Alerta De Seguridad para prophylactic PIP breast implant

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

¿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
  • Fecha de publicación del evento
  • 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
    Medical Device Safety Alert
  • Causa
    Sweden suggests prophylactic pip breast implant removal the medical products agency and the national board of health and welfare in sweden published updated recommendations regarding silicone breast implants manufactured by poly implant prothèse (pip). these changes to the recommendations are based on an analysis of the new studies of pip implants which have been conducted in sweden and abroad. pip implants have been shown to have a coating which has poor durability. this increases the risk of rupture when compared with other brands of silicone breast implant. the medical product agency's investigation has shown that there are two types of pip implant, manufactured from different types of silicone. one type of silicone contains a substance octamethylcyclotetrasiloxane (d4) which is irritant to tissues. this is present in such quantity that it may constitute a risk of serious inflammation in surrounding tissues. a leak of d4 from the pip implant into the surrounding tissues cannot be excluded as the cause of local inflammation. the possible long-term effects of chronic inflammation caused by silicone containing d4 cannot be determined. the groups of women who have pip implants are relatively young and may be expected to carry their breast implants for a very long time. it is also not possible, with any certainty, to identify which type of silicone is in any woman's pip implants. based on these findings, the medical products agency and the national board of health and welfare will recommend the followings based on the precautionary principle: clinics that have implanted pip implants should contact the women concerned to inform them about the state of knowledge and about the risks of keeping the pip implants in relation to the risks of undergoing an operation to remove the pip implants. clinics that have implanted pip implants should remove them. this should be done as a preventative measure even in cases where there are no indications of problems. in individual cases, there may, with reference to the patient's current health situation, be medical reasons to refrain from removing the pip implants. clinics that have implanted pip implants should make any women who choose not to have their pip implants removed aware of the signs of rupture or of the symptoms of inflammation in the breast area, and, if these occur, it is recommended that they consult a doctor and also that they have the pip implants removed. the signs of rupture or inflammation could be changes in the shape of the breast, lumps, pain, swelling, swollen lymph nodes etc. in or around the breast and armpit. for more information, please refer to the website of the medical products agency, sweden: http://www.Lakemedelsverket.Se/english/all-news/nyheter-2013/ pip-implants-should-be-removed-for-preventative-reasons/ posted on 05 jun 2013.


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  • Descripción del producto
    Medical Device Safety Alert: [5 Jun 2013] Sweden suggests prophylactic PIP breast implant removal
  • Manufacturer