthi iziguli zibonisa ukuzithiba okungcono, ngaphansi ukuvinjelwa, nokungazami ukudla ukudla. "
Kodwa abaholi emphakathini wokuphazamiseka kokudla abavumelani. Ba nomuzwa wokuthi ukusebenzisa idivaysi kungaholela ekuziphatheni okungenampilo. U-Eva Maria Trujillo, MD, FAED, ungumongameli we-Academy of Eating Disorders. Ngemuva kokuthi i-FDA ivunyelwe i-AspireAssist, yaqoqa abaholi emphakathini odla ukukhathazeka futhi yathumela incwadi enhlanganweni ibabuza ukuba ibuyiselwe imvume yedivayisi.
"Njengabachwepheshe emkhakheni wokuphazamiseka kokudla, sikholelwa ukuthi le nsizakalo iyingozi futhi imelela ukukhubazeka okubuhlungu kwetheknoloji ekhonza ukuthuthukisa impilo," wabhala, eveza ukukhathazeka ukuthi ukupompa kwesisu kungasetshenziswa ukusiza iziguli ukuba ziqhubeke nokuziphatha okungenampilo. "Nakuba i-FDA ithi le mkhiqizo ayihloselwe ukusetshenziswa kubantu abanezinkinga zokudla, sibheka lo mshicileli ukuthi awunelisekile ngokweqile ngenxa yokuxilongwa kwabantu abanenkinga yokudla, ikakhulukazi ekudleni ukukhathazeka kwesifo kanye nesisindo esiphakeme i-anorexia nervosa. "
Ezingxoxweni zabezindaba, abanye odokotela, izondlo zokudla kanye nezithulu zokulahlekelwa isisindo ziye zaveza ukukhathazeka ngale ndlela engavamile yokwelapha ngokweqile. Kodwa imithombo esekela i-AspireAssist ithi njengoba izindlela zendabuko ziqhubeka nokunikeza imiphumela enganiselwe ekwelapheni ukukhuluphala, khona-ke le ndlela kufanele itholakale ezigulini ezifuna ukunciphisa ukuthuthukisa impilo yazo.
Ukuqhathaniswa Nezinye Izindlela
Uma ucabangela ukwelashwa kokunciphisa umzimba futhi awufuni ukuhlinzwa , kunezinketho eziningi ongayicabangela ngazo. Iningi lezazi zincoma ukuthi uzame ukudla okuvamile kanye nokuzivocavoca kuqala. Umhlinzeki wakho wokunakekelwa kwezempilo angakwazi ukukudlulisela ku-dietitian obhalisiwe, uchwepheshe wezokwelapha noma uchwepheshe wezempilo ukuziphatha ukuze unikeze usizo lomuntu siqu.
Kukhona nemithi yokulahlekelwa kwesisindo somzimba ongakhuluma nodokotela wakho. Kodwa uma lezo zindlela zingasebenzi, kunezinhlobo ezine zokwelapha ngokweqile okungezona ukuhlinzwa ezikhonjiswe yi-FDA.
- Ukukhipha isisu (njenge-AspireAssist). Le nketho ayihlanganiswa yomshuwalense futhi inokusizwa okungathí sina, kodwa akusizi kakhulu emphakathini wokulahlekelwa kwesisindo.
- Ama-gastric bands (aphinde abizwa ngokuthi ama- LAP bands ) abe yindlela eqinisiwe yokusindiswa kwesisindo kunamafutha futhi (amanye) iziguli ezikhulu kakhulu. Le ndlela ingadla ku-$ 15,000 kodwa ingafakwa ngumshuwalense. Le ndlela ibuye ibe nezingozi nemiphumela emibi.
- Izindlela zokuvuselela ugesi (njenge-vBloc) lapho isithuthukisi kagesi sifakwa esiswini ukuvimbela umsebenzi wezinzwa phakathi kobuchopho nesisu. Le ndlela iphathelene nentengo efanayo nokuhlinzwa kwesisindo (cishe u-$ 18,000-20,000) futhi angeke ihlanganiswe umshuwalense. Ibuye ithole ukwesekwa okulinganiselwe kwabanikezeli bezempilo.
- Ama- ballon ye- gastric , njenge- Orbera noma i-ReShape , athathe isikhala esiswini ukuze unciphise inani lokudla ongayidla. Izindleko ezivela ku-$ 6,500 kuya ku-$ 10,000 futhi ngokuvamile azihlanganiswa nomshuwalense.
Umthombo omuhle wolwazi mayelana nendlela yokulahlekelwa kwesisindo efanele kakhulu kuwe ngumhlinzeki wakho wezempilo. Khuluma nodokotela wakho ngomlando wakho wezempilo kanye nokukhathazeka kwakho ukuthola indlela evumelana nesabelomali yakho nendlela yakho yokuphila.
> Imithombo:
> I-Aspire Bariatrics. Inqubo yokulahlekelwa kwesisindo esingeyona yokuhlinzwa. http://www.aspirebariatrics.com/about-the-aspireassist/.
> Aspire Bariatrics Ochwepheshe bezeMpilo - AspireAssist inqubo yokulahlekelwa kwesisindo esingeyona yokuhlinzwa. http://www.aspirebariatrics.com/healthcare-professionals/.
> Scientific American. Isidumbu-ukuhlunga isisindo sokulahlekelwa kwesisindo sidonsa emuva emuva kokuvunywa kwe-FDA. https://www.scientificamerican.com/article/stomach-purging-weight-loss-device-draws-backlash-against-fda-approval/.
> Ukuphathwa Kwezokudla Nezidakamizwa zase-US. Amadivaysi Ezokwelapha-Amadivaysi Avunyelwe Kamuva. I-AspireAssist - P150024. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm506551.htm
> Ukuphathwa Kwezokudla Nezidakamizwa zase-US. Amadivaysi yokwelapha ngokweqile. Imikhiqizo nezinqubo zezokwelapha. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ObesityDevices/default.htm