GalaFlex Lite

Additional Manufacturer Narrative

NO CONCLUSIONS CAN BE MADE. THE PATIENT'S ATTORNEY ALLEGES THAT THE PATIENT HAD PAIN IN THE IMPLANT SITE ASSOCIATED WITH THE HERNIA MESH USED TO TREAT THE PATIENT. THE PATIENT'S ATTORNEY ALLEGES THAT THE PATIENT HAD ADDITIONAL SURGICAL INTERVENTION TO REMOVE THE GLAFLEX LITE IMPLANT; HOWEVER, NO DETAILS HAVE BEEN PROVIDED. A REVIEW OF MANUFACTURING RECORDS WAS CONDUCTED AND SHOWS THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. NOTE, THE DATE OF EVENT (15-JAN-2026) IS CONSIDERED TO BE THE BEST ESTIMATE. 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 AND REVISION PROCEDURE ON (B)(6) 2024, DURING WHICH A GALAFLEX LITE WAS IMPLANTED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AT THE IMPLANTATION SITE, AND AROUND (B)(6) 2026, THE PATIENT REQUIRED AN ADDITIONAL SURGICAL PROCEDURE TO SURGICALLY EXCISE THE GALAFLEX LITE. 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.