GALAFLEX

Description of Event or Problem

AS REPORTED, PATIENTS UNDERWENT PREPECTORAL BREAST RECONSTRUCTION WITH IMPLANT OF GALAFLEX MESH. THE PATIENTS WITH PREPECTORAL PLACEMENT HAVE BEEN GRADUALLY EXPERIENCING A HARD AND TIGHT SENSATION FOR TWO MONTHS POST-OPERATION. CURRENTLY, THE SURGEON ADVISES PATIENTS TO OBSERVE FOR A WHILE BUT IS UNCERTAIN IF REMOVAL IS NECESSARY. THIS FILE REPRESENTS PATIENT #4.

Additional Manufacturer Narrative

AS REPORTED, PATIENT HAD HARD AND TIGHT SENSATION OF BREAST POST IMPLANT OF GALAFLEX MESH. BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE AS TO WHAT IF ANY EXTENT THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENTS POST OPERATIVE COURSE. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT IS CONSIDERED TO BE A BEST ESTIMATE AS 02-JAN-2025 BASED ON THE DATE OF AWARENESS. 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.