PHASIX MESH

Description of Event or Problem

PER JOURNAL ARTICLE: "PRIMARY VENTRAL HERNIA REPAIR AND THE RISK OF POSTOPERATIVE SMALL BOWEL OBSTRUCTION: INTRA VERSUS EXTRAPERITONEAL MESH". THE AIM OF THE ARTICLE WAS TO COMPARE THE LIKELIHOOD OF BOWEL OBSTRUCTION ACCORDING TO THE PLACEMENT OF THE MESH (EITHER INTRAPERITONEAL OR EXTRAPERITONEAL) IN VENTRAL HERNIA REPAIRS. PATIENTS WERE DIVIDED INTO TWO GROUPS: AN INTRAPERITONEAL (IP) GROUP (MESH PLACED BY LAPAROSCOPY OR WITH AN OPEN APPROACH) AND AN EXTRAPERITONEAL (EP) GROUP (OPEN APPROACH). THE STUDY WAS CONDUCTED BETWEEN MARCH 2008 AND JULY 2021, 318 PATIENTS WERE INCLUDED, WITH 99 PATIENTS IN THE EP GROUP (71 MESHES PLACED PREPERITONEAL AND 28 PLACED RETROMUSCULARLY) AND 219 PATIENTS IN THE IP GROUP (175 PATIENTS OPERATED ON LAPAROSCOPICALLY VERSUS 44 PATIENTS BY DIRECT APPROACH). AMONG 318 PATIENTS, 1 PATIENT FROM IP GROUP AND 9 PATIENTS FROM EP GROUP USED PHASIX AND PHASIX ST MESH. A TOTAL OF 10 PATIENTS WERE TREATED WITH PHASIX AND PHASIX ST MESH, THE REMAINING WERE TREATED WITH OTHER MANUFACTURERS DEVICES. POST OP COMPLICATIONS FOR IP GROUP INCLUDE SEROMA (2), HEMATOMA (9), WALL INFECTION (10), BULGING (27), INTESTINAL OBSTRUCTION (3), SMALL BOWEL PERFORATION (2) AND EP GROUP INCLUDE SEROMA (6), HEMATOMA (6), WALL INFECTION (12), AND BULGING (7). THE PATIENT IN EP GROUP WITH CONSEQUENTLY A HIGHER RATE OF REVISION SURGERY AND THERE WERE TWO PATIENTS FROM IP GROUP. THE FIRST PATIENT REQUIRED SURGICAL REVISION WITH A SIMPLE SUTURE OF TWO PERFORATIONS AND THE SECOND PATIENT REQUIRED A TWO-STAGE SURGERY BECAUSE OF SEPTIC SHOCK WITH RESECTION AND ANASTOMOSIS OF THE SMALL INTESTINE AND A 48-H STAY IN THE INTENSIVE CARE UNIT. INFORMATION IS PRESENTED WITHOUT PATIENT/CASE SPECIFIC DETAILS. IT IS NOT KNOWN IF ANY OF THE PATIENTS TREATED WITH PHASIX AND PHASIX ST MESH EXPERIENCED A POST-OP COMPLICATION. THE ARTICLE CONCLUDES THAT THE COMPARISON OF ACUTE BOWEL OBSTRUCTION AFTER PRIMARY UMBILICAL OR PERIUMBILICAL HERNIA REPAIR ACCORDING TO THE POSITION OF THE MESH AND ALL CASES OF OBSTRUCTION HAPPENED IN THE INTRAPERITONEAL MESH GROUP. 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 TO THE HEALTH AUTHORITY. THIS FILE REPRESENTS THE PHASIX MESH.

Additional Manufacturer Narrative

BASED ON THE INFORMATION AVAILABLE, NO CONCLUSIONS CAN BE MADE. THE INFORMATION OBTAINED IS LIMITED TO THE ARTICLE, PER FOLLOW UP WITH CO-AUTHOR PATIENT/CASE SPECIFIC DETAILS ARE NOT AVAILABLE. IT IS NOT KNOWN IF ANY OF THE PATIENTS TREATED WITH PHASIX AND PHASIX ST MESH EXPERIENCED A POST-OP COMPLICATION. THERE IS NO DISCUSSION WITHIN THE ARTICLE, OR INDICATION OF THE IMPLANT BEING DIRECTLY OR INDIRECTLY RELATED TO ANY REPORTED PATIENT OUTCOME. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (01-MAR-2008) 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.