PHASIX MESH

Description of Event or Problem

PER JOURNAL ARTICLE: "BIO-RESORBABLE POLY-4-HYDROXYBUTYRATE (P4HB) MESH FOR ABDOMINAL WALL RECONSTRUCTION IS EFFECTIVE IN HIGH-RISK PATIENTS AND CONTAMINATED ABDOMEN" THE ARTICLE PRESENTS A RETROSPECTIVE REVIEW OF 48 PATIENTS (FEMALE = 34, MALE = 14) WHO UNDERWENT ABDOMINAL WALL RECONSTRUCTION USING P4HB MESH BETWEEN JUNE 2016 AND OCTOBER 2019. TWO TYPES OF P4HB MESHES WERE USED: PHASIX (N = 3) IN ELECTIVE GROUP AND PHASIX ST (N = 45) (33 IN EMERGENCY AND 12 IN ELECTIVE GROUP). MOST MESHES (71%) WERE PLACED IN AN UNDERLAY POSITION. OVERALL, THE STUDY REPORTED SURGICAL SITE OCCURRENCES (SSOS) (N = 22), WITH COMPARABLE RATES BETWEEN THE EMERGENCY GROUP (N = 14) AND THE ELECTIVE GROUP (N = 8). DEEP SURGICAL-SITE INFECTIONS WERE AMONG THE MOST COMMON COMPLICATIONS, OCCURRING IN 13 PATIENTS (N = 13), WITH SIMILAR DISTRIBUTIONS IN BOTH EMERGENCY (N = 9) AND ELECTIVE (N = 4) SUBGROUPS. ADDITIONAL WOUND-RELATED COMPLICATIONS INCLUDED ENTERIC LEAKS (N = 4)¿THREE IN EMERGENCY CASES AND ONE IN AN ELECTIVE CASE¿AS WELL AS SEROMAS (N = 3), WHICH OCCURRED EXCLUSIVELY IN THE EMERGENCY COHORT. LESS FREQUENTLY OBSERVED COMPLICATIONS INCLUDED HEMATOMA (N = 1) AND SKIN NECROSIS (N = 1), BOTH IDENTIFIED IN ELECTIVE PATIENTS. LONG TERM FOLLOWS UP REVEALED HERNIA RECURRENCE IN 8 OF 47 PATIENTS (N = 8). AMONG THE EMERGENCY GROUP RECURRENCE CASES, PATIENTS HAD UNDERLAY PHASIX ST WITHOUT MFR (N = 5), NPWT USE (N = 2), AND CONCOMITANT BOWEL RESECTION (N = 4). IN THE ELECTIVE GROUP, RECURRENCE OCCURRED IN PATIENTS TREATED WITH BRIDGE REPAIR USING PHASIX ST WITH MFR (N = 1), UNDERLAY PHASIX ST WITHOUT MFR (N = 3), AND UNDERLAY WITH MFR (N = 1). ADDITIONAL ASSOCIATED PROCEDURES IN THESE ELECTIVE RECURRENCE CASES INCLUDED SKIN GRAFT REMOVAL (N = 1), ENTERIC FISTULA TAKEDOWN WITH MESH EXPLANTATION (N = 1), AND EXPLORATORY LAPAROTOMY WITH ADHESIOLYSIS (N = 1). OVERALL, THE AUTHORS CONCLUDED THAT P4HB MESH IS WELL TOLERATED AND PROVIDES DURABLE ABDOMINAL WALL RECONSTRUCTION WITH ACCEPTABLE HERNIA RECURRENCE RATES FOLLOWING BOTH EMERGENCY AND ELECTIVE ABDOMINAL CLOSURE. THESE FINDINGS SUPPORT P4HB MESH AS A RELIABLE AND SENSIBLE OPTION FOR ABDOMINAL WALL RECONSTRUCTION IN PATIENTS WITH HIGH-RISK COMORBIDITIES AND CONTAMINATED SURGICAL FIELDS. 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.

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 POSTOPERATIVE COMPLICATIONS. THE INFORMATION OBTAINED IS LIMITED TO THE CONTENT OF THE ARTICLE. THE ARTICLE DOES NOT REPORT 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 HERNIA RECURRENCE ARE CLINICALLY UNDERSTOOD POTENTIAL COMPLICATIONS OF SURGERY/USE OF THE DEVICE AND ARE IDENTIFIED IN THE INSTRUCTIONS-FOR-USE PROVIDED WITH THE DEVICE, AS POSSIBLE COMPLICATIONS. REGARDING INFECTION, THE WARNINGS SECTION OF THE IFU 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 THE REMOVAL OF THE MESH" NOTE, THE DATE OF EVENT ((B)(6) 2016) 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.