PHASIX MESH

Description of Event or Problem

PER JOURNAL ARTICLE: "THREE YEAR FOLLOW UP OF THE GRIP CONCEPT: AN OPEN, PROSPECTIVE, OBSERVATIONAL REGISTRY STUDY ON BIOMECHANICALLY CALCULATED ABDOMINAL WALL REPAIR FOR COMPLEX INCISIONAL HERNIAS." THE ARTICLE DESCRIBES A RETROSPECTIVE STUDY AIMED TO INVESTIGATE THE EFFECTIVENESS OF BIOMECHANICALLY CALCULATED ABDOMINAL WALL RECONSTRUCTIONS FOR INCISIONAL HERNIAS OF VARYING COMPLEXITY IN AN OPEN, PROSPECTIVE OBSERVATIONAL REGISTRY TRIAL. THE STUDY CONDUCTED WITH 198 PATIENTS WITH COMPLEX INCISIONAL HERNIA FROM JULY 1ST, 2017, TO DECEMBER 31ST, 2020. 7 DECEASED PATIENTS WERE EXCLUDED FROM THE ANALYSIS AND REMAINING 190 PATIENTS (95 MEN AND 95 WOMEN) WERE EVALUATED FOR COMPLEXITY OF INCISIONAL HERNIA. 18 PATIENTS NO LONGER UNDERWENT A COMPLEX INCISIONAL HERNIA REPAIR. IN THE REMAINING 172 PATIENTS, 44 PERCENTAGE OF CASES HAD A SECOND MESH PLACED IN THE INTRAPERITONEAL UNDERLAY REPAIR USUALLY WITH A BIOSYNTHETIC PHASIX MESH. THE NUMBER OF USES OF PHASIX IS NOT SPECIFIED AND NO EVENTS DIRECTLY ATTRIBUTED TO PHASIX. THE POST OPERATIVE COMPLICATION INCLUDES SINGLE CASE HERNIA RECURRENCE OCCURRED IN A FEMALE LIVER TRANSPLANT RECIPIENT UNDER CONTINUOUS IMMUNOSUPPRESSION. SOME PATIENTS EXPERIENCED PAIN AT DISCHARGE AND AFTER THE 1ST MONTH. AT THE 3 YEAR FOLLOW UP, ONLY ONE PATIENT OCCASIONALLY TOOK AN ANALGESIC, WHILE 189 PATIENTS DID NOT TAKE ANY. INFORMATION IS PRESENTED WITHOUT PATIENT/CASE SPECIFIC DETAILS. THE ARTICLE CONCLUDES THAT THE FINDINGS OF THIS STUDY SUGGEST THAT THE BIOMECHANICAL STABILITY, DEFINED AS THE RESISTANCE TO CYCLIC LOAD, IS CRUCIAL IN PREVENTING POSTOPERATIVE COMPLICATIONS, INCLUDING RECURRENCES AND CHRONIC PAIN. IN FOLLOW UP WITH A CO AUTHOR IT WAS STATED THAT "THERE WERE NO PHASIX MESH RELATED POSTOPERATIVE COMPLICATIONS." NOTE: THERE IS NO INFORMATION PROVIDED IN THE ARTICLE INDICATING THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE POSTOPERATIVE PATIENT COMPLICATIONS. HOWEVER, AS POSTOPERATIVE COMPLICATIONS DID PRESENT AND MAY REQUIRE MEDICAL/SURGICAL INTERVENTION WE ARE REPORTING THIS AS A SERIOUS INJURY MDR.

Additional Manufacturer Narrative

THERE IS NO DISCUSSION WITHIN THE ARTICLE, OR INDICATION OF THE PHASIX MESH BEING DIRECTLY OR INDIRECTLY RELATED TO ANY REPORTED PATIENT OUTCOME AND PER INFORMATION PROVIDED IN FOLLOW UP WITH A CO-AUTHOR "THERE WERE NO PHASIX MESH RELATED POSTOPERATIVE COMPLICATIONS." NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. PAIN AND HERNIA RECURRENCE ARE LISTED IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE AS POSSIBLE COMPLICATIONS. NOTE, THE DATE OF EVENT (01-JUL-2017) IS CONSIDERED TO BE A BEST ESTIMATE. 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.