GALAFLEX LITE

Additional Manufacturer Narrative

AS REPORTED, PATIENT DEVELOPED CAPSULAR CONTRACTURE POST IMPLANT OF GALAFLEX LITE. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE CAPSULAR CONTRACTURE AS POSSIBLY RELATED TO THE STUDY DEVICE AND PROBABLY RELATED 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 COURSE IS UNKNOWN. 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.

Description of Event or Problem

AS REPORTED PER CLINICAL TRIAL (B)(4): THE SUBJECT PATIENT UNDERWENT SURGERY ON (B)(6) 2025, DURING WHICH A GALAFLEX LITE WAS PLACED. ON (B)(6) 2025, PATIENT WAS DIAGNOSED WITH GRADE 2 CAPSULAR CONTRACTURE. DURING BREAST EXAM BILATERAL BREAST FIRMNESS WAS NOTED. RIGHT BEING GREATER THAN LEFT. NO BREAST DISTORTION. PER THE PATIENT NO PROGRESSION OF FIRMNESS. THE REPORTED ADVERSE EVENT (CAPSULAR CONTRACTURE) HAS BEEN ASSESSED PER CLINICIANS AS POSSIBLY RELATED TO THE STUDY DEVICE AND PROBABLE 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).