PHASIX MESH

Description of Event or Problem

PER JOURNAL ARTICLE: INGUINAL HERNIA REPAIR USING ABSORBABLE BIOSYNTHETIC MESH VERSUS PERMANENT POLYPROPYLENE MESH: A PRELIMINARY COMPARATIVE STUDY OF 1-YEAR OUTCOMES RETROSPECTIVE ANALYSIS OF PATIENTS UNDERGOING ELECTIVE UNILATERAL INGUINAL HERNIA OPERATIONS WITH ABSORBABLE BIOSYNTHETIC (PHASIX MESH AND PHASIX ST MESH AS PHASIX ) AND PERMANENT SYNTHETIC (BARD SOFT MESH AND VENTRALIGHT ST MESH AS ¿PP¿) HERNIA REPAIR RECORDED FROM 5TH JANUARY 2009 TO 6TH JANUARY 2022. AMONG 1,185,067 PATIENTS FROM 954 CENTERS, 8,286 PATIENTS FIT THE INCLUSION CRITERIA, 75 PATIENTS WITH ABSORBABLE MESH ¿ PHASIX GROUP, AND 8,211 PATIENTS WITH SYNTHETIC MESH ¿ PP GROUP. PATIENTS UNDERWENT STANDARD OPEN TENSION-FREE HERNIOPLASTY WAS PERFORMED, WITH MESH PLACEMENT ACCORDING TO GROUP ALLOCATION AND ROUTINE POSTOPERATIVE CARE. AT 1-YEAR FOLLOW-UP, THERE WERE NO RECURRENCES REPORTED FOR EITHER GROUP. THERE WERE NO SIGNIFICANT DIFFERENCES IN 1-YEAR OUTCOMES INCLUDING PAIN (ON EXERTION, AT REST, AND REQUIRING TREATMENT) BETWEEN PHASIX AND PP GROUPS. POST OPERATIVE COMPLICATIONS: ON 1-YEAR FOLLOW-UP IN PHASIX GROUP: PAIN ON EXERTION: (N=8), PAIN AT REST: (N=4), PAIN REQUIRING TREATMENT: (N=2), SEROMA: (N=3), INFECTION: (N=1). IN PP GROUP: COMPLICATION-RELATED REOPERATION: (N=1), PAIN ON EXERTION: (N=5), PAIN AT REST:(N=2), PAIN REQUIRING TREATMENT: (N=1). CONCLUSION: COMPLICATIONS AND 1-YEAR OUTCOMES FOLLOWING INGUINAL HERNIA REPAIR ARE NOT STATISTICALLY DIFFERENT BETWEEN ABSORBABLE BIOSYNTHETIC AND PERMANENT SYNTHETIC MESH. 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. THIS REPORT REPRESENTS THE PHASIX MESH.

Additional Manufacturer Narrative

BASED ON THE ARTICLE, NO CONCLUSIONS CAN BE DRAWN. THE INFORMATION OBTAINED IS LIMITED TO THE CONTENT OF THE ARTICLE. IT NOTES THAT SOME PATIENTS TREATED WITH THE PHASIX MESH EXPERIENCE SEROMA, PAIN AND INFECTION. 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, PAIN, AND INFECTION AS POSSIBLE COMPLICATIONS. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. THIS REPORT DOCUMENTS INFORMATION RELATED TO THE PHASIX MESH. ADDITIONAL MDRS HAVE BEEN SUBMITTED TO DOCUMENT INFORMATION RELATED TO SOFT MESH, PHASIX ST MESH AND VENTRALIGHT 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.