Description of Event or Problem · 1
THIS PATIENT HAD BILATERAL MASTECTOMIES WITH RECONSTRUCTIVE SURGERY AND SILICONE IMPLANTS IN 1977 (15 YEARS AGO) IN ANOTHER FACILITY....NAME UNKNOWN. SHE WAS SEEN IN APRIL OF 1992, BY A PLASTIC SURGEON, COMPLAINING OF BREAST PAIN AND DEFORMITY. SEVERAL MONTHS AGO SHE NOTED SUDDEN SWELLING OCCURING IN THE UPPER POLE OF OF THE RECONSTRUCTED RIGHT BREAST. THIS WAS COIPLED WITH A FIRMNESS WHICH WAS NOTED IN BOTH BREAST. SHE COMPLAINED OF SEVERE PAIN IN BOTH BREAST BUT ESPECIALLY ON THE LEFT SIDE. THIS PAIN WAS MADE WORSE BY ANY MOVEMENT OF THE LEFT SHOULDER GRIDLE. THE SILICONE IMPLANTS BILATERALLY ARE NOT FELT TO BE RUPTURED AT PRESENT BUT THE PRESENCE OF SCAR TISSUE CONTRACTURES MAKE BOTH BREASTS TENDER, PAINFUL AND DEFORMED. SHE HAS REQUESTED THE PLASTIC SURBGEON BILATERAL CAPSULAR RELEASE AND REPLACEMENT OF THE IMPLANTS WITH SALINE PROSTHESIS. APRIL 22, 1992....HAD SALINE IMPLANTS INSERTED AND REMOVAL OF SILICONE IMPLANTS. PRE-OP DIAGNOSIS=BILATERAL CONTRACTURES WITH DEFORMITIES. APRIL 25, 1992....DISCHARGED FROM OUR FACILITY IN GOOD CONDITION. PATHOLOGY REPORT STATES "CAPSULES OF THE RIGHT AND LEFT BREAST IMPLANTS SHOWING EVIDENCE OF SILICONE MASTITIS, BILATERAL CAPSULECTOMIESINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NO DATA. THE DEVICE WAS DESTROYED/DISPOSED OF.