PHASIX MESH

Additional Manufacturer Narrative

BASED ON THE INFORMATION AVAILABLE, NO CONCLUSIONS CAN BE MADE. THE INFORMATION PROVIDED IN THE ARTICLE INDICATES THAT THE PATIENT EXPERIENCED AN INFECTED SEROMA AND UNDERWENT DRAINAGE AND TREATMENT WITH ANTIBIOTICS. THE INFORMATION OBTAINED IS LIMITED TO THE CONTENT OF THE ARTICLE. THE ARTICLE DOES NOT REPORT THAT ANY SPECIFIC DEVICE MALFUNCTION OR ALLEGED 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. INFECTION AND SEROMA ARE LISTED 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". NOTE, THE DATE OF EVENT (01-DEC-2016) 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.

Description of Event or Problem

PER JOURNAL ARTICLE: "MANAGING A LARGE INCISIONAL HERNIA IN AN OBESE AND IMMUNOSUPPRESSED PATIENT: A CASE REPORT" THE ARTICLE DESCRIBES THE CASE REPORT OF A 38-YEAR-OLD OBESE FEMALE (BMI = 45) WITH KIDNEY FAILURE UNDERWENT A KIDNEY TRANSPLANTATION IN EARLY MARCH 2016. IN DECEMBER 2016, A LAPAROTOMY WAS PERFORMED THROUGH THE PREVIOUS KIDNEY TRANSPLANTATION INCISION TO REPAIR THE LEFT INGUINAL HERNIA (LIH). DUE TO THE ABSENCE OF FASCIA IN THE ABDOMINAL WALL, TRADITIONAL RECONSTRUCTIVE TECHNIQUES, SUCH AS CST, WERE NOT FEASIBLE. INSTEAD, A BIOLOGICAL MESH OF 20 × 25 CM (STRATTICE¿) WAS CHOSEN FOR BRIDGING THE FASCIA. THE MESH WAS PLACED INTRAPERITONEALLY, DIRECTLY COVERING THE LARGE DEFECT IN THE ABDOMINAL WALL. THE WELL-VASCULARIZED HERNIA SAC WAS PRESERVED AND SEWN TO THE ANTERIOR SURFACE OF THE ABDOMINAL WALL OVER THE BIOLOGICAL MESH (STRATTICE¿) PROVIDING NATURAL REINFORCEMENT AND ENSURING COMPLETE COVERAGE. A JACKSON-PRATT DRAIN WAS PLACED BETWEEN THE HERNIA SAC AND THE STRATTICE¿ MESH TO PREVENT FLUID COLLECTION. AN ABSORBABLE MESH (PHASIX MESH) WAS ADDED AS A SECONDARY LAYER TO FURTHER STRENGTHEN THE RECONSTRUCTION. IT OFFERS TEMPORARY MECHANICAL SUPPORT AND PROMOTES COLLAGEN FORMATION AS IT DEGRADES. THE MESH WAS SUTURED AT THE EDGES TO THE ABDOMINAL WALL AND SECURED CENTRALLY WITH TISSUCOL (FIBRIN GLUE), MINIMIZING TISSUE TENSION AND PROMOTING UNIFORM ATTACHMENT. WHITE SPONGES WERE PLACED TO REDUCE INFECTION RISK AND FACILITATE POSTOPERATIVE NEGATIVE PRESSURE WOUND THERAPY (NPWT). WITHIN THREE WEEKS, THE PATIENT DEVELOPED A WOUND INFECTION. SEROMA FORMED BETWEEN THE BIOLOGICAL MESH AND HERNIA SAC, WHICH BECAME INFECTED. DRAINAGE AND ANTIBIOTICS WERE USED. BY TWO MONTHS THE SEROMA HAD LARGELY RESOLVED, AND SKIN EDGES WERE HEALING (WITH CONTINUED DRAINAGE). THE WOUND CLOSED AFTER SEVEN MONTHS, WITH NO RECURRENCE OBSERVED DURING FOLLOW-UP. THE ARTICLE CONCLUDED THAT THE USE OF A MULTILAYER RECONSTRUCTION APPROACH THAT COMBINES A BIOLOGIC MESH AND THE REUSE OF THE HERNIA SAC, OFFERING A VIABLE OPTION FOR MANAGING COMPLEX HERNIAS IN HIGH-RISK, IMMUNOSUPPRESSED PATIENTS. THIS TECHNIQUE MINIMIZES INFECTION RISK AND PROVIDES STABLE LONG-TERM OUTCOMES, EVEN IN CHALLENGING CLINICAL SETTINGS. 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.