Alerta De Seguridad para Poly Implant Prothese breast implants

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Poly Implant Prothese (PIP).

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Press release
  • Causa
    Adverse events related to poly implant prothese breast implants a spokesman for the department of health (dh) said today (december 22) the department is aware that the french medical device regulatory authority, afssaps, is continuing to monitor adverse events reported in patients with silicone gel breast implants manufactured by a french company named poly implant prothese (pip). on december 21, dh was informed by the afssaps of their updated figures on serious adverse events related to pip breast implants. this included a fatal case of anaplastic large cell lymphoma (alcl), a rare form of cancer of the immune system, which was earlier reported in november. however, it was not possible for them to conclude whether pip implant was an additional risk. dh noted that to date, the french authority has not made any decision on the need to remove the pip implants, and that an expert meeting is expected to provide further recommendations on the management and follow-up of patients with such implants. “dh has contacted afssaps to obtain further information and sought their assistance to obtain information about distribution of the affected products in hong kong.” he said. in march 2010, the afssaps has made a decision to recall and suspend the marketing, distribution, export and the use of the silicone gel breast implants manufactured by pip, as there were increased reports of ruptures of the implants due to quality defects. a press release was also made by dh on march 31, 2010 in response to afssaps’ announcement. in hong kong, dh has so far not received any report of adverse events associated with pip breast implants. meanwhile, the department will closely follow up with the recommendations issued by afssaps and other medical device regulatory authorities. members of the public who have received breast implants, particularly those implanted with the affected products, should continue to routinely monitor their breast implants and consult their implanting surgeons if they have any concerns or doubt. “the department will closely monitor the situation,” the spokesman added. ends.


  • Modelo / Serial
  • Descripción del producto
    Press release: Adverse events related to Poly Implant Prothese breast implants
  • Manufacturer