GALAFLEX LITE

Description of Event or Problem

AS REPORTED, PATIENT UNDERWENT SURGERY, THE GALAFLEX LITE SCAFFOLD WAS CUT IN HALF AND USED ½ EACH SIDE. THE PATIENT DEVELOPED SIGNIFICANT MALPOSITION PRESENTING AT THE 9 MONTH FOLLOW UP APPT ON (B)(6) 2025. THE REPORTED MALPOSITION WAS ON THE LEFT BREAST ONLY. PATIENT IS SCHEDULED FOR A REVISION SURGERY, AUGMENTATION W/ GALAFLEX PLACEMENT.

Additional Manufacturer Narrative

AS REPORTED, POST IMPLANT PATIENT HAD MALPOSITION OF GALAFLEX LITE. BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE AS TO WHAT IF ANY EXTENT THE MESH CAUSED OR CONTRIBUTE TO THE PATIENTS POST OPERATIVE COURSE. MIGRATION IS KNOWN INHERENT RISK OF THE SURGERY/USE AND IS LISTED IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE, AS A POSSIBLE COMPLICATION. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING (B)(4). 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.