Alerta De Seguridad O Notificaciones De Seguridad para Silicone gel filled breast implants

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Poly Implant Prothese.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • Número del evento
    MDA/2010/078
  • Fecha
    2010-10-04
  • Fecha de publicación del evento
    2014-12-17
  • País del evento
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Notas adicionales en la data
    Clinical management of women implanted with PIP silicone gel filled implants.On Tuesday 30 March 2010, the French medical device regulatory authority (AFSSAPS) informed the MHRA that it had suspended the marketing, distribution, export and the use of silicone gel filled breast implants manufactured by PIP (a French breast implant manufacturer). AFSSAPS recalled all of these devices. The MHRA issued MDA/2010/025 on 31 March 2010 advising UK clinicians not to implant these devices.AFSSAPS had carried out an inspection of the PIP manufacturing plant and established that breast implants manufactured by the company since 2001 had been filled with a silicone gel with a composition different from that approved.AFSSAPS has carried out testing of affected implants to look at the genotoxicity (potential for cancer), chemical toxicity of the filler material and mechanical properties of the implant shell. The MHRA also commissioned tests to look at genotoxicity and chemical toxicity.Test results have not shown any evidence of genotoxicity or chemical toxicity of the filler material. One of the French genotoxicity tests was, however, inconclusive and further testing will be conducted by AFSSAPS with results expected in early 2011.Mechanical testing of the implant shells carried out by AFSSAPS suggests that there may be an increased risk of rupture. However, the Therapeutic Goods Administration (TGA) of the Australian government also carried out tests on PIP silicone gel filled breast implants and found that these implants conformed to the relevant international standards for this type of product, including those for gel cytotoxicity and shell strength.
  • Causa
    (poly implant prothese (pip)) advice for implanting surgeons to identify women with pip implants and advise them that further testing will be carried out. (mda/2010/078).
  • Acción
    Implanting surgeons/implanting centres:Identify women who were implanted with PIP silicone gel filled implants after 1 January 2001. Reassure them that there is no current evidence of health risk associated with the filler and there is no indication for routine action in the form of explantation or ultrasound. Advise them that further information about the testing (see problem) is available on the MHRA website and that further information about clinical management is available on the websites of the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS)  and the Association of Breast Surgery (ABS) . .GPs:Advise women who are concerned about their PIP implants to consult their implanting surgeon or implanting centre.Note: the recommendations in this MDA update the advice given in MDA/2010/025.

Device

  • Modelo / Serial
  • Descripción del producto
    Silicone gel filled breast implants manufactured by Poly Implant Prothese (PIP).All devices implanted after 1 January 2001.
  • Manufacturer

Manufacturer