GALAFLEX LITE

Description of Event or Problem

AS REPORTED PER CLINICAL TRIAL (B)(4): ON (B)(6) 2026, THE SUBJECT PATIENT UNDERWENT SURGERY DURING WHICH THE PATIENT WAS IMPLANTED WITH GALAFLEX LITE. (B)(6) 2026: ADVERSE EVENT REPORTED, BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE II). THE REPORTED ADVERSE EVENT (BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE II) IN BREASTS) HAS BEEN ASSESSED PER CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE AND THE ADVERSE EVENT IS NOT RECOVERED/NOT RESOLVED. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT). THIS FILE REPRESENTS GALAFLEX LITE (LEFT).

Additional Manufacturer Narrative

AS REPORTED, PATIENT DEVELOPED BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE II) POST IMPLANT OF GALAFLEX LITE. THE CLINICIAN HAS ASSESSED THE PATIENT'S POSTOPERATIVE CAPSULAR CONTRACTURE AS POSSIBLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE AND NOT RECOVERED/RESOLVED. HOWEVER, BASED ON THE INFORMATION PROVIDED THE DEGREE TO WHICH THE GALAFLEX LITE IMPLANT USED TO TREAT THE PATIENT, MAY HAVE CAUSED, OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE CAPSULAR CONTRACTURE IS UNKNOWN. THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS CAPSULAR CONTRACTURE AS A POSSIBLE COMPLICATION. A REVIEW OF MANUFACTURING RECORDS WAS CONDUCTED AND SHOWS THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. NOTE, THIS EVENT IS REPORTED FROM CLINICAL TRIAL (B)(4). THE PRODUCT NUMBER GFLT0025IDE AND REPORTED LOT LXKV0017 WAS MADE EXCLUSIVELY FOR USE IN THE CLINICAL TRIAL. THE PRODUCT IS NOT FOR GENERAL COMMERCIAL USE. THE PRODUCT CODE (GFLT0025IDE) IS A "SIMILAR DEVICE" TO GFLT0025 (GALAFLEX LITE). AS SUCH THERE IS NO UDI INCLUDED. THIS MDR REPRESENTS GALAFLEX LITE (LEFT). AN ADDITIONAL MDR WAS SUBMITTED TO REPRESENT GALAFLEX LITE (RIGHT). 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.