Ectopic Bone Formation ndi Medtronic Controversy

Ectopic imatanthawuza chinthu kapena minofu ya munthu imene imapanga kapena ilipo kumene siili. Ectopic bone mapangidwe ndi kukhazikitsidwa kwa mafupa atsopano (mwa njira yotchedwa ossification) m'madera, kachiwiri, kumene nkhaniyi siili. Ndondomekoyi yachitidwa ndi maselo otchedwa osteoblasts.

Liwu loti ectopic limachokera ku Agiriki, ndipo limatanthauza "kutali ndi malo." Zotsutsa zake, zomwe ndi "fupa la orthotopic" fupa - lotengedwa kuchokera ku Greek - limatanthawuza fupa lomwe limapangidwira pamalo ake olondola, monga Scott ndi.

A., m'nkhani yawo yakuti "Kupenda Mwachidule kwa Ma Modulo a Ectopic Bone Formation." Nkhaniyi inafalitsidwa mu magazini ya March 2012, Stem Cells Development.

Ectopic bone mapangidwe akhoza kukhalapo pakuberekera, chifukwa cha chibadwa kapena kuwuka monga chovuta cha matenda ena monga paraplegia ndi / kapena kupsinjika kuvulaza (kutchula owerengeka chabe.) Scott, et. al. kunena kuti ectopic bone mapangidwe amalingaliridwa kuti amayambitsidwa ndi kutupa kwanuko komwe kumatsatiridwa ndi kusonkhana kwa maselo a mafupa a chigoba. Malingana ndi webusaiti ya Boston Children's Hospital, khungu lachibadwa likufanana ndi selo la tsinde kupatula kuti liri lochepa kwambiri mwa mitundu ya maselo yomwe ikhoza kukhala yomwe imagawanika. Masenje oyendayenda amachokera ku maselo amkati koma si maselo akuluakulu.

Ectopic Bone Formation Chifukwa cha Opaleshoni Yamakono

Scott, ndi. Al, amanena kuti odwala 10 peresenti omwe akuchitidwa opaleshoni yosayembekezereka - ndipo opaleshoni yam'mbuyo imalowa m'gulu lino - idzakhazikitsa ectopic bone mapangidwe.

Mu msana, mawu akuti "ectopic bone mapangidwe" nthawi zina amagwiritsidwa ntchito polongosola zosafunika zomwe zimapezeka mumtsempha wamtsempha . Mu 2002, a FDA anavomereza mapuloteni a mafupa opangidwa ndi Medtronic otchedwa Infuse kuti agwiritsidwe ntchito pa opaleshoni ya mphuno ya lumbar. Njira yogwiritsiridwa ntchito ndi FDA inali yodziwika bwino: Monga fupa losakanizidwa ndi kamodzi kamodzi Anterior Lumbar Interbody Fusion (ALIF) mkati mwa dongosolo la Lumbar Tapered Fusion Device (LT-Cage.) Whew!

Koma atangomvomereza, madokotala ambiri opaleshoni anayamba kugwiritsa ntchito mawu akuti "off-label," omwe amatanthauza zina osati zomwe avomerezedwa ndi FDA. Kugwiritsa ntchito pamatumiziwa kunaphatikizapo opaleshoni ya msana ya chiberekero yomwe inachititsa "zochitika zovuta," kapena AE kuti zidziwike kwa FDA. Ectopic bone mapangidwe anali imodzi ya AE, koma mndandanda munali zinthu zina zazikulu monga arachnoiditis, kuchuluka kwa mapulogalamu a ubongo, kubwezeretsa kukomoka, khansara ndi zina zambiri. Osati okongola!

Medtronic Controversy

Lipoti la Milwaukee Journal Sentinal Watchdog Report, lomwe latengera nkhaniyi kuyambira 2011 (ndipo ikupitiriza kuchita zimenezi), linanena kuti mkati mwa masabata a mayesero oyamba opatsirana pogonana, Ectopic bone anapanga odwala 70% mwa ophunzirawo. Ena mwa odwalawa ankafuna opaleshoni imodzi kapena kuposerapo kuti akonzetse fupa losafunikira komanso / kapena mavuto omwe adachokera kwa iwo.

Poganizira za umboni wofalitsidwa mu Surgery Neurology International mu 2013, Epstein anayerekeza makampani 13 omwe amapereka maphunziro ku maphunziro ena omwe adasindikizidwa m'magazini, komanso malemba a FDA ndi zomwe zili m'mabuku. Iye akunena kuti akupeza "zochitika zosasindikizidwa zomwe poyamba sizinasindikidwe ndi kusagwirizana koyambirira" ndi maphunziro ovuta.

Amanenanso kuti 40 peresenti ya zovutazo zinayambitsidwa ndi ALIF (opaleshoni ya khosi "yopanda pake" yomwe inachitika), kuwonjezera kuti zina mwa zochitikazi zinali zoopsya.

Panthawiyi, Milwaukee Journal Sentinel inati Medtronic mwina sanafotokoze kapena sananenepo zotsatirazi kwa FDA mu 2004 lipoti lolembedwa ndi madokotala a Medtronic. MJS inati "madokotala omwe analemba pepala la 2004 adzalandira madola mamiliyoni ambirimbiri ndi ndalama zina kuchokera ku Medtronic."

Mu Meyi wa 2014, a MJS adatsata nkhaniyi ndi nkhani ina kuti Medtronic adavomereza kulipira madola 22 miliyoni kuti athetse milandu 1000 pa mlandu wawo.

Nkhaniyo inanenanso kuti Medtronic imapatula $ 140 kuti igwirizane ndi zomwe akunenazo.

Zotsatira:

Chipatala cha Ana a Boston. Kodi Progenitor Cells ndi chiyani? Masamba akuluakulu a Stem 101 tsamba. Webusaiti ya Boston Children's Hospital. Idakwanira Dec 2015.

Epstein, N. Mavuto chifukwa cha ntchito ya BMP / INFUSE pa opaleshoni ya msana: Umboni ukupitirirabe. Opaleshoni Neurol Int. 2013: Kufikira Dec 2015.

Fauber, J., Infuse anafotokozera odwala opweteka kwambiri a mafupa. Zotsatira Zotsatira. Malipoti a Olemba Zolemba Zolemba. Journal Interactive. June 2011.

Fauber, J. Medtronic kulipira madola 22 miliyoni kuti athetsere mlandu wokhudza mlandu wa spie mankhwala. Malipoti Owonerera. Milwaukee Wisconsin Journal Sentinel. May 6, 2014.

Scott, M., A., Levi, B., ASkarinam, A., Nguyen, A., Rackohn, T., Ting, K., Soo, C., Kukambitsirana Kwachidule kwa Ectopic Bone Formation. Maselo a Stem Dev. 2012 Mar 20; 21 (5): 655-667.