MDR event

Additional Manufacturer Narrative

REPORTED DEFECT: DEFLATION OF LEFT BREAST IMPLANT. BILATERAL EXCHANGE WITH MENTOR DEVICES. BACKGROUND: ORIGINAL SURGERY WAS PERFORMED BY DR IN 2000, USING HUTCHISON HSH 500CC SALINE-FILLED IMPLANTS, WHICH WERE FILLED TO A VOLUME OF 540CC, WHICH IS 10CC'S OVER THE MAXIMUM FILL VOLUME LIMIT. PT UNDERWENT BILATERAL REPLACEMENT SURGERY IN 2006. THE IMPLANTS WERE REPLACED WITH MENTOR DEVICES. CONDITION UPON RECEIPT: PRODUCT WAS RECEIVED IN A PEEL POUCH. THE PACK INCLUDED DISTRIBUTORS REPORT AND HEALTH PROFESSIONALS' PAPERWORK, INCLUDING DECONTAMINATION CERTIFCATE. VISUAL INSPECTION: VISUAL INSPECTION IDENTIFIED A PATCH - SHELL TEAR ON THE POSTERIOR SURFACE MEASURING APPROX 32MM IN LENGTH WHICH IS LOCATED BETWEEN THE 6 AND 8 O'CLOCK POSITIONS. (WHEN THE PRODUCT WAS HELD IN SUCH A POSITION THAT THE BRAND NAME WAS UPRIGHT AND HORIZONTAL). PRODUCT INSPECTION: PRESSURE TESTING COULD NOT BE COMPLETED DUE TO THE SIZE & POSITION OF THE TEAR. MICROSCOPIC EXAMINATON (X10) CONFIRMED THE BREACH WHICH FOLLOWS THE EDGE OF THE BARRIER PATCH, ALTHOUGH THE EXACT CAUSE COULD NOT BE DETERMINED. THE PRODUCT MET ALL MFG AND QUALITY SPECIFICATIONS POST MFR. CONCLUSION: A CONCLUSION COULD NOT BE DRAWN.