Additional Manufacturer Narrative · 1
ORIGINAL SURGERY WAS PERFORMED IN 1998 USING HUTCHISON HSL 0300 SALINE-FILLED IMPLANTS, WHICH WERE FILLED TO A VOLUME OF 0350CC (LEFT ) & 0350CC (RIGHT), WHICH IS WITHIN THE MAXIMUM FILL VOLUME LIMITS. PATIENT UNDERWENT BILATERAL REPLACEMENT SURGERY IN 2006. THE IMPLANTS WERE REPLACED WITH MENTOR DEVICES. VISUAL INSPECTION IDENTIFIED A BREACH ON THE PERIPHERY OF THE PRODUCT MEASURING APPROXIMATELY 18MM IN LENGTH, WHICH IS LOCATED ON THE 12 O'CLOCK POSITION (WHEN THE PRODUCT WAS HELD IN SUCH A POSITION THAT THE BRAND NAME WAS UPRIGHT AND HORIZONTAL). PRESSURE TESTING COULD NOT BE COMPLETED DUE TO THE SIZE AND POSITION OF THE BREACH. MICROSCOPIC EXAMINATION (X10) OF THE BREACH IDENTIFIED A CLEAR INITIATION POINT AND WELL DEFINED EDGES WHICH ARE INDICATIVE OF MECHANICAL TRAUMA. THE PRODUCT MET ALL MANUFACTURING AND QUALITY SPECIFICATIONS POST MFR. THE BREACH IS NOT A MANUFACTURING FAULT.