GALAFLEX 3DR

Additional Manufacturer Narrative

AS REPORTED, PATIENT EXPERIENCED MIGRATION OF MESH AND SAGGING OF RIGHT BREAST, POST IMPLANT OF GALAFLEX. BASED ON THE INFORMATION AVAILABLE, NO CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE COMPLICATION. MIGRATION IS A KNOWN INHERENT RISK OF THE SURGERY/USE OF THE DEVICE AND INCLUDED AS A POSSIBLE COMPLICATION IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THE DEVICE. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (04-NOV-2025) IS CONSIDERED TO BE THE BEST ESTIMATE BASED ON THE DATE OF AWARENESS. ADDENDUM: H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT THE PRODUCT IDENTIFIERS. ` A REVIEW OF MANUFACTURING RECORDS WAS CONDUCTED AND SHOWS THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF 283 UNITS. UPDATED FIELDS: B4, D4 (PRODUCT CATALOG NO., CORPORATE LOT NO., UDI NO., EXPIRY DATE, MEDICAL DEVICE MODEL), G3, G6, H2, H4, H6, H10, H11 CORRECTED FIELDS: D1 (BRAND NAME), 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, PATIENT UNDERWENT A BREAST REPAIR PROCEDURE WITH GALAFLEX IMPLANT ON (B)(6) 2025. IT WAS REPORTED THAT THE PATIENT FELT THE MESH WAS POSITIONED DIFFERENTLY ON EACH SIDE. PLACEMENT ON THE RIGHT WAS FELT TO BE POSITIONED MORE BELOW THE BREAST, IN CONTRAST TO THE LEFT, WHERE IT WAS ALONG THE SIDE. THE RIGHT SIDE IS REPORTED TO BE SAGGING SIGNIFICANTLY. PER THE PATIENT "I AM DEFINITELY NOT HAPPY WITH THE LOOK, AND THE REASON I GOT THE MESH WAS SO THAT THEY WOULDN¿T SAG¿AT LEAST NOT SO QUICKLY. THESE ARE ONLY 7 MONTHS OLD. THE MESH ON THE LEFT COMES MORE UP THE SIDE, BUT THE MESH ON THE RIGHT IS MORE UNDER THE BREAST SO THE RIGHT BREAST IS FALLING TO THE SIDE AND DOWN."

Description of Event or Problem

AS REPORTED, PATIENT UNDERWENT A BREAST REPAIR PROCEDURE WITH GALAFLEX IMPLANT ON (B)(6) 2025. IT WAS REPORTED THAT THE PATIENT FELT THE MESH WAS POSITIONED DIFFERENTLY ON EACH SIDE. PLACEMENT ON THE RIGHT WAS FELT TO BE POSITIONED MORE BELOW THE BREAST, IN CONTRAST TO THE LEFT, WHERE IT WAS ALONG THE SIDE. THE RIGHT SIDE IS REPORTED TO BE SAGGING SIGNIFICANTLY. PER THE PATIENT "I AM DEFINITELY NOT HAPPY WITH THE LOOK, AND THE REASON I GOT THE MESH WAS SO THAT THEY WOULDN¿T SAG¿AT LEAST NOT SO QUICKLY. THESE ARE ONLY 7 MONTHS OLD. THE MESH ON THE LEFT COMES MORE UP THE SIDE, BUT THE MESH ON THE RIGHT IS MORE UNDER THE BREAST SO THE RIGHT BREAST IS FALLING TO THE SIDE AND DOWN."

Additional Manufacturer Narrative

AS REPORTED, PATIENT EXPERIENCED MIGRATION OF MESH AND SAGGING OF RIGHT BREAST, POST IMPLANT OF GALAFLEX. BASED ON THE INFORMATION AVAILABLE, NO CONCLUSIONS CAN BE MADE AS TO THE DEGREE TO WHICH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE COMPLICATION. MIGRATION IS A KNOWN INHERENT RISK OF THE SURGERY/USE OF THE DEVICE AND INCLUDED AS A POSSIBLE COMPLICATION IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THE DEVICE. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (04-NOV-2025) IS CONSIDERED TO BE THE 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.