Additional Manufacturer Narrative · 1
ORIGINAL SURGERY WAS PERFORMED IN 2000 USING HUTCHISON HTH 0450 SALINE-FILLED IMPLANTS, WHICH WERE FILLED TO AN UNKNOWN VOLUME. PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY IN 2006. THE IMPLANTS WERE REPLACED WITH MCGHAN DEVICES. VISUAL INSPECTION IDENTIFIED TWO BREACHES. BREACH 1 IS LOCATED ON THE PERIPHERY AT THE 9 O'CLOCK POSITION (WHEN THE PRODUCT WAS HELD IN SUCH A POSITION THAT THE BRAND NAME WAS UPRIGHT AND HORIZONTAL), MEASURING APPROX 3MM IN LENGTH. BREACH 2 IS LOCATED 20MM FROM THE PATCH ON THE 9 O'CLOCK POSITION MEASURING APPROX 3MM IN LENGTH. ALSO IDENTIFIED WAS A PATCH-SHELL TEAR APPROX 10MM IN LENGTH WHICH IS LOCATED ON THE 6 O'CLOCK POSITION. PRESSURE TESTING COULD NOT BE COMPLETED DUE TO THE NUMBER OF BREACHES AND THEIR POSITIONS. MICROSCOPIC EXAMINATION (X10) OF THE BREACHES IDENTIFIED CLEAR INITIATION POINTS AND WELL DEFINED EDGES WHICH ARE INDICATIVE OF MECHANICAL TRAUMA. MICROSCOPIC EXAMINATION (X10) OF THE PATCH SHELL TEAR CONFIRMED THE TEAR FOLLOWS THE EDGE OF THE BARRIER PATCH, ALTHOUGH THE EXACT CAUSE COULD NOT BE DETERMINED. THE PRODUCT MET ALL MANUFACTURING AND QUALITY SPECIFICATIONS POST MFR. A CONCLUSION CANNOT BE DRAWN.