Alerta De Seguridad para Metal-metal prostheses

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por N/A.

¿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
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  • 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
    1. The ANVISA Technovigilance Unit is following the discussions; 2. the registry holders of products in Brazil were contacted, who informed that they did not receive complaints involving their products; 3. The NOTIVISA database, adverse event notification or technical complaint involving this technology has not been included so far; 4. Publication available on the FDA website on the internet reinforces some of the care already applied to patients who need implants or who have undergone orthopedic implant surgeries: (i). To choose the type of implant, a physician should choose to use a metal-to-metal hip implant only after determining that the benefit-risk of using one metal to metal exceeds the use of another type of technology; (ii). Patients implanted should be monitored periodically, through physical and imaging exams; (iii). The decision to review a metal-to-metal hip implant should be made according to the patient's clinical situation.
  • Causa
    News published by foreign bodies, including regulators, point to the possibility of adverse events associated with the use of metal-metal prostheses. the friction of the metal can cause particle release and consequent wear of the device and thus cause damage to the surrounding bone and / or soft tissues. such damage can result in pain, loosening of the implant and need for surgical revision procedure. it is also being raised the possibility of release of ions into the bloodstream, which would cause systemic damage. according to the fda, there is currently insufficient scientific data to specify the concentration of metal ions in a patient required to produce systemic adverse effects. in addition, the reaction appears to be patient-specific.
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