{"id":482,"date":"2016-02-11T11:53:35","date_gmt":"2016-02-11T10:53:35","guid":{"rendered":"https:\/\/www.somospacientes.com\/aepa-atm\/?p=482"},"modified":"2016-02-26T12:52:11","modified_gmt":"2016-02-26T11:52:11","slug":"expertos-aconsejan-a-los-pacientes-que-necesitan-protesis-realizar-siempre-pruebas-de-alergia-a-metales","status":"publish","type":"post","link":"https:\/\/www.somospacientes.com\/aepa-atm\/noticias\/firmas\/expertos-aconsejan-a-los-pacientes-que-necesitan-protesis-realizar-siempre-pruebas-de-alergia-a-metales\/","title":{"rendered":"Facultativos aconsejan a los pacientes que necesitan pr\u00f3tesis realizar pruebas de alergia a metales"},"content":{"rendered":"

La Asociaci\u00f3n Norteamericana de Pacientes afectados por Dolor de la Articulaci\u00f3n temporomandibular publica que en los \u00faltimos a\u00f1os, algunos pacientes a los que se les ha colocado implantes articulares de esta articulaci\u00f3n se han vuelto sensibles a un material o varios materiales de los implantes colocados en las articulaciones temporomandibulares. <\/p>\n

\"foto-para-MTD\"<\/a><\/p>\n

Los materiales m\u00e1s comunes que pueden provocar alergias son ciertos metales. Sobre todo, el n\u00edquel. Las compa\u00f1\u00edas de implantes han respondido a este problema mediante la fabricaci\u00f3n de dichos implantes sin los materiales est\u00e1ndar con estos metales, y fabricando los implantes totalmente de titanio. Dos empresas de implantes de ATM han estado fabricando implantes \u201cAll Titanio\u201d. -Biomet Microfijaci\u00f3n (recientemente adquirida por Zimmer, Inc.) y la marca TMJ Concepts.<\/p>\n

La FDA ha aprobado los dispositivos de stock de Biomet Microfijaci\u00f3n. Estos implantes son de un dise\u00f1o y material espec\u00edfico, los fabrican en diferentes tama\u00f1os y son 100% de titanio.<\/p>\n

Las pr\u00f3tesis de TMJ Concepts pueden contener los siguientes materiales: cobalto, cromo, molibdeno y polietileno de peso ultra alto molecular. Y, est\u00e1n aprobadas por la FDA. Se fabrican de forma personalizada a la medida del paciente de acuerdo con la anatom\u00eda craneofacial de cada persona.<\/p>\n

Recientemente, la Administraci\u00f3n de Alimentos y Medicamentos (FDA) acaba de aprobar las pr\u00f3tesis totalmente de titanio fabricadas por Zimmer, pero est\u00e1n limitadas s\u00f3lo por uso compasivo y s\u00f3lo se pueden fabricar cinco por a\u00f1o, lo que est\u00e1 de acuerdo con la \u00faltima ley de reautorizaci\u00f3n dispositivo FDA.<\/p>\n

Por ese motivo, los pacientes con implantes tradicionales que experimentan s\u00edntomas de sensibilidad est\u00e1n preocupados de que los implantes compuestos todo por titanio (All Titanio) no vayan a estar disponibles para ellos a causa de esta limitaci\u00f3n por parte de la FDA.<\/p>\n

Debido a esta situaci\u00f3n, la Asociaci\u00f3n Norteamericana estableci\u00f3 contacto con la FDA. Y, la FDA ha autorizado a la marca TMJ Concepts y Biomet Microfixation la producci\u00f3n de pr\u00f3tesis s\u00f3lo de titanio S\u00d3LO por \u201cUso Compasivo\u201d. Esto significa que las empresas fabricantes de estas pr\u00f3tesis s\u00f3lo ser\u00e1n capaces de fabricar un implante para un paciente con evidencia de sensibilidad a los materiales utilizados rutinariamente. Estos son los criterios que las empresas tendr\u00e1n que cumplir.<\/p>\n

Mientras, el Presidente de la marca TMJ Concepts, Dave Samson, ha comentado que \u00abellos est\u00e1n explorando la posibilidad de hacer frente a los criterios que la FDA establece para la fabricaci\u00f3n del implante ATM todo-titanio para Uso Compasivo.\u00bb<\/strong><\/p>\n

www.pacientesatm.com<\/a><\/p>\n

www.morethandoctors.com<\/a><\/p>\n

+34 638 989 769<\/a><\/p>\n

Noticia original en ingles:<\/span><\/p>\n

Need an All Titanium TMJ Implant?<\/strong><\/span><\/p>\n

Increasingly over the past several years patients with temporomandibular total joint implants have been telling us that they have become sensitive to a material, or materials in the implants. The most common material they’re sensitive to is nickel. The implant companies have responded to this problem by manufacturing the implant without the standard materials, and manufacturing implants of all titanium. Two TMJ device companies have been manufacturing all titanium devices–Biomet Microfixation (recently acquired by Zimmer, Inc.) and TMJ Concepts.<\/p>\n

The FDA has approved Biomet Microfixation stock product devices–stock meaning that they are of a specific design and material but made in different sizes. The materials in the stock products are cobalt, chromium, molybdenum and ultra-high molecular weight polyethylene. They also have approval to manufacture all titanium stock products, however they do not have FDA approval to manufacture a custom all titanium device.<\/p>\n

TMJ Concepts manufactures custom TMJ implants meaning that they make the devices according to the individual’s craniofacial anatomy. TMJ Concepts has FDA approval to manufacture these devices composed of: titanium alloy, cobalt, chromium, molybdenum alloy, titanium mesh and ultra-high molecular weight polyethylene. They do not have FDA approval to distribute an all titanium device in the United States.<\/p>\n

Recently the Food and Drug Administration (FDA) has limited the manufacture of non-approved devices to five per year, which is in accordance with the last FDA device reauthorization bill. Naturally, patients with traditional implants experiencing symptoms of sensitivity are concerned that the all titanium implants are not available to them because of this limitation. <\/p>\n

We contacted the FDA about this situation and were told that TMJ Concepts and Biomet Microfixation, after they produced the limited five devices per year, are able to then provide a \u00absmall\u00bb number of the all titanium custom devices on a Compassionate Use exemption basis. That means the companies will be able to manufacture an implant for a patient with evidence of sensitivity to routinely used materials. There are criteria that the companies will have to fulfill in order to do this.<\/p>\n

Mr. Dave Samson, President of TMJ Concepts, stated that \u00abthey are exploring the feasibility of addressing the criteria FDA lays out for manufacturing the all-titanium TMJ implant for Compassionate Use.\u00bb <\/p>\n","protected":false},"excerpt":{"rendered":"

La Asociaci\u00f3n Norteamericana de Pacientes afectados por Dolor de la Articulaci\u00f3n temporomandibular publica que en los \u00faltimos a\u00f1os, algunos pacientes a los que se les ha colocado implantes articulares de esta articulaci\u00f3n se han vuelto sensibles a un material o varios materiales de los implantes colocados en las articulaciones temporomandibulares. Los materiales m\u00e1s comunes que […]<\/p>\n","protected":false},"author":305,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1160],"tags":[],"be_disease":[],"be_general":[],"be_media_type":[],"class_list":["post-482","post","type-post","status-publish","format-standard","hentry","category-firmas"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.somospacientes.com\/aepa-atm\/wp-json\/wp\/v2\/posts\/482","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.somospacientes.com\/aepa-atm\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.somospacientes.com\/aepa-atm\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.somospacientes.com\/aepa-atm\/wp-json\/wp\/v2\/users\/305"}],"replies":[{"embeddable":true,"href":"https:\/\/www.somospacientes.com\/aepa-atm\/wp-json\/wp\/v2\/comments?post=482"}],"version-history":[{"count":14,"href":"https:\/\/www.somospacientes.com\/aepa-atm\/wp-json\/wp\/v2\/posts\/482\/revisions"}],"predecessor-version":[{"id":509,"href":"https:\/\/www.somospacientes.com\/aepa-atm\/wp-json\/wp\/v2\/posts\/482\/revisions\/509"}],"wp:attachment":[{"href":"https:\/\/www.somospacientes.com\/aepa-atm\/wp-json\/wp\/v2\/media?parent=482"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.somospacientes.com\/aepa-atm\/wp-json\/wp\/v2\/categories?post=482"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.somospacientes.com\/aepa-atm\/wp-json\/wp\/v2\/tags?post=482"},{"taxonomy":"be_disease","embeddable":true,"href":"https:\/\/www.somospacientes.com\/aepa-atm\/wp-json\/wp\/v2\/be_disease?post=482"},{"taxonomy":"be_general","embeddable":true,"href":"https:\/\/www.somospacientes.com\/aepa-atm\/wp-json\/wp\/v2\/be_general?post=482"},{"taxonomy":"be_media_type","embeddable":true,"href":"https:\/\/www.somospacientes.com\/aepa-atm\/wp-json\/wp\/v2\/be_media_type?post=482"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}