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Implantes mamarios ocupan el sexto puesto de incidentes en Colombia – Invima
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El Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Invima), participó en el marco del evento académico sobre cáncer de mama, 3 Cali Breas Meeting 2019, donde expuso de acuerdo a la base de datos del Programa Nacional de Tecnovigilancia 2005 – 2018, que los implantes mamarios ocupan el sexto puesto entre los dispositivos médicos con mayor cantidad de reportes por eventos e incidentes adversos en el país.
Reportes médicos de implantes mamarios
A la fecha se tiene un registro de 966 reportes, de los cuales 233 se encuentran relacionados al paciente, 187 asociados al dispositivo, 71 a los profesionales de la salud, 86 que no se encuentran asociadas al dispositivo y 399 se encuentran en proceso de estudio. Para cada caso, el Invima realiza seguimiento hasta el cierre de todas las actividades de vigilancia que se deriven.
Adicionalmente, durante el desarrollo del evento se destacó el proceso de evaluación premercado, técnico científico que se realiza en la entidad para evaluar la calidad, seguridad y el desempeño de los dispositivos médicos, previo al proceso de emisión de autorización para comercialización en el país.
Seguimiento del Invima a los incidentes con implantes mamarios
Actualmente el Invima se encuentra articulado con las sociedades científicas colombianas, realizando seguimiento y gestión de los eventos e incidentes adversos relacionados con los implantes mamarios en el territorio nacional.
El Director del Invima, Julio César Aldana Bula, hace un llamado a la ciudadanía en general para que reporten cualquier efecto o situación no deseada que presenten con un dispositivo médico, a través del aplicativo de Tecnovigilancia en la página web de la entidad y consulten inmediatamente a los profesionales de la salud.
Señales de alerta para el cuidado del paciente
El Invima recuerda a los pacientes, importadores y profesionales de la salud, prestar especial atención a señales de alerta como el endurecimiento del área del seno alrededor del implante, la ruptura de este, la acumulación de fluidos en la zona, el aumento de tamaño en el seno afectado, dolor, infección, inflamación, enrojecimiento e irritación. Así mismo, recuerda a las pacientes solicitar copia de la tarjeta del implante, la cual permite identificar plenamente su prótesis mamaria.
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