PHASIX MESH

Additional Manufacturer Narrative

NO CONCLUSIONS CAN BE MADE. BASED ON THE ARTICLE, THESE ARE HIGHLY COMPLEX CASES WITH PRODUCTS PLACED IN CONTAMINATED SITES. THE INFORMATION OBTAINED IS LIMITED TO THE ARTICLE. THERE IS NO DISCUSSION WITHIN THE ARTICLE, OR INDICATION OF THE DEVICE BEING DIRECTLY OR INDIRECTLY RELATED TO ANY REPORTED PATIENT OUTCOME. THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE (IFU), SUPPLIED WITH THE DEVICE IDENTIFIES INFECTIONS, SEROMA, HEMATOMA, WOUND DEHISCENCE, FISTULA AND HERNIA RECURRENCE AS POSSIBLE COMPLICATIONS. THE IFU 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." NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (01-JAN-2015) IS CONSIDERED TO BE A BEST ESTIMATE BASED ON THE INFORMATION AVAILABLE. THIS REPORT DOCUMENTS INFORMATION RELATED TO THE PHASIX MESH. AN ADDITIONAL MDR HAS BEEN SUBMITTED TO DOCUMENT INFORMATION RELATED TO THE XENMATRIX GRAFT. 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: "ONLAY RESORBABLE BIOSYNTHETIC VERSUS UNDERLAY BIOLOGIC MESH VENTRAL HERNIA REPAIR IN CONTAMINATED FIELDS." THE ARTICLE DESCRIBES A SINGLE-CENTER RETROSPECTIVE REVIEW FROM 2015 TO 2021 WAS PERFORMED EXAMINING 94 SUBJECTS WHO UNDERWENT VENTRAL HERNIA REPAIR (VHR) WITH ABDOMINAL WALL REPAIR (AWR) IN CONTAMINATED FIELDS USING BIOLOGICAL MESH (XENMATRIX (47 PATIENTS)) AND BIOSYNTHETIC MESH (PHASIX MESH (47 PATIENTS). ONLAY MESH PLACEMENT WAS USED FOR ALL PATIENTS IN THE STUDY WHO RECEIVED BIOSYNTHETIC MESH WHEREAS AN UNDERLAY MESH PLACEMENT WAS USED FOR ALL PATIENTS WHO RECEIVED BIOLOGIC MESH. THE POSTOPERATIVE COMPLICATIONS OF BIOLOGIC MESH (XENMATRIX) INCLUDE CELLULITIS (11) REQUIRED ANTIBIOTICS, SURGICAL SITE OCCURRENCE (34), SURGICAL SITE INFECTIONS (11), SEROMA (10), DELAYED HEALING (24), WOUND DEHISCENCE (3), INFECTED MESH (4), FISTULA (8), POST OPERATIVE OBSTRUCTION (3), ILEUS (3) WHICH WERE REQUIRED SURGICAL INTERVENTION AND HERNIA RECURRENCE (14) REQUIRED REPAIR. THE POSTOPERATIVE COMPLICATIONS OF BIOSYNTHETIC MESH (PHASIX MESH) INCLUDE CELLULITIS (2) REQUIRED ANTIBIOTICS, SURGICAL SITE OCCURRENCE (22), SURGICAL SITE INFECTIONS (11), SEROMA (4), HEMATOMA (2), DELAYED HEALING (13), WOUND DEHISCENCE (1), INFECTED MESH (1), FISTULA (2), POST OPERATIVE OBSTRUCTION (4), ILEUS (3) WHICH WERE REQUIRED SURGICAL INTERVENTION AND HERNIA RECURRENCE (7) REQUIRED REPAIR. INFORMATION IS PRESENTED WITHOUT PATIENT/CASE SPECIFIC DETAILS. THE ARTICLE CONCLUDES THAT INFECTION AND HERNIA RECURRENCE ARE TWO FEARED COMPLICATIONS ASSOCIATED WITH VHR WITH AWR. THE USE OF MESH IS KNOWN TO REDUCE RATES OF RECURRENCE AND MESHES THAT LIMIT THE BODY¿S INFLAMMATORY RESPONSE TO FOREIGN OBJECTS ARE THOUGHT TO BE PREFERABLE IN CONTAMINATED FIELDS. OUR FINDINGS SUGGEST THAT ON LAY RESORBABLE BIOSYNTHETIC MESH MAY BE PREFERABLE TO UNDERLAY BIOLOGIC MESH IN CONTAMINATED FIELDS DUE TO LOWER RATES OF SURGICAL SITE OCCURRENCES AND INTERVENTIONS, ULTIMATELY REDUCING BOTH THE POSTOPERATIVE CLINICAL AND FINANCIAL BURDEN FOR THIS PATIENT POPULATION. NOTE: THERE IS NO INFORMATION OF THE DEVICE BEING DIRECTLY OR INDIRECTLY RELATED TO ANY REPORTED PATIENT OUTCOME. THIS REPORT REPRESENTS PHASIX MESH.