GALAFLEX LITE

Description of Event or Problem

AS REPORTED PER CLINICAL TRIAL (B)(4): (B)(6) 2025 - THE SUBJECT PATIENT UNDERWENT SURGERY DURING WHICH A GALAFLEX LITE WAS PLACED. (B)(6) 2026 - PATIENT WAS DIAGNOSED WITH RIGHT BREAST GRADE II CAPSULAR CONTRACTURE AND RIGHT BREAST MALPOSITION. THE REPORTED ADVERSE EVENTS (GRADE II CAPSULAR CONTRACTURE AND RIGHT BREAST MALPOSITION) HAVE BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND THE PROCEDURE AND NOT RECOVERED/RESOLVED. THE REPORTED AE DOES NOT MEET THE DEFINITION OF A SAE (SERIOUS ADVERSE EVENT) AND THE DEFINITION OF USADE (UNANTICIPATED SERIOUS ADVERSE DEVICE EVENT).

Additional Manufacturer Narrative

AS REPORTED, PATIENT'S RIGHT BREAST WAS MALPOSITIONED AND DEVELOPED A GRADE II CAPSULAR CONTRACTURE POST IMPLANT OF GALAFLEX LITE. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE COMPLICATIONS AS POSSIBLY RELATED TO THE STUDY DEVICE AND TO THE PROCEDURE AND NOT RECOVERED/RESOLVED. 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 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. 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.