GALAFLEX

Additional Manufacturer Narrative

AS REPORTED, OF 357 BREAST CANCER PATIENTS TREATED WITH P4HB, 5 PATIENTS EXPERIENCED BREAST CANCER RECURRENCE. THE INFORMATION IS LIMITED AND CANNOT BE FOLLOWED UP ON AS NO CASE SPECIFIC INFORMATION CAN BE OBTAINED. BASED ON THE INFORMATION AVAILABLE, NO CONCLUSION CAN BE MADE. IN AN ABUNDANCE OF CAUTION, EVENTS FOR WHICH RELATEDNESS CANNOT BE COMPLETELY RULED OUT ARE PROCESSED FOR MDR REPORTING. THE ACTUAL DEVICE USED TO TREAT THE PATIENT IS UNKNOWN, THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (28-JAN-2025) IS CONSIDERED TO BE A BEST ESTIMATE. THIS MDR REPRESENTS THE PATIENT/CASE #1. ADDITIONAL MDRS WERE SUBMITTED TO REPRESENT THE PATIENT/CASE #2, #3, #4 AND #5. 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

VICE PRESIDENT, MEDICAL AFFAIRS OBTAINED DEIDENTIFIED DATA ON USE OF P4HB IN BREAST RECONSTRUCTION. THE INFORMATION IS LIMITED AND CANNOT BE FOLLOWED UP ON AS NO CASE SPECIFIC INFORMATION CAN BE OBTAINED. DATA NOTES OF 357 BREAST CANCER PATIENTS TREATED WITH P4HB, 5 PATIENTS EXPERIENCED BREAST CANCER RECURRENCE.