GALAFLEX 3DR

Description of Event or Problem

PER INFORMATION PROVIDED: ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT BREAST AUGMENTATION REVISION SURGERY ON (B)(6) 2025, DURING WHICH A GALAFLEX 3DR MESH WAS IMPLANTED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AT THE IMPLANTATION SITE AND ON (B)(6) 2025, THE PATIENT UNDERWENT AN ADDITIONAL SURGICAL PROCEDURE TO REMOVE THE IMPLANTED MESH. AS ALLEGED, THE PATIENT EXPERIENCED ADDITIONAL 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.

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 3DR IMPLANT USED TO TREAT THE PATIENT. THE PATIENT'S ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION TO REMOVE THE IMPLANTED GLAFLEX 3DR; HOWEVER, NO DETAILS HAVE BEEN PROVIDED. A REVIEW OF MANUFACTURING RECORDS CONFIRMS 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.