PHASIX MESH

Additional Manufacturer Narrative

BASED ON THE INFORMATION AVAILABLE, NO CONCLUSIONS CAN BE MADE. THE INFORMATION PROVIDED IN THE ARTICLE INDICATES THAT SOME PATIENTS EXPERIENCED MINOR COMPLICATIONS, AND SOME UNDERWENT SURGICAL REVISION. 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, HERNIA RECURRENCE AND HEMATOMA 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-FEB-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: "LONG-TERM OUTCOME OF PROPHYLACTIC BIOSYNTHETIC MESH REINFORCEMENT AT THE TIME OF LOOP ILEOSTOMY REVERSAL FOR COLORECTAL CANCER¿ RESULTS OF A CASE-MATCHED STUDY". THE ARTICLE DESCRIBES THE OUTCOMES OF CONSECUTIVE PATIENTS UNDERGOING ILEOSTOMY CLOSURE WITH PROPHYLACTIC BIOSYNTHETIC MESH REINFORCEMENT FOR COLORECTAL CANCER, PERFORMED BY THE PARTICIPATING MEMBERS OF THE CLUB HERNIA BETWEEN FEBRUARY 2016 AND FEBRUARY 2020. A TOTAL OF 100 PATIENTS UNDERWENT ILEOSTOMY REVERSAL: 50 WITH BIOSYNTHETIC MESH AUGMENTATION USING PHASIX MESH (MESH GROUP) AND 50 WITH STANDARD FASCIAL CLOSURE WITHOUT MESH (CONTROL GROUP). FIVE (10%) PATIENTS EXPERIENCED AT LEAST ONE OR MORE POSTOPERATIVE COMPLICATIONS IN THE MESH GROUP. ONE (2%) PATIENT EXPERIENCED A POSTOPERATIVE ILEUS. AN SSI OCCURRED IN 2 (4%) PATIENTS: ONE WAS MANAGED CONSERVATIVELY AND THE OTHER REQUIRED SURGICAL REINTERVENTION AT POSTOPERATIVE DAY 7 FOR DRAINAGE AND NEGATIVE PRESSURE WOUND THERAPY. THE OTHER 3 SSOS CONSISTED OF 3 HEMATOMAS WITHOUT NEED OF ANY PROCEDURAL INTERVENTION. THUS, THERE WAS ONLY ONE SSOPI (2%) IN TOTAL. 4 (8%) PATIENTS DEVELOPED AN INCISIONAL HERNIA AT THE FORMER STOMA SITE AFTER A PERIOD OF 21 ± 26 MONTHS. ALL WERE CLINICALLY DETECTABLE AND 2 REQUIRED REOPERATION. THERE WAS NO NEED FOR MESH EXPLANTATION. THE ARTICLE CONCLUDED THAT PROPHYLACTIC USE OF A SLOWLY ABSORBABLE BIOSYNTHETIC MESH AT THE TIME OF ILEOSTOMY REVERSAL FOR COLORECTAL CANCER WAS SAFE AND EFFECTIVE IN REDUCING THE RATE OF SSIH WITHOUT INCREASING SURGICAL SITE INFECTION. 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.