PHASIX MESH

Additional Manufacturer Narrative

BASED ON THE INFORMATION AVAILABLE, NO CONCLUSIONS CAN BE MADE. THE INFORMATION PROVIDED IN THE ARTICLE INDICATES THAT THE PATIENTS EXPERIENCED HERNIA RECURRENCE. 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 THAT 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. HERNIA RECURRENCE IS LISTED IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE AS A POSSIBLE COMPLICATION. NOTE, THE DATE OF EVENT (01-JAN-2015) 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 "MODIFIABLE COMORBIDITIES IMPACT ON VENTRAL HERNIA RECURRENCE FOLLOWING ROBOTIC ABDOMINAL WALL RECONSTRUCTION USING RESORBABLE BIOSYNTHETIC MESH: 36-MONTH FOLLOW-UP." THE STUDY EVALUATED THE IMPACT OF MODIFIABLE COMORBIDITIES (MCMS) ON 36-MONTH HERNIA RECURRENCE RATES AFTER ROBOTIC TRANSVERSUS ABDOMINIS RELEASE (TAR) WITH RESORBABLE BIOSYNTHETIC MESH UNDERLAY FOR PRIMARY VENTRAL HERNIA REPAIR. THIS STUDY INCLUDED 175 PATIENTS THAT MET THE INCLUSION CRITERIA AND ALL PATIENTS UNDERWENT ROBOTIC TAR WITH P4HB RESORBABLE BIOSYNTHETIC MESH WERE IDENTIFIED BETWEEN JANUARY 2015 AND MAY 2022. POST-OPERATIVE OUTCOMES REPORTED INCLUDED: HERNIA RECURRENCE AT 36-MONTH FOLLOW UP BY MCM (MODIFIABLE COMORBIDITIES) - 17 (9.7 %) EXPERIENCED HERNIA RECURRENCE DURING THE 36-MONTH FOLLOW-UP. THIS INCLUDED 1 PATIENT IN THE NO MCM GROUP (2.7 %) 4 ± 21 WEEKS, 10 PATIENTS IN THE 1 MCM GROUP (12 %) 11 ± 39 WEEKS, AND 6 PATIENTS IN THE 2+ MCM GROUP (11 %) 10 ± 36 WEEKS. HERNIA RECURRENCE AT 36-MONTH FOLLOW UP BY OBESITY CLASS IN 6.2 % (N = 1) OF PATIENTS IN THE HEALTHY BMI GROUP, 5.3 % (N = 2) OF PATIENTS IN THE OVERWEIGHT BMI GROUP, 11 % (N = 10) OF PATIENTS IN THE OBESE BMI GROUP AND 12 % (N = 4) OF PATIENTS IN THE MORBIDLY OBESE BMI GROUP. THE ARTICLE CONCLUDED THAT THAT THE ROBOTIC TAR METHOD WITH P4HB MESH UNDERLAY IS ASSOCIATED WITH REMARKABLY LOW RECURRENCE RATES AT 36 MONTHS IRRESPECTIVE OF THE DIFFERENT MCMS AND BMI CLASSES. NO SIGNIFICANT DIFFERENCE IN THE RECURRENCE RATE AND LENGTH OF TIME BETWEEN SURGERY AND RECURRENCE WAS OBSERVED BETWEEN THE GROUPS. NO GROUP, SINGLE COMORBIDITY, OR A COMBINATION OF COMORBIDITIES WAS FOUND TO HAVE SIGNIFICANTLY INCREASED ODDS OF RECURRENCE AT 36 MONTHS. 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.