Alerta De Seguridad para Name of the product: SISTEMA ESSURE /// Registration number: 80274190001 /// model: ESS305 /// Lots: ALL LOTS /// Product risk class: IV.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por COMERCIAL COMMED PRODUTOS HOSPITALARES LTDA.; Bayer Health Care LLC.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notas adicionales en la data
    The company states that "endometrial ablation and the Essure procedure should not be performed during the same surgical session. Reviewing medical information on women who underwent both an Essure procedure and an endometrial ablation revealed that they may be at increased risk for certain events known to be associated with each procedure. " ### UPDATE ON 7/13/2017: (i). In compliance with the requirement, the company presented a clinical dossier for the registration area of ​​Anvisa, which was evaluated, being considered that the company fully complied with the request. (ii). According to the reports sent by the company, measures were implemented to strengthen post-market follow-up of the product, based on the awareness and training of physicians, as well as the availability of training modules that can be accessed by the Commercial Commed website. The aforementioned post-market awareness program is underway, with the completion of the actions planned for December / 2017.
  • Causa
    Commercial commed warns that the "thermablate eas procedure and the essure micro implant can not be performed on the same day due to potential damage to non-target tissue. the procedure should be performed only after the tubal occlusion confirmation test of 3 months ".
  • Acción
    Action code: 001/2016 /// The field action consists of issuing Field Alert regarding endometrial ablation and the Essure procedure. Any intrauterine procedure, including endometrial ablation, may result in stretching or removal of the micro implant Essure. This could affect the patient's ability to rely on Essure for contraception. /// LETTER TO THE CUSTOMER IN ANNEX.