GALAFLEX 3D

Additional Manufacturer Narrative

AS REPORTED, PATIENT DID NOT HEAL AND PRESENTED WITH EXPOSED IMPLANT ON THE RIGHT BREAST POST BREAST AUGMENTATION WITH IMPLANT OF GALAFLEX 3D MESH. BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE DEVICE USED IN THE PROCEDURE MAY HAVE CAUSED OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATION. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. 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, PATIENT UNDERWENT BILATERAL BREAST AUGMENTATION WITH IMPLANT OF GALAFLEX 3D MESH ON (B)(6) 2025. AT THE 4 WEEK FOLLOW UP APPOINTMENT THE PATIENT PRESENTED WITH EXPOSED IMPLANT ON THE RIGHT BREAST POST IMPLANT. IT WAS REPORTED THAT IT DID NOT HEAL, AND NO ISSUE WAS FOUND ON THE LEFT BREAST POST IMPLANT. SURGEON PLANNED TO REMOVE THE IMPLANT ON (B)(6) 2025 AND TO REPLACE WITH NEW IMPLANT ONCE THE HEALED. NO FURTHER INFORMATION HAS BEEN PROVIDED ON WHETHER THE IMPLANT WAS REMOVED.