Safety Alert Or Field Safety Notices for Silicone gel filled breast implants

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Poly Implant Prothese.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event Number
    MDA/2012/011
  • Date
    2012-03-15
  • Event Date Posted
    2014-12-17
  • Event Country
  • Event Source
    MHRA
  • Event Source URL
  • Notes / Alerts
    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.
  • Extra notes in the data
    In March 2010 the MHRA was informed by the French regulatory authorities (AFSSAPS) that most PIP silicone gel breast implants manufactured from January 2001 were filled with an unapproved silicone gel material. The MHRA’s advice for the management of women implanted with PIP silicone gel breast implants after 1 January 2001 was given in MDA/2010/078, published in October 2010.Updated information from AFSSAPS suggests that there is no guarantee that PIP silicone gel breast implants manufactured prior to 2001 contained the approved filler. Therefore, all women implanted with PIP silicone gel breast implants should be supported and managed in line with the Department of Health’s recommendations of January 2012.Information recently received from the UK supplier of PIP breast implants suggests that up to 7,000 women may have received PIP silicone gel breast implants prior to January 2001. This is in addition to the approximately 40,000 women previously believed to have received affected implants after 1 January 2001.
  • Reason
    (poly implant prothese (pip) no guarantee that silicone gel breast implants manufactured before 2001 contain approved filler. (mda/2012/011).
  • Action
    Implanting surgeonsIdentify additional women who were implanted with PIP silicone gel breast implants prior to 1 January 2001. Offer all women with these implants the support and management as set out on the Department of Health’s website .GPsFollow the advice provided by the Department of Health on its website .Note: the recommendations in this MDA update the advice given in MDA/2010/025 and MDA/2010/078.

Device

  • Model / Serial
  • Product Description
    Silicone gel filled breast implants manufactured by Poly Implant Prothese (PIP).All devices implanted after 1 January 2001.
  • Manufacturer

Manufacturer