PHASIX MESH

Description of Event or Problem

PER JOURNAL ARTICLE: EFFECTIVENESS OF PREOPERATIVE CHEMICAL COMPONENT SEPARATION WITH COMPUTED TOMOGRAPHY GUIDED INTRAMUSCULAR INJECTION OF ONABOTULINUMTOXINA IN OUTCOMES OF LARGE COMPLEX INCISIONAL VENTRAL ABDOMINAL HERNIA REPAIR: A PROPENSITY SCORE WEIGHTED COMPARATIVE ANALYSIS. THIS RETROSPECTIVE CASE CONTROL STUDY WAS CONDUCTED INCLUDING 97 PATIENTS WITH LARGE VENTRAL ABDOMINAL HERNIAS WHO UNDERWENT COMPLEX VENTRAL INCISIONAL HERNIA REPAIR BETWEEN NOVEMBER 2017 AND OCTOBER 2021. OF THESE, 37 RECEIVED BOTOX INJECTIONS BEFORE SURGERY, WHILE 60 UNDERWENT REPAIR WITHOUT BOTOX. THE BOTOX PROCEDURE WAS PERFORMED VIA CT GUIDED BILATERAL INJECTIONS INTO ABDOMINAL WALL MUSCLES, FOLLOWED BY STANDARD SURGICAL REPAIR TECHNIQUES. HERNIA RECURRENCE RATES WERE LOWER IN THE BOTOX GROUP (8 PERCENTAGE) COMPARED WITH THE NON-BOTOX GROUP (22 PERCENTAGE). 12 PATIENTS WERE IMPLANTED WITH PHASIX MESH, 21 PATIENTS WERE IMPLANTED WITH VENTRALEX MESH AND REST OF THE PATIENTS WERE IMPLANTED WITH NON-BD MESHES. 30 PATIENTS HAD COMPLICATIONS, 4 PATIENTS HAD POST OPERATIVE PAIN CONTROL ISSUES, 16 PATIENTS HAD HERNIA RECURRENCE (4 PATIENTS WITH PHASIX AND 2 PATIENTS WITH VENTRALEX) AND 7 PATIENTS HAD HOSPITAL STAY. THE ARTICLE CONCLUDED THAT CT GUIDED CHEMICAL COMPONENT SEPARATION WITH INTRAMUSCULAR INJECTION OF ONABOTULINUMTOXINA MAY BE EFFECTIVE IN REDUCING THE RISK OF POST SURGICAL RECURRENCE OF LARGE COMPLEX INCISIONAL VENTRAL ABDOMINAL HERNIAS. BOTOX PATIENTS HAD FEWER RECURRENCES, HIGHER DISCHARGE TO HOME RATES, AND SIMILAR CLOSURE/COMPLICATION OUTCOMES. 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, SOME OF WHICH MAY HAVE REQUIRED MEDICAL/SURGICAL INTERVENTION, WE ARE REPORTING THIS AS A SERIOUS INJURY MDR.

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, OF PAIN, HERNIA RECURRENCE AND HOSPITALIZATION. 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 VENTRALEX 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.