GALAFLEX 3DR

Additional Manufacturer Narrative

AS REPORTED PATIENT HAD SEROUS YELLOW FLUID AND UNDERWENT EXPLANT POST IMPLANT OF GALAFLEX 3DR IN THE BREAST. 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. SEROMA 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 LOT OF 384 UNITS. 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, THE PATIENT HAD A BILATERAL BREAST IMPLANT EXCHANGE WITH CAPSULECTOMY AND PLACEMENT OF COHESIVE IMPLANTS ON (B)(6) 2025. PATIENT CAME IN FOR FOLLOW UP ON (B)(6) 2025 FOR BILATERAL SWELLING. NO REDNESS, WARMTH, OR BILATERAL SWELLING FOUND. IT WS REPORTED THAT ON (B)(6) 2025 THE PATIENT WENT INTO OR FPR WHAT WAS THOUGHT TO BE (R) BREAST HEMATOMA EVACUATION, BUT ONCE OPENED NO BLOOD WAS FOUND, ONLY A SIGNIFICANT AMOUNT OF SEROUS YELLOW FLUID; FOUND ON BOTH SIDES, BUT MORE SO ON THE (R) THAN THE (L). THE SURGEON REMOVED BOTH GALAFLEX MESHES.