PHASIX MESH

Description of Event or Problem

AS REPORTED, PATIENT UNDERWENT AN OPEN RECURRENT VENTRAL INCISIONAL HERNIA REPAIR WITH IMPLANT OF A PHASIX MESH IN 2018. IT WAS REPORTED THAT THE PATIENT FELT THEY STARTED HAVING A REACTION TO THE PHASIX MESH ABOUT 1.5 YEARS POST IMPLANT.

Additional Manufacturer Narrative

AS REPORTED, A PATIENT WITH A MEDICAL HISTORY SIGNIFICANT FOR SYSTEMIC MASTOCYTOSIS, AND ALLERGIES TO MULTIPLE MEDICATIONS UNDERWENT HERNIA REPAIR WITH A PHASIX MESH. ONE AND A HALF YEARS POST IMPLANT THE PATIENT FELT SHE WAS STARTING TO HAVE A REACTION TO THE MESH. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. PHASIX MESH IS A RESORBABLE SYNTHETIC MESH IMPLANT. ABSORPTION OF THE PHASIX MESH MATERIAL WILL ESSENTIALLY COMPLETE WITHIN 12 TO 18 MONTHS OF IMPLANT. 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 REPORTED PATIENT¿S REACTION. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS ALLERGIC REACTION 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 IS CONSIDERED TO BE A BEST ESTIMATE AS 07-FEB-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."