Silicone Gel filled Breast Implants manufactured by Poly Implant Prothese (PIP). (All models and lot numbers). 에 대한 현장 안전성 서한

Field Safety Notice

SN2011(09)

2011-05-26

Ireland

HPRA

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

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).

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.