GALAFLEX 3D

Additional Manufacturer Narrative

AS REPORTED 9 MONTHS AFTER UNDERGOING REVISION OF THE RIGHT INFRAMAMMARY FOLD WITH INSERTION OF GALAFLEX 3D THE MESH HAD DEHISCED FROM THE PECTORALIS MUSCLE AND HAD NOT INCORPORATED INTO THE PATIENT'S TISSUES. BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE AS TO WHY THE MESH MIGRATED FROM THE MUSCLE AND DID NOT INCORPORATE INTO THE TISSUE 9 MONTHS POST OP. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT IS CONSIDERED TO BE A BEST ESTIMATE AS 25-MAR-2026 BASED ON THE DATE OF AWARENESS. THE INSTRUCTION FOR USE (IFU) STATES THAT, "P4HB BIORESORBS THROUGH A PROCESS OF HYDROLYSIS AND HYDROLYTIC ENZYMATIC DIGESTION. BIORESORPTION OF THE SCAFFOLD MATERIAL WILL BE ESSENTIALLY COMPLETE WITHIN 18-24 MONTHS." 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 REVISION SURGERY OF THE RIGHT INFRAMAMMARY FOLD WITH THE IMPLANT OF GALAFLEX 3D. AFTER 9 MONTHS, PATIENT NEEDED BREAST SURGERY. DURING THE LAST PROCEDURE, THE GALAFLEX 3D HAD DEHISCED FROM THE PECTORALIS MUSCLE AND HAD NOT INCORPORATED INTO THE PATIENT'S TISSUES.