GALAFLEX 3DR

Additional Manufacturer Narrative

NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES PAIN AND INJURY ASSOCIATED WITH THE GALAFLEX 3DR USED TO TREAT THE PATIENT. THE PATIENT'S ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DURING WHICH THE GALAFLEX 3DR IMPLANT WAS REMOVED; HOWEVER, NO DETAILS HAVE BEEN PROVIDED. A REVIEW OF MANUFACTURING RECORDS WAS CONDUCTED AND SHOWS THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. 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.

Description of Event or Problem

PER INFORMATION PROVIDED: ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION SURGERY ON (B)(6) 2021, DURING WHICH A GALAFLEX 3DR WAS IMPLANTED. ON (B)(6) 2026, THE GALAFLEX MESH WAS SURGICALLY EXCISED DUE TO THE REPORTED PAIN AND INJURY. PATIENT WAS INJURED SEVERELY AND PERMANENTLY. AS ALLEGED, THE PATIENT EXPERIENCED SURGICAL INTERVENTION, MENTAL ANGUISH AND 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.