Events

Field Safety Notices about Silicone Gel filled Breast Implants manufactured by Poly Implant Prothese (PIP). (All models and lot numbers).

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Poly Implant Prothese (PIP).

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
    Field Safety Notice
  • Event Number
    SN2010(13)
  • Date
    2010-10-05
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/silicone-gel-filled-breast-implants-manufactured-by-poly-implant-prothese-(pip).-(all-models-and-lot-numbers)-05-10.2010&id=388af825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Extra notes in the data
  • Reason
    A recall of silicone gel filled breast implants manufactured by the french company poly implant prothese (pip) was initiated in ireland on the 30th march 2010. the recall follows a manufacturing site inspection in france which identified unauthorised silicone gel being used in the product.
  • Action
    The IMB recommends that:  Implanting surgeons / Implanting centres  • Identify women who were implanted with PIP silicone gel filled implants after 01 January 2001.  • Reassure them that there is no current evidence of health risk associated with the implants.  • Advise them that further information about the testing is available on the IMB, Therapeutic Goods Administration in Australia, Medicines And Healthcare products Regulatory Agency in UK and French Regulatory Agency AFSSAPs websites. (web addresses provided above).  GPs  Advise patients who are concerned about their PIP implants to consult their implanting surgeon/ implanting centres.

Device

Silicone Gel filled Breast Implants manufactured by Poly Implant Prothese (PIP). (All models and ...
  • Model / Serial
  • Product Description
    Silicone Gel filled Breast Implants manufactured by Poly Implant Prothese (PIP). (All models and lot numbers)
  • Manufacturer
    Poly Implant Prothese (PIP)

Manufacturer

Poly Implant Prothese (PIP)