PHASIX MESH

Description of Event or Problem

PER JOURNAL ARTICLE: HYBRID LAPAROSCOPIC REPAIR OF COMPLEX ABDOMINAL WALL HERNIAS WITH TRANSABDOMINAL PARTIALLY EXTRAPERITONEAL MESH FIXATION: PRELIMINARY RESULTS. THIS RETROSPECTIVE CASE¿CONTROL STUDY WAS CONDUCTED INCLUDING 40 PATIENTS WHO UNDERWENT HYBRID LAPAROSCOPIC HERNIA REPAIR (HLHR) WITH TRANSABDOMINAL PARTIALLY EXTRAPERITONEAL (TAPE) MESH FIXATION BETWEEN 2017 AND 2023 WERE ANALYZED. OF THE 40 PATIENTS, THREE WERE LOST TO FOLLOW-UP AND THEREFORE EXCLUDED FROM THE STUDY. OF THE REMAINING 37 PATIENTS (16 MALE AND 21 FEMALE) 34 PATIENTS HAD INCISIONAL HERNIA OF WHICH 17 (50%) WERE REFERRED FOR RECURRENT VENTRAL/INCISIONAL HERNIA. A TOTAL OF 43 MESHES WERE USED ACROSS THE SITES, WITH FOUR PATIENTS RECEIVING TWO PROSTHESES AND PATIENT RECEIVING THREE. VENTRALIGHT ST (8) 18.6% OF CASES; VENTRALEX ST (3) 7%; SEPRAMESH (3) 7% OF CASES; PHASIX (2) 4.6%. THERE WERE EIGHT (21.6%) MINOR POSTOPERATIVE COMPLICATIONS, INCLUDING SUPERFICIAL SITE INFECTIONS (SSI) IN TWO CASES (5.4%) REQUIRING ORAL ANTIBIOTICS, ONE WOUND DEHISCENCE (2.7%) NECESSITATING INSERTION OF A VACUUM ASSISTED CLOSURE (VAC) DRESSING, ONE SUPERFICIAL THROMBOPHLEBITIS (2.7%) FROM A CANULA SITE, A CHRONIC SUBCUTANEOUS HEMATOMA (2.7%) REQUIRING DRAINAGE ON A PATIENT ON APIXABAN, AND THREE CHRONIC SEROMA (8.1%) FORMATIONS INCLUDING ONE CAPSULE EXCISION AT 8 MONTHS POSTOPERATIVELY. ONE PATIENT WHO HAD A RECURRENT INCISIONAL HERNIA THAT OCCURRED AT THE 23-MONTH FOLLOW-UP (OVERALL RECURRENCE RATE OF 2.7%). THIS STUDY DEMONSTRATES THAT THE HYBRID APPROACH FOR COMPLEX MEDIUM- TO LARGE-SIZED ABDOMINAL WALL HERNIAS IS A VIABLE ALTERNATIVE TO TRADITIONAL OPEN AND LAPAROSCOPIC TECHNIQUES, OFFERING THE COMBINED BENEFITS OF BOTH WITHOUT INCREASING RISK. 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.

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 MEDICAL/SURGICAL INTERVENTION. 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. THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE IDENTIFIES SEROMA, HEMATOMA, WOUND DEHISCENCE, INFECTION AND HERNIA RECURRENCE AS POSSIBLE COMPLICATIONS. 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 REPORT DOCUMENTS INFORMATION RELATED TO THE PHASIX MESH. ADDITIONAL MDRS HAVE BEEN SUBMITTED TO DOCUMENT INFORMATION RELATED TO THE VENTRALEX ST MESH, VENTRALIGHT ST MESH AND SEPRAMESH IP. 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.