GALAFLEX

Additional Manufacturer Narrative

AS REPORTED, PATIENT HAS EXPERIENCED BILATERAL INNER BREAST PAIN (BURNING PAIN) WITH YELLOW SKIN DISCOLORATION POST IMPLANT OF GALAFLEX. BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S POST OPERATIVE COURSE. THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LIST PAIN AS A POSSIBLE COMPLICATION. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (17-OCT-2025) IS CONSIDERED TO BE THE BEST ESTIMATE. 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, PATIENT HAD AUGMENTATION MASTOPEXY WITH GALAFLEX, ABOUT 30 DAYS POST IMPLANT THE PATIENT EXPERIENCED BILATERAL INNER BREAST PAIN (BURNING PAIN) WITH YELLOW SKIN DISCOLORATION. IT WAS REPORTED THAT THE PATIENT'S REPORTED ISSUES HAVE BEEN RESOLVED.