PHASIX MESH

Additional Manufacturer Narrative

BASED ON THE INFORMATION PROVIDED IN THE ARTICLE, NO DEFINITIVE CONCLUSIONS CAN BE DRAWN. THE AVAILABLE DATA IS LIMITED TO THE CONTENT PRESENTED IN THE PUBLICATION, AND FOLLOW-UP WITH A CO-AUTHOR CONFIRMED THAT NO ADDITIONAL DETAILS ARE AVAILABLE. THE ARTICLE DOES NOT DESCRIBE THAT ANY DEVICE MALFUNCTION OR POSTOPERATIVE COMPLICATIONS WERE CAUSED BY, OR ATTRIBUTED TO, THE USE OF PHASIX MESH. IT IS IMPORTANT TO NOTE THAT THE STUDY POPULATION RECEIVING PHASIX AND PHASIX ST MESH UNDERWENT IMPLANTATION IN THE SETTING OF INFECTED SYNTHETIC MESH EXPLANTATION. CONSEQUENTLY, THE SURGICAL ENVIRONMENT IN WHICH THESE MESHES WERE PLACED WAS COMPROMISED BY EITHER ACUTE OR CHRONIC INFECTION. HERNIA RECURRENCE AND INFECTION ARE CLINICALLY UNDERSTOOD POTENTIAL COMPLICATIONS OF SURGERY / USE OF THE DEVICE AND ARE IDENTIFIED IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE AS POSSIBLE COMPLICATIONS. REGARDING INFECTION THE WARNING SECTION STATES, "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. CONSIDERATION SHOULD BE GIVEN REGARDING THE NEED TO REMOVE THE MESH. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE DEVICE". NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (01-JAN-2017) IS CONSIDERED TO BE A BEST ESTIMATE. THIS MDR REPRESENTS THE PHASIX MESH. AN ADDITIONAL MDR WAS SUBMITTED TO REPRESENT THE PHASIX ST 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: "MESH REMOVAL AND VENTRAL HERNIA REPAIR WITH LONG-TERM ABSORBABLE MESH IN CASE OF MESH INFECTION". THIS RETROSPECTIVE COHORT STUDY EVALUATED THE SHORT- AND LONG-TERM OUTCOMES OF A STRATEGY INVOLVING EXPLANATION OF THE INFECTED MESH AND INSERTION OF A LONG-TERM ABSORBABLE MESH IN ACUTE (AMI) AND CHRONIC MESH INFECTIONS (CMI). THE STUDY INCLUDED 29 PATIENTS (15 WOMEN AND 14 MEN) TREATED BETWEEN 01 JAN 2017 AND 31 DEC 2024, WHO HAD VENTRAL MESH INFECTIONS MANAGED ACROSS TWO TERTIARY CENTERS. THE COHORT CONSISTED OF ACUTE MESH INFECTIONS (N = 14) AND CHRONIC MESH INFECTIONS (N = 15). ACUTE MESH INFECTION WAS DEFINED AS INFECTION OCCURRING WITHIN 90 POSTOPERATIVE DAYS, WHEREAS CHRONIC MESH INFECTION WAS DEFINED AS INFECTION OCCURRING AFTER 90 POSTOPERATIVE DAYS. NINE PATIENTS IN EACH GROUP DEVELOPED POSTOPERATIVE COMPLICATIONS. MANAGEMENT CONSISTS OF COMPLETE EXPLANTATION OF THE INFECTED MESH, FOLLOWED BY REINFORCEMENT USING A LONG TERM ABSORBABLE P4HB MESH (PHASIX®). PHASIX ST® IS USED SPECIFICALLY FOR INTRAPERITONEAL PLACEMENT, DUE TO ITS HYDROGEL ADHESION BARRIER LAYER THAT REDUCES THE RISK OF VISCERAL ADHESIONS. IN ACUTE MESH INFECTIONS GROUP, MINOR COMPLICATION(N=7), MAJOR COMPLICATIONS (N=2), SURGICAL-SITE OCCURRENCES (11), SURGICAL SITE INFECTION (N=6), REOPERATION (8), HERNIA RECURRENCE (3) AND MESH REMOVAL (1). IN CHRONIC MESH INFECTIONS GROUP, MINOR COMPLICATION(N=7), MAJOR COMPLICATIONS (N=2), SURGICAL-SITE OCCURRENCES (5), SURGICAL SITE INFECTION (N=2) AND REOPERATION (1). NO HERNIA RECURRENCE AND NO MESH REMOVAL OCCURRED. THE ARTICLE CONCLUDES THAT THIS STRATEGY IS ASSOCIATED WITH HIGH SHORT-TERM MORBIDITY, BUT PROVIDES FAVORABLE LONG-TERM OUTCOMES, WITH LOW MESH EXPLANTATION AND HERNIA RECURRENCE RATES. THE AUTHORS NOTE THAT LONGER FOLLOW UP AND LARGER PATIENT POPULATIONS ARE NEEDED TO BETTER EVALUATE RECURRENCE AND REINFECTION RISK OVER TIME. 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 MAY REQUIRE MEDICAL/SURGICAL INTERVENTION WE ARE REPORTING THIS AS A SERIOUS INJURY MDR. THIS RECORD REPRESENTS THE PHASIX FLAT MESH.