PHASIX MESH

Additional Manufacturer Narrative

AS REPORTED, THE PATIENT EXPERIENCED PAIN AND INFLAMMATION TWO YEARS POST IMPLANT OF PHASIX MESH. PER THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE, "ABSORPTION OF THE MESH MATERIAL WILL BE ESSENTIALLY COMPLETE WITHIN 12 TO 18 MONTHS." BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE ISSUES EXPERIENCED BY THE PATIENT TWO YEARS POST IMPLANT. THE SURGEON IS CONTINUING TO MONITOR THE PATIENT, SHOULD ADDITIONAL INFORMATION BE PROVIDED A SEMDR WILL BE SUBMITTED. A LOT NUMBER WAS NOT PROVIDED, AS SUCH A REVIEW OF THE MANUFACTURING RECORDS CANNOT BE CONDUCTED. NOTE, THE EVENT DATE (21-JUL-2025) IS CONSIDERED TO BE A BEST ESTIMATE BASED ON THE DATE OF AWARENESS. 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

AS REPORTED, THE PATIENT WAS IMPLANTED WITH PHASIX MESH TWO YEARS AGO AS AN ONLAY DURING A DIASTASIS RECTI REPAIR. THE PATIENT RECENTLY DEVELOPED PAIN AND CHRONIC BOILS AND THE SURGEON SUSPECTED INFECTION. THE SURGEON REOPERATED ON ONE SIDE OF THE C-SECTION INCISION AND FOUND THAT BITS OF MESH WERE STILL PRESENT. THE BITS OF MESH WERE SENT FOR LAB TESTING WHICH SHOWED INFLAMMATORY MARKERS BUT NO SIGN OF INFECTION. SURGEON IS WAITING TO SEE WHETHER THE REOPERATION RESOLVES SYMPTOMS BEFORE ADDRESSING THE OTHER SIDE.

Additional Manufacturer Narrative

AS REPORTED, THE PATIENT EXPERIENCED PAIN AND INFLAMMATION TWO YEARS POST IMPLANT OF PHASIX MESH. PER THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE, "ABSORPTION OF THE MESH MATERIAL WILL BE ESSENTIALLY COMPLETE WITHIN 12 TO 18 MONTHS." BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE ISSUES EXPERIENCED BY THE PATIENT TWO YEARS POST IMPLANT. THE SURGEON IS CONTINUING TO MONITOR THE PATIENT, SHOULD ADDITIONAL INFORMATION BE PROVIDED A SEMDR WILL BE SUBMITTED. A LOT NUMBER WAS NOT PROVIDED, AS SUCH A REVIEW OF THE MANUFACTURING RECORDS CANNOT BE CONDUCTED. ADDENDUM 1: H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT THE DATE OF EVENT. AS REPORTED, THE TREATING SURGEON COULD NOT DETERMINE THE ROOT CAUSE OF THE INFLAMMATORY RESPONSE. BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE ISSUES EXPERIENCED BY THE PATIENT. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO THE SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF 111 UNITS RELEASED FOR DISTRIBUTION. UPDATED FIELDS: A2, B4, B6, D4 (PRODUCT CATALOG NO., CORPORATE LOT NO., UDI NO., EXPIRY DATE), D.6A, D.6B, G3, G6, H2, H4, H6, H10, H11 CORRECTED FIELD: B3 (DATE OF EVENT) ADDENDUM 2: H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO CORRECT THE PMA/510(K). PAIN AND INFLAMMATION ARE LISTED AS THE POSSIBLE COMPLICATIONS IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE, PROVIDED WITH THE DEVICE. UPDATED FIELDS: B4, G3, G6, H2, H10, H11. CORRECTED FIELD: G4 (PMA/510(K)) 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

AS REPORTED, THE PATIENT WAS IMPLANTED WITH PHASIX MESH TWO YEARS AGO AS AN ONLAY DURING A DIASTASIS RECTI REPAIR. THE PATIENT RECENTLY DEVELOPED PAIN AND CHRONIC BOILS, AND THE SURGEON SUSPECTED INFECTION. THE SURGEON REOPERATED ON ONE SIDE OF THE C-SECTION INCISION AND FOUND THAT BITS OF MESH WERE STILL PRESENT. THE BITS OF MESH WERE SENT FOR LAB TESTING WHICH SHOWED INFLAMMATORY MARKERS BUT NO SIGN OF INFECTION. SURGEON IS WAITING TO SEE WHETHER THE REOPERATION RESOLVES SYMPTOMS BEFORE ADDRESSING THE OTHER SIDE. ADDENDUM: DATE OF IMPLANT WAS (B)(6) 2023, DATE OF REVISION SURGERY WAS (B)(6) 2025. SURGEON STATES, "THE PATIENT IS OTHERWISE HEALTHY, MILD OBESITY. NO REASONS WHY THIS WOULD NOT HAVE DISSOLVED AND WOULD HAVE CREATED THIS TYPE OF INFLAMMATORY RESPONSE."

Additional Manufacturer Narrative

AS REPORTED, THE PATIENT EXPERIENCED PAIN AND INFLAMMATION TWO YEARS POST IMPLANT OF PHASIX MESH. PER THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE, "ABSORPTION OF THE MESH MATERIAL WILL BE ESSENTIALLY COMPLETE WITHIN 12 TO 18 MONTHS." BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE ISSUES EXPERIENCED BY THE PATIENT TWO YEARS POST IMPLANT. THE SURGEON IS CONTINUING TO MONITOR THE PATIENT, SHOULD ADDITIONAL INFORMATION BE PROVIDED A SEMDR WILL BE SUBMITTED. A LOT NUMBER WAS NOT PROVIDED, AS SUCH A REVIEW OF THE MANUFACTURING RECORDS CANNOT BE CONDUCTED. ADDENDUM: H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT THE DATE OF EVENT. AS REPORTED, THE TREATING SURGEON COULD NOT DETERMINE THE ROOT CAUSE OF THE INFLAMMATORY RESPONSE. BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE IMPLANT MAY HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE ISSUES EXPERIENCED BY THE PATIENT. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO THE SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF 111 UNITS RELEASED FOR DISTRIBUTION. UPDATED FIELDS: A2, B4, B6, D4 (PRODUCT CATALOG NO., CORPORATE LOT NO., UDI NO., EXPIRY DATE), D.6A, D.6B, G3, G6, H2, H4, H6, H10, H11. CORRECTED FIELD: B3 (DATE OF EVENT). 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

AS REPORTED, THE PATIENT WAS IMPLANTED WITH PHASIX MESH TWO YEARS AGO AS AN ONLAY DURING A DIASTASIS RECTI REPAIR. THE PATIENT RECENTLY DEVELOPED PAIN AND CHRONIC BOILS, AND THE SURGEON SUSPECTED INFECTION. THE SURGEON REOPERATED ON ONE SIDE OF THE C-SECTION INCISION AND FOUND THAT BITS OF MESH WERE STILL PRESENT. THE BITS OF MESH WERE SENT FOR LAB TESTING WHICH SHOWED INFLAMMATORY MARKERS BUT NO SIGN OF INFECTION. SURGEON IS WAITING TO SEE WHETHER THE REOPERATION RESOLVES SYMPTOMS BEFORE ADDRESSING THE OTHER SIDE. ADDENDUM: DATE OF IMPLANT WAS (B)(6) 2023, DATE OF REVISION SURGERY WAS (B)(6) 2025. SURGEON STATES, "THE PATIENT IS OTHERWISE HEALTHY, MILD OBESITY. NO REASONS WHY THIS WOULD NOT HAVE DISSOLVED AND WOULD HAVE CREATED THIS TYPE OF INFLAMMATORY RESPONSE."