GALAFLEX
Received Feb 17, 2026 · Event occurred Jan 27, 2026
Report 1213643-2026-00152 · MDR key 24369394
Device
Generic name
Breast - Absorbable Mesh
Manufacturer
Tepha, Inc. - 3005670760Model number
NICatalog number
UNKAA128
Lot number
NI
Product problems
- Material Rupture
Patient
NA · Female
- Physical Asymmetry
Narrative
Additional Manufacturer Narrative
AS REPORTED, POST-IMPLANT OF GALAFLEX, THE PATIENT¿S IMPLANT RUPTURED AND HER BREASTS ARE FALLING TO THE SIDE. BASED ON THE INFORMATION PROVIDED A DEFINITVE CAUSE CANNOT BE DETERMINED. THE DEGREE TO WHICH THE GALAFLEX IMPLANT USED TO TREAT THE PATIENT, MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE COURSE IS UNKNOWN. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (27-JAN-2026) IS CONSIDERED TO BE THE BEST ESTIMATE 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.
Description of Event or Problem
AS REPORTED, THE PATIENT WAS IMPLANTED WITH GALAFLEX IN (B)(6) 2021 AND POST-IMPLANTATION, THE DEVICE WAS RUPTURED AND THE PATIENT'S BREASTS ARE FALLING TO THE SIDE.