GALAFLEX 3DR

Description of Event or Problem

AS REPORTED, DURING BILATERAL BREAST REVISION AUGMENTATION SURGERY, THE PATIENT WAS IMPLANTED WITH 775 IMPLANTS AND GALAFLEX 3DR (DEVICE #1 & #2) FOR SOFT TISSUE SUPPORT ON (B)(6) 2022. IT WAS REPORTED THAT SURGEON CONFIRMS THAT THERE WAS MESH LUMPS ON BOTH SIDES. THE GALAFLEX WAS NOT SUTURED IN PLACE. THE PATIENT HAS ¿BOTTOMED OUT ¿ AND CAN STILL FEEL THE GALAFLEX "VERY EASILY.¿ IT WAS REPORTED THAT THE PATIENT AND THE SURGEON ARE CONCERNED THAT THE PRODUCT DID NOT INTEGRATE AS EXPECTED AND PLANS TO REMOVE THE MESHES SOON.

Additional Manufacturer Narrative

AS REPORTED, PATIENT HAD BOTH BREASTS "BOTTOMING OUT AND CAN FEEL THE GALAFLEX 3DR MESH VERY EASILY". BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE AS TO WHAT IF ANY EXTENT THE MESH CAUSED OR CONTRIBUTE TO THE PATIENTS POST OPERATIVE COURSE. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF 524 UNITS RELEASED FOR DISTRIBUTION IN MAY 2022. PRE-CLINICAL IMPLANTATION STUDIES INDICATE THAT GALAFLEX 3DR SCAFFOLD RETAINS APPROXIMATELY 70% OF ITS STRENGTH AT 12 WEEKS. BIORESORPTION OF THE SCAFFOLD MATERIAL WILL BE ESSENTIALLY COMPLETE WITHIN 18-24 MONTHS. THE OUTER RIM MAY BE PALPABLE THROUGHOUT THE EXPECTED PERIOD OF HEALING. NOTE, THE DATE OF EVENT (B)(6) 2024 IS CONSIDERED TO BE A BEST ESTIMATE BASED. THIS MDR REPRESENTS GALAFLEX 3DR (DEVICE #2). ANOTHER MDR IS SUBMITTED TO REPRESENT GALAFLEX 3DR (DEVICE #1). 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.

Additional Manufacturer Narrative

AS REPORTED, PATIENT HAD BOTH BREASTS "BOTTOMING OUT AND CAN FEEL THE GALAFLEX 3DR MESH VERY EASILY". BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE AS TO WHAT IF ANY EXTENT THE MESH CAUSED OR CONTRIBUTE TO THE PATIENTS POST OPERATIVE COURSE. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF 524 UNITS RELEASED FOR DISTRIBUTION IN MAY 2022. PRE-CLINICAL IMPLANTATION STUDIES INDICATE THAT GALAFLEX 3DR SCAFFOLD RETAINS APPROXIMATELY 70% OF ITS STRENGTH AT 12 WEEKS. BIORESORPTION OF THE SCAFFOLD MATERIAL WILL BE ESSENTIALLY COMPLETE WITHIN 18-24 MONTHS. THE OUTER RIM MAY BE PALPABLE THROUGHOUT THE EXPECTED PERIOD OF HEALING. ADDENDUM: H11: THIS SUPPLEMENTAL MDR IS SUBMITTED TO DOCUMENT THE ADDITIONAL INFORMATION RECEIVED. UPDATED FIELDS: B4, B5, D4 (UNIQUE IDENTIFIER (UDI)), D6.B (MEDICAL DEVICE EXPLANT DATE), G3, G6, H2, H6, H10, H11. CORRECTED FIELD: B3 (DATE OF EVENT). THIS SUPPLEMENTAL MDR REPRESENTS GALAFLEX 3DR (DEVICE #2). AN ANOTHER SUPPLEMENTAL MDR IS SUBMITTED TO REPRESENT GALAFLEX 3DR (DEVICE #1). 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, DURING BILATERAL BREAST REVISION AUGMENTATION SURGERY, THE PATIENT WAS IMPLANTED WITH 775 IMPLANTS AND GALAFLEX 3DR (DEVICE #1 & #2) FOR SOFT TISSUE SUPPORT ON (B)(6) 2022. IT WAS REPORTED THAT SURGEON CONFIRMS THAT THERE WAS MESH LUMPS ON BOTH SIDES. THE GALAFLEX WAS NOT SUTURED IN PLACE. THE PATIENT HAS ¿BOTTOMED OUT ¿ AND CAN STILL FEEL THE GALAFLEX "VERY EASILY.¿ IT WAS REPORTED THAT THE PATIENT AND THE SURGEON ARE CONCERNED THAT THE PRODUCT DID NOT INTEGRATE AS EXPECTED AND PLANS TO REMOVE THE MESHES SOON. ADDENDUM: AS REPORTED, PATIENT HAD SURGERY ON (B)(6) 2025 TO REMOVE THE GALAFLEX 3DR (DEVICE #1 & #2) AND THE PRODUCT DIDN'T DISSOLVE.