PHASIX MESH

Additional Manufacturer Narrative

AS REPORTED, THE SUBJECT PATIENT WAS DIAGNOSED WITH A HERNIA OCCURRENCE POST IMPLANT OF A PHASIX MESH. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE HERNIA OCCURRENCE AS POSSIBLY RELATED TO THE STUDY DEVICE AND CAUSALLY RELATED TO THE PROCEDURE. HOWEVER, BASED ON THE INFORMATION PROVIDED, THE EXTENT TO WHICH THE PHASIX MESH IMPLANT USED TO TREAT THE PATIENT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT'S POSTOPERATIVE HERNIA IS UNKNOWN. HENCE, NO CONCLUSIONS CAN BE MADE. A REVIEW OF MANUFACTURING RECORDS WAS CONDUCTED AND SHOWS THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. REGARDING HERNIA OCCURRENCES THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE STATES, "TO PREVENT RECURRENCES WHEN REPAIRING HERNIAS OR TO PREVENT OCCURRENCES WHEN REINFORCING SURGICAL INCISIONS PROPHYLACTICALLY, THE MESH SHOULD BE SIZED WITH APPROPRIATE OVERLAP FOR THE SIZE AND LOCATION OF THE DEFECT OR SURGICAL INCISION, TAKING INTO CONSIDERATION ANY ADDITIONAL CLINICAL FACTORS APPLICABLE TO THE PATIENT. CAREFUL ATTENTION TO MESH FIXATION PLACEMENT AND SPACING WILL HELP PREVENT EXCESSIVE TENSION OR GAP FORMATION BETWEEN THE MESH AND FASCIAL TISSUE." 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 PER CLINICAL TRIAL (B)(6). THE SUBJECT PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024. ON (B)(6) 2024 THE PATIENT UNDERWENT AN OPEN PRIMARY LAPAROTOMY EPIGASTRIC INFRAUMBILICAL SUPRAPUBIC, DURING WHICH THE PATIENT WAS IMPLANTED WITH PHASIX FLAT MESH THE MESH WHICH WAS TRIMMED AND PLACED USING AN ONLAY TECHNIQUE AND SECURED WITH ABSORBABLE MONOFILAMENT SUTURES. THE MIDLINE FASCIA WAS COMPLETELY CLOSED WITH SLOW ABSORBING MONOFILAMENT 1 PDS CONTINUOUS SINGLE SUTURES. THE PATIENT WAS PERI-OPERATIVELY PRESCRIBED CEFAZOLIN. THE PATIENT WAS DISCHARGED ON (B)(6) 2024. AS REPORTED ON (B)(6) 2025, THE PATIENT DEVELOPED A POST-OPERATIVE HERNIA OCCURRENCE AND THE CT SCAN WAS PERFORMED ON (B)(6) 2025 AND THE HERNIA SIZE WAS ESTIMATED AS 5CM. THE REPORTED ADVERSE EVENT (HERNIA OCCURRENCE) HAS BEEN ASSESSED PER CLINICIAN AS POSSIBLY RELATED TO THE STUDY DEVICE AND CAUSALLY RELATED TO THE PROCEDURE. THE ADVERSE EVENT WAS ASSESSED AS MILD IN SEVERITY, NOT RECOVERED/NOT RESOLVED. NO HOSPITALIZATION OR ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. THE EVENT DOES NOT MEET THE DEFINITION OF A SERIOUS ADVERSE EVENT (SAE).