PHASIX MESH

Additional Manufacturer Narrative

AS REPORTED, THE PATIENT UNDERWENT RE-OPERATION TO REMOVE A PREVIOUSLY IMPLANTED CHRONICALLY INFECTED MESH. DURING THIS PROCEDURE A PHASIX MESH WAS IMPLANTED AS A PRE-PERITONEAL REPAIR AFTER ADDRESSING A CHRONIC INFECTION AND DRAINING SINUS IN THE AREA. ABOUT 5 MONTHS POST IMPLANT THE PATIENT PRESENTED WITH A RECURRENCE OF THE INFECTION AND DRAINING SINUS AND UNDERWENT RE-OPERATION. THE SURGEON REPORTS HE FOUND THAT A PORTION OF THE PHASIX MESH WAS ENCAPSULATED, NOT INCORPORATED, AND WAS WRINKLED. NO DEFINITIVE CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S POSTOPERATIVE COURSE. HOWEVER, THE USE OF THE PHASIX MESH IN A COMPROMISED ENVIRONMENT MAY HAVE CONTRIBUTED TO THE ISSUES THAT PRESENTED. THE WARNING SECTION OF THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE, STATES, "THE USE OF ANY MESH OR PATCH IN A CONTAMINATED OR INFECTED WOUND CAN LEAD TO FISTULA FORMATION AND/OR EXTRUSION OF THE MESH." AND "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. CONSIDERATION SHOULD BE GIVEN REGARDING THE NEED TO REMOVE THE MESH. AN UNRESOLVED INFECTION MAY REQUIRE THE REMOVAL OF THE MESH." NOTE, THE DATE OF EVENT (12-SEP-2025) IS CONSIDERED TO BE A 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, PATIENT HAD PREVIOUSLY UNDERGONE INGUINAL HERNIA REPAIR WITH THE PLACEMENT OF AN UNIDENTIFIED PERMANENT MESH. THE MESH BECAME CHRONICALLY INFECTED AND THE PATIENT UNDERWENT RE-OPERATION. DURING THIS PROCEDURE THE INFECTED MESH WAS REMOVED, AND A PHASIX MESH WAS IMPLANTED AS A PRE-PERITONEAL REPAIR AFTER ADDRESSING A CHRONIC INFECTION AND DRAINING SINUS IN THE AREA. AFTER 5 MONTHS, THE PATIENT HAD RECURRENCE OF THE INFECTION AND DRAINING SINUS. THE SURGEON OPERATED AND FOUND THAT A PORTION OF THE PHASIX MESH WAS ENCAPSULATED, NOT INCORPORATED, AND WRINKLED. THE UNINCORPORATED PHASIX MESH WAS REMOVED AND THE ABDOMEN WAS CLOSED PRIMARILY.