GALAFLEX LITE

Description of Event or Problem

AS REPORTED PER CLINICAL TRIAL (B)(4): ON (B)(6) 2025 - THE SUBJECT PATIENT UNDERWENT SURGERY DURING WHICH A TWO GALAFLEX LITE WAS IMPLANTED (LEFT AND RIGHT BREAST). ON (B)(6) 2026 - THE SUBJECT PATIENT WAS DIAGNOSED WITH BILATERAL BAKER SCALE GRADE II IN BOTH (LEFT AND RIGHT) BREAST (AE1) AND MALPOSITION OF THE LEFT BREAST (AE2). ADDITIONAL INFORMATION: NO ADDITIONAL ACTION IS NEEDED AT THIS TIME - PI WILL CONTINUE TO MONITOR. THE REPORTED ADVERSE EVENT (BILATERAL BAKER SCALE GRADE II) (MALPOSITION OF THE LEFT BREAST) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND PROCEDURE AND OUTCOME AS NOT RECOVERED/RESOLVED. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND THE DEFINITION OF UADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT). THIS FILE REPRESENTS GALAFLEX LITE (RIGHT BREAST).

Additional Manufacturer Narrative

AS REPORTED, PATIENT DEVELOPED CAPSULAR CONTRACTURE (BAKER SCALE GRADE II) IN BOTH THE BREASTS AND MALPOSITION OF THE LEFT BREAST POST IMPLANT OF GALAFLEX LITE. THE CLINICIAN HAS ASSESSED THE PATIENT'S POSTOPERATIVE COMPLICATIONS AS POSSIBLY RELATED TO THE STUDY DEVICE AND THE PROCEDURE AND OUTCOME AS 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 COURSE IS UNKNOWN. THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS MALPOSITION AND CAPSULAR CONTRACTURE AS POSSIBLE COMPLICATIONS. A REVIEW OF MANUFACTURING RECORDS WAS CONDUCTED AND SHOWS THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. NOTE, THIS EVENT IS REPORTED FROM CLINICAL (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 EMDR REPRESENTS THE GALAFLEX LITE (RIGHT). AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE GALAFLEX LITE (LEFT). 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.