GALAFLEX 3D

Additional Manufacturer Narrative

AS REPORTED, THE PATIENT WAS IMPLANTED WITH GALAFLEX 3D DURING AN IMPLANT EXCHANGE PROCEDURE. THE IMPLANT IN THE LEFT BREAST HAS SHIFTED LATERALLY AND INFERIORLY. BASED ON THE INFORMATION PROVIDED THE DEGREE TO WHICH THE GALAFLEX 3D IMPLANT USED TO TREAT THE PATIENT, MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE COURSE IS UNKNOWN. A REVIEW OF MANUFACTURING RECORDS WAS CONDUCTED AND SHOWS THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FROM THIS MANUFACTURING LOT OF (B)(4) UNITS. NOTE, THE DATE OF EVENT (23-OCT-2025) IS CONSIDERED TO BE THE BEST ESTIMATE. 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, THE PATIENT WAS IMPLANTED WITH GALAFLEX 3D DURING AN IMPLANT EXCHANGE PROCEDURE. IT WAS REPORTED THAT 5 MONTHS POST IMPLANTATION THE IMPLANT IN THE LEFT BREAST HAS SHIFTED LATERALLY AND INFERIORLY. THE SURGEON IS PLANNING TO REPLACE THE GALAFLEX WITH ANOTHER VERSION AND TO PERFORM ADDITIONAL INTERNAL TIGHTENING TO REPOSITION THE IMPLANT.