GALAFLEX

Additional Manufacturer Narrative

AS REPORTED, PATIENT EXPERIENCED REDNESS AND BLANCHING ON LOWER POLE OF ONE BREAST ABOUT ONE MONTH POST IMPLANT OF GALAFLEX. PHOTO PROVIDED PRESENTS PATIENT CONDITION, SUPPORTING THE REPORT OF REDNESS AT THE LOWER POLE OF HER LEFT BREAST. THE CAUSE OF THE PATIENT¿S POST-OP COMPLICATIONS CANNOT BE DETERMINED BASED ON PHOTO EVALUATION. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, NO CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S POSTOPERATIVE ERYTHEMA. SEROMA IS KNOWN INHERENT RISK OF THE SURGERY/USE AND IS LISTED IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE, AS A POSSIBLE COMPLICATION. A REVIEW OF MANUFACTURING RECORDS WAS CONDUCTED AND SHOWS THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF (B)(4) UNITS. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

AS REPORTED ON (B)(6) 2025 THE PATIENT UNDERWENT BILATERAL MASTOPEXY USING GALAFLEX. THE PATIENT INITIALLY HAD MILD REACTIONS TO A DRESSING AT WEEK ONE POSTOP, BUT THE SURGEON DOES NOT THINK THIS IS RELEVANT. THE PATIENT THEN EXPERIENCED REDNESS AND BLANCHING ON THE LOWER POLE OF ONE BREAST, BECOMING SLIGHTLY WARM TO THE TOUCH. THE PATIENT ALSO EXPERIENCED FLU SYMPTOMS, WHICH IMPROVED AFTER TAKING ANTIBIOTICS. THE BREAST FELT CLINICALLY SOFT. LABORATORY RESULTS SHOWED A NORMAL WHITE CELL COUNT OF 8.9 BUT A SEVERELY ELEVATED CRP OF 86. THE PATIENT WAS ADMITTED FOR ANTIBIOTIC TREATMENT AND AFTER THE DRAINAGE OF SEROMA THE REDNESS AND OTHER SYMPTOMS WERE RECOVERED.