GALAFLEX 3DR

Additional Manufacturer Narrative

AS REPORTED, POST IMPLANT OF GALAFLEX 3DR THE PATIENT HAD EXPERIENCED CONSTANT PAIN, DISCOMFORT, PINCHING SENSATION AND ALSO AND FELT LIKE THE GALAFLEX IMPLANT WAS FOLDED. THE TREATING PHYSICIAN STATED, "ITS "NORMAL" AND REFUSES TO TAKE IT OUT AND HAS TOLD THE PATIENT TO WAIT FOR IT TO ABSORB." BASED ON THE INFORMATION PROVIDED, THE DEGREE TO WHICH THE GALAFLEX 3DR IMPLANT USED MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S POSTOPERATIVE COURSE IS UNKNOWN. THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE IDENTIFIES PAIN AS A POSSIBLE COMPLICATION. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. 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

AS REPORTED, DURING A BILATERAL BREAST REDUCTION SURGERY THE PATIENT WAS IMPLANTED WITH GALAFLEX 3DR ON (B)(6) 2024. REPORTEDLY, POST ONE (1) WEEK OF IMPLANTATION, THE PATIENT REPORTED PAIN AND PINCHING SENSATION AND FELT LIKE THE GALAFLEX WAS FOLDED OVER. THE PATIENT HAS BEEN EXPERIENCING CONSTANT PAIN ON THE LEFT BREAST WITH POSITIONING SINCE IMPLANT, ALSO REPORTED IT ALMOST FEELS LIKE THE GALAFLEX IS PINCHING A NERVE. AS REPORTED THE RIGHT BREAST IS NOT AS PAINFUL BUT DOES ACHE FROM TIME TO TIME AND THE OUTLINE OF THE GALAFLEX CAN BE FELT. THE TREATING PHYSICIAN STATED, "ITS "NORMAL" AND REFUSES TO TAKE IT OUT AND HAS TOLD THE PATIENT TO WAIT FOR IT TO ABSORB." THE PATIENT IS HAVING A BREAST MRI ON (B)(6) 2026 FOR ROUTINE BREAST CANCER SCREENING.