GalaFlex 3D

Description of Event or Problem

ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE ON (B)(6) 2022, DURING WHICH A GALAFLEX MESH WAS IMPLANTED. IN (B)(6) 2023, THE MESH BECAME EXPOSED. SUBSEQUENTLY, ON OR ABOUT (B)(6) 2023, THE PATIENT REQUIRED AN ADDITIONAL SURGICAL INTERVENTION DUE TO PAIN AT THE IMPLANT SITE, DURING WHICH THE GALAFLEX MESH WAS REMOVED. AS ALLEGED, THE PATIENT EXPERIENCED ADDITIONAL SURGICAL INTERVENTION, MENTAL ANGUISH AND CHRONIC PAIN. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE DEVICE WAS DEFECTIVE.

Additional Manufacturer Narrative

NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES ADVERSE PATIENT OUTCOME ASSOCIATED WITH THE HERNIA MESH USED TO TREAT THE PATIENT. THE PATIENT'S ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION; HOWEVER, NO DETAILS HAVE BEEN PROVIDED. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (30-APR-2026) IS CONSIDERED TO BE THE BEST ESTIMATE BASED ON THE DATE OF AWARENESS. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED. 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.