PHASIX MESH

Description of Event or Problem

PER JOURNAL ARTICLE ¿ROBOTIC TRANSVERSUS ABDOMINIS RELEASE (TAR) FOR VENTRAL HERNIA REPAIRS IS ASSOCIATED WITH LOW SURGICAL SITE OCCURRENCE RATES AND LENGTH OF STAY DESPITE INCREASING MODIFIABLE COMORBIDITIES¿ THE ARTICLE AIMS TO ASSESS THE SHORT-TERM POSTOPERATIVE OUTCOMES IN PATIENTS WHO UNDERWENT HERNIA REPAIR USING THE ROBOTIC TRANSVERSUS ABDOMINIS RELEASE (TAR) METHOD WITH P4HB RESORBABLE BIOSYNTHETIC MESH RETRO MUSCULAR SUBLAY. THE STUDY INCLUDED 334 PATIENTS THAT MET THE INCLUSION CRITERIA AND UNDERWENT THE ROBOTIC PROCEDURE BETWEEN JANUARY 2015 AND MAY 2022. ALL PATIENTS UNDERWENT ROBOTIC TAR WITH P4HB RESORBABLE BIOSYNTHETIC MESH. POST-OPERATIVE OUTCOMES REPORTED INCLUDED: 15 PATIENTS (4.4%) EXPERIENCED A SUPERFICIAL SSO WITHIN THE FIRST 60 DAYS FOLLOWING SURGERY AND 10 OF THE 15 (66.7%) WERE SUPERFICIAL ABSCESSES, 1 (6.6%) WAS CELLULITIS AROUND THE WOUND, AND 4 (26.6%) WERE THE FORMATION OF A SEROMA. THE ARTICLE CONCLUDED THAT ROBOTIC TAR TECHNIQUE WITH P4HB MESH REPRESENTS A SIGNIFICANT ADVANCEMENT IN VENTRAL HERNIA REPAIR, THE PRESENCE OF MULTIPLE MCMS (MODIFIABLE COMORBIDITIES), PARTICULARLY DIABETES PLUS OBESITY, REMAINS A RISK FACTOR FOR INCREASED SSOS (SURGICAL SITE OCCURRENCES). HOWEVER, THE PRESENCE OF ANY NUMBER OF MCMS WAS NOT ASSOCIATED WITH INCREASED ODDS OF PROLONGED LOS. 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 INFORMATION AVAILABLE, NO CONCLUSIONS CAN BE MADE. THE INFORMATION PROVIDED IN THE ARTICLE INDICATES THAT SOME OF THE PATIENTS EXPERIENCED POST OPERATIVE COMPLICATIONS. THE INFORMATION OBTAINED IS LIMITED TO THE ARTICLE. THERE IS NO DISCUSSION WITHIN THE ARTICLE, OR INDICATION OF THE IMPLANT BEING DIRECTLY OR INDIRECTLY RELATED TO ANY REPORTED PATIENT OUTCOME. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. SEROMA FORMATION IS A CLINICALLY UNDERSTOOD POTENTIAL COMPLICATION OF SURGERY/USE OF THE DEVICE AND IS IDENTIFIED IN THE INSTRUCTIONS-FOR-USE PROVIDED 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.