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 GALAFLEX LITE WAS PLACED ON LEFT AND RIGHT BREAST. ON (B)(6) 2026 - PATIENT WAS DIAGNOSED WITH BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE II) AS NOT RELATED TO DEVICE AND PROCEDURE. ON (B)(6) 2026 - THE PATIENT WAS INITIALLY DIAGNOSED WITH BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE II) ON (B)(6) 2026, WHICH WAS ASSESSED AS NOT RELATED TO THE DEVICE OR PROCEDURE. UPON REASSESSMENT ON (B)(6) 2026, THE CONDITION WAS CONSIDERED POSSIBLY RELATED TO THE DEVICE AND PROCEDURE, AND THE DIAGNOSIS WAS UPGRADED TO BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE III) INVOLVING BOTH THE LEFT AND RIGHT BREASTS. AND NO PLANS FOR SURGICAL INTERVENTION AT THIS TIME. THE REPORTED ADVERSE EVENT (BILATERAL GRADE III CAPSULAR CONTRACTURE AND BILATERAL MALPOSITION) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE AND 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 (LEFT).

Additional Manufacturer Narrative

AS REPORTED, PATIENT DEVELOPED CAPSULAR CONTRACTURE (BAKER GRADE III) AND BILATERAL BREAST MALPOSITION POST IMPLANT OF GALAFLEX LITE. THE CLINICIAN HAS ASSESSED THE PATIENT'S POSTOPERATIVE CAPSULAR CONTRACTURE (BAKER GRADE III) AND BILATERAL BREAST MALPOSITION AS POSSIBLY RELATED TO THE STUDY DEVICE AND 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 COURSE IS UNKNOWN. THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE IDENTIFIES CAPSULAR CONTRACTURE AND MALPOSITION 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 TRIAL (B)(4). THE PRODUCT NUMBER GFLT0025IDE AND REPORTED LOT LXJN0002 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.