PHASIX MESH

Additional Manufacturer Narrative

BASED ON THE CONTENTS OF THE ARTICLE, NO CONCLUSIONS CAN BE MADE. THE INFORMATION PROVIDED IN THE ARTICLE INDICATES THAT SOME PATIENTS EXPERIENCED POST OPERATIVE COMPLICATIONS, INCLUDING SURGICAL REVISION. THE INFORMATION OBTAINED IS LIMITED TO THE CONTENT OF THE ARTICLE. THE ARTICLE DOES NOT REPORT ANY SPECIFIC DEVICE MALFUNCTION OR POST-OP COMPLICATIONS WERE CAUSED OR CONTRIBUTED TO THE USE OF THE PHASIX MESH. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. THIS REPORT DOCUMENTS INFORMATION RELATED TO THE PHASIX MESH. AN ADDITIONAL MDR HAS BEEN SUBMITTED TO DOCUMENT INFORMATION RELATED TO THE FLAT MESH. 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

PER JOURNAL ARTICLE: "BIOSYNTHETIC COMPARED WITH SYNTHETIC MESH IN RETRORECTUS VENTRAL HERNIA REPAIR: A MATCHED ANALYSIS WITH 3-YEAR OUTCOMES" THE ARTICLE AIMS TO COMPARE LONG TERM OUTCOME OF RETRORECTUS VENTRAL HERNIA REPAIR USING BIOSYNTHETIC MESH (POLY-4-HYDROXYBUTYRATE (PHASIX MESH)) AND SYNTHETIC MESH (UNCOATED POLY PROPYLENE (FLAT MESH) IN CLEAN WOUNDS FROM 1 JANUARY 2015 TO 31 DECEMBER 2021. A TOTAL OF 160 PATIENTS WERE INCLUDED FOR THE STUDY WITH 49 PATIENTS UNDERWENT REPAIR WITH SYNTHETIC MESH AND 111 UNDERWENT REPAIR WITH BIOSYNTHETIC MESH. PATIENTS WERE FOLLOWED FOR UP TO 3 YEARS OR UNTIL HERNIA RECURRENCE. PATIENTS WITH DOCUMENTED RECURRENCES HAD CONFIRMATION EITHER VIA IMAGING OR BY A CLINICAL DIAGNOSIS MADE BY THE HERNIA REPAIR SURGEON. PATIENTS WHO UNDERWENT REPAIR WITH SYNTHETIC (FLAT) MESH (49) HAD COMPLICATIONS SUCH AS SURGICAL-SITE OCCURRENCES (SSOS) (13), CELLULITIS (2), SURGICAL-SITE INFECTION (3), SEROMA (4), HEMATOMA (2), DELAYED WOUND HEALING (9), AND WOUND DEHISCENCE (2), HERNIA RECURRENCE REQUIRING REPAIR (1), EMERGENCY DEPARTMENT VISITS (5), READMISSIONS (8), AND SURGICAL-SITE OCCURRENCES REQUIRING PROCEDURAL INTERVENTION (6) WERE REPORTED, WITH AN OVERALL REOPERATION RATE IN 8 PATIENTS. PATIENTS WHO UNDERWENT REPAIR WITH BIOSYNTHETIC (PHASIX) MESH (111) HAD COMPLICATIONS SUCH AS SSO (41), CELLULITIS (8), SURGICAL-SITE INFECTION (14), SEROMA (11), HEMATOMA (1), DELAYED WOUND HEALING (25), WOUND DEHISCENCE (5), BOWEL OBSTRUCTION (3), ENTEROCUTANEOUS FISTULA (1), HERNIA RECURRENCE REQUIRING REPAIR (7), EMERGENCY DEPARTMENT VISITS (19), READMISSIONS (23), AND SURGICAL-SITE OCCURRENCES REQUIRING PROCEDURAL INTERVENTION (15), WITH AN OVERALL REOPERATION RATE IN 20 PATIENTS. THE ARTICLE CONCLUDED THAT BIOSYNTHETIC AND SYNTHETIC MESHES PROVIDE SIMILAR LONG-TERM OUTCOMES IN CLEAN RETRORECTUS VENTRAL HERNIA REPAIR WITH NO CLEAR SHORT-TERM ADVANTAGE OF BIOSYNTHETIC MESH DESPITE ITS HIGHER COST AND POTENTIAL FOR REDUCED FOREIGN BODY EXPOSURE FURTHER STUDIES WITH EXTENDED FOLLOW-UPS RECOMMENDED TO ACCESS LONG TERM COMPLICATIONS AND COST EFFECTIVENESS. NOTE: THERE IS NO INFORMATION PROVIDED IN THE ARTICLE INDICATING THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE POSTOPERATIVE PATIENT COMPLICATION(S). HOWEVER, AS POSTOPERATIVE COMPLICATIONS DID PRESENT AND SOME REQUIRING MEDICAL/SURGICAL INTERVENTION WE ARE REPORTING THIS AS A SERIOUS INJURY MDR.