PHASIX MESH

Additional Manufacturer Narrative

BASED ON THE INFORMATION AVAILABLE, NO CONCLUSIONS CAN BE MADE. 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. WOUND DEHISCENCE, HEMATOMA AND EXTRUSION ARE LISTED IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE AS POSSIBLE COMPLICATIONS. NOTE, THE DATE OF EVENT (23-JUN-2023) 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: "PERINEAL HERNIA AS A SEQUELA OF ANAL RECONSTRUCTION SURGERIES IN PERIANAL CROHN¿S DISEASE." THE ARTICLE DESCRIBES A CASE REPORT OF 53-YEAR-OLD MAN WITH A HISTORY OF PERIANAL CROHN¿S DISEASE (PCD) AND MULTIPLE PERIANAL SURGERIES. THREE MONTHS POST OPEN PRIMARY HERNIA REPAIR PATIENT DIAGNOSED WITH RECURRENT LEFT PERINEAL HERNIA THEREBY UNDERWENT SECONDARY HERNIA REPAIR WITH IMPLANT OF PHASIX MESH. THE PATIENT RECOVERED WITHOUT EVENT ASIDE FROM A SUPERFICIAL HEMATOMA WITHIN THE LEFT LEG. A WEEK LATER PATIENT EXPERIENCED SKIN DEHISCENCE AND MESH EXTRUSION WITH AN EXPOSED FLAP THEREBY UNDERWENT EXAMINATION UNDER ANESTHESIA WITH DEBRIDEMENT OF THE VIABLE FLAP, EVACUATION OF SUPERFICIAL HEMATOMA, AND REAPPROXIMATION OF THE SKIN OVER THE GRACILIS MUSCLE. IN CONCLUSION, PERINEAL HERNIA IS A RARE COMPLICATION OF PELVIC SURGERIES. IT CAN OCCUR IN PATIENTS WITH SYMPTOMATIC PCD AS A LONG-TERM OUTCOME OF SURGICAL TREATMENT OF COMPLEX FISTULAS. MRI CAN DIAGNOSE PERINEAL HERNIAS AND ASSESS FOR OTHER COMPLICATIONS OF PCD. THERE IS CURRENTLY NO PREFERRED SURGICAL TREATMENT ALTHOUGH COMBINED MESH AND FLAP CLOSURE IS A PROMISING METHOD THAT COULD DECREASE RECURRENCE RATES. THIS CASE REPORT HIGHLIGHTS ONE OF THE MANY REASONS WHY THE SURGICAL MANAGEMENT OF PCD AND ITS COMPLICATIONS ARE CHALLENGING. 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.