I-Ectopic Bone Formation ne-Medtronic Controversy

I-Ectopic ibhekisela kwizinto okanye izicubu zomntu ezenzayo okanye ezikhoyo apho zingekho. Ukwakhiwa kwethambo le- Ectopic ukubeka phantsi amathambo amathambo amatsha (ngokusebenzisa inkqubo ebizwa ngokuba yi-ossification) kwiindawo, kwakhona, apho le nto ingabikho. Le nkqubo yokunyusa iyenziwa ngamaseli abizwa ngokuba yi-osteoblasts.

Igama elithi ectopic livela kumaGrike, kwaye lithetha "kude nendawo." Intsingiselo yayo, ebizwa ngokuthi "orthotopic" bone - nayo evela kwisiGrike-ibhekisela kwithambo eyakhelwe kwindawo yayo eyiyo, ngokutsho kukaScott, kunye.

al., kwinqaku labo elinesihloko esithi "Ukuhlaziywa okufutshane kweModeli ye-Ectopic Bone Formation." Le nqaku yashicilelwa kwiphepha leMatshi ka-2012, iStem Cells Development.

Ukubunjwa kwe-Ectopic bone kungabikho ekuzalweni, kuba ngenxa yemfuza okanye kuvela njengengxaki yezilwanyana ezithile zonyango ezifana neparaplegia kunye / okanye ukulimala okubi (ukubiza nje ezimbalwa.) Scott, et. al. ithi ukubunjwa kwe-ectopic bone kugqithiselwa ukutshaywa kwendawo elandelwa yimbutho yamaseli angama-skeletal cells. Ngokutsho kwiwebhsayithi yebhedlele yeBoston Children's, i-cell progenitor ifana ne-cell stem ngaphandle kokuba iyancinci ngokwemiqathango yeseli ingaba njengoko ihlula. Iiseli ezingama-progenitor zivela kwiiseli ze-stem kodwa aziyizikhulu zeseli ezindala.

I-Ectopic Bone Formation Ngenxa yoBugqirha bezandla

Scott, kunye. al, uthi ukuya kwi-10% yezigulane ezithotyelwayo-kwaye ukuhlinzwa ngokutsha ngokuqinisekileyo kuwela kweli qela-kuya kuphuhlisa i-ectopic bone formation.

Ngomthunzi, igama elithi "i-ectopic bone formation" ngamanye amaxesha lisetyenziselwa ukuchaza izicubu ezingafunekiyo zethambo ezifunyanwa kwisigodlo somgudu . Ngo-2002, i-FDA ivume iprotheni yethambo eyenziwa nguMedtronic ebizwa ngokuba yi-Infuse yokusetyenziswa kwi-lumbar. Imilinganiselo yokusetyenziswa echazwe yi-FDA yayicacile kakhulu: Njengoko ithambo lifakwe kwizinga elilodwa I-Anterior Lumbar Interface Fusion (ALIF) ngaphakathi kwenkqubo yeLumbar Tapered Fusion Device (LT-Cage.) Whew!

Kodwa emva kokuvunywa, abaninzi oogqirha baqala ukusebenzisa izinto "ngaphandle kwelebuli," oku kuthetha ezinye iinjongo ngaphandle kwezinto ezivunyiwe yi-FDA. Ukusetyenziswa kwelebula ezingekhoyo kubandakanywa uphando lwentambo yomlomo oluye lwaphumela "kwiimpawu ezimbi," okanye i-AE ibikwa kwi-FDA. Ukubunjwa kwe-Ectopic bone kwakungenye ye-AE, kodwa uluhlu lubandakanya ezinye izinto ezinzulu kakhulu ezifana ne- arachnoiditis, ukwanda kweengxaki zegazi, ukuhlaziywa kwe-ejaculation, umdlavuza kunye nokunye. Akuntle!

Uxinzelelo lweMedtronic

Ingxelo ye-Milwaukee Journal Sentinal Watchdog Report, elandele eli bali kusukela ngo-2011 (kwaye iyaqhubeka ukwenza njalo), ithi phakathi kweeveki zokuvavanywa kwekliniki yokuqala ye-Infuse, i-ectopic bone form formation yafunyanwa kwi-70% yezigulane zezifundo. Ezinye zezi zi gulane zifuna enye okanye ngaphezulu ukuhlinzwa ukuze kulungiswe ithambo engafunekiyo kunye / okanye iingxaki zonyango ezivela kuyo.

Ekuhlaziyweni kwakhe kobubungqina obupapashwe ngo-2013 lwe- Surgery Neurology International , u-Epstein uthelekise icandelo le-13 linikeze izifundo kwezinye iiphando eziye zapapashwa kumajelo, kunye namaxwebhu e-FDA kunye nolwazi olufumaneka kwiinkcukacha. Ubika ukuba ufumana "imicimbi engabonakaliyo engabonakaliyo kunye nokungahambelani kwangaphakathi" kunye nezifundo zokungena.

Uphinde uchaze ukuba i-40% yeziganeko ezimbi zibangelwa yi-ALIF ("ngaphandle kwelebuli" ukuhlinzwa kwentamo eyenziweyo,) wongezelela ukuba ezinye zeziganeko zazizisongela ubomi.

Okwangoku, i-Milwaukee Journal ye-Sentinel ibika ukuba iMedtronic mhlawumbi ingaphantsi kwengxelo okanye ayizange ibhengeze yonke imiphumo emibi kwi-FDA kwingxelo ka-2004 ebhaliwe ngabagqirha abaxhaswa ngemali. I-MJS ithi "oogqirha ababhala iphepha le-2004 baya kuqhubeka befumana izigidi zeedola kwiirhafu kunye nezinye iintlawulo ezivela eMedtronic."

Ngomhla ka-Meyi ka-2014, i-MJS ilandele eli bali ngamanye athi athi uMedtronic wayevumile ukuhlawula i-$ 22 yezigidi ukulungisa izibambiso ezili-1000 ezichasene nazo.

Ibali likhankanya kwakhona ukuba iMedtronic ibeka eceleni enye i-$ 140 ukukhawulela "amabango alindelekileyo."

Imithombo:

Isibhedlele sezingane zaseBoston. Ziziphi iiCentergitor Cells? Iphepha le-Stem yamaSelule angama-101. Iwebhusayithi yeBoston Children's Hospital. Fumaneka ngoDisemba 2015.

Epstein, N. Iingxaki ngenxa yokusetyenziswa kwe-BMP / INFUSE ekutyunjweni kwemigudu: Ubungqina buyaqhubeka. Uphulo lwe-Neurol Int. Ngo-2013: Kufumaneka ngo-Dec 2015.

UFauber, J., Infuse echazwe kwiithambo ezibuhlungu zethambo. Imiphumela. Ingxelo ye-Sentinel Watchdog Report. Journal Interactive. Juni 2011.

UFauber, J. Medtronic ukuhlawula iidola ezingama-22 ukulungisa izibango zomthetho ngaphezu kwemveliso ye-spie. Imibiko yoLwazi. Milwaukee Wisconsin I-Journal Sentinel. Meyi 6, 2014.

UScott, M., A., uLevi, B., ASkarinam, A., Nguyen, A., Rackohn, T., Ting, K., Soo, C., Uvavanyo olufutshane lweModeli ye-Ectopic Bone Formation. Izixhobo zeStem Dev. 2012 uMatshi 20; 21 (5): 655-667.