Events

Alerta De Seguridad para PIP 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
    2011-12-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/press_20111228.html
  • 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
    Recommendation by the french authority on removal of pip breast implants a spokesman for the department of health (dh) said today (december 23) the department noted the recommendation by the french ministry of health regarding the management of patients implanted with silicone gel breast implants manufactured by the french company, poly implant prothese (pip). the french ministry of health announced today its recommendation for patients to remove their pip silicone gel breast implants as a preventive measure. the decision was made after an expert meeting, which found that women with pip implants did not have a higher risk of cancer than women with implants made by other companies, but that there were well-established risks of ruptures. “since the issue came to our attention, dh has been contacting the french medical device regulatory authority, agence francaise de securite sanitaire des produits de sante (afssaps) to obtain information, and sought their assistance to ascertain the distribution of the affected products in hong kong.”the spokesman said. “according to afssaps, the french manufacturer of the products has closed down in 2010. official data on the distribution and usage of the products in hong kong are not available,” he explained. “however, based on the information at hand, the product is not popular in hong kong,” he said. dh noted that while individual health authorities may recommend the removal of pip implants as a precautionary measure, other health authorities have not recommended their removal. the spokesman reiterated that members of the public who have received breast implants, particularly those implanted with the affected products, should consult their implanting surgeons or surgeons experienced in this field if they have any concerns or doubt. so far, the department has not received any adverse events in relation to the pip breast implants. "the department will continue to closely monitor the situation," the spokesman added. end.

Device

PIP breast implants
  • Modelo / Serial
  • Descripción del producto
    Press release: Recommendation by the French authority on removal of PIP breast implants
  • Manufacturer
    Poly Implant Prothese (PIP)

Manufacturer

Poly Implant Prothese (PIP)