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
    SN2011(09)
  • Date
    2011-05-26
  • 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)&id=0486f825-9782-6eee-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
    The latest test results confirm no evidence of genotoxicity or chemical toxicity of the filler material in breast implants manufactured by the french company poly implant prothese (pip).
  • Action
    The IMB recommends that:  Implanting surgeons / implanting centres  1. Ensure that all patients who were implanted with PIP silicone filled implants are advised of the content of this safety notice and the previous safety notice that was issued by IMB, Safety notice SN2010(13).  2. Highlight the key findings to the patient:      • Test results show no evidence of genotoxicity or chemical toxicity of the filler material in the implants.      • Mechanical testing of the implant shell carried out by AFSSAPS confirmed that there may be      an increased risk of rupture.  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)