GalaFlex 3D

Additional Manufacturer Narrative

NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES THE PATIENT HAD PAIN IN THE IMPLANT SITE ASSOCIATED WITH THE GALAFLEX 3D MESH USED TO TREAT THE PATIENT. THE PATIENT'S ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION TO REMOVE THE IMPLANTED GALAFLEX 3D; HOWEVER, NO DETAILS HAVE BEEN PROVIDED. REVIEW OF MANUFACTURING RECORDS CONFIRMS THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. THIS EMDR REPRESENTS THE GALAFLEX 3D (DEVICE 2). AN ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE GALAFLEX 3D (DEVICE 1). 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 SURGERY ON (B)(6) 2022, DURING WHICH A GALAFLEX 3D MESH WAS IMPLANTED. ADDITIONALLY, ON (B)(6) 2023, PLAINTIFF UNDERWENT BREAST REVISION SURGERY AND IMPLANTED GALAFLEX 3D. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AT THE IMPLANTATION SITE AND ON (B)(6) 2024, THE GALAFLEX MESH WAS SURGICALLY EXCISED DUE TO THE REPORTED PAIN. 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.