GALAFLEX 3D

Description of Event or Problem

AS REPORTED, THE PATIENT UNDERWENT A BREAST IMPLANT EXCHANGE ON (B)(6) 2025. ABOUT 5 WEEKS POSTOP, THE PATIENT PRESENTED IN WITH AN UNSPECIFIED INFECTION VERY LATE IN THE HEALING PROCESS ON THE RIGHT BREAST. ON (B)(6) 2025, PATIENT UNDERWENT REMOVAL OF THE MESH AS IT WAS POTENTIAL AFFECTED BY THE INFECTION AND WAS TREATED WITH ANTIBIOTICS.

Additional Manufacturer Narrative

AS REPORTED, THE PATIENT WAS DIAGNOSED WITH POSTOPERATIVE INFECTION FOLLOWING THE IMPLANTATION OF GALAFLEX 3D WHICH POTENTIALY AFFECTED THE MESH, SO IT WAS REMOVED. BASED ON THE INFORMATION AVAILABLE, NO CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S POSTOPERATIVE COURSE. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THE LOT WAS MANUFACTURED TO SPECIFICATION. INFECTION IS A KNOWN INHERENT RISK WITH THE USE OF THIS PRODUCT, AND IT IS LISTED IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE, AS POSSIBLE COMPLICATION. REGARDING INFECTION, THE WARNING SECTION STATES "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE SCAFFOLD." 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.