PHASIX MESH

Additional Manufacturer Narrative

THE INFORMATION PROVIDED IN THE ARTICLE INDICATES THAT SOME PATIENTS EXPERIENCED ADVERSE COMPLICATIONS, AND SOME UNDERWENT SURGICAL REVISION. 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 BD/BARD MESH. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (01-JAN-2012) IS CONSIDERED TO BE A BEST ESTIMATE. THIS MDR REPRESENTS THE PHASIX MESH. ADDITIONAL MDR'S WERE SUBMITTED TO REPRESENT THE PHASIX ST MESH, FLAT MESH, SOFT MESH, VENTRALEX MESH, VENTRALEX ST MESH, VENTRALIGHT ST MESH, VENTRIO MESH, VENTRIO 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.

Description of Event or Problem

PER JOURNAL ARTICLE: "EARLY WOUND MORBIDITY AND CLINICAL OUTCOMES ASSOCIATED WITH P4HB MESH COMPARED TO PERMANENT SYNTHETIC MESH IN UMBILICAL AND SMALL TO MEDIUM, ROUTINE VENTRAL HERNIA REPAIRS". THE ARTICLE DESCRIBES THE RETROSPECTIVE ANALYSIS WHICH WAS COMPLETED UTILIZING DATA COLLECTED PROSPECTIVELY THROUGH THE ABDOMINAL CORE HEALTH QUALITY COLLABORATIVE (ACHQC) DATABASE). THE ACHQC DATABASE WAS QUERIED FOR PATIENTS UNDERGOING UMBILICAL OR SMALL TO MEDIUM, ROUTINE VENTRAL HERNIAS BETWEEN JANUARY 2012 AND SEPTEMBER 2022. THE STUDY GROUP WAS COMPRISED OF P4HB MESHES IMPLANTED IN 357 PATIENTS (PHASIX MESH OR PHASIX ST MESH); THE COMPARATOR GROUP WAS AN AGGREGATE OF PP MESHES IMPLANTED IN 357 PATIENTS (BARD MESH, BARD SOFT MESH, VENTRALEX HERNIA PATCH, VENTRALEX ST HERNIA PATCH, VENTRALIGHT ST MESH, VENTRIO HERNIA PATCH, AND VENTRIO ST HERNIA PATCH) USED IN BOTH UMBILICAL AND SMALL TO MEDIUM, ROUTINE VENTRAL HERNIAS. POST OPERATIVE COMPLICATIONS FOR P4HB MESHES INCLUDES SEROMA (11), WOUND SEROUS DRAINAGE (3), HEMATOMA (3), GASTROINTESTINAL COMPLICATION (4). POST OPERATIVE COMPLICATIONS FOR PP MESHES INCLUDES SEROMA (10), WOUND SEROUS DRAINAGE (6), HEMATOMA (3), GASTROINTESTINAL COMPLICATION (2). SMALL NUMBER OF PATIENTS EXPERIENCED WOUND CELLULITIS (3), FASCIAL DISRUPTION (1), NON-HEALING INCISIONAL WOUND (1), SEPSIS (1) AND PAIN (5) REQUIRING PROCEDURAL/MEDICAL INTERVENTIONS. INFORMATION IS PRESENTED WITHOUT PATIENT/CASE SPECIFIC DETAILS. CONCLUSION: SHORT-TERM CLINICAL OUTCOMES ASSOCIATED WITH RESORBABLE P4HB MESH ARE COMPARABLE TO PERMANENT SYNTHETIC PP MESH IN UMBILICAL AND SMALL TO MEDIUM, ROUTINE VENTRAL HERNIA REPAIRS, DESPITE SIGNIFICANT DIFFERENCES IN OPERATIVE TIME AND LENGTH OF STAY. LONGER-TERM FOLLOW-UP IS NEEDED TO EXPAND ON THE CLINICAL RELEVANCE OF THESE SHORT-TERM FINDINGS. 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. THIS FILE REPRESENTS THE PHASIX FLAT.